chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist reported that he only received two doses of GARDASIL 9. It has been a few years and pharmacist has still not received the third dose of GARDASIL 9.; No additional AE reported.; This spontaneous report was received from a pharmacist reffering to himself, the male patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided). Pharmacist reported that he only received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It had been a few years and he had still not received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No additional adverse events were reported.
Pain, hardness, hot, and redness at injection site. Symptoms still present on the third day. Benadryl and Tylenol taken and cold packs applied frequently.
Medication Error:  Covid-19 vaccine (orange cap formulation for 5 through 11 year old individuals) administered to 9 year old male patient on 6/2/22. This was the child's 3rd dose of orange cap pfizer covid vaccine. The vial used was 14 days past the refrigeration use by date. RN contacted Pfizer customer service and received stability data for product. Per stability data and CDC guidelines, dose was considered invalid and should be repeated immediately.  RN contacted mother of child via phone on 6/10/22. RN explained that the dose given on 6/2/22 was invalid, and advised mother to bring child back to clinic to be re-vaccinated. Mother was receptive and verbalized understanding of the medication error, invalid dose, and need for child to receive a repeat dose. Mother states she will call RN next week to schedule an appointment to have dose repeated. RN gave mother contact information and encouraged her to call with any questions or concerns.
7FEB95 t101 R; 8FEB95 t104; 9FEB95 t102-cold sx, rash all over, extremely irritable, to FMD-felt reaction to vax; 13FEB 101; 14FEB WBC 14,000; didn't move rt arm; infect; 23FEB95 strep test pos 15FEB in blood stream & treated;
Tight chest, breathing difficult on 11/11 and 11/12 (today).
headache; site of injection feels hot; site of injection developed red marks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (site of injection feels hot), VACCINATION SITE ERYTHEMA (site of injection developed red marks) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE WARMTH (site of injection feels hot) and VACCINATION SITE ERYTHEMA (site of injection developed red marks). On 09-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, VACCINATION SITE WARMTH (site of injection feels hot), VACCINATION SITE ERYTHEMA (site of injection developed red marks) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Aspirin.
Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm soreness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PHENOBARBITAL (PHENOBARBITONE COX), TOPIRAMATE (TOPAMAX) and PRAVASTATIN for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Injection arm soreness) outcome was unknown.            Treatment information was included Tylenol  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-098701 (E2B Linked Report).; Sender's Comments:  MOD-2021-098701:same patient, 2nd dose
Chest pains and headaches that lasted for 3 weeks after first Pfizer Covid-19 vaccination.  Chose not to receive second dose due to the unusual chest pains and headaches that occurred.
Whelps/Hives (raised, red, pruritic "rash") reported by mother on 6/8/07 - first noted approximately 32-36 hrs after immunizations were given. Lesions were the size of pennies per mother. Also, the patient's hands and feet became swollen and red. Hives were first noted around 10:00pm 6/7/07 and were still present when she reported on 6/8/07. the patient ran "low grade fever" after shots on 6/7/07, treated and controlled with Ibuprofen x 2 separate doses. Otherwise the mother states no respiratory symptoms, no wheezing. Patient's main discomfort was itching. Instructed to take child to the ER for exam and to call this clinic with an update.
Tongue lesions with high fever, speeding heartbeat,  stomach pain, diarrhea and skin rash. High fever and high heart rate started approx 12 hours after injection. Fever abated approx 72 hours after. Ongoing high heart rate, stomach pain, rash and tongue lesions, but not life threatening. Lesions and rash appeared approx 48 hours after injection. Similar rxn of fever, rash and lesions with prior Moderna injections. New with Pfizer is heart rate and stomach pain/diarrhea.
sore arm (second injection); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm (second injection)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm (second injection)). At the time of the report, VACCINATION SITE PAIN (sore arm (second injection)) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-076831, MOD-2021-077197, US-MODERNATX, INC.-MOD-2021-077211 (E2B Linked Report).; Sender's Comments:  MOD-2021-076831:Same reporter MOD-2021-077197:Same reporter US-MODERNATX, INC.-MOD-2021-077211:Same reporter
HEART POUNDING; TIGHTNESS IN CHEST; BACK PAIN; SWEATING; SLIGHT CONFUSION; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, environmental allergy (pollen and grass), and dust allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient is athletic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 in total was administered on 13-JUL-2022 to right arm for covid-19 prophylaxis. No concomitant medications were reported.  On 13-JUL-2022, at 12:30 in the morning, patient called his mother and informed that he had tightness in his chest and his heart was pounding and his resting heart rate was 140 beats per minute after waking from sleep. The patient also had back pain. His mother took his pulse again and the reading at that time was 130 beats per minute, after 15 minutes it went down to 120 beats per minute. The patient's body was very hot, sweating and he was slightly confused. His mother took him to the ER (emergency room), where they processed him. Had taken ibuprofen at home, was given acetaminophen on admittance, and an Electrocardiogram was done and the Electrocardiogram showed mild tachycardia. The patient had fever of 101 degree Celsius on admittance to hospital. Duration of hospitalization was 1 day. Hospitalization date and discharge date information was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding on 21-JUL-2022, and back pain, sweating, slight confusion, and fever on 14-JUL-2022, and the outcome of tightness in chest was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220746027 and 20220745936.; Sender's Comments: V0- 20220745839-covid-19 vaccine ad26.cov2.s - Heart ponding, back pain, sweating, slight confusion, tightness in chest.-. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220745839-covid-19 vaccine ad26.cov2.s - Fever. This event(s) is labeled per the agency and is therefore considered potentially related.
asthma, bronchitis; bronchitis; nausea; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma, bronchitis), BRONCHITIS (bronchitis), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006MZ0A) for COVID-19 vaccination.     The patient's past medical history included Polycythemia (Polycythemia vera blood disorder). Concomitant products included HYDROXYUREA and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 04-Mar-2021, the patient experienced ASTHMA (asthma, bronchitis), BRONCHITIS (bronchitis) and NAUSEA (nausea). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) at an unspecified dose and frequency. At the time of the report, ASTHMA (asthma, bronchitis), BRONCHITIS (bronchitis), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: clear (normal) clear. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events also included an unspecified rescue inhaler and steroid.
That night I started to experience high fever, chills and muscular aches, which lasted approx. 24 hours.
Upon waking the morning after the 1st dose, was dizzy and had sweating; Upon waking the morning after the 1st dose, was dizzy and had sweating; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 17Sep2021 at 07:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) 20 mg (milligram) and unspecified oral birth control; both from unknown dates for unknown indications and unknown if ongoing. On 18Sep2021 at 07:45, upon waking the morning after the first dose, the patient was dizzy and had sweating. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upon waking the morning after the 1st dose, was dizzy and had sweating was unknown at the time of the report.
27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter/Source case
Breakthrough case admission after 3 vaccines Pfizer 2/13/21 Lot# El9267;  Pfizer 3/6/21 Lot# EN6206;  Pfizer 11/18/21 Lot# FH8027;
It's ongoing since 12/2022, I have been feeling sick. I have had a fever on and off for the last three months. The doctor referred me an infectious disease specialist. I stopped seeing him because he said he could not help me anymore.  A pulmonologist in March 2023,  looked at my X-ray from December 20222 and diagnosed me with Pneumonia and put me on antibiotics and also told me I had Emphysema. My COPD had become worse. My pulmonologist ordered another chest X-ray I asked him to send it to my PCP. My PCP did not tell me I had pneumonia she put me on antibiotics because I was running a fever of 101 in her office. I have been on antibiotics 3 or 4 times. I do not know if I should go on them again. When I was driving to my pulmonologist appointment, I wasn't it feeling well. I cancelled my appointment. I have been feeling too tired to do anything. I lost confidence in my PCP for not telling me I had pneumonia. I am scheduled to get my lab work on 05/03/2023.
This case was reported by a nurse via sales rep and described the occurrence of fatigue in a adult patient who received SHINGRIX prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced extreme fatigue, as a result fell and broke multiple ribs.
From telephone contact with reporting physician it was stated that a 4 year old male patient received his 5th dose of Tripedia at 11:00 am on 07/31/01. Patient developed swelling of thigh and knees 12 hours later with redness, no pain or fever.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. The patients' pertinent medication, drug reactions/allergies and concomitant medication were not reported. From 01-AUG-2016 to 09-AUG-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M003659 with expiration date 20-SEP-2017; dose, dose number and route were not reported). No adverse effect was reported. This is one of several reports from the same reported. Additional information has been requested.
11/10/2021 I started to notice I had a rash developing midway of my upper arm between the injection site and elbow. After reaching out to my doctor, they stated that this has been occurring with patients that received Moderna vaccines and that it would go away after a few days which it did. My arm was very sore and I was also very fatigued. This all lasted around 3 days post vaccine and then the rash subsided. No reoccurring symptoms to report.
Irritated eyes Itchy throat Dry nose Fatigue Heart felt like it was going to burst at times.
Fever (highest 101.5 degrees F while taking 1,000 mg acetaminophen every 6 hours and 600 mg ibuprofen every 8 hours), body aches, joint pains in knees, severe fatigue
Injection was given in the upper left arm at shoulder area. Swollen upper arm down to my elbow, redness down to my elbow, warmth in upper arm to elbow, soreness down to the elbow, itching down to my elbow, discoloration of upper arm to yellow,  faint feeling and nauseated for 2 hours the day after vaccination, and limited range of motion in left arm. Symptoms began about 1 hour after the injection and lasted 4 days except for the soreness which is ongoing at 5 days.
Body Chills; Body aches; Rash; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 22-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 03Apr2021 at 13:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included patient had known allergies to penicillin allergy and gluten. The patient had received unspecified concomitant medication within two weeks of vaccination. Prior to the vaccination, on an unknown date the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 23:00, the patient experienced body chills, body aches, rash, headache and sore arm. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of body chills, body aches, rash, headache and sore arm was not resolved.  No follow-up attempts are needed. No further information is expected.
Moderna Pediatric Lot# AR4504B  0.5 ml dose was given in error to this patient.  The wrong vial was opened and administered.
Headaches for a week, plus a swollen, sore lymph node under left arm -- the size of a chicken egg -- that grew over the course of a week and a half, then took a few days to subside.
Pt fainted 20-30min p/shots, trembled & fell, hit head; Taken to ER by ambulance; appeared well rt occipital hematoma; refused tests;
Fever of 100.7 and continued fever until seen in office 08/11/2010
The pt developed redness, swelling and tender at DTaP injection site two hours post vaccination.
Two days after receiving vaccine, patient reported an outbreak of pustules to her arms bilaterally and her lower legs, below the knee bilaterally. She also reported general malaise and body aches.
About a month after the 2nd vaccine, I started experiencing periods of feeling faint, chest pressure and weakness.  Initially, this would happen once a week.  Then it started increasing to where this was happening 3-4 times a week.  On July 21, 2021, I was experiencing a bad episode and decided to seek medical care.  The urgent care center thought I was experiencing stroke systems and referred me to the ER.  The ER ran several tests and admitted me to the hospital for possible stroke.  In the end,  it was thought I was experiencing transient ischemic attack.  I thought it was worth reporting.
itchy on face and other parts of body; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3247, expiration date: 31May2021), via unspecified route of administration on right arm on 21Jan2021 at 13:30PM at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient mentioned she didn't have any of the side effects they mentioned on the paper. Stated about two hours later she started to feel itchy on her face and then it became itchy on other parts of her body including her back. Added she had no rash or welts. This continued to midnight. Added she woke up about a quarter to twelve and then fell back to sleep so she thought it was better. She still felt slightly itchy this morning, so she took Zyrtec this morning at 08:00AM and now she felt perfectly fine. Mentioned she would have taken the Zyrtec last night but she took Amitriptyline 10mg at night and didn't want to take them together. She was scheduled for the second dose of the vaccine on 11Feb2021. None of adverse events required a visit to physician or ER. None prior vaccinations within 4 weeks. The outcome of the event was recovered on 22Jan2021.
PROQUAD being administered after an excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, medical history, concurrent conditions, drug reactions or allergies were not reported.  On 03-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 ml, lot #U029319, expiration date: 19-MAR-2023 (anatomical location and route of administration were not provided) for prophylaxis, after the vaccine undergone temperature excursion in -2 Celsius degrees (C) for 1 hour and 12 minutes (on 25-APR-2022) (Product storage error). Previous temperature excursions were as follows: -10 C up to 8 C (7.3C) for 2 hours 37 minutes 0 seconds, and -10 C up to 8 C (0.7C) for 2 hours 56 minutes 0 seconds.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA002581: US-009507513-2205USA002473: US-009507513-2205USA002531: US-009507513-2205USA002678: US-009507513-2205USA002635:
Zoster outbreak right C4-C5 dermatome. Clinical diagnosis 4/24/03.
Migraines that last about three days about twice a month starting the week of getting my second dose.
Patient tested positive for COVID on 11/8/2021 Developed severe respiratory syndrome 2ndary to COVID pneumonia required up to 50L heated high flow oxygen due to respiratory failure Received remdesivir, dexamethasone Was in the ICU. Patient's wishes were to be DNR. Patient placed on comfort care and subsequently died on 11/22/2021