chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a program. A contactable consumer (patient) reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 27Jan2021 (Batch/Lot number: EL926S, as reported) (at the age of 68 years old) as dose 1, single; and via an unspecified route of administration, administered in right arm on 04Mar2021 (Batch/Lot Number: EN6206) (at the age of 68 years old) as dose 2, single for COVID-19 immunisation. Medical history included kidney transplant performed on 29Dec2015, ongoing diabetes, and hypertension (both diagnosed about 15 years ago). There were no concomitant medications. No prior vaccinations (within 4 weeks). The patient experienced fully vaccinated and admitted to the hospital with COVID-19 on 17Jul2021, she received her Pfizer-Biontech COVID-19 vaccine doses in Jan2021 and Feb2021. She reported a history of COVID infection on 17Jul2021. The patient was hospitalized from 17Jul2021 to 21Jul2021 for 4 days. The patient stated that she was treated with an infusion that she can't pronounce. Event required a visit to Emergency Room and Physician Office. She and her husband were both fully vaccinated and admitted to the hospital with COVID-19. She was admitted for about 4 days and her husband, who had several symptoms, was in the hospital for about 3 weeks. She presented to her local pharmacy, yesterday, for the 'booster dose' but was denied. The pharmacist told her she had to wait 90 days after the infusion. She wanted to know why and when can she get her booster dose. The patient underwent lab tests and procedures which included COVID-19 test positive on 17Jul2021. The outcome of the event was recovered in Jul2021. On 17Aug2021, additional information from product quality included 17Aug2021 11:36 AM added ID-052326. Based on reporter providing lot number as EL926S it is not clear if the lot number is one of the ones provided above or EL9265. Added lot number EN6206 to product grid above. 17Aug2021 11:15 AM added ID-052326: Duplicate received in ID 6240336: Description of complaint: Hospitalized with Covid 19 after both doses of Pfizer Covid 19 Vaccine. Additional lot numbers: EL926S, documented as provided by the caller, EN6206. Processing for additional lot number provided in duplicate. Added AER#.16Aug2021 05:17 PM initial Product Name: Pfizer Covid 19 Vaccine NDC Number: Not Provided. COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot # EL9262 (as reported)".  Follow-up attempts are completed. No further information is expected.
No additional AE; PROQUAD being administered to a patient over age 12; This spontaneous report was received from a medical assistant and refers to a patient over age 12 of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection (product administered to patient of inappropriate age), 0.5 milliliter, lot #W016356, expiration date: 16-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event (AE) was reported.
Hepatitis B antigen positive  This case was reported by a nurse to a sales representative and described a neonate subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) and subsequently tested positive for hepatitis B antigen.  On 07 February 2006 the subject received a dose of Engerix-B (dose number and lot number not provided). "Approximately one or two hours later," on 07 February 2006, the subject "tested positive" for hepatitis B antigen. At the time of initial reporting, 08 February 2006, the event was improved.
Patient reported (1) Flu-like symptoms (2) sharp pain radiating down limbs (3) Hot/sweaty (4) Chest pains and (5) Crying from pain.
Children received DTaP and HEP A (L) thigh, IPV, Varicella (R) thigh and MMR (L) deltoid. Came back 2 days later with redness, swelling and blisters surrounding injection site. Received Abx.
On December 26, 2022, he woke up with a cough, congestion, lack of appetite, and lethargy. We didn't test him for COVID-19, but both parents tested positive for COVID-19. It was assumed he was positive for COVID-19, too. He vomited once and had painful gas that prevented him from sleeping. His symptoms lasted approximately five days.
Headache, Joint Pain, Eye Muscle Pain, Skin Sensitivity, Injection Site Pain. The joint pain and injection site pain lasted roughly two days after the vaccination. All other symptoms still ongoing as of two and a half days after vaccination but with less intensity than the first two days.
Given to 18 yr old. Wasn't aware that 18 yr old was to be given pediatric dose.
This spontaneous report as received from a register nurse via company representative refers to an unspecified group of patients of unknown age and gender. The reporter stated that on unspecified dates all patients received GARDASIL one injection annually or yearly for a series of three (dose number, dose, lot number and expiration date were not provided). Additional information is not expected, because reporter refused additional contact.
Hospitalization: PT WITH SOB, FATIGUE, LIGHTHEADED OVER PAST MONTH. STATES NAUSEA, NO VOMITING/DIARRHEA/FEVER.   SYMPTOMS STARTED AFTER 1ST COVID VACCINE, IMPROVED AND RETURNED AFTER 2ND COVID SHOT ON 4/9
Per student's mother, he felt "slightly confused" about 1 hour after the vaccination and it continued at home until about 6 PM. Mother states "it was not necessary to call his doctor because it ended at dinner time and he was fine."
12 hours after receiving the vaccine the patient developed a very large hive at about 1 inch below the injection site. Mother took him to the closest clinic and was told to use BENADRYL or ZYRTEC for what was diagnosed as a Urticaria.
Severe ringing in the ears since 3rd booster shot was given and has gotten worse daily.
The immediate effect was rapid heartbeat and felt extremely hot.  Then almost passed out.    During the next two weeks after the 2nd dose I continued to have where the heart had extreme rates.   Then also I could not swallow for days upon days.  It would come and with extreme heart rate.   I would get very what felt like warm sensations throughout the whole body.     This has continue where evon 9/24/2021 three weeks after the second dose the heart rate and heat sensation occurred.
Erythema Nodosum, both knees/legs.  Red, swollen bumps.  Hot to touch, painful.  Bruising and swelling
>Increasing size of red/irritated skin around injection site. First two days after injection, was about the size of a quarter. About the diameter of a soda can this morning (Saturday--received the injection on Wednesday).   >Periods of abrupt and intense vertigo--as if the entire world begins violently spinning on an axis. Lasts 15-40 seconds then sensation of rotation slows down and gradually stops.   >Bouts of nausea that are not always related to the vertigo.   >Increased swelling/soreness in upper arm where injected.
stomach cramps, nausea, diarrhea for 3 hours from 9am to 12 noon; abated without treatment
not feeling well; aches; 102.4 fever; have a headache that she can't get rid of; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling well), PAIN (aches), PYREXIA (102.4 fever) and HEADACHE (have a headache that she can't get rid of) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced FEELING ABNORMAL (not feeling well), PAIN (aches), PYREXIA (102.4 fever) and HEADACHE (have a headache that she can't get rid of). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (not feeling well) outcome was unknown, PAIN (aches) was resolving, PYREXIA (102.4 fever) had resolved and HEADACHE (have a headache that she can't get rid of) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine (received at the age of 60 years). Concomitant products included calcium carbonate, vitamin d (Calcium With Vitamin D), ciclopirox olamine (Ciclopirox), thyroxine sodium (Levothyroxine), magnesium hydrogen aspartate dihydrate (Magnesium), polyethylene glycol (Miralax), propranolol hydrochloride (Propranolol), cyclosporin (Restasis), simvastatin, acetylsalicylic acid (Baby Aspirin), curcuma longa (Turmeric), raloxifene, zolpidem and mesterolone (Restore). On 30th April 2018, the patient received the 1st dose of SHINGRIX. On 9th June 2018, 40 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she received the SHINGRIX vaccine late in the morning and she was diagnosed with a very mild case of shingles a couple of days ago. The shingles presented itself on her upper right arm and above her right wrist and there are a couple of spots on the base of her thumb on her hand. The patient's physician claims that the case was very mild and possibly a case of shingles but they are treating her accordingly.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 17-year-old female patient received TRUMENBA, HPV vaccine, and varicella zoster vaccine, via unspecified routes of administration on 01Aug2018 (at approximately noon) at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bad headache around 3pm (reported as today) along with some chills on an unspecified date in Aug2018. Per nurses instruction, the patient was given ibuprofen and was resting. Outcome of the events was unknown. No follow-up attempts are possible; information about the batch number cannot be obtained.
This spontaneous report was received from a pharmacist regarding an approximately 70 year old female patient (reported as in 70's now). Pharmacist stated that patient also reported that she had multiple cases of shingles prior to vaccination. No information about drug reactions and allergies was specified. No concomitant medications were reported. On an unknown date, more than five years ago, the patient was vaccinated with ZOSTAVAX (lot #, dose, route not reported) and immediately post vaccination she developed a mild case of shingles. No VZVIP packet sent as reported case of shingles was more than 5 years ago. The pharmacist asked whether a booster was recommended. There was no product quality complaint with ZOSTAVAX. The outcome of mild case of shingles is unknown. The causality of the event was not specified by the reporter. {Additional information has been requested./Additional information is not expected.}
Info has been received from a physician concerning an adolescent pt who was vaccinated SC, with a 1st 0.5 ml dose of varicella virus vaccine live. It was reported that the pt experienced breakthrough varicella. It was noted that the pt did not appear to be sick. The pt may have had a slight fever. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Swollen face, blister under eye (mostly right side), chills and fever, and muscleache.
Menstruation cycle abnormal since second dose of Moderna vaccine. Since February, cycles have been heavier and cramps more painful. Menstruation time period is normal (5-7 days), breast tenderness/enlargement worse than before. Heavy days have increased. Cramps will wake me up in the middle of the night. Nausea and hot flashes also occur now. Cannot exercise/run during cycle due to cramps becoming so severe I'm doubled over in pain until it subsides. Ibuprofen continues to help, though it feels like I take more than usual. This will be cycle number 4 post Moderna vaccine where periods have been noticeably different than before.
Pt. Noticed rash on antecubital area of both arms - worse on Left (vaccine side) then he felt flushes, his face turned slightly pink. Code called. Paramedics arrived. Waited extra 15 mins & walked out with no issues.
is having headaches; This is a spontaneous report from a contactable consumer (patient's grandchild) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on an unknown date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after first dose, patient started to have headaches. Reporter inquired whether patient could take Tylenol for event. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient (13 years old) was inadvertently given the Moderna Covid-19 shot although it is not indicated for use under the age of 18.
This spontaneous report was received from a consumer and refers to a female patient of unknown age, who was reporting on herself. The patient had no pertinent medical history or any known drug reaction or allergies. Concomitant therapy included thyroid medicine and a water pill. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX, 0.65 milliliter (ml) injection, (route of administration, lot # and expiration date were not reported) to prevent shingles. On an unknown date reported as ''over 2 years ago'', the patient began to occasionally break out in little red dots that last for 2 or 3 weeks and then go away. The spots hurt but they did not itch. The patient's doctor told these spots were not shingles. On unknown date in 2017 reported as ''a little more than a tear ago'', she began experiencing hearing loss and the patient's hearing loss was getting worse. The patient had 2 or 3 hearing tests this year and she would need a special high powered hearing aid. On unknown date, the patient had once taken an unspecified antibiotics that ''starts with E'' and that hurt (her) stomach. The outcome of hearing loss was reported as not recovered. The outcome of little red dots/spots hurt was not recovered also reported as ''the patient did not specify if she at the time of the report has any red dots appearing on her body''. The outcome of hurt stomach was unknown. The causality assessment between the ZOSTAVAX and the events was not provided. Upon internal review, the event of hearing loss was considered to be medially significant.
papulovesicular rashes scattering over the trunk, face & extremities;Augmentin;strep group A & Reye's synd orientation;isolation;dx varicella;
Generalized Convulsive Seizure x 45 seconds on 4/21/22 @8pm
miss the second dose on 17Mar2021; he fractured his ankle; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program.  A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 24Feb2021 (at the age of 79-years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Feb2021 (same day of vaccination), the patient fell down a flight of stairs and broke his ankle. The patient was scheduled to get the second dose on 17Mar2021 but unfortunately, he fractured his ankle which required him to undergo surgery and miss the second dose. Patient would like to know when to get the second dose of the vaccine and asks if he would need to restart the vaccination series due to the incident and if not, how long would he have in between the doses to receive the second vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left arm pain, swelling and redness at injection site x 3 days. Patient with left upper arm swelling and redness for 2 days. She had PNEUMOVAX on same arm at 2 PM and her symptoms started around 6 PM. Her whole upper arm was swollen and was difficult to even raise the arm. The swelling has improved, but redness is worse. She has applied ice and heat.
Single kidney(loss to cancer); Single kidney(loss to cancer); This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (Single kidney(loss to cancer)) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Chronic kidney disease.   On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form On an unknown date, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Single kidney(loss to cancer)) (seriousness criterion medically significant) and SINGLE FUNCTIONAL KIDNEY (Single kidney(loss to cancer)). At the time of the report, NEOPLASM MALIGNANT (Single kidney(loss to cancer)) and SINGLE FUNCTIONAL KIDNEY (Single kidney(loss to cancer)) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient had 3 Moderna shots and 1 shot for Season's Flue. No treatment information was reported.  Company comment:  This spontaneous case report concerns an 82-year-old male patient with medical history of Chronic kidney disease, who experienced serious (medically significant) unexpected event of Neoplasm malignant and non serious unexpected event of Single functional kidney. According to current available information, it was only provided that the patient had cancer and that due to cancer the patient had only single kidney. It remained unclear when the reported cancer occurred and whether it was actually part of the patient's medical history or it occurred after vaccination, since no dates were provided. At the time of this report, the company causality for the event of Neoplasm malignant and Single functional kidney is assessed as not related to the mRNA-1273.222 vaccine, having in mind that until this date, there is no evidence to suggest that mRNA-1273.222 vaccine had oncological potential. In addition, as per provided information due to cancer, the patient had single kidney due to cancer loss. The patient's elderly age remains a confounder. Case will be re-assessed upon receipt of additional information. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live followup received contains No new Information.
This spontaneous prospective pregnancy report as received from a physician refers to a 17 year old female patient. The patient's pertinent medical history and concomitant medications were reported as none. The patient was allergic to clindamycin. On 22-JUL-2016 the patient was at 5 weeks gestation was vaccinated with first dose of GARDASIL 9 (dosing details were not reported) intramuscularly. The reporter stated that the patient was with an adverse event while on GARDASIL 9 therapy. The reporter stated that patient after receiving her first dose of GARDASIL 9 injection today, 22-JUL-2016 after which she discovered that she was pregnant. The LMP (last menstrual period) and EDD (estimated date of delivery) were not known. The outcome of pregnancy was not known. Patient sought medical attention. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown demographics. On multiple unspecified dates, the patients were administered improperly stored with ROTATEQ (K004795; 11-FEB-2016). Other suspect therapies included GARDASIL (J006236; 25-FEB-2016; K005881; 14-JAN-2017) and RECOMBIVAX HB (K010535; 27-AUG-2016) (dose, route unspecified). No adverse effect reported. It was reported that during her previous call on 10-AUG-2015, the same nurse also inquired about the stability of a particular lot number and expiration date of M-M-R II (J016235; 19-DEC-2015), but none of that particular M-M-R II, was administered and was included in this AE. In addition, this nurse also inquired about the stability of another lot number and expiration date of M-M-R II, (K012473; 26-AUG-2016) on her call from today (09/09/2015); however, this particular lot number and expiration date of M-M-R II did not under go a temperature excursion and is not included in this AE. No further information was provided. Additional information has been requested.