chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just a fever for one day; This is a spontaneous report from a contactable consumer. This Consumer reported for a patient (reporters' husband) that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced just a fever for one day on unspecified date in 2021. The outcome of the event was reported as recovered on unspecified date in 2021.
swelling & puffiness of hands & feet x 24 hrs; p/combined vax administered; no fever, not cranky, feeding well, no sacral or periorbital edema, no change in urinary pattern; gradual resolution by 72 hrs post vax;
pt recvd 3 injects for Hep B & 1st 2 inject were Recombivax & the 3rd was Engerix-B; 2 days following the 3rd dose pt devel redness, itchiness & swelling from head to toe; pt is 90% recovered;
pt states 2-3 hr p/vax felt bad, hot, sweaty, fever 101-102;achy all over;did not report until time for next inj;
Fully vaccinated individual, hospitalized on 9-20-21 for COVID. Passed away 9-24-21.
PATIENTS AIRWAY WAS CLOSING COULDN'T BREATH, USED EPIPEN THAT SHE HAD AT HOME THEN WENT TO ER.
rash reportedly urticarial w/in 12 hrs, irritability; tx in ER;
Fatigue, headache, body aches, joint pain, chills.  Felt better after 12 hours of sleep.  Still have some fatigue and body aches on 03/22/2021 at 3:30 PM.
I have had nonstop headaches since the moment I received the vaccine. This has never been a problem before.
This spontaneous report was received from a physician via a company representative refers to a 93 year old female patient. The patient's current condition included allergy to BACTRIM and sulfa. Approximately on an unknown date in 1994, reported as approximately 20 years ago, the patient was vaccinated with PNEUMOVAX23 (lot number, strength, dose, site of administration and route of administration were not reported). There were no concomitant medications reported. On an unknown date after receiving PNEUMOVAX23 the patient's arm swelled up. The swelling was not only at the injection site. On an unknown date the physician performed unspecified diagnostic tests to rule out infection and the patients arm was found to be negative for infection. The patient sought medical attention by visiting physician's office. There was no product quality complaint (PQC) involved. The outcome of arm swelled up was unknown. The causality of the event was not provided. Additional information has been requested.
Moderate to severe headache, chills, and fatigue every day for 9 days for which I took acetaminophen at least once daily. Irregular non-period related bleeding the day after the vaccine. Redness and swelling at the injection site for about 3 days beginning August 14th.
under 18 years old patient received the first shot of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old patient received the first shot of the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old patient received the first shot of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old patient received the first shot of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments..
Patient stated that about 15 to 20 minutes after receiving the vaccine, she noticed a bruise on her left hand that she did not notice before. She stated the bruise did heal, and she did not report the same reaction after the second dose.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 04-DEC-2014, the patient was vaccinated with a dose of M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Chronic severe headache all day 24/7 Dizziness comes and goes more often
2 patients administered dose from vial greater then 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients administered dose from vial greater then 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021 at 12:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients administered dose from vial greater then 30 day use by date). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 patients administered dose from vial greater then 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided. Date the vial was initially stored in the refrigerator: 30Aug2021 at 8:45 pm   Reporter did not allow further contact
This spontaneous report was received from a healthcare professional regarding unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. The reporter stated that since 01-OCt-2015 till December 2015, unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) lot # L024122 expiration date 30-DEC-2016 (route, site of administration, dose unknown). The vaccine was stored at unknown temperatures exceeding 46 F for an unspecified duration. There was no previous temperature excursion. This was not part of any digital data logger. The reporter was not aware of any adverse effects. This is one of the several reports from the same reporter. Additional information has been requested.
This is an initial spontaneous report by a contactable consumer. This male consumer (age unknown) was administered with PREVNAR 13 unknown dose intramuscular vaccine unknown frequency on arm on 18Jul2012. Relevant medical history included high blood pressure and it was unknown if he had recovered from it. Vaccines given on the same day was unknown. Vaccines taken within the last four weeks were unknown. Relevant concomitant medications included unspecified medication for high blood pressure and it was unknown if he was still taking this medication. On 18JUL2012 while on PREVNAR 13 unknown dose unknown frequency he experienced soreness in arm. On 19JUL2012 while on PREVNAR 13 unknown dose unknown frequency he experienced headache, chills, overall soreness, was lethargic and had no appetite. Relevant lab data was unknown. At the time of report it was unknown that he was administering PREVNAR 13. At the time of report he had not recovered from the above mentioned events.
Migraine headache...2 weeks so far. Have been given  Sumatriptan 50mg...It will relieve the symptoms some, but the headache never fully goes away
Worsening shortness of breath that progressed to at rest. Worsened by activity, lying flat, eating or bending over. Over the course of about 4-5 months the symptoms improved but left me deconditioned.
Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: SWEATING
Rcvd call from pt. wife stating husband c/o sore throat and one side of his tongue is sore, being tired and that injection site is swollen and warm and is about quarter-sized.  Wife is unsure as to whether tonge soreness is on same side as injection as husband is out fishing.  Wife states, "I guess he can't feel too bad.".  Wife verifies that husband is able to eat normally, uses hand without a problem.  Recommended cold pack on injection site.  F/U call on 4/22; no answer, left msg.  4/23/09 8:52am Rcvd. voice mail from pt.; he states "It's all better now.  Got up this morning and everything was fine."
This report described toxic effects of mercury in a 24 month old male who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. He received injections of Engerix B on 1/27/00 (lot ENG3074A2) and 5/2/00 (lot ENG3084A2). He also received injections of Tir-Immunol 8/4/98, 9/28/98 and 12/4/98; Hib-Titer 12/4/98; Act HIB 1/7/00; Tripedia 1/7/00. The subject's attorney alleged that "at approximately between 24 and 36 months of age, the subject was neurologically devastated by the accumulation of mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to, inability to speak, unresponsive to his environment, and initial loss of language skills, motor skills and effect." Treatment and outcomes of thee events were not reported. The toxic effects of mercury and developmental regression in this report are considered medically serious (OMIC).
Pt reports redness & swelling shorly after injection given. Reddened and swollen area is just distal to left deltoid and measures approx 9cmX9cm and is tender to tough
This spontaneous report as received from a 69 years old male patient with heart attack and no drug allergy refers to himself. The patient was vaccinated with 0.65 ml ZOSTAVAX (Lot# unspecified) Subcutaneously on 02-SEP-2009. No other co-suspects were reported. Concomitant medication included: TOPROL XL (tablets). After the vaccination the patient had repeated attacks of itching, not at the injection site, but below the elbow and extending downward on his arm. This started 3 - 4 days after the vaccination, on approximately 05-SEP-2009, and was still ongoing. He would have the itching for 3 - 4 days, then it disappeared, only to reappear 3-4 days later. No treatment information was given. The outcome of the event was reported as not recovered at time of the report. No lab test was performed. The patient had sought medical attention via talking to the pharmacist. Additional information has been requested.
4 hrs after vaccines given patient experienced throbbing pain thru out her body, legs were tingling, tachycardia. Unable to ambulate temp 101.8. Patient went to ED patient had given IVF and d/c.
Patient awake at 0300. When going into the room to get him ready for dialysis he was cold to touch, unresponsive other than to sound, and nonverbal. O2 sat was 67 via finger probe. Oxygen immediately initiated and a venturi mask retrieved and initiated. When unable to arouse him via sternal rub this RN called 911.  Send to ED.  Febrile 39.2 and hypotensive 58/43.  Admitted.  unknown after that as patient expired in hospital.
Patient complained of waking up in night following vaccination with fever and chills and the following morning having a redness and swelling on injection site on left arm.
There is a pattern after 2 month from each shot where the periods get irregular and painful; There is a pattern after 2 month from each shot where the periods get irregular and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FE3592), in arm for covid-19 immunisation. The patient's relevant medical history included: "Patient's medical history: None" (unspecified if ongoing), notes: Patient's medical history: None. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:01, Anatomical site of injection: Arm, Batch/Lot number: Pfizer EN6207), administration date: 31Mar2021, for COVID-19 Immunization, reaction(s): "There is a pattern after 2 month from each shot where the periods get irregular and painful", "There is a pattern after 2 month from each shot where the periods get irregular and painful"; BNT162b2 (Dose:02, Anatomical site of injection: Arm, Batch/Lot number: Pfizer ER8729), administration date: 21Apr2021, for COVID-19 Immunization, reaction(s): "There is a pattern after 2 month from each shot where the periods get irregular and painful", "There is a pattern after 2 month from each shot where the periods get irregular and painful". The following information was reported: MENSTRUATION IRREGULAR (non-serious), DYSMENORRHOEA (non-serious), outcome "not recovered" and all described as "There is a pattern after 2 month from each shot where the periods get irregular and painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular, dysmenorrhea.  Additional information: All COVID-19 tests have came back negative. Never have had a positive case of COVID-19. Was not on birth control and have not been since 2018. No hormonal medications since 2018. No prescribed medications. Started taking Flovitamins Jan2023 to help with period symptoms since shot has had no effect. In summer 2021, noticed periods were not on time. Periods became random by 2022. Patient reported that "I didn't take much note as I was not in relationships at that time. In summer 2022, patient started tracking her cycle. I'd gone from 4 week cycle to 45 days cycle skipping weeks at a time. Periods were long, painful and severe. Periods have never returned to normal with no birth control or medications being used since 2018, the only thing that's changed besides a flu shot in me is the C-19 shot. There was a pattern after 2 months from each shot where the periods get irregular and painful. They have not gone back to normal and we fear this will affect the ability to get pregnant with non-regular cycles". Patient received 4th dose on 19Oct2022 at Arm, Lot: GJ2524. Prior vaccinations within 4 weeks: None. Specific relevant test for thromboembolic events with thrombocytopenia: None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201364680 same patient/drug, different dose;
acute onset fever, vomiting, diarrhea 4-6 hrs p/vax t104, lethargy; next AM hematemesis, diarrhea(hemocult-neg stool); impression that of coincidental, viral G-E, temporal relationship to vax impressive;
COVID pneumonia; A spontaneous report was received from a 78-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced COVID pneumonia.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient developed COVID pneumonia. She was hospitalized from 22 Jan to 27 Jan 2021. The patient received antibiotic and steroid medications at the hospital.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, COVID pneumonia, was considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information, mRNA -1273 does not contain a virus.The onset of COVID-19 pneumonia on the same day the patient received the vaccine makes the assessment of the event unlikely related to mRNA-1273.
Severe rash-whole body requiring emergency room visit same day of injection- Had local erythema/swelling at site of Hib injection -but not at DTaP injection site. Rash has recurred for more than 2 weeks controlled by a 12-24 feet treatment with Benadryl.
This spontaneous report as received from a registered nurse refers to patients unknown age. It was reported that RECOMBIVAX B (dose and lot# not reported) experienced excursion of 1.7C for 3 hours, as well as a prior excursion of 0 C for 8 hours. Excursion supported. Both products have been administered post excursion. No adverse effects reported. This is one of the reports from the same reporter (lined with MARRS# 1409USA012752). Additional information has been requested.
@1410 Pt was brought in to the observation room via wheelchair. Per report, pt became dizzy and weak post vaccination. Fluids and crackers provided. Pt tol PO intake well even though she has complains of nausea. Elevated feet up with a chair.    @1415 Pt stated that she still feels nauseated but is a bit better. Attempted to stand pt, unable to. Pt automatically sat down halfway standing her up d/t "room is spinning." Transferred pt to a gurney. Placed on supine position. No sob noted. No s/sx of distress noted. Resp even and unlabored.    @1420 Pt is feeling better. Instructed to drink a can of juice and water. Tol well. Dizziness is mild. Nausea slightly. Tolerated PO fluids.    @1430 Orthostatics VS supine 125/72 (89) 84 99% RA 18. VS sitting 134/82 (96) 111 99%RA 18 with slight dizziness. Encourage pt to finish all her PO fluids as tolerated. Pt stated that she was in school earlier today and has been busy with everything. Pt stated that she didn't have a chance of drinking water.    @1440 Finished all her fluids. Pt is feeling better. Pt stated that her dizzy and headache are mild. C/O weakness to legs. Encourage to move around legs and feet to increase circulation. C/O wanting to urinate.    @1445 Transferred to from the gurney. Pt able to stand up straight without any problems. Gait stable and able to transfer by herself. Escorted bu nurse and mother to the bathroom. Pt able to transfer from the wheelchair to commode well. Pt able to go to the bathroom herself. Gait stable. Voided x1.    @1450 Pt is confident on going home. Mother is confident and willing to take her home. PT is feeling better with some mild weakness to legs, very mild dizziness.  Instructed to follow up with Primary Doctor and go to the ED for worsening symptoms. Pt and mother verbalized understanding.  Made Dr aware of the situation and agreed with plan.    @1500 Wheeled patient to outside and to mother's car. Pt tolerated activity well.
No other AE and no PQC; HBP calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient.  No symptoms or further details reported.  No other AE and no PQC; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, unk, lot #U032086, expiration date: 29-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 14-SEP-2023, HBP called to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient. No symptoms or further details reported. No other AE and no PQC.
General malaise, achiness, and tired.  Extremely sore injection site, inability to move arm.
Severely swollen, painful lymph node in left armpit. Visible mass when raising arm.
Patient had swelling and itching at site of injection. Parent reported no breathing problems and was told to apply a cold compress to site.
Information has been received from a nurse concerning an 18 year old female patient who on 10-JUL-2007 was vaccinated with the first dose of the Gardasil (Lot # 658490/0802U). n 10-JUL-2007, within the ten minutes of the vaccination, the patient fainted. Unspecified medical attention was sought. On 10-JUL-2007, the patient recovered. This report is one of two reports from the same source. Additional information has been requested.
Patient was given expired vaccine. Patient was monitored for any adverse reaction, and patient was revaccinated no adverse reactions occurred.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old female. Neither medical history nor concomitant medication were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had and expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the result of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Covid test and tested positive/feeling a little sick with headache, runny nose and a sore throat; Covid test and tested positive/feeling a little sick with headache, runny nose and a sore throat; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 11Mar2021, the following Saturday (13Mar2021), the patient started feeling a little sick with headache, runny nose and a sore throat. The patient got a covid test and tested positive and then went again on Thursday (15Mar2021) and it came back negative. The patient wanted to know if it has shown positive covid test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
15NOV93 onset of intermittent fever (to 103), nausea/diarrhea, chest pain, dizziness, fatigue, numbness extremities, numbness of face on 19NOV93 myalgia; 21NOV93 lt sided weakness, absent deep tendon reflexes;
Initial and follow-up information has been received through the Merck pregnancy registry from a registered nurse concerning an 18 year old female with 1 previous pregnancy that resulted in miscarriage, who on 27-OCT-2006 was vaccinated with the first dose of Gardasil (lot # 653937/0637F) when she was 17 1/7 weeks pregnant, last menstrual period 29-JUN-2006. Concomitant medication included hormonal contraceptives (unspecified). On 03-DEC-2006 the patient found out she was pregnant via a home beta-human chorionic gonadotropin test (unspecified) and concomitant medication was stopped. A full term baby was born on 25-MAR-2007. Subsequently, the infant was born with a left club foot and two vessel umbilical cord. On 04-MAY-2007 the patient was vaccinated with the second dose of Gardasil (lot # 0210U). There were no other birth defects in the family. The nurse felt that the left club foot and two vessel umbilical cord were other important medical events. This is one of two patients received from the same source. This is an amended report. The terms Medication error and No adverse effect and information regarding the events have been deleted from this report and entered into WAES 0701USA02073.
Hives, injection site redness and swelling: hives began the next night after immunizations.