chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gets pain as lifting arm, gets spontaneous pain and tingling shooting down arm into fingers, sometimes has difficulty clenching fingers
This spontaneous case report was received from a nurse (PVX2018-1725) on 01-Jun-2018. The report describes a 22-year-old adult female consumer who "ate granola bar 45 minutes before receiving VAXCHORA". The consumer was receiving oral VAXCHORA as cholera vaccine. It was reported that consumer took the first dose of VAXCHORA on 01-Jun-2018. She ate a granola bar 45 minutes before the taking the dose. The action taken with VAXCHORA with respect to the event "ate granola bar 45 minutes before receiving VAXCHORA" was not applicable. The clinical outcome of the event "ate granola bar 45 minutes before receiving VAXCHORA" was unknown. Sender's Comments: Company's Comment: The causality of the event "ate granola bar 45 minutes before receiving VAXCHORA" was considered as not applicable.
Fatigue; Chills; Diarrhea; This is a spontaneous report from a non-contactable consumer (Patient) via Pfizer sales representative. A male patient of an unspecified age received second dose of BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. They had covid about a year before they had the vaccine. On an unspecified date, patient experienced fatigue, chills and diarrhea. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Received TD on Monday 12/1/03. On 12/2/03 right arm was sore and hard to move. Said it was moving after putting ice on and off. On Wednesday 12/3/03  in school arm was still hurting. Teacher referred to school head nurse. On evaluating right arm : slight swelling, no redness. Conversation with mother (who said didn't give any med for discomfort) post TD instructed to give Tylenol or Motrin (no aspirin).
Patient received their vaccine on 6/17 and had no complaints of adverse effects. The patient was found unconscious at some point between 6/17-6/18. They appeared jaundice and had low BP. They were airlifted to the hospital and died on 6/18/21.
pt recv vax SEP96 & 21MAY97 pt devel chickenpox consisting of bumps on forehead that had the appearance of bee stings;devel forty itchy chickenpox that appeared raised bumps w/red ring around them;loss of appetite;
Patient received three doses of Moderna Vaccine.  Dates were as follows  1/11/2021, 2/3/2021, 3/11/21.  Patient had moved facilities and new facility was unaware that patient had been vaccinated at previous home.  Pharmacy alerted facility when data was inputed into computer.  Patient was lethargic the following day and transported to hospital.
Small, red rash at the injection site. Didn?t appear until  8 days after I received my first dose. The rash subsided after ~24 hours. It wasn?t itchy or bothersome. No other symptoms observed/felt.
Post day 1: lethargy, headache, sore arm  Post day 2: fever, chills, shoulder of left arm ache, aching of upper jaw under teeth , severe nausea, vomiting, and diarrhea, unable to hold even water down   Post day 3: nausea and vomiting, alternating feeling of hot and cold but no fever. Unable to hold water down until the very end of the day.  Post day 4: only one episode of diarrhea, improvement
sore arm; rashes all over the body; This is a spontaneous report from a Pfizer sponsored program Covax US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number, and Expiration Date: Not Reported) via unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm and rashes all over the body on an unspecified date. Patient wanted to know what to do with her experience. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever over 102 for 2 days, swollen lymph nodes with moderate pain in same arm
Big time flu symptoms. Couldn't move for over 48 hours. Severe body pain.
Severe swelling in left armpit region the next day. Painful and very tender. Several days later I noticed a swollen lymph node on the left side of my neck. The armpit region swelling reduced after about 5 days. Pain subsided. There is minimal swelling present there to this day. My neck still has an enlarged lymph node (6 cm diameter) today.
10 days after immunizations patient had FUO and febrile seizure.  We would like recommendations about giving MMR booster at age 5 years.
fainting; runny nose; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Down Syndrome" (unspecified if ongoing); "asthma" (unspecified if ongoing); "encopresis" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE. Vaccination history included: Covid-19 vaccine (Primary Immunisation Series Complete, Unknown Manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (booster), Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 01Nov2022 at 12:00, outcome "unknown", described as "diarrhea"; SYNCOPE (medically significant) with onset 01Nov2022 at 12:00, outcome "unknown", described as "fainting"; RHINORRHOEA (non-serious) with onset 01Nov2022 at 12:00, outcome "unknown", described as "runny nose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Negative, notes: Nasal Swab, Orange box. Therapeutic measures were taken as a result of syncope, rhinorrhoea, diarrhoea. Treatment for adverse events were Peptiva bismol, electrolytes and Tylenol Rapid Rel. The patient had no covid prior vaccination. The patient was covid tested post vaccination; Covid test post vaccination: Nasal Swab, Orange box, on 31Aug2022, result=Negative.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient reported that day after 2nd dosage of SHINGRIX on 3/27/18 (first dosage was on 1/19/18), injection site became swollen, red, warm to touch, and red bumps. On 4/5/18 patient reported injection site was a hard lump and there are still red bumps around the site. Patient said it does look like it is healing and did nothing for treatment.
Initial report received from a healthcare professional on 23 September 2013. A male patient, whose age, medical history and concomitant medication were not reported and has had flu vaccine in the past, had received FLUZONE (batch number, dose, site of administration were not reported) intramuscularly on 19 January 2012. On unspecified date, the patient complaint that hands and feet were swollen for 3 days with itchy skin. The patient received ZYRTEC as corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient was recovered from the event. Documents held by sender: none. Follow-up received on 21 November 2013: No new information received.
Arm was red/swollen/tender. Was seen by routine doctor and nurse suggested to have arm looked at.
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
could not walk far without getting out of breath; did not eat; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk far without getting out of breath), DECREASED APPETITE (did not eat) and NAUSEA (nauseous) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk far without getting out of breath), DECREASED APPETITE (did not eat) and NAUSEA (nauseous). At the time of the report, GAIT DISTURBANCE (could not walk far without getting out of breath), DECREASED APPETITE (did not eat) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported.
stomach pain/cramps; diarrhea; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain/cramps) and DIARRHOEA (diarrhea) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain/cramps) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain/cramps) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date in 2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
pt recvd vax;started crying at 1pm until 4pm;crying episodes were off & on;apap given;cont to be irritable the next day & T 102.8;saw MD;arm was sore;pain;
Narrative: 12/13/2022:  Patient presented to PCP clinic for flu shot and requested the covid booster at the same time. Nursing went to retrieve the covid vaccine and drew up and administered the dose at 11:00am, after administration it was discovered that vial was expired as it had been punctured the previous day (12/12/2022) at 11:45am and had not been removed from the pyxis the previous afternoon. The manufacturer was contacted, and they stated effectiveness would be preserved as it had been less than 24 hours since the vial was punctured. Patient was contacted and educated to watch for any signs and symptoms of infection due to the administration being beyond the 12 hours post vial puncture recommended by manufacture. Patient reported no ADR thus far.
Received the 2nd shot in my left arm a 8am Saturday morning. By early afternoon was experiencing some pain in my right armpit. By that evening I could feel an a lump/mass growing in my armpit. It proceeded to get larger, to a golf ball size, and more painful through Monday. The pain made it difficult to lift or move my right arm. Any contraction of my bicep muscles would trigger pain. Proceeded to make a doctor's appointment for Tuesday, April 13th.
Burning sensation to side at waist line. Pain level is 2-3. No rash or blisters.
Guillain barre syndrome; Initial information was received on 17-Nov-2020 regarding an unsolicited valid serious social media case from a consumer via social media.   This case involves a patient (unknown demography) who experienced Guillain barre syndrome, when received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain barre syndrome, (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory data was not reported.  The patient reported that she will never get another flu shot again it was a waste of time.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly document case received from Facebook concerns a patient with unknown demography who experienced Guillain-Barre syndrome, after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
2JUL92 recvd 1st dose of Engerix-B & 16JUL92 devel hives & pruritus; the next day hives cont plus swelling @ wrist & intense itching;
Tingling/numbness in left side of upper and lower lips, and into left naso-labial fold.
Patient admitted for fever s/p vaccine injection. Monitored. No respiratory distress rashes or morbid events.
GARDASIL given 7-15-11, patient returned today with a wart at the injection site. Cryofreeze was performed. (The wart appeared & started getting larger gradually over time).
The HCP administering the vaccines did not add the diluent prior to injecting the patient with the vaccine. The patient was given an injection of the covid vaccine without diluent. Patient's parent was spoken to, and no adverse reaction or events have been reported at this time.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received on 18-MAY-2015 and on 19-MAY-2015 from the reporting medical assistant and the physician, respectively. The physician provided information regarding the patients identifiers, lot number and date of vaccination. It was reported that the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX, lot number K015970 on 30-MAR-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Initial misuse report received from a healthcare professional. The child patient needed two doses FLUZONE and received first dose on 04th October and second dose on 25th October week earlier than they should have. This was an invalid schedule. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Dizziness, nausea, lightheaded, diaphoretic; BP 146/95, HR 89 RR 16 SpO2 100%.
This spontaneous report was received from a pharmacist via a company representative refers to a female patient of unknown age. In February 2016 the patient was inadvertently vaccinated with 2nd dose of ZOSTAVAX (dosing regimen and lot # unspecified) (extra dose administered). The pharmacist reported that he inadvertently administered a "2nd dose of ZOSTAVAX in February 2016 (specific date unspecified)" on an anonymous patient. The patient incorrectly stated on pharmacy patient questionnaire that she had never been vaccinated for shingles, however, the patient's husband reminded the patient (when she returned home) that she had already been vaccinated with ZOSTAVAX in November 2015 (specific date unspecified). No adverse effect reported. No additional information was provided. Additional information has been requested.
pt. had a little tightness in her throat which  got better a couple of minutes later.  She was able to swallow water with no issues.  pt. is allergic to peanut, and had Epipen with her.  Symptoms resolved 8 minutes later, and mom drove her home.  V/S 113/73, 79, R-18, O2Sat 98%
Jaw, ear, neck pain 5 days after vaccine. Headache and eye pain 5 days after.
Patient began feeling symptoms of tongue and hand tingling and throat tightening 5 minutes after receiving her dose. Her vitals were taken and were stable. After 5 more minutes her hands stopped tingling and within 15 minutes her throat symptoms resolved. She continued to have tongue tingling without any facial or tongue swelling. After 25 minutes a physician was contacted and cetirizine 10mg was administered. 25 minutes later her symptoms were resolved and her vitals are stable. She was allowed to go home after that time and was advised to follow up to her PCP.
Pt recvd 3 doses of Engerix-B vax 10MAY91, 3JUN91, & 14NOV91 on 14NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
Hib and Prevnar given upper lateral right thigh 05/13. Not sure which one on upper injection. Developed warm, red, itchy by 05/15. Gave Benadryl 05/15 and resolved by 05/16
Administered TDAP vaccine on 8/17/11 - on 8/18/11, patient experienced chills, Temp 103 degrees, body aches, sore throat, headache.
elevated temp to 104-105.2 (40hr later when temp reached highest point)-elevated temp lasted x 3 days, started day p/vax;controlled (or lowered) w/APAP et advil alternated q 2hr per PA order;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: Anti viral details: Product: COVID 19 Treatment, Brand: Pfizer paxlovid, Treatment start date: 12Aug2022, Treatment stop date: 16Aug2022 and Indication: Treatment of COVID-19. Adverse event: Tested negative, then tested positive. Four days after treatment ended began experiencing covid symptoms, namely congestion and small fever while testing positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 14-JUL-2015 the patient was vaccinated with one dose of improperly stored PEDVAXHIB, lot# L002867 with expiration date of 11-NOV-2015 (strength, dosage, frequency and rout unspecified)(incorrect product storage). No adverse effects were reported. thi sis one of 4 reports received from the same reporter. Following review, it was determined that the report did not meet criteria for a quality investigation. Incorrect product storage was not considered a true Adverse event and there were no reported adverse effects. Additional information has been requested.
SarspCoV-2 Antigen  detected 11/5/2021 Hospitalized 11/5/2021  DX Pneumonia
A report was received from a health care professional on 13 November 2003 concerning a male vaccinee in his 40s who inadvertently received influenza vaccine (brand not specified) subcutaneously on 12 November 2003. On 12 November 2003, the vaccinee received influenza vaccine (brand unspecified) subcutaneously. At the time of the report no adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Update, 01 March 2004: Follow up information received from a health care professional indicated that there is no additional information forthcoming from the vaccinee. No follow up pending.
1 week later on 2/12/21 just below injection site I got a small circle like looked like small bites on left arm that itched terribly. I called my doctor, was told it was Covid Arm and nothing could be done and would go away. That day it itched profusely!  I put anabiotic cream on it but no help. It turned red and spread around the top of my arm. It did all go away by Wednesday.  My 2nd shot was 3/5/21 and 4 days later I developed a bad headache, felt like it was either allergies or onset of a cold. Today 3/12/21 I feel better.
Patient received vaccine on 03/17/2021. Began having erythema, induration, tenderness, and warmth at area of injection on 03/27/2021. Denies any trauma or breaks to skin since injection/prior to symptom onset. Prescribed keflex for possible cellulitis.
Headache, Myalgia, Diarrhea, NauseaVomiting, FATIGUE Narrative:  WILL TEST FOR COVID 19 FOR POSSIBLE INFECTION AROUND TIME OF VACCINE, DOING BETTER TODAY