chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache
Clinical narrative: fatigue; dizziness; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (The patient received the Pfizer vaccine for her primary vaccination series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Nov-2021, the patient experienced FATIGUE (fatigue), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache) had resolved.            No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site swelling
Clinical narrative: had very bad reaction for those two injection/had a very bad reaction; for three days they have swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling). At the time of the report, VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  It was reported that the patient had two shots of the Moderna COVID 19 vaccines and had very bad reaction for those two injection and wants to take the booster on the hip or somewhere else on that is not the arm, because they had a very bad reaction, for three days they had swelling and was very concern but it went away. Treatment information was not provided.   This case was linked to MOD-2022-528838 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: someone in the family had quite reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (someone in the family had quite reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (someone in the family had quite reaction). At the time of the report, VACCINATION COMPLICATION (someone in the family had quite reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant and treatment medications were reported.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received a full 3rd dose despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full 3rd dose despite not being immunocompromised) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ACCIDENTAL OVERDOSE (Received a full 3rd dose despite not being immunocompromised). At the time of the report, ACCIDENTAL OVERDOSE (Received a full 3rd dose despite not being immunocompromised) outcome was unknown.            No concomitant medications were reported. It was reported that patient received a full third dose despite not being immunocompromised. No treatment details were reported.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 045J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.   On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of accidental overdose (received a full 100mcg dose for her first booster dose) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 039K202A) for COVID-19  immunization. No medical history reported. On Jan 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 100 microgram. On an unknown date, patient experienced accidental overdose (received a full 100mcg dose for her first booster dose). At the time of the report, accidental overdose (received a full 100mcg dose for her first booster dose) outcome: unknown. Patient not immunocompromised. No concomitant medication or treatment information reported. This case linked to MOD-2022-529115 (patient link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose - 25 Jan 2021, 2nd dose - 04 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25 Jan 2021, 2nd dose - 04 Mar 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency, Leukemia and Blood pressure high. Concomitant products included VALSARTAN, AMLODIPINE and HYDRALAZINE HCL for Blood pressure high.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25 Jan 2021, 2nd dose - 04 Mar 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25 Jan 2021, 2nd dose - 04 Mar 2021) outcome was unknown.            Patient height was reported as 5 feet and 9 inches.  Patient does not had any allergies and not had any Covid-19 diagnosis prior to or after getting the vaccine. . No treatment medications were provided.   This case was linked to MOD-2022-529246 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (Vomited after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomited after 2nd dose). At the time of the report, VOMITING (Vomited after 2nd dose) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-529319, MOD-2022-528692 (Patient Link).   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Tongue discomfort, Tongue eruption, Tongue pruritus
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of CANDIDA INFECTION (the reaction "looks like thrush"/reaction in her mouth like thrush), TONGUE ERUPTION (rash on tongue), TONGUE DISCOMFORT (tongue burning) and TONGUE PRURITUS (Tongue is itching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 048F21A) for COVID-19 vaccination. The patient's past medical history included Oral surgery. Concurrent medical conditions included Allergy to antibiotic and Thrush (The reaction had happened in the past with antibiotics.). On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced CANDIDA INFECTION (the reaction "looks like thrush"/reaction in her mouth like thrush), TONGUE ERUPTION (rash on tongue), TONGUE DISCOMFORT (tongue burning) and TONGUE PRURITUS (Tongue is itching). The patient was treated with BAPTISIA TINCTORIA, BENZOIC ACID, BORIC ACID, CINEOLE, ETHANOL, MENTHOL, METHYL SALICYLATE, THYMOL (LISTERINE [BAPTISIA TINCTORIA;BENZOIC ACID;BORIC ACID;CINEOLE;ETHANOL;MENTHOL;METHYL SALICYLATE;THYMOL]) at an unspecified dose and frequency. At the time of the report, CANDIDA INFECTION (the reaction "looks like thrush"/reaction in her mouth like thrush) had not resolved and TONGUE ERUPTION (rash on tongue), TONGUE DISCOMFORT (tongue burning) and TONGUE PRURITUS (Tongue is itching) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was a retired physician. The patient never had COVID positive test or diagnosis. The patient received unspecified antibiotics that were given within 1 month prior to Moderna COVID-19 vaccine. The patient received both the doses on left arm non-dominant. The patient had mouth burning sensation and tongue became yellow and white in color. The patient reported that she "drove dentist crazy" with questions. As per the patient, she took numerous amounts of medicine and not sure what to rule out. It went away only by using Listerine constantly. The patient went to see the oral specialist and several other doctors, but they cannot figure it out. The patient had 9 teeth pulled and now was going through recovery with tongue. Also, the patient would go for oral surgery again, so would like to figure out what it was.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication ("second shot put me down for two weeks") and inappropriate schedule of product administration (more than 35 days between first and second shot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 001C21A and 016B21A) for COVID-19  immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 10, 2021, patient received second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 10, 2021, patient experienced inappropriate schedule of product administration (more than 35 days between first and second shot). On an unknown date, patient experienced vaccination complication ("second shot put me down for two weeks").  At the time of the report, vaccination complication ("second shot put me down for two weeks") resolved and inappropriate schedule of product administration (more than 35 days between first and second shot) outcome: unknown. No concomitant medication or treatment information reported. The patient received the first and second shot. He stated the second shot put him down for two weeks. The patient was worried about getting the booster shot. Most recent follow-up information incorporated: On Mar 31, 2022: Follow-up received contained no new information.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (sick/"vaccine made me very sick") and feeling abnormal ("thought I was getting ready to die") in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (sick/"vaccine made me very sick") and feeling abnormal ("thought I was getting ready to die"). At the time of the report, illness (sick/"vaccine made me very sick") resolved and feeling abnormal ("thought I was getting ready to die") outcome: unknown.  No concomitant or treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (dose administrated after 24 hours punctured vial) and product storage error (vial stored for more than 24 hours after first puncture) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On Mar 30, 2022, at 1:48 pm, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. March 2022, patient experienced product storage error (vial stored for more than 24 hours after first puncture). On Mar 30, 2022, at 1:48 pm, patient experienced administered expired product (dose administrated after 24 hours punctured vial). At the time of the report, administered expired product (dose administrated after 24 hours punctured vial) and product storage error (vial stored for more than 24 hours after first puncture) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vial that was punctured March 29, 2022, at 1:39 pm, was administered on March 30, 2022 at 1:48 pm.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy, Maternal exposure during breast feeding, Pain in extremity
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), FEELING ABNORMAL (head fog), LETHARGY (lethargic) and PAIN IN EXTREMITY (sore arm) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Mar-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), FEELING ABNORMAL (head fog), LETHARGY (lethargic) and PAIN IN EXTREMITY (sore arm). On 30-Mar-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), FEELING ABNORMAL (head fog) and LETHARGY (lethargic) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. It was reported, patient had a child on 25-OCT-2021.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well). At the time of the report, ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) had not resolved and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well) outcome was unknown. mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged. Concomitant medications details were not reported by the reporter. It was reported that as per the medical history patient did check with her doctor first and the doctor felt that it was better to get the shot than not. Treatment details were not reported by the reporter. This case was linked to MOD-2022-529920, MOD-2022-529919 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well). At the time of the report, ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) had not resolved and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well) outcome was unknown. Not Provided. Concomitant medication was not reported. It was reported that as per the medical history patient did check with her doctor first and the doctor felt that it was better to get the shot than not. Treatment medication was not reported. This case was linked to MOD-2022-529920, MOD-2022-529893 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage, Wrong technique in product usage process
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program. A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown" and all described as "the vaccine was administered to the patient using the Z-track method and a bloody fluid sprayed out of the injection site at the removal of the needle"; UNDERDOSE (non-serious), outcome "unknown", described as "the person who administered it thought that the majority of the 0.2 ML got expelled". Additional information: Reporter stated, because she received a phone call from a parent whose child received the 5-11 (PEDS) pediatric vaccine. Reporter stated uncertain of the colour cap. She also mentioned that the vaccine was administered to the patient using the Z-track method and a bloody fluid sprayed out of the injection site at the removal of the needle and the person who administered it thought that the majority of the 0.2 ML got expelled and they recommended administering another dose right away based on the CDC's guidelines. Reporter wants to know if there's anything different that they would recommend. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (11Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: added the event "vaccination site haemorrhage" to the reported verbatim "the vaccine was administered to the patient using the Z-track method and a bloody fluid sprayed out of the injection site at the removal of the needle" and removed Classification of At risk.
Age: 47.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Alopecia, Anger, Blood urine present, Diarrhoea, Dizziness
Clinical narrative: major head aches, vomiting, ringing in my ears, hair loss, still neck, numbness in my legs and hands, urinating blood, diaheria, crawling sensation in my head,  sore throat, swollen lymph in arm pits and inner thighs, gray spots in eyes, extreme head ache, slurred speech, seizures, bad foggy thinking, memory issues, crawling in my head, insomnia, dizziness, feeling of crawling in my armpits and head, liver pain, parasites, heart palpitation, muscle twitching, painful feel and legs, PTSD, fearful, anger.  Alternative treatments
Age: 47.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Dysarthria, Fear, Feeling abnormal, Formication, Headache
Clinical narrative: major head aches, vomiting, ringing in my ears, hair loss, still neck, numbness in my legs and hands, urinating blood, diaheria, crawling sensation in my head,  sore throat, swollen lymph in arm pits and inner thighs, gray spots in eyes, extreme head ache, slurred speech, seizures, bad foggy thinking, memory issues, crawling in my head, insomnia, dizziness, feeling of crawling in my armpits and head, liver pain, parasites, heart palpitation, muscle twitching, painful feel and legs, PTSD, fearful, anger.  Alternative treatments
Age: 47.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Hepatic pain, Hypoaesthesia, Infection parasitic, Insomnia, Lymphadenopathy
Clinical narrative: major head aches, vomiting, ringing in my ears, hair loss, still neck, numbness in my legs and hands, urinating blood, diaheria, crawling sensation in my head,  sore throat, swollen lymph in arm pits and inner thighs, gray spots in eyes, extreme head ache, slurred speech, seizures, bad foggy thinking, memory issues, crawling in my head, insomnia, dizziness, feeling of crawling in my armpits and head, liver pain, parasites, heart palpitation, muscle twitching, painful feel and legs, PTSD, fearful, anger.  Alternative treatments
Age: 47.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Memory impairment, Mental impairment, Muscle twitching, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: major head aches, vomiting, ringing in my ears, hair loss, still neck, numbness in my legs and hands, urinating blood, diaheria, crawling sensation in my head,  sore throat, swollen lymph in arm pits and inner thighs, gray spots in eyes, extreme head ache, slurred speech, seizures, bad foggy thinking, memory issues, crawling in my head, insomnia, dizziness, feeling of crawling in my armpits and head, liver pain, parasites, heart palpitation, muscle twitching, painful feel and legs, PTSD, fearful, anger.  Alternative treatments
Age: 47.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pain in extremity, Palpitations, Post-traumatic stress disorder, Seizure, Tinnitus
Clinical narrative: major head aches, vomiting, ringing in my ears, hair loss, still neck, numbness in my legs and hands, urinating blood, diaheria, crawling sensation in my head,  sore throat, swollen lymph in arm pits and inner thighs, gray spots in eyes, extreme head ache, slurred speech, seizures, bad foggy thinking, memory issues, crawling in my head, insomnia, dizziness, feeling of crawling in my armpits and head, liver pain, parasites, heart palpitation, muscle twitching, painful feel and legs, PTSD, fearful, anger.  Alternative treatments
Age: 47.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Vitreous floaters, Vomiting
Clinical narrative: major head aches, vomiting, ringing in my ears, hair loss, still neck, numbness in my legs and hands, urinating blood, diaheria, crawling sensation in my head,  sore throat, swollen lymph in arm pits and inner thighs, gray spots in eyes, extreme head ache, slurred speech, seizures, bad foggy thinking, memory issues, crawling in my head, insomnia, dizziness, feeling of crawling in my armpits and head, liver pain, parasites, heart palpitation, muscle twitching, painful feel and legs, PTSD, fearful, anger.  Alternative treatments
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Uveitis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: UVEITIS (medically significant), outcome "unknown", described as "severe case of Uveitis after booster"; PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations after booster". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pancreatitis
Clinical narrative: sick with pancreatitis; sick with pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination or not. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. The following information was reported: PANCREATITIS (medically significant), MALAISE (non-serious), outcome "not recovered" and all described as "sick with pancreatitis". The event "sick with pancreatitis" was evaluated at the physician office visit. The physician told the patient that this were one of the side effects of the vaccine. Therapeutic measures were taken as a result of pancreatitis and malaise which included unspecified medications. It was unknown if the patient was tested for COVID-19 since the vaccination or not.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Motion sickness, Nausea, Vomiting
Clinical narrative: Her motion sickness (within normal was a rare event for her) has gotten worse since the 2nd dose; Her motion sickness (within normal was a rare event for her) has gotten worse since the 2nd dose; nausea; threw up 10 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Jan2022 10:00 (Lot number: FL0007) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Time: 1000, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Pfizer FK5618), administration date: 04Jan2022, when the patient was 6 years old, for COVID-19 immunization, reaction(s): "threw up once"; Bnt162b2 (DOSE 1, Time: 1000, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Pfizer FK5618), administration date: 04Jan2022, for COVID-19 immunization, reaction(s): "motion sickness". The following information was reported: NAUSEA (disability) with onset 26Jan2022, outcome "recovered with sequelae" (27Jan2022), described as "nausea"; VOMITING (disability) with onset 26Jan2022, outcome "recovered with sequelae" (27Jan2022), described as "threw up 10 times"; MOTION SICKNESS (disability), CONDITION AGGRAVATED (disability), outcome "unknown" and all described as "Her motion sickness (within normal was a rare event for her) has gotten worse since the 2nd dose". The events "nausea" and "threw up 10 times" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, vomiting. The clinical course was reported as follows: The reporter informed that after patient's first dose on 04Jan2022, she threw up once 2 minutes after the vaccine was administered. It was in the waiting room of the vaccine clinic. The patient (her daughter) received her second Pfizer dose at step pediatrics on 25Jan2022 around 10:00 AM. On 26Jan2022 around noon, she complained of nausea and threw up. For the next 12 hours, she threw up 10 times, she could not even keep water down. She was traumatized from her nausea and vomiting. On 27Jan2022, based on the pediatrician's advice, they gave her Zofran 4 mg orally at 11:00 am. She managed to keep liquids down after the Zofran. They gave her 2 doses of Zofran 4mg each on 27Jan2022. She started soft food diet on 28Jan2022. Her motion sickness (within normal was a rare event for her) has gotten worse since the second dose. The vaccine was administered in a doctor's office/urgent care and not at military facility. The patient had no prior vaccinations, no relevant family medical history, and no relevant tests. The reporter considered the BNT162B2 had a causal effect to the adverse events.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Investigation, Pain, SARS-CoV-2 test, Thyroid function test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 13:30 (Lot number: FF2589) as dose 3 (booster), single, administered in arm right, administration date 13Feb2021 11:30 (Lot number: EL9266) as dose 2, single and administered in arm right, administration date 23Jan2021 12:00 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergy: Parabens" (unspecified if ongoing); "known allergy: several antibiotics" (unspecified if ongoing); "known allergy: garlic/onions" (unspecified if ongoing); "known allergy: rosemary" (unspecified if ongoing); "known allergy: Nut" (unspecified if ongoing); "known allergy: Sulfa" (unspecified if ongoing); "known allergy: raisins" (unspecified if ongoing); "known allergy: citrus" (unspecified if ongoing). Concomitant medication(s) included: THYROID. Past drug history included: Tylenol, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Office visit too late to ID Covid as cause"; PAIN (non-serious) with onset 03Oct2021 08:00, outcome "recovering", described as "body ache". The event "body ache" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: (unspecified date) unknown results; sars-cov-2 test: (04Oct2021) negative, notes: Nasal Swab; thyroid function test: (unspecified date) abnormal thyroid results. Therapeutic measures were taken as a result of pain. Facility type vaccine reported as pharmacy or Drug Store. If other vaccine in four weeks reported as no and other medications in two weeks reported as thyroid. After the 2nd vaccination had marked shortness of breath, headache, tiredness & body ache. Office visit too late to ID Covid as cause and had abnormal thyroid results which complicated diagnosis. Symptoms almost gone Sep2021. After 3rd shot all symptoms immediately returned and have decreased as of now, but only the headache is totally gone. Employer required Covid testing every 2 weeks--routinely tested between mid Aug and Dec. 2021--all tests were negative. Reporter was very interested to know if there is a test for allergy to some or all components of the vaccine. Reporter don't want to go through the symptoms a 3rd time. A treatment reported as inhaler to help with shortness of breath. Covid prior vaccination reported as no. Treatment ae reported as yes. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 cannot be excluded. Linked Report(s): US-PFIZER INC-202200461578 similar report from same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 13:30 (Lot number: FF2589) as dose 3 (booster), single, administered in arm right, administration date 13Feb2021 11:30 (Lot number: EL9266) as dose 2, single and administered in arm right, administration date 23Jan2021 12:00 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergy: Parabens" (unspecified if ongoing); "known allergy: several antibiotics" (unspecified if ongoing); "known allergy: garlic/onions" (unspecified if ongoing); "known allergy: rosemary" (unspecified if ongoing); "known allergy: Nut" (unspecified if ongoing); "known allergy: Sulfa" (unspecified if ongoing); "known allergy: raisins" (unspecified if ongoing); "known allergy: citrus" (unspecified if ongoing). Concomitant medication(s) included: THYROID. Past drug history included: Tylenol, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Office visit too late to ID Covid as cause"; PAIN (non-serious) with onset 03Oct2021 08:00, outcome "recovering", described as "body ache". The event "body ache" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: (unspecified date) unknown results; sars-cov-2 test: (04Oct2021) negative, notes: Nasal Swab; thyroid function test: (unspecified date) abnormal thyroid results. Therapeutic measures were taken as a result of pain. Facility type vaccine reported as pharmacy or Drug Store. If other vaccine in four weeks reported as no and other medications in two weeks reported as thyroid. After the 2nd vaccination had marked shortness of breath, headache, tiredness & body ache. Office visit too late to ID Covid as cause and had abnormal thyroid results which complicated diagnosis. Symptoms almost gone Sep2021. After 3rd shot all symptoms immediately returned and have decreased as of now, but only the headache is totally gone. Employer required Covid testing every 2 weeks--routinely tested between mid Aug and Dec. 2021--all tests were negative. Reporter was very interested to know if there is a test for allergy to some or all components of the vaccine. Reporter don't want to go through the symptoms a 3rd time. A treatment reported as inhaler to help with shortness of breath. Covid prior vaccination reported as no. Treatment ae reported as yes. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 cannot be excluded. Linked Report(s): US-PFIZER INC-202200461578 similar report from same reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Pharmacist). An elderly male patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHYLPREDNISOLONE, start date: 16Mar2022, stop date: 18Mar2022; HYDROCHLOROTHIAZIDE; LISINOPRIL; DIVALPROEX. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 18Mar2022, outcome "unknown" and all described as "indication=Treatment of COVID-19 / acute COVID-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient was prescribed Paxlovid for acute COVID-19 infection and on day 2 of treatment began having multiple episodes of non-bloody, non-bilious vomiting. He was found to be hyponatremic secondary to vomiting, attributed to COVID-19 infection, as well as possibly Paxlovid, with other medications contributing to hyponatremia - chiefly methylprednisolone, hydrochlorothiazide and divalproex. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of Covid-19 and drug ineffective is: expected. The case will be reassessed further upon receipt of additional information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 (Lot number: FF2588) at the age of 76 years as dose 3, booster, administered in arm right, administration date 11Feb2021 (Lot number: EM9810) as dose 2, single and administered in arm right, administration date 19Jan2021 (Lot number: EL3247) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: Jan2018; NITROFURANTOIN MONO/MAC, start date: Mar2022, stop date: Mar2022; VITAMIN D3, start date: Oct2021; CRANBERRY, start date: Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "indication=Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "swelling of face, lips indication=Treatment of COVID-19". Anti-viral details: Product: Covid-19 treatment, Brand: Pfizer, Treatment start date: 22Mar2022, Treatment stop date: 23Mar2022, Lot Number: FX2741, Indication: Treatment of Covid-19, Adverse event: Allergic reaction (swelling of face, lips and hives on thighs and buttocks). Reaction happened immediately after evening dose on 1st day of treatment. No reaction to morning dose on 1st day. Adverse event country: Unknown, Adverse event start date: 22Mar2022, adverse event start time: 11:45PM, AE resulted in: Hospitalization, number days hospitalization: 1, If treatment AE: Yes, AE treatment: IV Benadryl in ambulance, Known allergies: No, medical history: None, Privacy policy consent: Yes. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID 19 after receiving the booster.; tested positive for COVID 19 after receiving the booster.; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID 19 after receiving the booster.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: She tested positive for COVID 19 after receiving the booster. Clinical Course: Patient received Pfizer BioNTech COVID 19 vaccine for her initial 2 doses as well as the booster. She tested positive for COVID 19 after receiving the booster. She said that her symptoms were similar to a cold. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID19 infection; Breakthrough COVID19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A child female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Dec2021, outcome "recovered", DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown" and all described as "Breakthrough COVID19 infection". It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine, unknown whether prior to vaccination, the patient was diagnosed with COVID-19 or unknown since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID-19 infection; Breakthrough COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A child female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "recovered" and all described as "Breakthrough COVID-19 infection". It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was unknown if COVID prior vaccination or tested post vaccination. Other vaccine in four weeks was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, Pneumonia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2), administration date 08Mar2022 (Lot number: FK9894) as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Heart Issue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacture: Unknown, Caller reports her husband has received all of the COVID-19 vaccines.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; PNEUMONIA (medically significant), outcome "unknown", described as "Pneumonia"; MALAISE (non-serious), outcome "unknown", described as "did not feel to good". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: he had COVID-19 as well. Clinical course: The reporter reports her husband has received all the COVID-19 vaccines which she and her husband received together, and he had COVID-19 as well. She reports that she received the COVID-19 vaccine booster dose on 08Mar2022. Caller states her husband is 6'2" and her husband is 2 of her. The reporter states her husband is bigger than herself. The reporter states her husband's heart issues was the whole reason behind getting the COVID-19 vaccines. Caller states all of this is trial and error and no one will know unless she calls. The reporter states her husband is like 3 years younger than her. The information regarding, Product strength, count size dispensed and sample of the product available to be returned is not applicable. If packaging sealed and intact is not provided on call. No follow-up attempts are possible. No further information is expected.