chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired vaccine) outcome was unknown.            No concomitant medication were reported.   No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up document contain no new information.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired doses of the Moderna COVID-19 vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 059H21A) for COVID-19 immunization. No medical history reported. On Mar 28, 2022, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 28, 2022, patient administered expired product (received expired doses of the Moderna COVID-19 vaccine). At the time of the report, administered expired product (received expired doses of the Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. It was reported the vial did not undergo any temperature excursions. The vial initially stored in the refrigerator on Mar 25, 2022. 8 patients received expired doses of the Moderna COVID-19 vaccine. This case linked to MOD-2022-534443 (patient link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (only have a little reaction after the second booster), vaccination site pruritus (a little swelling and itching on the site of the injection) and vaccination site swelling (a little swelling and itching on the site of the injection) in an male patient, of unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 5, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the 3rd, 2nd and 1st dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 6, 2022, patient experienced vaccination complication (only have a little reaction after the second booster), vaccination site pruritus (a little swelling and itching on the site of the injection) and vaccination site swelling (a little swelling and itching on the site of the injection). At the time of the report, vaccination complication (only have a little reaction after the second booster), vaccination site pruritus (a little swelling and itching on the site of the injection) and vaccination site swelling (a little swelling and itching on the site of the injection) outcome: unknown.  It was reported the patient had a little swelling and itching on the site of the injection, but he was fine. No concomitant medication or treatment information reported.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient that came in 14 years old with Pfizer 1st and second dose and was given the Moderna booster; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that came in 14 years old with Pfizer 1st and second dose and was given the Moderna booster) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Pfizer 1st dose lot#EW0183) on 08-Jun-2021 and Pfizer (Pfizer 2nd dose lot#EW0180) on 29-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 01-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that came in 14 years old with Pfizer 1st and second dose and was given the Moderna booster). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that came in 14 years old with Pfizer 1st and second dose and was given the Moderna booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported stated that the patient had not reported any side effects.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Fatigue, Feeding disorder
Clinical narrative: Can't eat; Abdominal pain; Diarrhea; Dizziness; Fatigue; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no allergies, did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine and had no chronic illnesses prior vaccination.  The patient's past medical history included COVID-19 in November 2021.    On 05-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Apr-2022 at 9:00 PM, the patient experienced FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Patient stated that he does not take any concomitant medication. Patient also stated that he took Tylenol as a treatment for the symptoms but did not felt better.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Can't eat; Abdominal pain; Diarrhea; Dizziness; Fatigue; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no allergies, did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine and had no chronic illnesses prior vaccination.  The patient's past medical history included COVID-19 in November 2021.    On 05-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Apr-2022 at 9:00 PM, the patient experienced FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Patient stated that he does not take any concomitant medication. Patient also stated that he took Tylenol as a treatment for the symptoms but did not felt better.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose/ Dose administered greater than 12 hours post puncture) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose/ Dose administered greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose/ Dose administered greater than 12 hours post puncture) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Reporter stated that on 04-Apr-2022 morning, nurse drew up Moderna, but it was never disposed of at the end of the day and stored in a refrigerator for up to 24 hours before being administered. And on 05-Apr-2022, the nurse was on leave and a medical assistant grabbed those expired Moderna doses and administered them to a patient and it was greater than 12 hours post puncture. No treatment medications were reported. Doses were pre drawn into syringes and stored in a refrigerator for up to 24 hours before being administered. Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Time gap between post puncture and administration of vaccine was updated. On 07-Apr-2022: Reporter's details, vaccine batch number and date of administration were updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza like illness, Musculoskeletal chest pain, Pain
Clinical narrative: kind of sick/felt sick; slight temp; headachey; pains in rib cage; sharp pains/really hurt; arm got sore/arm hurt; felt really flu-like/kind of sick/like got the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu), ILLNESS (kind of sick/felt sick), MUSCULOSKELETAL CHEST PAIN (pains in rib cage), PAIN (sharp pains/really hurt) and PYREXIA (slight temp) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K214, 051F21A, 013A21A and 028220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma (When she was around 55-56 years old). Concurrent medical conditions included Pollen allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu) and PAIN IN EXTREMITY (arm got sore/arm hurt). On 05-Apr-2022, the patient experienced MUSCULOSKELETAL CHEST PAIN (pains in rib cage) and PAIN (sharp pains/really hurt). On an unknown date, the patient experienced ILLNESS (kind of sick/felt sick), PYREXIA (slight temp) and HEADACHE (headachey). At the time of the report, INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu), ILLNESS (kind of sick/felt sick), MUSCULOSKELETAL CHEST PAIN (pains in rib cage), PAIN (sharp pains/really hurt), PYREXIA (slight temp), HEADACHE (headachey) and PAIN IN EXTREMITY (arm got sore/arm hurt) had not resolved.            Patient took vitamin D as Concomitant drug. She was amazingly healthy; her vitals were perfect. She was shocked that she was sick.   This case was linked to MOD-2021-367368 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: kind of sick/felt sick; slight temp; headachey; pains in rib cage; sharp pains/really hurt; arm got sore/arm hurt; felt really flu-like/kind of sick/like got the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu), ILLNESS (kind of sick/felt sick), MUSCULOSKELETAL CHEST PAIN (pains in rib cage), PAIN (sharp pains/really hurt) and PYREXIA (slight temp) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K214, 051F21A, 013A21A and 028220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma (When she was around 55-56 years old). Concurrent medical conditions included Pollen allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu) and PAIN IN EXTREMITY (arm got sore/arm hurt). On 05-Apr-2022, the patient experienced MUSCULOSKELETAL CHEST PAIN (pains in rib cage) and PAIN (sharp pains/really hurt). On an unknown date, the patient experienced ILLNESS (kind of sick/felt sick), PYREXIA (slight temp) and HEADACHE (headachey). At the time of the report, INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu), ILLNESS (kind of sick/felt sick), MUSCULOSKELETAL CHEST PAIN (pains in rib cage), PAIN (sharp pains/really hurt), PYREXIA (slight temp), HEADACHE (headachey) and PAIN IN EXTREMITY (arm got sore/arm hurt) had not resolved.            Patient took vitamin D as Concomitant drug. She was amazingly healthy; her vitals were perfect. She was shocked that she was sick.   This case was linked to MOD-2021-367368 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, SARS-CoV-2 antibody test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine (Batch no: 1808609, Expiry date : 06-Sep-2021 and anatomical site: left arm) on 23-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Janssen COVID-19 Vaccine. On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2022, the patient experienced COUGH (dry cough) and HEADACHE (headache). At the time of the report, COUGH (dry cough) and HEADACHE (headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2022, SARS-CoV-2 antibody test: negative (Negative) Binax rapid test: negative. No concomitant drug information was provided. Causality for Janssen COVID-19 Vaccine both reporter and manufacturer for both the events was given as possible. No treatment drug information was reported. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: May have used an expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry/full dose of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (May have used an expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry/full dose of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (May have used an expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry/full dose of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (May have used an expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry/full dose of expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. Vial didn't undergo any temperature excursions. Pharmacist pulled the expired vial around 07:45 pm on April 5th and put in refrigerator. Refrigeration date of vial: 05-APR-2022 No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Reporter Mail added. Suspect information added. Narrative updated.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient did not received 3rd dose before 1st booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient did not received 3rd dose before 1st booster shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient did not received 3rd dose before 1st booster shot). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient did not received 3rd dose before 1st booster shot) outcome was unknown.            No Concomitant product use was reported.  It was reported that the Immunocompromised patient received first and second shot of the primary series, and the first booster dose of the Moderna COVID-19 Vaccine. The patient stated they recently discovered there was a third primary series dose for immunocompromised patients, but the patient not received it before first booster shot.  The vaccination date, lot number and expiration date were unknown.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. On 30-Mar-2022 at 10:50 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:50 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired). Patient race was reported as Black. No concomitant medications were reported. The vial was initially stored in the refrigerator on 01-Mar-2022. Vial did not undergone to any temperature excursion. No treatment medications were reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (administered expired vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 013H21B) for COVID-19 immunization. No medical history reported. On Mar 30, 2022, at 11:00 am, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .25 milliliter. On Mar 30, 2022, patient administered expired product (administered expired vaccine). At the time of the report, administered expired product (administered expired vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial initially stored in the refrigerator on Mar 1, 2022. The vial did not undergo any temperature excursions. The number of total doses: 17.
Sex: M
Vaccine: PNC13
Symptoms: Adenoidal hypertrophy, Cough, Nasal congestion, Viral titre
Clinical narrative: nasal congestion; cough; enlarged adenoids; This is a spontaneous report received from contactable reporter(s) (Other HCP)(nurse).  A 4 year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)(PREVNAR 13) (Batch/Lot number: unknown) as dose 3, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious), outcome "unknown", described as "nasal congestion"; COUGH (non-serious), outcome "unknown", described as "cough"; ADENOIDAL HYPERTROPHY (non-serious), outcome "unknown", described as "enlarged adenoids". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient was having nasal congestion over a prolonged period of time. He had 6 visits pertaining to the cough over 6 months. The nurse and physician ordered titers and 12 of the 13 serotypes were lower than normal  between 0.3 and 0.5.The office will vaccinate with PNEUMOVAX 23.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Allergy; Swelling; This is a spontaneous report received from contactable reporter (Other HCP).  A 67-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy"; SWELLING (non-serious), outcome "unknown", described as "Swelling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: My arm is swelling up; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot unknown, single); Bnt162b2 (dose 2, lot unknown, single); Bnt162b2 (dose 3, lot unknown, single). The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "My arm is swelling up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: pain following injection; fever; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2021SA425655.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain following injection"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of pyrexia. Additional information: On an unknown date, the patient developed a non serious pain following injection (injection site pain) and fever (pyrexia) (unknown latency) following the administration of diptheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)HIB(PRP/T) vaccine and Prevnar 13. It was reported that pentacle is generally given at the same time and is likely cause of fever. The patient was treated with Tylenol (paracetamol) and Advil (Ibuprofen) for fever. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At time of reporting the outcome was unknown for all the reported events. There will be no information available on the batch number for this case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Rash, Type I hypersensitivity
Clinical narrative: This is a literature report for the following literature source(s): "Graded Administration of Second Dose of Moderna and Pfizer-BioNTech COVID-19 mRNA Vaccines in Patients with Hypersensitivity to First Dose", 2021; Vol:8 (12), DOI:10.1093/OFID/ofab507. The authors reported a case series of outpatients referred from the community from January to May 2021 for evaluation of symptoms consistent with immediate hypersensitivity reactions to the first dose of the Moderna or Pfizer-BioNTech COVID-19 vaccine, who subsequently received their second dose through a graded administration protocol. A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant), outcome "unknown", described as "immediate hypersensitivity reactions"; RASH (medically significant), outcome "unknown", described as "Non-urticarial rash", time of symptom onset 30 mins. The event "non-urticarial rash" was evaluated at the emergency room visit. The events "immediate hypersensitivity reactions" and "non-urticarial rash" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 17.85, notes: Log2 dilution. Therapeutic measures were taken as a result of type 1 hypersensitivity, rash which included diphenhydramine. Skin test was not performed. There was no reaction to second dose via graded administration. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect BNT162B2  may have contributed to the onset of reported events. Linked Report(s): US-PFIZER INC-202200151789 Same article/ drug/event and different patient.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Skin test, Type I hypersensitivity, Urticaria
Clinical narrative: This is a literature report for the following literature source: "Graded Administration of Second Dose of Moderna and Pfizer-BioNTech COVID-19 mRNA Vaccines in Patients with Hypersensitivity to First Dose", 2021; Vol:8 (12), DOI:10.1093/OFID/ofab507. The authors report a case series of outpatients from January to May 2021 for evaluation of symptoms consistent with immediate hypersensitivity reactions to the first dose of the Pfizer-BioNTech Covid-19 vaccine. A 63-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) administration date 2021 (lot number unknown) at the age of 63-years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient has no atopic history. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant) with onset 2021, outcome "unknown", described as "immediate hypersensitivity reactions", time onset of event reported as 40 minutes; URTICARIA (medically significant) with onset 2021, outcome "unknown", described as "urticaria", time onset of event reported as 40 minutes. The patient underwent the following laboratory tests and procedures: serum S IgG titer, log 2 dilution: (2021) 17.35; skin test: (2021) unknown results, notes: positive skin test component was none. Therapeutic measures were not taken as a result of type I hypersensitivity, urticaria. Emergency department evaluation was not required. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect COVID-19 VACCINE may have contributed to the onset of reported events. Linked Report(s): US-PFIZER INC-202200151789 Same article/drug and different patient/event.
Sex: M
Vaccine: MENB
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: redness at the injection site measuring 10cm, with pain; redness at the injection site measuring 10cm, with pain; This is a spontaneous report received from a contactable reporter(s).  A 17 year-old male patient received meningococcal group b rlp2086 (TRUMENBA), administration date 04Feb2022 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Feb2022, outcome "recovering", VACCINATION SITE ERYTHEMA (non-serious) with onset 05Feb2022, outcome "unknown" and all described as "redness at the injection site measuring 10cm, with pain". Additional information: 17.5 yo male received 1st dose of Trumenba on 04Feb, 30 hours later on 05Feb reported redness at the injection site measuring 10cm, with pain. On 06Feb, redness measured 13cm but less pain. Not other vaccines given on 4 Feb. No history of local vaccine reaction like this. 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: PNC13
Symptoms: Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program. The reporter is the patient.  A 68 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administration date 2017 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pneumococcal 23 (Approximately 15 years ago), administration date: 2007, for immunization. The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "Upper respiratory infection". Additional information: Approximately 15 years ago patient experienced a fairly serious topical reaction to the pneumococcal 23 vaccination administered to her then immunologist, Who advised her never to repeat Pneumococcal 23. She followed his advice. A little over 5 years ago her general practitioner administered Prevnar 13. She was a 68-year-old woman with a history of asthma, which is well-controlled except when she experience an upper respiratory infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: got sick from the Prevnar 13; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 76 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick from the Prevnar 13". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. A 46-year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Mar2022, outcome "unknown" and all described as "family member tested positive 22Mar and then he tested positive 27Mar symptoms unknown". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Mar2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: It was unknown if the patient had symptoms. Facility type vaccine was workplace clinic. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to COVID vaccine. It was also unknown if Covid test type post vaccination. Post vaccination the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Intracranial aneurysm, Myocardial infarction
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; INTRACRANIAL ANEURYSM (medically significant), outcome "unknown", described as "Brain Aneurysm". Additional information: "I have questions about the COVID-19 Vaccine vaccination record cards (how to get, how to get a replacement if lost, etc.)". The caller stated that he and his wife both got vaccinated with the Pfizer COVID 19 Vaccine and he has his card but can not find hers and she is currently in a rest home due to a heart attack and Brain Aneurysm and they want to see her card. "How can I go about getting her another card"? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Epilepsy, Seizure
Clinical narrative: This is a spontaneous report received from contactable reporter (consumer). The reporter is the parent. A 19 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 19 years as dose number unknown (initial Pfizer dose), single for COVID-19 immunisation. Relevant medical history included: "Type one diabetic" (unspecified if ongoing). The patient's 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: SEIZURE (medically significant) with onset 06Dec2021, outcome "unknown", described as "Seizure"; EPILEPSY (medically significant), outcome "unknown", described as "epilepsy"; BLOOD GLUCOSE ABNORMAL (non-serious), outcome "unknown", described as "blood sugar was in the 300's". The events were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood glucose abnormal: 300. Additional information: The caller's son is type one diabetic and had his booster. He was in college in November. The patient had a seizure and went to the hospital and his blood sugar was in the 300's so it wasn't related to the blood sugar at all. They went to a neurologist and did the follow up and didn't find anything. The patient can't drive for 6 months. They thought that maybe the patient had epilepsy, so he is on medications to prevent it. Everyone the caller has mentioned are all around the same age. It's such a weird coincidence and the caller decided to called Pfizer. Patient's weight is 180-185. The patient went to the hospital, and they ran tests in the emergency room, but he never stayed overnight. The lot number for BNT162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200495438 same reporter/drug, similar events, different patients; US-PFIZER INC-202200494202 same reporter/drug, similar events, different patients; US-PFIZER INC-202200494339 same reporter/drug, similar events, different patients.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Seizure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male 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: SEIZURE (medically significant), outcome "unknown", described as "Seizure"; BLOOD GLUCOSE INCREASED (medically significant), outcome "unknown", described as "blood sugar was in the 500's". The patient underwent the following laboratory tests and procedures: blood glucose: 500's. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Seizure
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer). A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 06Dec2021, outcome "unknown", described as "Seizure"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar was in the 300's". The patient underwent the following laboratory tests and procedures: blood glucose: 300's. Additional information: The caller was talking to the (company name withheld) guy about his son who is a type 1 diabetic and had a seizure. The patient's blood glucose was in the 300's. The patient also had the Pfizer Covid vaccine. The lot number for BNT162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200494170 same reporter/drug, similar events, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date (Batch/Lot number: unknown) at an unspecified age 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: SEIZURE (medically significant), outcome "unknown", described as "had a seizure and her sister rushed her to the hospital and they said it was not related to the blood sugar". The event "had a seizure and her sister rushed her to the hospital and they said it was not related to the blood sugar" was evaluated at the physician office visit and emergency room visit. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200494170 same reporter/drug, similar events, different patients
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Menstrual disorder, Vaginal haemorrhage
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 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: MENSTRUAL DISORDER (medically significant), outcome "unknown", described as "blood clots"; VAGINAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "vagina/been bleeding 60 days"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "I can't go back to work". Clinical course: Ever since the patient got the first dose of Pfizer COVID vaccine on 09Jan (as reported) 3 weeks proceeded of blood clots coming out of her vagina with only a 1 week pause then another 2 weeks of blood clots coming out of her vagina with a 2 week pause and then another 14 days. It was later stated that she could not go back to work with blood clots coming out of her vagina for 2 weeks at a time, and the longest she has been able to get it to stop was 2 weeks. Further stated that going into the month of Apr (as reported) and she has been bleeding 60 days since 09Jan (as reported). The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Panic attack, Suicidal ideation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Nov2021 (Lot number: FJ8757) at the age of 42 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Mild depression" (unspecified if ongoing); "bariatric surgery", start date: 2015 (unspecified if ongoing); "bariatric surgery", start date: 2021 (unspecified if ongoing); "thyroid problems" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if Covid prior vaccination: yes. Concomitant medication(s) included: SYNTHROID; LEXAPRO. Vaccination history included: Bnt162b2 (previous dose product: COVID-19, previous  dose brand: Pfizer, previous  dose brand unknown: False, previous  dose lot number: FF2593, previous  dose lot unknown: False, previous  dose administration date: 30Oct2021 previous  dose dose number: 1, previous  dose vaccine location: Left arm), administration date: 30Oct2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: PANIC ATTACK (hospitalization, disability) with onset 01Dec2021, outcome "not recovered", described as "Severe panic attacks"; SUICIDAL IDEATION (hospitalization, disability, medically significant) with onset 01Dec2021, outcome "not recovered", described as "suicide thoughts"; EMOTIONAL DISORDER (hospitalization, disability) with onset 01Dec2021, outcome "not recovered", described as "emotional breakdowns"; NERVOUSNESS (hospitalization, disability) with onset 01Dec2021, outcome "not recovered", described as "Nervous around people and big groups"; DIARRHOEA (hospitalization, disability) with onset 01Dec2021, outcome "not recovered", described as "diarrhea in nervous situations"; ANXIETY (hospitalization, disability) with onset 01Dec2021, outcome "not recovered", described as "severe anxiety"; CRYING (hospitalization, disability) with onset 01Dec2021, outcome "not recovered", described as "Crying episodes"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization, disability) with onset 01Dec2021, outcome "not recovered", described as "Missed several weeks of work. Can't handle any adult responsibilities". The patient was hospitalized for emotional disorder, diarrhoea, anxiety, crying, loss of personal independence in daily activities (hospitalization duration: 10 day(s)). The events "severe panic attacks", "suicide thoughts", "emotional breakdowns", "nervous around people and big groups", "diarrhea in nervous situations", "severe anxiety", "crying episodes" and "missed several weeks of work. can't handle and adult responsibilities" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of panic attack, suicidal ideation, emotional disorder, nervousness, diarrhoea, anxiety, crying, loss of personal independence in daily activities. The patient was not Covid tested post vaccination.