chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diffuse headache of moderate strength aggravated by visual sensitivity to light; Loose stool; Faint nausea; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the right arm on 22Mar2021 at 11:45 (at the age of 51-years-old) for COVID-19 immunisation. Medical history included hypertension and anxiety. The patient had a history of allergy to sulpha drugs, possibly imaging agents and mild reaction to some shellfish. Concomitant medications included losartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), quetiapine PRN (MANUFACTURER UNKNOWN), lorazepam PRN (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. The patient had not received any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 22Mar2021, the patient experienced diffuse headache of moderate strength aggravated by visual sensitivity to light, loose stools (but not diarrhea) and faint nausea. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of diffuse headache of moderate strength aggravated by visual sensitivity to light, loose stools (but not diarrhea) and faint nausea was resolving at the time of report.  No follow-up attempts are needed; information on lot/batch number has been requested.
The day after I spiked a fever. The morning after that, I woke up with immense stiffness in my left leg that persisted for a month.  It still continues on and off to this day. I had not exercised with any intensity in the days prior or day of vaccine.
Patient DOB: 11/09/1967.  Received her first dose Pfizer vaccine (LOT#: EW0187 EXP: 8/2021) at 15:26 on 6/01/21. Patient alerted EMT at 16:05. Patient stated that she felt a closing sensation in her throat. Patient was able to talk and did not have SOB. Patient stated she also felt nauseous and shaky. Patient stated that she felt very nervous before receiving the vaccine. PHN asked patient to stay an extra 30 minutes for further observation. Patient agreed to stay. EMT took patient vital signs. BP: 120/65, pulse: 76, O2: 96%. PHN assessed patient. PHN offered patient Diphenhydramine. Patient stated she was allergic to Diphenhydramine. Patient could not recall signs and symptoms that occurred with Diphenhydramine intake. Patient refused Diphenhydramine at 14:12. PHN offered patient EpiPen. Patient denied EpiPen at 16:13. Patient stated she was feeling better. PHN gave patient water. Patient was able to swallow water without any trouble. Patient stated her throat no longer felt like it was closing. Patient was talking the entire time with PHN and EMT. Patient denied any SOB or difficulty swallowing. EMT reassessed patient and retook vital signs at 16:25. BP: 120/68, pulse: 79, O2: 97%. Patient stated that she no longer felt any of her initial symptoms. EMT reassessed and retook patients vital signs at 16:36. Patient stated that she no longer had any symptoms. Patient completed her 30 minutes of observation. Patient was educated on worsening signs and symptoms of the vaccine side effects and when to call EMS or go to the ED/urgent care. Patient verbalized understanding of education. Patient left vaccination site at 16:40 unassisted and with a steady gait.
chest pain/ It was around mid-chest radiating up to his shoulder and midback; had really bad headaches for 5 days; fever; This is a spontaneous report from a contactable other hcp (Nurse). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced chest pain and it was around mid-chest radiating up to his shoulder and midback; had really bad headaches for 5 days and fever. It was reported that reporter son had it the worst reaction. Her son had chest pain that anticipated before he go to the emergency. Patient had It for several hours and it went away. Patient had been fine since then. It was around mid-chest radiating up to his shoulder and midback. Caller wants to know if her son should receive the second dose or not. Serious: No. The clinical outcome of event fever was unknown and other events were recovered on unspecified date in 2021.  Information about batch/lot number has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 04-MAY-2015 the patient was inadvertently vaccinated with a dose of GARDASIL 9, intramuscular after completing the GARDASIL (4) series on an unspecified date in 2011. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Patient began to complain of anorexia, unable to urinate, failure to thrive. She was in and out of the hospital 4 times. Eventually saw a Neurologist and was diagnosed with autoimmune autonomic ganglionopathy.
Received Td booster during routine physical 5/5/03 9:30 AM, he felt fine initially then woke up in the middle of the night, 1 AM, 5/6/03, complaining of muscle aches, chills, headache, which persisted through 5/7/03. On 5/7/03, still with some achiness.
pt did not receive vaccination at this facility pt left upper arm has a large  red area had complained that it was itching a few days ago.
1st dose in 12/2022, 2nd dose on on 01/24/2023; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 25-year-old male patient who received HAV (Havrix) (batch number 3J9G4, expiry date 30th August 2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 24th January 2023, the patient received Havrix. On 24th January 2023, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments: Nurse reporting primary dose of Havrix administered in December 2022 and booster dose administered less than 6 months later on 24th January 2023. The reporter consented to follow up. Additional Supportive Information: the patient received booster dose on 24th January 2023, earlier than recommended standard schedule, which led to shortening of the vaccination schedule.
Was having flu like symptoms, then tested leg swelled up below right knee , now still swollen and bruising down leg
Dizziness, weakness, muscle pain, headache, fever up to 105.0 the first night, pain in chest, shivering, lack of balance walking. Second day fever was 100.4 all day with shivers, muscle pain and headache. Third day shivers, headache fever 98.5 Fourth day fatigue. Fifth day went to Doctors Office and explained the reaction of the vaccine. Still not completely back to prior, condition, but glad it is over.
This spontaneous case was received on 04-Oct-2017, from other-health professional, concerns a 29-year-old female patient. On 04-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose 0.5 ml, batch number: 1618621 (as reported), expiry date: Apr-2017, route of administration, anatomical location: not reported). It was reported that the patient was administered with the vaccine that had expired in the month of April-2017 (explicitly coded as expired vaccine used). No adverse effect were reported. Revaccination with the current season was advised. The reporter assessed the event as non-serious. Follow-up received on 18-Oct-2017: Age and gender of the patient was updated. Narrative amended accordingly. Non-significant case correction received with IRD 04-Oct-2017: Corrected narrative (vaccine that had expired in the month of April-2017).
Information has been received from a registered nurse concerning an 18 month old male with no medical history and no known documented allergies who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 06JUN2003 the patient was seen in the physician's office for a routine visit. It was reported that he had lesions on his ribcage that "may be shingles". It is not known when the lesions started. No treatment was required. At the time of report 06JUN2003, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Moderna vaccine#2 given at 10:30 am. By 12:30 pm I felt very dizzy and lightheaded. Symptoms have not subsided and it is now 4 days later. Waves of dizziness come and go. Had a low grade fever the day after which subsided but the dizziness in my brain will not go away.  I haven't been checkout out yet bc I keep thinking it will go away but it won't.
the day following vax pt devel gastroenteritis sx w/vomiting & diarrhea.
Red and swollen and hard also feverish to touch. Slightly painful (didn't notice until change of clothes). Lesion approximately 20mm in size or she described as the size of a quarter.
Swelling at site & redness - was given BENADRYL 25 mg by mouth - pt felt fine was told to take BENADRYL at home also - kept pt in clinic for 45 min and checked on her the next day & swelling had started to go down.
April 2022, I first noticed a headache and I didn't think much. When I awoke on the 2nd day I still having a headache and back of the throat drainage. I tested negative with a home test. That night I felt congested and took some medicine. That next Thursday night April,07/2022 I tested positive. I started running a temperature of 100. The congestion I was, head congestion and I did have a cough and low grade temp. I continued having a temp and fatigue. It was the next week I started to feela bit better.
Muscle cramping, flu-like symptoms, body aches, cellulitis 6 in vertical and 4 in horizontal in size around injection site.
Never went back to get a second does; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not applicable. Till the time of reporting, the patient never went back to get his/her 2nd dose, which led incomplete course of vaccination. The reporter asked that was it fine to get the other one even though it had been longer than recommended. The follow-up could not be possible as no contact details were available.
Immediate chest tightness, heart palpitations, and dizziness upon administration.  Took awhile to transition out of store.  Pain, redness, soreness, swelling at injection site.  Symptoms worsened 3 days later, chest pain/tightness/pressure interfering with capacity to inhale, departure from work for doctor visit.  EKG was conducted, labs, Chest X-ray, and recommendation to see a Cardiologist.  Doc recommended rest, time off work, report to ER if symptoms worsened.  Symptoms did increase in intensity (incapacitating and could not engage in activities of previous daily living).  Ongoing difficulty breathing and chest pain.  Cardiologist ordered echocardiogram and additional labs (Dx; Chest pain, unspecified type).  Could not engage in exercise for months.
Swollen eyelids cough temp 100.4 sore throat oliguria concentrated foul urine nausea headache chills fatigue
female patient received  a dose of Havrix that had expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 07-APR-2023, the patient received Havrix. On 07-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: female patient received  a dose of Havrix that had expired ). 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: 10-APR-2023 The pharmacist reported that patient received on 7th April 2023 a dose of Havrix that had expired on 30th January 2023, which led to led expired vaccine used It was asked whether patient should revaccinate. The reporter did not consent to follow-up.  The vaccine administration facility is the same as primary reporter.
We administered 0..25ml to the patient instead of the 0.5ml (additional dose for immunocompromised).
Pt received both Pfizer vaccines on 1/15/2021 and 2/5/21. She had no short term issues following vaccination. She developed herpes zoster on 04/04/2021. This may be completely unrelated, but I wanted to report it, as she is young and healthy otherwise and this is the second case of shingles developing in an adult under 50 years after receiving Covid-19 Pfizer vaccines. She has had a significant amount of recent stress including death of a grandmother, and health issues in her mother.  She was treated with Valacyclovir 1gram TID x 7days, which was started on 04/06/2021. She is doing well with mild symptoms of itching only. Viral culture was positive for Varicella Zoster. Location of outbreak is left side of trunk beneath breast and circling around lateral trunk.
Side effect: Mom stated since the last Saturday 5 March he hasn't been eating much and just seems tired/fatigue.  Course: Patients Mother brought son in for an annual physical and was told by the provider he was due for vaccines, Hep A Vaccine and meningococcal Vaccine.  Patients mother brought patient to Immunization Clinic. Immunization Clinic reviewed chart and shot record and administered meningococcal and Hep A on 17 Aug 2015. In Ahlta there was very minimal documentation of the history of vaccines. The mother did state she had the shot record in Aug.  Patient and mom returned to Immunization Clinic on March 2nd stating he needed to have the second Hep A shot from Aug 2015. There was only one Hep A shot recorded and documented in AHLTA at the time. The nurse administered a second Hep A vaccine.  Pts. mother was advised to come in at her soonest with a recent shot record so we could document the 2nd Hep A shot.  When the mom returned today 08 March 2016 the nurse noted there were already 2 Hep A vaccines given on 22 May 2010 and again on 22 Sep 2010.  So patient received 4 Hep A vaccines. Pts mother was notified and it was documented on the shot record and again in AHLTA.  DHA was called to advise on any possible adverse reactions to look for.  DHA Provider stated that luckily there should not be any reaction and research shows that they do not have any document adverse events for multiple Hep A vaccines. However, DHA recommended placing a VAERS report.  Patients mother was educated on PSR and VAERS report and that she may receive a call or something in the mail regarding the VAERS report.
Pt. mother reports fever 7/25/18 around midnight of 103.5F. Fever resolved 7/25/18. Mother states red patch noted around site of injection 7/26/18.
PATIENT RECEIVED 1ST DOSE PFIZER IN MEXICO. TODAY HE RECEIVED 2ND DOSE MODERNA IN LD. NO ADVERSE REACTIONS, PATIENT FEELS WELL, PATIENT RETURNS TO MEXICO IN 1 WEEK.
W/in 1 wk of vax pt devel thrombocytopenia. Swelling & crepitus rt knee. 2cm ecchymosis rt arm.MD Dx thrombocytopenia to ITP onset 1981.MD suggests long-standing Hep B infect cause splenomegaly & hypersplenism.Constipated & weight gain See
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a female nurse practitioner with no known allergies to food or medicine and no medical history who "9 years ago," in 1997 was vaccinated with Varivax, 0.5ml subcutaneously. After the second dose she was tested (igg, igm) and she had a negative titre. "Years ago" she was given a third dose and also had negative titre. As of 29 Sep 2006, the nurse practitioner was 16.5 weeks pregnant and was taking pre-natal vitamins (therapy unspecified). on 28 Sep 2006, the nurse practitioner had three titres drawn and the varicella antibody test came back with positive results. She was surprised to know that she seroconverted. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX (batch number LL552, expiry date 8th June 2021) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included INFUSION (MEDICATION UNKNOWN). On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient's concomitant medications were unspecified Rheumatoid Arthritis infusion drug. The patient experienced continued arm soreness in the left shoulder where the injection was given. The reporter consented to follow up.
Child received KINRIX & MMR in same arm. Developed nausea, vomiting, tachycardia and a 1 cm red welt over location of MMR.
Swelling, erythema of Left deltoid and h__________, no fever, acting fine, playful in life. Treatment-Atarax. Prescription for Orapred on hold if needed.
Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; This is a spontaneous case from, reported by health professional to agency [reference number: SEQ19-05870] and initially received on 30-Oct-2019, concerning a 59-year-old male patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 29-Oct-2019, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number: 259808, expiration date: 31-May-2020] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced injection site redness, itchiness, puffiness, swilling and the injection site was warm to the touch. The patient was advised to apply cold compress and Benadryl cream.   On 05-Nov-2019, one week after experienced events, the patient recovered.  The case was assessed as non-serious.  The reporter did not provide causality assessment.   This case is linked to case 201905790 (same reporter).  Follow-up received from other health professional via agency (reference number: SEQ19-06729) on 20-Nov-2019: Age of the patient added. Stop dates added for all events and the outcome changed from not reported to resolved. Additional numbers were added.The narrative was amendment accordingly.   Company comment: Temporal relationship and description of reported events are suggestive for the causal role of Flucelvax. No plausible alternative aetiology was provided. Based on the available information reported adverse events are assessed as related to the suspect vaccine.; Sender's Comments: Temporal relationship and description of reported events are suggestive for the causal role of Flucelvax. No plausible alternative aetiology was provided. Based on the available information reported adverse events are assessed as related to the suspect vaccine.
Patient mentioned flu-like symptoms requiring her to stay in bed and take a day off of work. She stated being weak and achy, sweating, and chills.  In addition she had a rash at the injection side that was warm, swollen and itchy. She is still feeling a little down today 9/23, but better than yesterday.
dizziness; sore arm at injection site; nausea; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9265, Expiration date was not reported) via an unspecified route of administration, administered in the left arm on 12Feb2021 13:45 (at the age of 31-years-old), as dose 1, single for COVID-19 immunization. Patient had no relevant medical history. The patient's has no concomitant medications. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced dizziness, sore arm at injection site, and nausea on 12Feb2021. No treatment was received as result of the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Infertility. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling in armpit). At the time of the report, LYMPHADENOPATHY (swelling in armpit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Antibiotics are taken as concomitant medication. No treatment drugs were reported. This case was linked to MOD-2021-194126 (Patient Link).
Guillain Barre complex after vaccines of Tdap, Hep A, GARDASIL, Varicella, MENACTRA on 1/3/11; falls started on 1/5/11 - total of seven to date.
(R) thigh: 5" area erythema and warmth no induration on 6/23/10.