chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 103.6; chills; headache; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Oct2021 18:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Addison's disease" (ongoing). Concomitant medication(s) included: PREDNISONE; FLUDROCORTISONE; FEXOFENADINE. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrum". Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Location of injection: Arm Left , Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 50 years old, for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Location of injection: Arm Left , Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 50 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Oct2021 18:00, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 07Oct2021 08:30, outcome "recovered" (08Oct2021), described as "Fever 103.6"; CHILLS (non-serious) with onset 07Oct2021 08:30, outcome "recovered" (08Oct2021), described as "chills"; HEADACHE (non-serious) with onset 07Oct2021 08:30, outcome "recovered" (08Oct2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was with Tylenol, increased prednisone dose in accordance with sick day rules for Addison's disease. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccine was received in four weeks. The patient did not have Covid prior vaccination. The patient was not tested  for covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
No menstrual cycle since receiving the vaccine. No other health issues going on to cause it. Never missed a cycle before now.
Chills, aches all over including joints starting at 3am on 10/26 No treatment  Symptoms gone by morning of 10/27
01/11/2022: 55-year-old man with known history of end-stage renal failure on hemodialysis.  Patient has peripheral skeletal disease requiring amputation of the right leg.  Patient had cough and shortness of breath.  Patient had yellow to green sputum.  Patient was seen in the emergency room.  Patient was tested positive on January 7-on outpatient basis. Agree with Decadron
Presented via EMS w/ SOB, SaO2 low 80's on RA, AMS. Tx w/ steroids, abx, Vit C, Zinc, Remdesivir.
Information has been received from a physician concerning a 5 year old white female patient with no pre-existing allergies or medical conditions, who on 03MAR1999 was vaccinated SC with a first dose of varicella virus vaccine live. Concomitant therapy administered on 03MAR1999 included a first dose of measles mumps rubella vaccine administered SC, and a third dose of oral poliovirus vaccine. The physician noted the patient had no known illness at the time of vaccination. On 04JUN2003 at 10:00 AM (also reported as 07JUN2003), the patient developed shingles. The physician also described the event as varicella zoster rash to the L2 dermatome. According to the physician the patient was not hospitalized, and no treatment was required. The physician indicated acetaminophen (TYLENOL) was used for pain control. The physician declined participation in varicella zoster identification program due to the lack of lesions for sampling. According to the physician the patient is now "fine" and has recovered (also reported by the physician as 20JUN2003-improving). There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
had nausea, dizziness and went to the ED due to Migraine.. . Her vaccine was 1/12/2021.
- Severe, debilitating headache lasting over 12 hours - Eventually took 600 mg of ibuprofen and was able to sleep; woke the next morning and headache was gone
Description of Incident: We were at School providing a vaccination clinic (6-12 graders) for flu and covid vaccine. Each grade was called separately starting with 6th graders. While doing 9th grade class immunizations, there were 2 boys with the same first name in the same class ? While providing vaccines for patient, the other patient's paper was pulled by this RN and student was given the incorrect vaccines. Patient was signed up for Injectable flu and was given what other signed up for which was nasal mist flu and covid booster. When this RN handed Patient his card to bring home he mentioned that that the name written on the form was not his name, but another student in his grade. This RN apologized extensively. PC to parent to explain situation. This RN also explained measures we will take to prevent this from happening to any other student. Apologized extensively. Explained to mom that according to CDC if a booster dose of Pfizer covid vaccine is inadvertently given for the primary series that dose should not be repeated. This RN states if parent has any further questions she can call this RN.   Plan for future to prevent incident: students coming to vaccination clinic will be asked to recite full name and date of birth before receiving any injections and that information to be verified with what is on consent form. Vaccinators will pause before vaccination to be sure 5 vaccine rights are being upheld (right dose, right route, right patient, right time, right vaccine, right site and right documentation).
her left arm at injection site was itching; Swelling at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (her left arm at injection site was itching), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2021, the patient experienced VACCINATION SITE PRURITUS (her left arm at injection site was itching), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (her left arm at injection site was itching), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) was resolving.            No concomitant medications were reported.  Beginning on 24 December 2021, her left arm at injection site was itching with swelling and redness. Patient stated that she put alcohol pads and peroxide on the injection site area and her arm was getting better.
After injection, while waiting in lobby, patient felt lightheaded and nauseated and looked pale. Vomited once. Appeared to be a vasovagal response and patient was assisted by staff to lie down across 3 chairs. After several minutes laying flat she began to feel better. Sat up in chair and staff provided water and cool damp cloth. She remained for 10 more minutes after which she said she felt much better and color had returned to face. Staff ambulated with her to the lobby and she denied any more symptoms
Sore arm; Dizziness; Feeling so sick to my stomach; Second vaccine hit me with everything; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2023AMR051879).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm), dizziness (Verbatim: Dizziness), stomach discomfort (Verbatim: Feeling so sick to my stomach) and feeling abnormal (Verbatim: Second vaccine hit me with everything). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm, dizziness, stomach discomfort and feeling abnormal were not reported.   It was unknown if the reporter considered the pain in arm, dizziness, stomach discomfort and feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, dizziness, stomach discomfort and feeling abnormal to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051879   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both vaccines the first one didn't affect patient no other way but a sore arm. The second vaccine hit his/her with everything from sore arm to dizziness, and feeling so sick to my stomach.  But patient glad to have gotten them. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR051879:Same patient
12/29 at 12:00PM, febrile seizure that lasted longer than 5 minutes.  Fever continued through 12/30.  On 12/31 at 1:30PM, my daughter turned blue (face and chest).  Approximately 20 minutes later, she had a febrile seizure that lasted 30 seconds.  She was transported to the hospital and diagnosed with Pneumonia.  She was hospitalized for 3 days and put on antibiotics.  She had developed a rash on her back and extremeties in the days leading up to the first seizure.
Pain and hard lump at site of injection, 1 week later pain across shoulder girdle.
Problem with injection, not vaccine.  Tech used VERY LARGE and hollow needle.  She had trouble plunging it into  my (left) arm and I could feel it slicing through tissue.  I gasped as the pain was so extreme and it was all I could do to not cry.  Upon withdrawal, she was shocked that I was bleeding -- drops flowing out of injection site down to my elbow.  She had to ask another tech to help her stop the flow and wipe up the blood drips. That night, throbbing pain in my arm kept me from sleeping and I could not raise my arm without pain  for almost a month.   By the next day, I had a large hematoma.  Injection site continued to bleed internally over the next month.   Developed extensive bruising that kept "refreshing" as injection site continued to bleed internally (pooled red blood that would fade to green only to have more red appear).  Bruising spread to approx. 2.5" wide and 3.5" high.  It has been 4.5 weeks and it is still bruised and tender.  Received dose 2 on 3/14 with no issues or pain whatsoever.  I thought dose 1 injection used a defective needle but medical professional I have spoken to think the tech used a blunt fill needle by mistake.  I was shown a series of needles/sizes and identified the blunt fill one.  I will never forget it!  I was advised to get a COVID antibody test 2 weeks after dose 2 as no one can be sure the vaccine didn't wash out with all the blood.
Pain, swelling at injection site accompanied by enlarged R supraclavicular lymph nodes beginning to involve R cervical nodes. Afebrile, no neuro symptoms, c/o headache.
subjective fever, 3min gen shaking of extremities;on arrival to ER 1125PM-t102.4 exam showed lt OM;6,800;33;260K;52S, 16B, 28L, 2M;blood & urine cult negative;given med;
Since taking the shot I have not had my period. I missed my period in December and I am not sure if I am getting it on January.
INJECTION SITE HARDNESS; FEVER; CHILLS; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced injection site redness. On 10-MAR-2021, the subject experienced injection site hardness. Laboratory data included: Body temperature (NR: not provided) 100.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 11-MAR-2021, and the outcome of injection site redness and injection site hardness was not reported. This report was non-serious.
I have had three doses of Moderna.  Second on 2/24/21 (Lot#042L20A), third on 8/19/21 (Lot#017E21A). This effect began approximately around the first week of August.  I noticed that i could not see the signs in the grocery store.  My vision was blurred and hazy.  I had Lasik surgery 8 years ago, and usually have 20/10 vision.  I went home and used lubrication drops, and it cleared up.  It happened two or three more times over the next two weeks, but again, the drops cleared it up.  Within a day or two of having the third shot, the drops no longer worked, and my vision began deteriorating very quickly.  I could no longer read car tags or road signs while driving.  It was hard to see the TV.  I saw my optometrist on 8/20 for the first visit.  I have subsequently seen him approximately five more times.  I have also seen the Nurse Practitioner at my GP's office and ophthalmologist.  I have had a CT scan of my brain, which was unremarkable.  I had had my A-1C and glucose checked twice, both fine.  My blood pressure has been monitored.  I have had multiple eye scans.   Approximately two weeks ago, I woke up one morning and my close vision was also gone.  The night before I could read my phone, books, etc, reasonably well, and by the next day it was completely blurry and hazy. This has continued.  My visions shifts constantly now throughout the day, and is not stable.  I am wearing one contact in one eye and reading glasses. I believe this is the fourth prescription I've had since this began.
ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND FATIGUED.  LATER THAT EVENING AROUND 7PM THE SYMPTOMS I EXPERIENCED GOT WORSE, POUNDING HEADACHE, AND  CHILLS, AND EXTREME MUSCLE ACHE,.  INSOMNIA AS WELL.  7AM THE NEXT MORNING CHILLS WERE LESS BUT STILL THERE, BUT THE HEADACHE PERSISTED AND THE NAUSEA GOT WORSE.  STILL UNABLE TO SLEEP.  AROUND 3PM HEADACHE SLIGHT AND MILD NAUSEA.  NO CHILLS.  TODAY 2/24/2021 STILL HAVE SLIGHT NAUSEA AND HEADACHE.  BUT MUCH BETTER.
Information has been received from a pharmacist concerning a currently 64 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU, lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014126: US-009507513-1611USA014127: US-009507513-1611USA014128.
Patient received meningococcal vaccine in left arm IM and it was expired. Exp. date 2/4/07. Immpact. and patient notified.
Patient developed symptoms following vaccination late in the evening of the same day but did not specify exactly when.  Symptoms continued through the following day and began to subside the second day following vaccination (Sunday the 22nd).  Patient had body aches and pain, headache, loss of apatite, fatigue which interfered with ADL, and a body temperature of 103 F at highest measured point.  They did not seek clinical care.
I was monitored for anaphylaxis for 1 hour (because of previous allergies) but was ok during that time. About 6 hours afterwards I began to develop very strong symptoms- headache, fever, dizziness, elevated heart rate. By the following day the symptoms were not manageable- heart rate was 180 when lying down, unable to balance well enough to walk to the bathroom, unable to reduce heart rate. I went to the ED at hospital, was given steroids and observed for several hours until my condition was considered stable.  I had previously been exposed to Covid and was under treatment for long term symptoms including dysautonomia and MCAS. The vaccine increased my dysautonomia and MCAS symptoms to much more than they had ever been prior. Prior to the vaccine I did have light-headness and some dizziness, as well as heart palpitations but was never unable to walk and had never had a heart rate that high at rest. I was told that the vaccine might help with long-covid symptoms, but in my case it made symptoms much worse.   Steroids greatly reduced the symptoms, but it took about 4 weeks to return to my pre-vaccine health status.
Swollen lips, numb/tingling lips and tongue, rapid heartbeat  - later sore arm
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age. On unspecified dates the unspecified number of patients was vaccinated with GARDASIL (lot number, dose, route, indication and injection site were not reported). GARDASIL was stored at 29F for 48 and could not be supported. No adverse effects reported. The outcome and action taken were not provided. Additional information has been requested.
Pain at the injection site roughly 14 hours later; This is a spontaneous report from a contactable healthcare professional. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 16:45 in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. On 22Dec2020 06:00, the patient experienced pain at the injection site roughly 14 hours later from vaccination. No treatment was given to the patient for the event. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The outcome of event was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
On 4/7/22 pt had  shingles shot On 4/20/22 pt had Moderna covid booster   in late april, developed weakness in legs. Went on Trip. Was hospitalized. Spinal cord lesions seen there with MOG antibody positive. Got IVIG and is doing well overall now
Onset of high fever - 103.3. Lasted about 24 hours. Severe shaking/shivering. Body aches in lower back and base of head/neck
Unable to stand or move arms, admitted to the hospital due to high risk conditions and inability to care for himself.  On many medications.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125: case (1 of 56 patient)
1 day /p vax mom noted prolonged cry lasting 4 3/4 hrs, placed pt in bath & stopped crying. Cry unusual, was hurt cry. Other symptoms-swelling& erythema < 1" on HIB leg, HIB leg pain to touch @ 24 hrs, pt irritable & tired, T 99.4, DX:fussy
10/03/2021 a head ache, tired and fatigue, loss of energy, series of cold like symptions, stuffy, body aches, tired and sore throut, 10/04/2021 - 10/05/2021 from head and throught to running noise and low grade fever and took over the counter medication. Break through case of COVID  10/05/2021. Quartine and care protical was provided. Still recovering slight cough and headache.
Headache and dizziness hours after shot. Body aches / muscle pain next morning at 6am. Headache all day the day after shot. Fatigued since shot was administered.
Mom reports received routine vaccines for her 12 month old daughter on 4/14/2016. Varicella (MSD lot L013067) to right thigh SQ and MMR (MSD lot L002873) SC left thigh and Hep A (SKB lot X22P4 and influenza quad pres free (SKB lot U5320AA) IM to left thigh. Approximately 4/23/15 (day 9 after vaccination) she developed a spot to right thigh varicella immunization site. Over next 24 hours it progressed to a large hard knot that was red and TTP. She had a fever of 101.5F. Mom denied any other symptoms (loss appetite, irritability, SOB, anaphylactic like symptoms, etc). on 4/25 she developed a generalized red macular rash all over body and was seen by HCP on 4/26/16. HCP noted rash first on abdomen then chest and face described as one firm nodule to right thigh not TTP or warm; multiple erythematosus papules to abdomen, back, chest legs and cheeks that blanch to touch, with T 97.6 F rectally. No other symptoms/exam nl. Diagnosed with mild pruritic rash and nodule to right thigh s/p immunization - rash unknown etiology and referred to clinic. Px ZYRTEC and topical hydrocortisone cream. 4/28/16 child doing well and playing happily with siblings w/o fever and rash is resolving - less red per mom.