chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; This is a spontaneous report from a contactable consumer (patient) received through.  A female patient of an unspecified age received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. on an unspecified date the patient experienced sore throat. Caller schedule for second dose wants to know if it is okay to take the second dose. The event outcome was unknown.  Follow-up attempts completed. No further information expected.
I received the fifth dose of the Pfizer Bivalent vaccine on 09/20/2022 and I started to experience symptoms of COVID-19 on 10/14/2022. I tested on 10/16/2022 for COVID-19 and the test was positive. I've also experience hives/rash around my lips and face. I was prescribed PAXLOVID for COVID-19 and it has helped a little, but I am still extremely fatigued.
Fever, blister like rash 15-16 days post 1st dose varicella vaccine.
Patient received immunization 2/22/08.  On 3/3/88 patient developed vomiting and diarrhea.  Admitted to the hospital 3/5/08.  Barium enema revealed intussusception.  Unable to reduce in radiology, taken to the operating room for surgical laparoscopic reduction.  04/07/2008 MR received for DOS 3/5-7/2008 with D/C DX: Intussusception.  Laparoscopic reduction of Intussusception.   Infant presented to hospital with bilious vomiting and one bout of hematochezia, decreased activity and very sleepy. Pt was recovering from a recent respiratory infection which was improving on abx.  PE(+) for palpable bowel loop in RLQ, (+) abd tenderness, mild to moderately dehydrated and fussy. Intussusception seen on Barium Enema but unable to reduce.  Taken to OR for a Laparoscopic reduction of IS. A small serosal tear was identified on the terminal ileum.  Tolerated surgery well and d/c on  POD #2.
left arm was tingling; numb feeling all the way to fingers; pain in arm down to her finger  joints; pain in arm down to her finger joints; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ES1685, via an unspecified route of administration in the left arm, from 08Jan2021 12:45 at a single dose, for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), dairy intolerance and perfume sensitivity. The patient's concomitant medications were not reported. On 08Jan2021 13:15, a half hour after the vaccination, the patient experienced that her left arm was tingling, a numb feeling all the way to fingers; it lasted about one hour after it came on, but now she have pain in arm down to her finger joints. The outcome of events was reported as recovered with sequelae. No treatment was received/given due to the events.  No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Patient developed  feverishness 2 days following  vaccinationfollowed by neck pain 4 days following  vaccination. this was then followed by significant shoulder and hand synovitis.
after 5 minutes of initial shot had 5 minutes of severe stinging followed by redness, heat and swelling which lasted few days......on 8th day, began itching badly. was trying to only lightly rub spot and not scratch. began spreading redness, swelling and heat. On 9th day, redness was about 3" x 5" patch at its worse. it slowly went away after several days. I was asked to "report" this by a professional.
Bilious vomiting started 2/12/16. Presented to ED 2/14/16 and diagnosed with suspected intussusception. Transfered to another hospital with ileocecal intussusception reduction performed in OR.
This 17 year old who returned for Pfizer booster was given a Moderna COVID vaccine in error by a medical assistant student who was volunteering at vaccine clinic. No adverse reaction occurred during monitoring period. Error was not discovered until data entry staff where documenting vaccine and brought to my attention.
Moderna COVID-19 Vaccine EUA 5-10 minutes after receiving the vaccine the following symptoms were experienced:  Dizziness, weakness, brain fog, breathing difficulties, lowered O2 saturation, nausea, elevated BP and elevated / thready pulse. O2 was administered, I was placed in a response room and monitored by staff nurses (RN and LPN's)  MD checked on progress.  O2 saturation returned to 100% after 15 minutes and an EPI pen was determined to be not required.  Walked out of the hospital 2 hours after administration of the vaccine.
Fever, weakness, pain in body, heart palpitations, vomiting and diarrhea. Fever 100 next day worst symptoms.
Experiencing soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Experiencing soreness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Experiencing soreness). At the time of the report, VACCINATION SITE PAIN (Experiencing soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: 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.
Hoarseness to voice, bilateral periorbital edema, tightness in neck/throat, chest pain and pressure, exercise intolerance.
Pt presented 6/6 w/redness, swelling and warmth at the injection site. Pt went to PCP 6/6 and was diagnosed w/an allergic rxn no vaccine. She was treated w/hydrocortisone cream, BENADRYL, ALLEGRA and cold compress. Pt also given KEFLEX for use if fever presented.
Tested positive on June 1st . Symptoms lasted for  11 days . Experienced nasal congestion, headache, fatigue, a slight sore throat and cough, one episode and diarrhea.
Pt states noted swelling, redness, soreness at injection site (R) arm morning after receiving shot - VZV vaccination - increasing to about 4" hard red area - rash (red) under side of arm - elbow up mid arm. No pox, warm to touch - lymph node enlarged inside (R) arm, still swollen to elbow Friday 11/9/07 - some tingling in (R) finger ? due to swelling at elbow.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 31 and R; 112, 30 and R; 24, 32 and R; 104, 33 and R; 72, 29 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This particular patient has a past medical history of multiple sclerosis. She has been on Copaxone injections for many years without issue. She recently received the COVID19 vaccination. Upon injecting her Copaxone about 3 weeks later (after her COVID19 vaccine), she developed rapid onset vertigo afterwards. This has never happened while taking Copaxone. This lasted for several minutes and she even fell down. Of note, about 3 weeks after her second COVID19 vaccination, the patient experienced this same vertigo post-Copaxone injection. She believes that it was related to her COVID19 vaccination because of the similar timeline post-COVID19 vaccine injection.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-OCT-2015 09:22, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.9 and 1.6 (5mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sore arm; sore shoulder; This is a spontaneous report from a non-contactable pharmacist (patient). A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration, administered in left arm on 06Mar2021 at 16:00 pm (at the age of 29-year-old) as dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included Hypothyroidism from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included (within two weeks) Junel and Levothyroxine for unknown indication from an unknown date and unknown if ongoing. Prior to vaccination, patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient administered no other vaccine four weeks prior to vaccination. It was reported that on 06Mar2021 22:00 patient experienced Sore arm and Sore shoulder. Patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
arm swelling at injection site and soreness, followed by that evening fever to 100.2 , bp 140/80 pulse 85. (usually bp around 120/80 with 60 pulse, really bad headache, skin sensitivity,  significant fatigue,  unable to sleep well, chills lasting until Monday  morning 9/23/19.  As of this report right arm at injection site is still very sensitive to touch and when flexing muscle.
Red rash, itchy, very warm arm surrounding injection site. Spread out approximately 4 inches.
Shoulder blade pain with sharp pain that feels like it is on fire. Hurts to do daily activities (i.e. carry cup, extend arm, lift anything). Have tried Ibuprofen 800 mg, heat patch, and heating pad with no improvement. Ongoing all day since 2.14.21
12/11/2017- office visit for rash- generalized rash- pink to red 1-2 mm macular papular rash; all other systems in exam were within normal limits. Diagnosis of echovirus. 12/12/2017 early am- ER visit at Hospital- ER physician agreed with PCP with diagnosis of echovirus.
The pt experienced a fever 1 week prior to onset of rash. The pt developed red lesions - formed vesicles and scabs.
After the expiration date of 27Apr2021, about 180 patients received the vaccine between that date and 16Aug2021.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date of 27Apr2021, about 180 patients received the vaccine between that date and 16Aug2021.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B12A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date of 27Apr2021, about 180 patients received the vaccine between that date and 16Aug2021.). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date of 27Apr2021, about 180 patients received the vaccine between that date and 16Aug2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   42 cartons of Moderna COVID-19 vaccine were received on 27-MAR-2021, which were placed in refrigerator at a temperature of 7.5°C on 28-MAR-2021 and thus it was viable for 30 days.  No concomitant product information was provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Suspect drug Lot number, temperature details were updated. On 30-Aug-2021: Follow up received and contains no new information. On 30-Aug-2021: Follow up received and contains no new information. On 30-Aug-2021: Reporter's contact number and  the temperature range was 7.5°C for the refrigerator were added.
24 hours after immunization, Left arm red,swollen and is painful and itchy. Left upper arm redness and induration(7cm). Slightly tender. Treatment: cool compresses, analgesics. recheck PRN
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 13-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# L011083, expiration date, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
The injection was given on 03/03/21. The next day, 03/04/21, I woke up from sleeping to have my middle left finger's first joint above the fingernail bent downward; appears to look like osteoarthritis; however, I have no arthritis elsewhere. My fingernail is now bent inwards into the skin such as ingrown toenails do. It's painful, hard to use, and has never gone away. I think this synchronized with the COVID-19 vaccination. My Dr. already knows about this as I showed him. Arthritis is an autoimmune disorder and the vaccination "hits" the autoimmune system as well.
Mom says that 1 day post vax infant screamed for 3 days & 3 nights about 2 wks later she called MD & recommended DT for next immun;
Fever 101.6, chills, sweats, nausea, muscle aches and pain, exhaustion,swollen itchy red ears, hives all over body
patient started having seizure like activity.  nursing staff noticed her having jerking movements, started triaging patient.  Patients regular nurse for the day stated she had been acting off for the last few days.  Patient was not very cognitive when addressing her before giving her the vaccine which is not unheard of as she was on Memory support hall.  Patient was removed from the room and nursing director was going to get in touch with patients family to see what they wanted to do going forward.  Patient did become somewhat verbal but for only seconds at a time.
MMR, VZV given on 1/9, patient developed rash on 1/18
Caller stated that 10 hours after she got her vaccine she started to have a severe headache, nausea, abdominal pain, weakness and shortness of breath. Stated all symptoms but the weakness and shortness of breath have resolved
Per mom possible reaction to flu shot-(R) arm swollen, hot and itchy-no fever.
Information regarding PREVNAR was received form a consumer regarding a 4-month-old male patient who experienced broke out all over with a rash. The patient received the second dose on an unspecified date. The reporter noted after her son's second PREVNAR dose, he broke out all over with a rash. The patient's outcome is unknown. No additional information was available at the time of this report.
Pt recieved the Pfizer Monovailent and should have recieved the third dose as the Bivailent
I started off getting chills and crams around 8:30 AM, which got progressively worse. As the muscle cramps got works I started to feel hot and tired. I laid down and fell asleep. When I woke up I was starting to feel better and took my temperature, about 12:30 PM. My temperature was 100.2 at that point. I'm now feeling even better and my temperature is down to 98.9.
On the fourth day following the injection I started to experience significant head pain along the left side of my head behind my left eye and  along the area of the trigeminal nerve.  I know it was the trigeminal nerve because I had a shingles flare up on the same side of my head along the trigeminal nerve approximately 11 years ago.  As before there was no significant external rash.  11 years ago a very slight rash appeared on the left side of my forehead above the eye.  On the morning of the fifth day after injection, the headache was less severe, but the skin around my left eye was red and swollen.  I have been taking Advil for headache pain because I am still experience headache discomfort in the area where I had shingles 11 years ago.  It appears that the vaccine may have triggered a flare up of the dormant virus or is generating vestigial pain along the trigeminal nerve.  My doctor prescribed  Valacyclovir on the sixth day after the vaccine administration.  I am still experiencing a dry cough.  I received the Pfizer Covid vaccine in February and March of 2021
Pt reports temp of 104.3 degrees F, headache, weakness onset this evening.  Also c/o SOB + wheezing.  Treatment - Ventolin.  No acetominophen or NSAIDS due to allergy.  Fever + symptoms resolved by morning.  Denies any local reaction @ injection site.
Shingles-like rash appeared 12 days post first COVID vaccination; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shingles-like rash, 12 days post first COVID vaccination. The outcome of the event was unknown.  Information about lot/batch number was requested.
No adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    This case contains information for the 12 of 16 patients described by the reporter. No concomitant medications were reported. It was reported no adverse event reported on any of the patients involved. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
We had five ped patients that received the PENTACEL. Out of the 5 patients one patient didn't receive the reconstitute ACTHHIB.
This spontaneous report as received from a registered nurse refers to her daughter, a 15 year old female patient. No concomitant medications, pertinent medical history, drug reactions or allergies were reported. On an unspecified day in October 2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route of administration were not provided) for immunisation. It was reported that the next morning, the patient broke out in hives from head to toe. The nurse gave her daughter a dose of BENADRYL and took her to pediatrician. The patient was prescribed prednisone (manufacturer unknown). No diagnostic laboratory tests were performed. The outcome of the event was reported as recovered/resolved. Hives resolved within 48 hours from the start of prednisone (manufacturer unknown). Causality was not provided. Additional information is not expected as the reporter did not wish to be contacted.
mom report one child recv vax 8AUG95 & another not vax devel chickenpox 15SEP95;also another child who was not vax w/varicella vax devel chickenpox 29SEP95 (WAES95101328);f/u info from MD indicated that pt did not devel chickenpox
Iscemic stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jul2021, for COVID-19 immunization. The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "Iscemic stroke". Therapeutic measures were taken as a result of ischaemic stroke.  Clinical course: Patient was fit and healthy. Patients employer required patient to take the COVID vaccine in Jul2021. Patient was given two doses of the Pfizer vaccine. Patient suffered an iscemic stroke just after the holidays. Patient did not know if it was related. Now patient had to take medication and rehab. Eliquis was one of them. The cost was extreme for supposedly lifesaving Rx. Patient mentioned patient would have preferred getting COVID again than a stroke. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dose expired on 15-may-2022 and was administered on 24-may-2022.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 24-May-2022 Reporter's Comments: The health care professional reported that the Havrix expired and was administered to the patient. The reporter asked how to proceed. No reactions reported. The reporter consented to follow up.  Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.