chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain that really hurt after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain that really hurt after first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer, Benign renal neoplasm (a benign mass on her left kidney), Stevens Johnson syndrome (after getting a facial after being in sun and also receiving radiation for breast cancer.), Radiation therapy and Chemotherapy (radiation and chemotherapy treatments for breast cancer 14 years ago.). Concurrent medical conditions included Immunocompromised (underlying autoimmune conditions and is considered immunocompromised due to a past medical history). Concomitant products included COLECALCIFEROL (VITAMIN D3) for Osteoporosis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ALPRAZOLAM, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), CLONAZEPAM (KLONOPIN), PITAVASTATIN CALCIUM (LIVALO), ZOLPIDEM TARTRATE (ZOLPIDEM [ZOLPIDEM TARTRATE]), DENOSUMAB (PROLIA), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC), AIRBORNE, FLUTICASONE PROPIONATE (ALLER FLO), DOXEPIN, CHONDROITIN SULFATE, GLUCOSAMINE (MOVE FREE [CHONDROITIN SULFATE; GLUCOSAMINE]), MULTIVITAMIN [VITAMINS NOS] and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain that really hurt after first dose). On 02-Feb-2021, PAIN IN EXTREMITY (arm pain that really hurt after first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.   Patient experienced arm pain that really hurt after receiving the vaccine; however, patient states she had "nothing" the next day.   Doses were administered in the patient's right upper arm, which is her dominant arm, due to lymphadenopathy in her left arm as a result of radiation and chemotherapy treatments for breast cancer 14 years ago.   This case was linked to MOD-2021-356901, MOD-2021-356902 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: one day of feeling crummy after second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (one day of feeling crummy after second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer, Benign renal neoplasm (a benign mass on her left kidney), Stevens Johnson syndrome (after getting a facial after being in sun and also receiving radiation for breast cancer.), Radiation therapy and Chemotherapy (radiation and chemotherapy treatments for breast cancer 14 years ago.). Concurrent medical conditions included Immunocompromised (underlying autoimmune conditions and is considered immunocompromised due to a past medical history). Concomitant products included COLECALCIFEROL (VITAMIN D3) for Osteoporosis, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC), AIRBORNE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE (ALLER FLO), ALPRAZOLAM, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), DOXEPIN, CLONAZEPAM (KLONOPIN), PITAVASTATIN CALCIUM (LIVALO), MULTIVITAMIN [VITAMINS NOS], ESTROGENS CONJUGATED (PREMARIN), ZOLPIDEM, DENOSUMAB (PROLIA) and CHONDROITIN SULFATE, GLUCOSAMINE (MOVE FREE [CHONDROITIN SULFATE;GLUCOSAMINE]) for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING ABNORMAL (one day of feeling crummy after second dose). On 02-Mar-2021, FEELING ABNORMAL (one day of feeling crummy after second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was provided.  Patient reports experiencing one day of "feeling crummy", but felt better the next day.  Doses were administered in the patient's right upper arm, which was her dominant arm, due to lymphadenopathy in her left arm as a result of radiation and chemotherapy treatments for breast cancer 14 years ago.   This case was linked to MOD-2021-356856, MOD-2021-356902.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: a couple of days later "hot"; red on the arm she got the shot; 10 days after she got a reaction on the arm she got the shot:sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she got a reaction 'red and sore' 10 days after getting the shot and a couple of days later, she reported it being 'hot'.  Patient was also treated with an unspecified antihistamine.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Muscular weakness, Pain in extremity
Clinical narrative: weakness in legs and upper body; Leg pain; Allergic reaction to vaccine; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs and upper body), PAIN IN EXTREMITY (Leg pain), ALLERGY TO VACCINE (Allergic reaction to vaccine) and ARTHRALGIA (Knee pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in legs and upper body), PAIN IN EXTREMITY (Leg pain), ALLERGY TO VACCINE (Allergic reaction to vaccine) and ARTHRALGIA (Knee pain). At the time of the report, MUSCULAR WEAKNESS (weakness in legs and upper body), PAIN IN EXTREMITY (Leg pain), ALLERGY TO VACCINE (Allergic reaction to vaccine) and ARTHRALGIA (Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.          No treatment information was provided
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: felt like her face was tight and swollen" at her jaw and underneath her eye; a rash in the back of her ear; This is a spontaneous report from a contactable consumer.   A 91-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 07Jul2021 (Batch/Lot number was not reported) (age at vaccination 91-year-old) as dose 2, single for covid-19 immunisation. The patient medical history included high blood pressure, heart attack and allergic to penicillin from an unknown date and unknown if ongoing. The patient is taking medications for heart attack. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unknown date as dose 1, single for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse events following prior vaccinations was reported as none. No family Medical History Relevant to adverse events and relevant tests was reported as none. On 19Jul2021 morning, the patient experienced felt like her face was tight and swollen" at her jaw and underneath her eye and a rash in the back of her ear. She has been putting ice on it. Treatment medications were reported as none. The adverse events did not resulted to visit emergency room or physician office. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Confusional state, Dizziness, Fatigue
Clinical narrative: Confused; Kind of dizzy; I dont have my balance; Really dont feel well enough to walk in to another room; Felt super super tired/Tired/really really tired; I got really sick/Feeling very very sick/I feel sick; Running a fever/still feel like I might have a low grade fever; Aching; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. On 21Jul2021, yesterday, patient got really sick/feeling very sick/i feel sick and had a running a fever/still feel like might have a low-grade fever, patient don't know exactly how high it was because the battery was dead in thermometer. But aching, chills, just really feeling very sick, so patient live alone and just basically felt super tired and went to bed, patient just got up a little while ago and patient still feel like patient might had a low-grade fever but like patient said the battery was dead, so patient cant check it to give you a number, so that part patient guess it's better. Okay the fever did go down, but patient still felt just out of it like super just confused and tired, really tired, kind of dizzy like patient didn't have balance and just felt sick. When patient was asked about immunisation card, patient stated don't feel well enough to walk into another room. Patient reported that the first vaccination didn't do this. At the time of this report, the outcome of event running a fever/still feel like i might have a low-grade fever was recovering and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Malaise, Pain, Pyrexia
Clinical narrative: Confused; Kind of dizzy; I dont have my balance; Really dont feel well enough to walk in to another room; Felt super super tired/Tired/really really tired; I got really sick/Feeling very very sick/I feel sick; Running a fever/still feel like I might have a low grade fever; Aching; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. On 21Jul2021, yesterday, patient got really sick/feeling very sick/i feel sick and had a running a fever/still feel like might have a low-grade fever, patient don't know exactly how high it was because the battery was dead in thermometer. But aching, chills, just really feeling very sick, so patient live alone and just basically felt super tired and went to bed, patient just got up a little while ago and patient still feel like patient might had a low-grade fever but like patient said the battery was dead, so patient cant check it to give you a number, so that part patient guess it's better. Okay the fever did go down, but patient still felt just out of it like super just confused and tired, really tired, kind of dizzy like patient didn't have balance and just felt sick. When patient was asked about immunisation card, patient stated don't feel well enough to walk into another room. Patient reported that the first vaccination didn't do this. At the time of this report, the outcome of event running a fever/still feel like i might have a low-grade fever was recovering and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Hypersensitivity
Clinical narrative: Bad allergic reaction through the Pfizer COVID-19 Vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization; acetylsalicylic acid (ASPIRIN (E.C.)), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypersensitivity- have allergies but haven't been tested in years. The patient's concomitant medications were not reported. The patient experienced bad allergic reaction through the pfizer covid-19 vaccine (hypersensitivity) on an unspecified date. She mentioned that she knows someone who have bad allergic reaction to Pfizer COVID-19 Vaccine. Limited information was available over the call. The action taken in response to the event(s) for acetylsalicylic acid was unknown. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Rash macular
Clinical narrative: rashes/blotches on skin; Hair loss; This is a spontaneous report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # (21K-163-4022416-00) via a contactable consumer (patient). A 14-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via intramuscular route, administered on 08Jun2021 (age at vaccination 14-year-old) as DOSE 2, SINGLE for COVID-19 immunization and adalimumab (HUMIRA 40mg/0.4ml (40 Milligram, Solution for injection in pre-filled pen) (ADALIMUMAB)) via subcutaneous route for Crohn's disease from 01Apr2021 and ongoing. The patient medical history included non-smoker and abstains from alcohol. The patient had no known allergies. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161, expiration date: Jul2021) via intramuscular route, administered on 15May2021 (age at vaccination 14-year-old), as single dose for COVID-19 immunization. On 21Jun2021, the patient experienced rashes/blotches on skin and hair loss. The patient underwent lab tests and procedures which included blood work on 21Jul2021: normal. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Condition aggravated, Headache, Memory impairment, Pain
Clinical narrative: fever and chills; Body aches; Forgetting stuff worsening; Forgetting stuff worsening; low Covid -19 antibody after receiving Covid-19 Vaccine; headache; fever and chills; This is a spontaneous report from a contactable consumer or other non hcp (patient) and Other HCP. A 48-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation; teriflunomide (AUBAGIO), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for multiple sclerosis. Medical history included ongoing allergies (hypersensitivity), ongoing GERD (Gastro oesophageal reflux disease), ongoing covid-19 pneumonia, ongoing jc virus infection, ongoing multiple sclerosis, ongoing migraine, ongoing nerve pain. Concomitant medications included gabapentin (GABAPENTIN); omeprazole (PROTONIX [OMEPRAZOLE]); azelastine (AZELASTINE); mometasone furoate (FLONASE [MOMETASONE FUROATE]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. On 18Mar2021 the patient experienced fever and chills, body aches, forgetting stuff worsening, condition aggravated, low covid -19 antibody after receiving covid-19 vaccine, headache. Following the first dose intake of Teriflunomide and bnt162b2. It was not reported if the patient received a corrective treatment for the adverse events. The action taken in response to the events for teriflunomide was unknown. At time of reporting, the outcome of all the events was resolved on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, SARS-CoV-2 antibody test negative
Clinical narrative: fever and chills; Body aches; Forgetting stuff worsening; Forgetting stuff worsening; low Covid -19 antibody after receiving Covid-19 Vaccine; headache; fever and chills; This is a spontaneous report from a contactable consumer or other non hcp (patient) and Other HCP. A 48-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation; teriflunomide (AUBAGIO), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for multiple sclerosis. Medical history included ongoing allergies (hypersensitivity), ongoing GERD (Gastro oesophageal reflux disease), ongoing covid-19 pneumonia, ongoing jc virus infection, ongoing multiple sclerosis, ongoing migraine, ongoing nerve pain. Concomitant medications included gabapentin (GABAPENTIN); omeprazole (PROTONIX [OMEPRAZOLE]); azelastine (AZELASTINE); mometasone furoate (FLONASE [MOMETASONE FUROATE]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. On 18Mar2021 the patient experienced fever and chills, body aches, forgetting stuff worsening, condition aggravated, low covid -19 antibody after receiving covid-19 vaccine, headache. Following the first dose intake of Teriflunomide and bnt162b2. It was not reported if the patient received a corrective treatment for the adverse events. The action taken in response to the events for teriflunomide was unknown. At time of reporting, the outcome of all the events was resolved on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Mass, Nipple pain
Clinical narrative: Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; This is a spontaneous report from contactable consumer. This consumer reported similar events for self and her daughter. This report is for daughter. This consumer (patient's mother) reported for a female patient (daughter) that. A non-pregnant female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number Batch/Lot Number: FC3180) via an unspecified route of administration, administered in Arm Left on 12Aug2021 18:30 pm as dose 1, single for COVID-19 immunisation. The patient medical history included lichen planus on an unspecified date. The concomitant medications were not reported. Other medications she took in two weeks was Prilosec. She did not receive any other vaccines in 4 weeks. She had no known allergies. Prior to vaccination she was not tested for COVID. She was not tested for COVID post vaccination. The patient experienced me and my daughter has vaccine same day and time. we both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness on 15Aug2021 16:00 pm. She did not receive treatment for the adverse events. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101057825 same event/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: joint pain; Headache; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female consumer reported in response to Non-HCP follow up letter sent in cross reference case which included that:  A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:43 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypersensitivity, anaemia and oral herpes from an unknown date and unknown if ongoing. Concomitant medications included levocetirizine (LEVOCETIRIZINE) taken for hypersensitivity from 25May2021 to 01Jun2021; famciclovir (FAMCICLOVIR) taken for oral herpes from 11Jun2021 to an unspecified stop date and ferrous gluconate (POLY-IRON [FERROUS GLUCONATE]) from 2021 to an unspecified date [Been taking this or a long time- on and off. I was taking the iron pill days before the 03Jun2021 1st dose] for anaemia. On 03Jun2021 patient experienced joint pain and headache. The outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Insomnia, Nausea
Clinical narrative: Severe Headache; LT arm numbness and shaking; LT arm numbness and shaking/Involuntary muscle jerks in LT arm and shoulder; Nausea; Vomitting; Fatigue; Insomnia; This is a spontaneous report from a contactable other health care professional (patient).   A 31-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration, administered in left arm on 27Aug2021 at 01:45 (at the age of 31-year-old) as single dose for COVID-19 immunization. Patient had known allergies to penicillins, Ibuprofen. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. The patient received within 2 weeks of vaccination naproxen sodium (ALEVE, batch/lot number not reported), route of administration, start and stop date, dose not reported. The patient previously took ibuprofen and experienced drug hypersensitivity. On 27Aug2021 at 14:00 the patient experienced severe headache, arm numbness and shaking, involuntary muscle jerks in lt arm and shoulder, nausea, vomiting, fatigue, insomnia. Treatment received with OTC medications for the event headache. No treatment received for other events. Device Date: 29Aug2021. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Severe Headache; LT arm numbness and shaking; LT arm numbness and shaking/Involuntary muscle jerks in LT arm and shoulder; Nausea; Vomitting; Fatigue; Insomnia; This is a spontaneous report from a contactable other health care professional (patient).   A 31-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration, administered in left arm on 27Aug2021 at 01:45 (at the age of 31-year-old) as single dose for COVID-19 immunization. Patient had known allergies to penicillins, Ibuprofen. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. The patient received within 2 weeks of vaccination naproxen sodium (ALEVE, batch/lot number not reported), route of administration, start and stop date, dose not reported. The patient previously took ibuprofen and experienced drug hypersensitivity. On 27Aug2021 at 14:00 the patient experienced severe headache, arm numbness and shaking, involuntary muscle jerks in lt arm and shoulder, nausea, vomiting, fatigue, insomnia. Treatment received with OTC medications for the event headache. No treatment received for other events. Device Date: 29Aug2021. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: headache; fever; tired; This is a Spontaneous report based on the information received by Pfizer. (Manufacturer Control No: 2021SA257190). A contactable consumer (mother) reported for a 14-year-old male patient who received the first dose of BNT162B2 (Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in Jul2021 as dose 1, single for COVID-19 immunization and dupilumab (Dupixent) at an unknown dose for an unknown indication. The patient's medical history, concomitant medications and family history were not reported. On an unknown date in Jul2021 following the first dose intake, the patient developed headache, pyrexia and fatigue. In the context of Covid-19 crisis, the batch number and expiration date were not requested. It was reported that patient's mother mentioned that her son got the Pfizer Covid vaccine and his dupilumab shot was due today but he felt tired, had a headache and a very mild fever and was out of it. It was not reported if the patient received a corrective treatment for the events (headache, fever, tired). On an unknown date in 2021 the patient recovered.  No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Dyspepsia
Clinical narrative: cholesterol is high; acid indigestion; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration on 07Apr2021 (age at vaccination 58 years) as DOSE 1, SINGLE for COVID-19 immunization. Patient had no known drug allergies. The patient medical history and concurrent conditions was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks was reported. Prior vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID- 19. Relevant past drug history was reported as no. The patient previously received other vaccine via an unspecified route of administration administered in arm right on 07Apr2021 (Lot number: Unknown) (age at vaccination 58 years) as dose 2, single. On 22Apr2021, patient experienced cholesterol is high and acid indigestion. It was reported that he has had acid indigestion since the vaccine and have not before. The patient never had cholesterol high before. The events were reported as non-serious. The patient underwent lab tests and procedures which included cholesterol : high on 22Apr2021 (cholesterol is high). It was unknown whether patient received any treatment for adverse events. The outcome of the events was unknown.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further in-formation is expected.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product use issue
Clinical narrative: prepared syringe was administered to a patient between 20-25 minutes past the beyond use time for the dose; prepared syringe was administered to a patient between 20-25 minutes past the beyond use time for the dose; This is a spontaneous report from a contactable other healthcare professional (Nurse).  A 12-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date caller explained that prepared syringe was administered to patient between 20-25 minutes past the beyond use time for the dose. Caller also explained that vaccine dose in question was diluted, drawn into a syringe, with the prepared syringe was labeled with expiration and dose and stored in the fridge. The undiluted vial was placed at room temperature, then reconstituted with diluent, drawn into syringes, then placed in the fridge after being labeled with expiration time. outcome of events was unknown.  Information about batch/lot number is not available. Follow-up attempts completed and no further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle twitching, Sleep disorder
Clinical narrative: back twitching/ her fingers and feet twitching at night when lays in bed and also her butt twitching sometimes/ her eyes will twitch on and off too/ arms, legs, hands, calves twitching; arms, legs, hands, calves twitching was reported as worsened; The twitching is interrupting her sleep at night; This is a spontaneous report from a contactable consumer or other non hcp (patient).    A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Aug2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 57-year-old) for covid-19 immunisation. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for blood pressure abnormal from an unspecified start date and ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced back twitching/ her fingers and feet twitching at night when lays in bed and also her butt twitching sometimes/ her eyes will twitch on and off too/ arms, legs, hands, calves twitching on 21Aug2021, arms, legs, hands, calves twitching was reported as worsened (condition aggravated) on an unknown date in 2021 and the twitching is interrupting her sleep at night on an unknown date in 2021. Caller states she had a question, states she got her first dose of the Pfizer Covid vaccine on 21Aug2021, when she got home her leg started twitching, caller states when she lays down at night arms and legs will twitch, states her calves will twitch and her eyes will twitch on and off too, states her eye is not that bad, its mostly her legs and arms and even her butt sometimes. Caller wants to know if this is a side effect or if it has been reported. Caller states she was supposed to get the second dose on Saturday but has not because she is scared to due to this side effect. Also noted caller stated that the twitching doesn't happen while she is up walking, only when she is laying down. The outcome for event The twitching is interrupting her sleep at night was unknown while rest were not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Insomnia
Clinical narrative: Headache; heart beating really fast; trouble sleeping; This is a spontaneous report from contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in arm left on 14Sep2021, given around 13:00 (at the age of 38-years) as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient past drug event includes Anthrax. some 20 years ago, the patient 2002 or 2003 he had the anthrax shots and had a bad reaction to it. The patient was in the navy and had a booster at 6 months and then every 12 months. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: FC3182) (at the age of 38-years), via an unspecified route of administration, administered in arm left on 24Aug021 given around 13.00 as dose 1, single for covid-19 immunization. Caller reporting on the Pfizer COMIRNATY, the covid shot and who explains the patient took it yesterday and was told to call if felt anything afterward. It was his second dose. Last night the patient had trouble sleeping. Patient just hopes he was really tired to night and will be able to catch up on his sleep. His heart had been, the patient feel like he ran a marathon for 12-13 hours it had been beating really fast, which started around 22:00 last night, was about the same, the patient just feels like he ran a marathon, his heart was beating really hard and fasting. He drank water. Patient also had a slight headache which started about 9-10pm last night, it was about the same. The patient explains that he gets migraines so it was nothing like normally gets. He was treatment with excedrin. The patient did not visit in emergency. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reports the patient thinks he was doing fine but his heart was beating really fast. The patient underwent lab test: heat rate: elevated (heart is beating really fast). The outcome of the events headache and heart beating really fast was not recovered while the outcome of the event insomnia was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: He got the Pfizer Covid 19 Vaccine and afterwards now his heart rate has been high; I did check it here today and seems little higher than normal first one I roam around and it goes even higher; This is a spontaneous report from a Pfizer sponsored program. This is a spontaneous report from a contactable 57-year-old male consumer (patient) .A 57-year-old male received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 17Sep2021 as DOSE 2, SINGLE for covid-19 immunization.The patient medical history had included blood clots and  received blood thinner for blood clots. The patient concomitant had included vitamin B-complex and vitamin D. It was reported that patient did not receive any vaccination prior to the vaccination. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number:FC3180 ) via an unspecified route of administration on 27Aug2021 as DOSE 1, SINGLE for covid-19 immunization.On Sep 2021 the patient had experienced that after getting Pfizer Covid 19 Vaccine and afterwards now his heart rate has been high and reported that check it here today and seems little higher than normal first one I roam around and it goes even higher. The clinical outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Breast mass
Clinical narrative: had a lump and breast issues; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna VACCINE, solution for injection, date (Batch/Lot number was not reported)), via an unspecified route of administration on an unspecified as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a lump and breast issues. At the time of this report, the outcome of events was unknown.  The lot number for, the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Severe left sciatic nerve pain; This is a spontaneous report from a contactable consumer (patient).  A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Sep2021 13:00 (Batch/Lot number was not reported) age at vaccination of 26-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Sep2021 13:00 (Batch/Lot number was not reported) age at vaccination of 26-years-old, as single dose, for covid-19 immunisation. The patient previously took ceclor and experienced drug hypersensitivity. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left sciatic nerve pain on 25Sep2021 05:00. Facility type vaccine: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Eye pain, Lethargy
Clinical narrative: dizziness; some eye ache; focus issues.; Lethargy; This is a spontaneous report from contactable consumer (patient).  A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Sep2021 10:30 (Batch/Lot Number: FF2588) age at vaccination of 75-years-old, as single dose, for covid-19 immunisation. Medical history included granulomatosis with polyangiitis from an unknown date and unknown if ongoing Wegener's GPA. The patient previously took tamiflu and experienced hypersensitivity, antibiotics and experienced hypersensitivity.  The patient previously BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Sep2021 10:30 (Batch/Lot Number: FF2588) age at vaccination of 75-years-old, as single dose, for covid-19 immunisation. Concomitant medications included prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning one day after second shot on 23Sep2021 at 01:45 AM (and continuing into third day after second shot) the patient experienced dizziness, he also experienced while walking or standing, when sitting he had some eye ache and focus issues. The patient also experienced lethargy on 23Sep2021 at 01:45 AM. No treatments were administered. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not recovered from the events.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Terrible arm pain; This is a spontaneous report from a contactable other HCP (Patient's parent).  A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Right on 24Sep2021 13:00 (Batch/Lot number was not reported) age at vaccination of 29-years-old, as single dose, for covid-19 immunisation.  Medical history included drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy), covid-19 from an unknown date and unknown if ongoing if covid prior vaccination. The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced terrible arm (non-serious) on 24Sep2021 13:30. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Immunisation, Off label use, Pain
Clinical narrative: body aches; headaches; weak for 2 days; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ff8839, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 04Oct2021 at 16:45 (at the age of 51-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported, patient was not pregnant at the time of vaccination), via an unspecified route of administration, on 20Jan2021 (at the age of 50-year-old) as DOSE 2, SINGLE; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported, patient was not pregnant at the time of vaccination), via an unspecified route of administration, on 30Dec2020 (at the age of 50-year-old) as DOSE 1, SINGLE both for covid-19 immunisation. No other vaccine received in four weeks. No covid prior vaccination and no covid tested post vaccination. On 04Oct2021, the patient experienced dose number=3, on 05Oct2021 patient experienced body aches, headaches, weak for 2 days. No treatment received for events. The outcomes of events (body aches, headaches, weak for 2 days) were recovering.  Follow-Up (15Oct2021): Follow-up attempts are completed. No further information is expected.