chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Paraesthesia
Clinical narrative: 15 minutes after her shot c/o pins and needles  to her arms, feet followed by a flushed chest. Developed flushing to her face, arms.  Administered 50mg PO Benadryl (employee declined IM Benadryl). VS remained stable during observation period.  Hydration provided.  Also took 40 mg Pepcid.  Reported symptom relief, declined ER observation and obtained transport home.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Paraesthesia
Clinical narrative: Site red and itchy on day after vaccine 1/8/2021.  Patient reported left arm and hand tingling as of 1/19/2021.  Spoke with her primary care provider who instructed her it would most likely resolve on its own.  No treatment provided.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram thorax, Pain in extremity, SARS-CoV-2 test, Scan with contrast
Clinical narrative: Site red and itchy on day after vaccine 1/8/2021.  Patient reported left arm and hand tingling as of 1/19/2021.  Spoke with her primary care provider who instructed her it would most likely resolve on its own.  No treatment provided.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site reaction, Paraesthesia
Clinical narrative: Site red and itchy on day after vaccine 1/8/2021.  Patient reported left arm and hand tingling as of 1/19/2021.  Spoke with her primary care provider who instructed her it would most likely resolve on its own.  No treatment provided.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Swelling, hardness, hot to touch  12 days after injection on left upper arm.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, hardness, hot to touch  12 days after injection on left upper arm.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chest pain, Dyspnoea, Mechanical ventilation, Pneumonia
Clinical narrative: Systemic: Heart Attack, Systemic: Administrator said pt complained of chest pain was taken to ER.  Was told that vaccine could have caused a relapse of previous COVId however pt had no covid symptoms. pt was documented to have had MI
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Troponin increased
Clinical narrative: Systemic: Heart Attack, Systemic: Administrator said pt complained of chest pain was taken to ER.  Was told that vaccine could have caused a relapse of previous COVId however pt had no covid symptoms. pt was documented to have had MI
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: Systemic: Heart Attack, Systemic: Administrator said pt complained of chest pain was taken to ER.  Was told that vaccine could have caused a relapse of previous COVId however pt had no covid symptoms. pt was documented to have had MI
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Wrong Dose of Vaccine - Too High
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Wrong Dose of Vaccine - Too High
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Pneumonia
Clinical narrative: Resident noted with shortness of breath, oxygen applied, labs done, STAT Chest X-ray done. Chest X-ray showed infiltrates, Antibiotics ordered. Resident found unresponsive on 1-14-2021 at 11:35 am CPR started medics called. Resident pronounced in facility at 12:32 am.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Death, Dyspnoea, Laboratory test, Lung infiltration
Clinical narrative: Resident noted with shortness of breath, oxygen applied, labs done, STAT Chest X-ray done. Chest X-ray showed infiltrates, Antibiotics ordered. Resident found unresponsive on 1-14-2021 at 11:35 am CPR started medics called. Resident pronounced in facility at 12:32 am.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Resuscitation, Unresponsive to stimuli
Clinical narrative: Resident noted with shortness of breath, oxygen applied, labs done, STAT Chest X-ray done. Chest X-ray showed infiltrates, Antibiotics ordered. Resident found unresponsive on 1-14-2021 at 11:35 am CPR started medics called. Resident pronounced in facility at 12:32 am.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under the age of 18, no other signs or symptoms.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient under the age of 18, no other signs or symptoms.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dissociation, Dysphagia, Hot flush, Palpitations, Sensation of foreign body
Clinical narrative: Indicated that her heart was racing and her throat felt like it had a lump in it 5 10 minutes after receiving the vaccine. She indicated that she did not say anything to anyone because she thought that she just needed a drink of water. The symptoms persisted for about two hours. She contacted her primary care physician for a different reason and mentioned the reaction and her primary provider instructed her to report it to said that her doctor told her it was ok for her to receive the second dose if she pre-medicates with benedryl and zyrtec and if she waits the full 30 minutes for monitoring.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Indicated that her heart was racing and her throat felt like it had a lump in it 5 10 minutes after receiving the vaccine. She indicated that she did not say anything to anyone because she thought that she just needed a drink of water. The symptoms persisted for about two hours. She contacted her primary care physician for a different reason and mentioned the reaction and her primary provider instructed her to report it to said that her doctor told her it was ok for her to receive the second dose if she pre-medicates with benedryl and zyrtec and if she waits the full 30 minutes for monitoring.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Sensation of foreign body
Clinical narrative: Indicated that her heart was racing and her throat felt like it had a lump in it 5 10 minutes after receiving the vaccine. She indicated that she did not say anything to anyone because she thought that she just needed a drink of water. The symptoms persisted for about two hours. She contacted her primary care physician for a different reason and mentioned the reaction and her primary provider instructed her to report it to said that her doctor told her it was ok for her to receive the second dose if she pre-medicates with benedryl and zyrtec and if she waits the full 30 minutes for monitoring.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Movement disorder, Myalgia, Pain in extremity
Clinical narrative: muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about Lot/Batch has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about Lot/Batch has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 38.5°C (101.3°F) 24 hours; This is a spontaneous report from a contactable other HCP. This 49-year-old male other HCP reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) at Left Arm at single dose for COVID-19 immunization on 07Jan2021.  Relevant history and concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) Intramuscularly at Left arm at single dose on 16Dec2020, 12:00 PM for COVID-19 immunization. The patient experienced Fever 38.5°C (101.3°F) for 24 hours since 07Jan2021, 04:00 AM. Treatment was received for the event (unspecified), outcome of event was resolved on unknown date in Jan2021.  The patient was not COVID infected prior vaccination. The patient had not COVID tested post vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling of body temperature change, Headache, Malaise
Clinical narrative: Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Ocular hyperaemia, Sneezing, Vertigo
Clinical narrative: Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported; Improperly Stored PROQUAD was administered to patient.; This spontaneous report has been received from a medical assistant, referring about a patient of unknown gender and age. Information about the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions and allergies was not provided.  On 12-AUG-2020, the patient was vaccinated with an improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (therapy type: rHA), lot number S021326 with expiration date on 05-JAN-2021, administered for prophylaxis (dose and frequency were unknown by the reporter; strength, route of administration and anatomical location were not provided).  The temperature or the timeframe for the improperly stored vaccine was unknown by the reporter. It was unknown if there was a previous temperature excursion or if the call was due to a Digital Data Loger. No additional AE/PQC reported (no adverse event).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Vomiting
Clinical narrative: headache; vomiting; This spontaneous report was received from a nurse and refers to a 14 year old female patient. The patient's concurrent conditions included migraine and anxiety. No other information was given regarding the patient's concomitant medications or medical history.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route of adminstration, lot number and expiration date were not reported).    On an unknown date, after administration of the firs dose, the patient experienced headache and vomiting.      The outcome of headache and vomiting and the causal relationship between vaccination and the events were not reported.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Leaking ODT vial during administration; Leaking ODT vial during administration; No AE reported; This spontaneous non-valid report as received from a medical assistant via a company representative refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: 1691304; expiration date not reported, but upon internal validation established as 22-DEC-2021, dose and route of administration were not provided). Oral Dosing Tube (ODT) vial was leaking during administration (product leakage, accidental underdose). No adverse event was reported. Product quality complaint (PQC) was filled.   This report is non-valid due to the lack of the patient's identifiers.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 18-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally, lot # 1684157 and expiration date 26-JUN-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (°C) for 24 minutes on an unknown date of 2020; a previous temperature excursion was reported of below 2 °C (1.6°C) for 24 minutes.  The call was made due to a digital data logger. No adverse symptoms were reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly stored ROTATEQ was administered to patient; This spontaneous report was received from a registered nurse and refers to a 3-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 06-JAN-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen was not reported), lot # 1691133 and expiration date 28-NOV-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 35.2 degree fahrenheit (°F) for 45 minutes on 06-JAN-2021 at 1:30 AM; no previous temperature excursion were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2101USA001927: US-009507513-2101USA003974:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administered after improper storage of product; This spontaneous report was received from a medical assistant referring to a 4-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 07-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T022314, expiration date 30-JUN-2022, at a dose of 0.5 milliliter for prophylaxis  (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 7 degree Fahrenheit (°F) for 80 hours as recorded by a data logger. There was no previous temperature excursion reported.
Sex: F
Vaccine: PPV
Symptoms: Blood test, Immobile, Injection site urticaria, Insomnia, Pain
Clinical narrative: immobility; swelling; insomnia; hives around the injection site; More pain than the average vaccines; This spontaneous report  was received from a consumer referring to his wife a 58-year-old female patient.. Patient's concurrent conditions included cancer and allergy to sulfur based medications. Concomitant medications included, atorvastatin calcium (LIPITOR) and semaglutide (OZEMPIC). Information regarding  patient's historical conditions was not provided.   On an unspecified date in 2020 (reported as "roughly a month ago"),  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dosage form in the right arm, to prevent pneumonia  (prophylaxis) (strength, administration route, lot number and expiration date were not provided).       On 01-DEC-2020 (reported as "6 weeks ago"),  the patient experienced Immobility (paralysis), more pain than the average vaccine caused, swelling, insomnia and then she developed hives around the injection site. No treatment was given for the events, and a blood work was performed.   The outcome of the events was reported as recovered/resolved.     The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, Immobility was determined to be a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Paralysis, Swelling
Clinical narrative: immobility; swelling; insomnia; hives around the injection site; More pain than the average vaccines; This spontaneous report  was received from a consumer referring to his wife a 58-year-old female patient.. Patient's concurrent conditions included cancer and allergy to sulfur based medications. Concomitant medications included, atorvastatin calcium (LIPITOR) and semaglutide (OZEMPIC). Information regarding  patient's historical conditions was not provided.   On an unspecified date in 2020 (reported as "roughly a month ago"),  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dosage form in the right arm, to prevent pneumonia  (prophylaxis) (strength, administration route, lot number and expiration date were not provided).       On 01-DEC-2020 (reported as "6 weeks ago"),  the patient experienced Immobility (paralysis), more pain than the average vaccine caused, swelling, insomnia and then she developed hives around the injection site. No treatment was given for the events, and a blood work was performed.   The outcome of the events was reported as recovered/resolved.     The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, Immobility was determined to be a medically significant event.
Age: 47.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: shingles; approximately 47-year-old pt administered zoster vaccine live (ZOSTAVAX); Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 47 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or about December 2012, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a physician at a family medical facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider at a family medical group for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was not provided. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; The patient accidentally received an expired doseof VAQTA; This spontaneous report has been received from a nurse via office manager regarding on a 21-year-old female patient. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 14-JAN-2021, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), at a dose of 1 milliliter (ml), intramuscularly (IM), as prophylaxis, lot number reported and validated as S036494, expiration date reported and validated as 09-JAN-2021  (strength, anatomical site of vaccination, and vaccination scheme frequency were not reported).  It was reported that the patient was accidentally vaccinated with the expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (expired product administered) however, the vaccine was reported to be properly stored. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: minor sore arm; Early second dose / First dose on 21Sep2020 / Second dose on 27OCt2020; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 27th October 2020, the patient received the 2nd dose of Shingrix. On 27th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose on 21st September 2020. The reporter stated that, the patient received 2nd dose early than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up. This was 1 of 2 linkied cases, reported by same reporter for different patient.  Follow up information received from pharmacist on 23rd December 2020: The patient had no medical condition and or known allergies. Updated patient details. The patient received Shingrix by intramuscular route. Shingrix vaccine to be recommended to be administered 2 months apart, 2nd dose given at 5 weeks which led to drug dose administration interval too short. The patient experienced minor sore arm. The reporter considered minor sore arm to be related to Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213911: same reporter
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramps; This case was reported by a pharmacist and described the occurrence of stomach cramps in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced stomach cramps. On an unknown date, the outcome of the stomach cramps was unknown.   It was unknown if the reporter considered the stomach cramps to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient who one week after receiving the dose of Shingrix experienced stomach cramps. The reporter consented to follow up.  No other information provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Electric shock, Pain in extremity, Peripheral swelling
Clinical narrative: Pain affected my shoulder; Arm swelled up; I had pain; Doubt if the shot was done intramuscularly; Electric shock; Burning in second and third finger; A spontaneous report was received from a 67-years-old, female patient, who was also a nurse,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm swelled up, had pain, affected her shoulder, had an electric shock, burning second and third finger, and doubt if the shot was done intramuscularly.   The patient's medical history was not provided. Relevant concomitant medications reported included medication for blood pressure and diarrhea.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) in the left arm for prophylaxis of COVID-19 infection and experienced an electric shock and burning in her second and third finger, and she doubted that the shot was administered in her deltoid.  On 27 Dec 2020, about 6 hours later, the patient stated that her arm "was swelled up" and had pain.   Later, on an unknown date, the patient stated that the pain got a whole lot worse and it also affected her shoulder. She mentioned that it was not the normal kind of pain. Treatment included paracetamol.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, experienced arm swelled up, had pain, affected her shoulder, had an electric shock, burning second and third finger, were considered unknown. The outcome of the event, doubt if the shot was done intramuscularly, was resolved on 27 Dec 2020.; Reporter's Comments: This case concerns a 67-years-old, female subject with medical history of hypertension, who experienced a non-serious unexpected events of product administration error, electric shock, burning sensation; a non-serious expected event of arthralgia, peripheral swelling, and pain in extremity. There were no reported AEs associated with product administration error. The event of electric shock, burning sensation, peripheral swelling, and pain in extremity occurred apparently 6 hours after mRNA-1273 administration. The time of onset was not provided for the event of arthralgia. The subject's concomitant medications included for hypertension and for diarrhea (details not provided). The event was treated with Tylenol. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Pain affected my shoulder; Arm swelled up; I had pain; Doubt if the shot was done intramuscularly; Electric shock; Burning in second and third finger; A spontaneous report was received from a 67-years-old, female patient, who was also a nurse,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm swelled up, had pain, affected her shoulder, had an electric shock, burning second and third finger, and doubt if the shot was done intramuscularly.   The patient's medical history was not provided. Relevant concomitant medications reported included medication for blood pressure and diarrhea.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) in the left arm for prophylaxis of COVID-19 infection and experienced an electric shock and burning in her second and third finger, and she doubted that the shot was administered in her deltoid.  On 27 Dec 2020, about 6 hours later, the patient stated that her arm "was swelled up" and had pain.   Later, on an unknown date, the patient stated that the pain got a whole lot worse and it also affected her shoulder. She mentioned that it was not the normal kind of pain. Treatment included paracetamol.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, experienced arm swelled up, had pain, affected her shoulder, had an electric shock, burning second and third finger, were considered unknown. The outcome of the event, doubt if the shot was done intramuscularly, was resolved on 27 Dec 2020.; Reporter's Comments: This case concerns a 67-years-old, female subject with medical history of hypertension, who experienced a non-serious unexpected events of product administration error, electric shock, burning sensation; a non-serious expected event of arthralgia, peripheral swelling, and pain in extremity. There were no reported AEs associated with product administration error. The event of electric shock, burning sensation, peripheral swelling, and pain in extremity occurred apparently 6 hours after mRNA-1273 administration. The time of onset was not provided for the event of arthralgia. The subject's concomitant medications included for hypertension and for diarrhea (details not provided). The event was treated with Tylenol. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old male child received the first Moderna vaccine; A spontaneous report was received from a consumer concerning a 16-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in the event, 16 year old male child received the first Moderna vaccine.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient was 16 years of age when he received the mRNA-1273 vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, 16 year old male child received the first Moderna vaccine, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Chills; fever; muscle soreness; headaches; swollen lymphnodes; This is a spontaneous report from a contactable healthcare professional.  A 32-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EV5730, intramuscular in right arm on 17Dec2020, at 12:00 PM (at the age of 32 years old) as a single dose for COVID-19 immunization and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL 3246, intramuscular in right arm, on 07Jan2021 at 11:00 (at the age of 32 years-old) as a single dose for COVID-19 immunization. The vaccinations were administered at a hospital. Medical history included an allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was not known if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks (date not reported) of the vaccination. On 08Jan2021 at 00:00, the patient experienced chills, fever, muscle soreness, headaches, and swollen lymph-nodes. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events of Chills, fever, muscle soreness, headaches, and swollen lymph-nodes was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Pain
Clinical narrative: diarrhea; low appetite; felt achy/achiness; tired/fatigue; This is a spontaneous report from a contactable healthcare professional.  A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek9231, via an unspecified route of administration, in right arm on 31Dec2020 at 17:30 (at the age of 32 years-old)  as a single dose for COVID-19 immunization.  The vaccine was administered at a hospital. Medical history includes type 1 diabetes, anxiety, and anemia. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), drospirenone, ethinylestradiol (GIANVI), propranolol (PROPRANOLOL), sertraline (SERTRALINE). Past drug history included an allergy to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did take concomitant medications within 2 weeks prior to the vaccination. On 31Dec2020 and 01Jan2021, the patient was achy, tired, had diarrhea, low appetite. The clinical course was as follows: From 5 hours to about 24 hours after the vaccine she felt achy and tired. She felt fine after that. A week later (approximately 07Jan2021 at 18:00), she had diarrhea, low appetite, fatigue, and achiness. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events of achy, tired, had diarrhea, low appetite was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Taste disorder
Clinical narrative: Loss of taste - things don't taste normal; Loss of taste - things don't taste normal; This is a spontaneous report from a contactable nurse.  A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number=EK9231, intramuscular in right arm on 07Jan2021 at 08:45 (at the age of 62 years-old) as a single dose for COVID-19 immunization.  The vaccine was administered at a hospital. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included duloxetine (DULOXETINE), naproxen (NAPROXEN), ergocalciferol (VIT D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of the vaccine. On 08Jan2021, at 9:00, the patient experienced a loss of taste - "things don't taste normal". The patient was not hospitalized for the event nor received treatment. The clinical outcome of the events of loss of taste  things don't taste normal, was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Night sweats, Oropharyngeal pain, Pyrexia
Clinical narrative: She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever  was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever  was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Neck pain, Pruritus, Rash vesicular
Clinical narrative: sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; minor shingles outbreak; skin irritation; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 10:15 at a single dose on the left arm for COVID-19 immunization. Medical history included Afib/ flutter, ablation, and total hysterectomy. Patient had allergies to food: grapes. Concomitant medications included fish oil, zinc, and estradiol (1 mg, 2x/week) transdermal patch. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 20Dec2020 at 09:00, the patient experienced sharp pain R side of neck along dermatome, vesicles break out R anterior chest with mild burning and itching consistent with a minor shingles outbreak. MD had examined it and his opinion was that the minor shingles outbreak was most likely triggered by the vaccine. Very mild but skin irritation was also present. No treatment was given for the events. Since the vaccination, the patient has not tested for COVID-19. The outcome of the events was recovering at the time of the report.