chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Through out the night, she was nauseous; Through out the night, she had chills; She has pain in her ride side and hip; She has pain in her ride side and hip; She was shaking all over really bad; Headache; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via intramuscular route of administration, administered in Arm Right on 07Apr2021 09:45 (at the age of 80 years old) as dose 2, single for COVID-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date (her and her husband had covid in Nov 2020). There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration, administered in Arm Right on 17Mar2021 at 2:30PM (at the age of 80 years old) as single for COVID-19 immunisation and experienced had a back ache and Her neck and shoulder ached. The patient experienced she has pain in her ride side and hip on 07Apr2021, through out the night, she had chills, through out the night, she was nauseous on 08Apr2021, headache, she was shaking all over really bad on Apr2021. Reported as, She received her second dose of the covid vaccine on 07Apr 2021. Her second dose caused her to have chills in the night. Through out the night, she had chills and was nauseous. She also had pain in her ride side and hip. She was wondering. Now all of her symptoms are gone. Her headache was gone as of this morning. She still has pain in her right side and hip. She was wondering, if because she still has symptoms, is still contagious to others. She was shaking all over really bad. Her chills have completely resolved now. The chills stopped by the time she got up. Outcome of the event through out the night, she had chills, through out the night, she was nauseous recovered on 08Apr2021 and other event recovered on Apr2021.  No follow-up attempts are needed. No further information is expected.
Flu-like symtpoms on 6/22/18. Feeling a little better today, but still rather ill. Red welt on arm at site of injection.
Pt received. VZV on 10/24-On 11/3 began with rash on trunk & extremities - appears vesicular, then ruptures & has thin crust. No fever, not itchy, no ill contacts.
pt recvd vax & w/in hrs of vax exp flu synd, muscle aches, swollen neck glands;
note while patient was receiving his pneumonia vaccination he became diaphoretic and having some sob and dizziness. it was noted some redness on skin but not urticarial vitals were taken q2 mins and were stable the whole time Benadryl IM was ordered but not needed as patient quickly started to feel better and less diaphoretic or sob. within approx. 10 mins patient was baseline. he left room to be observed for 30 mins more walking with no assistance and not having anymore s/s as above.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 13May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm 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) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 26Jun2022 to 01Jul2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. Metallic taste in mouth starts 2-3 h after taking Paxlovid. On Jul2022 (Day 10-11),  fatigue came back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bad headache; Some shaking; Chills; Fever, still have a fever, but it is lower; Nauseous; Vomiting; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Some shaking), CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower), NAUSEA (Nauseous) and VOMITING (Vomiting) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMOXICILLIN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced TREMOR (Some shaking), CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower), NAUSEA (Nauseous), VOMITING (Vomiting) and ARTHRALGIA (Aching joints). On 16-Apr-2021, the patient experienced HEADACHE (Bad headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (Some shaking), VOMITING (Vomiting) and HEADACHE (Bad headache) outcome was unknown, CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower) and NAUSEA (Nauseous) was resolving and ARTHRALGIA (Aching joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Pt said shot hurt when I gave it. She had normal discomfort first night but the arm pain has not gone away. And is now radianting down her left arm heat made it worse but has done no other palitive care.
Rash on thighs bilaterally, extended inferiorly to calves then resolved over 1.5 hours.  No fever, no respiratory difficulty.
Patient already had shingles but had not seen doctor yet; Patient has severe head pain after 4th shot; Blisters developed two weeks after shot 4; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (Patient already had shingles but had not seen doctor yet), BLISTER (Blisters developed two weeks after shot 4) and HEADACHE (Patient has severe head pain after 4th shot) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053F22B, 004F21A, 026B21A and 036A219) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    It was reported that patient has never been diagnosed/tested positive for COVID-19.  Patient had no known allergies.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), SERTRALINE HYDROCHLORIDE (ZOLOFT), PREGABALIN (LYRICA), FUROSEMIDE, SIMVASTATIN, TRAZODONE and POTASSIUM CHLORIDE (K-TAB) for an unknown indication.   On 06-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 05-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Blisters developed two weeks after shot 4). On an unknown date, the patient experienced HERPES ZOSTER (Patient already had shingles but had not seen doctor yet) and HEADACHE (Patient has severe head pain after 4th shot). At the time of the report, HERPES ZOSTER (Patient already had shingles but had not seen doctor yet) outcome was unknown, BLISTER (Blisters developed two weeks after shot 4) had resolved and HEADACHE (Patient has severe head pain after 4th shot) had not resolved.            Concomitant products included KTAB6 10 milligram through oral route.  Blisters cleared but severe head pain still persists. so, far did not found medicine to help with the pain.  Treatment Medication use information was not provided by reporter.   This case was linked to MOD-2023-716112 (Patient Link).
2nd dose a year later; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (The patient received 1st dose of shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 11-JUN-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media. The patient received second dose of Shingles vaccine a year later. Additional Supportive Information: The patient received second dose of Shingles vaccine later than recommended interval, which led to lengthening of vaccination schedule.
Initial information has been received from a pharmacist concerning a 77 year old male who on 30-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck). It was reported that on 11-JAN-2009 the patient started having back pain which spread to the chest and stomach. On 12-JAN-2009, the date of the report, the pain was "all over" when he touched skin. The patient believed this might be from ZOSTAVAX (Oka/Merck). Additional information received from the patient reported that he started to experience the pain all over his body on the evening of 09-JAN-2009. It hurt to even lay down because the pain sensation took over. The patient did not have any other "flu symptoms" which was why he believed it might be because of the ZOSTAVAX (Oka/Merck). At the time of this report, the patient was not recovered. Follow-up information was received from the pharmacist concerning the 77 year old male with no illness at time of vaccination or pre-exisiting allergies who on 30-DEC-2008 at 15:00 was vaccinated SC with the first dose of ZOSTAVAX (lot # 662996/1618X). concomitant therapy included LOTEL, FLONASE and DYAZIDE. ON 13-JAN-2009, at 14:00 the patient experienced pain upon touching skin around torso area which recovered after approximately 1 days without any medication. No further information is available.
Pt. reported itchy throat and the feeling of her throat closing at 1:40 PM. Diphenhydramine HCl 50 mg. (1 capsule) was given orally. Pt reported symptoms had subsided at 2:00 PM.  Prescription Info: Exp. Date: 08/2021 and Lot # 182681
Woke up with hives in AM, also cold like symptoms, coughing,congestion,mild dizziness
2 SHINGRIX in 2018, year later shingles/suspected vaccination failure; shingles under breast, arm , around the back; Eczema; Psoriasis; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2018, the patient received the 2nd dose of Shingrix. On 29th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, eczema and psoriasis. On an unknown date, the outcome of the vaccination failure, eczema and psoriasis were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, eczema and psoriasis to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 05-DEC-2022 and 07-DEC-2022 Reporter's Comment: The case was reported by the patient. She received 2 doses of Shingrix in 2018 at clinic.  Despite receiving a full dose of Shingrix, patient had shingles 3 times.  The patient's first event of shingles occurred a year after the vaccination in 2019 and the shingles were under breast and under arm and around the back.  Second event of shingles occurred around 2020 or 2021, on right leg.  Third event of shingles occurred in October 2022 on right side of inner thigh and extended on the back of the right side.  All 3 events were resolved after a week post occurrence.  The reporter did not specify whether reporter diagnosed her with the eczema/psoriasis after each visited to clinic post shingles occurrence. However, she stated that, could not believe that shingles could happen that often.  They diagnosed this to be eczema or psoriasis and that was a wrong diagnosis totally. Because The patient never had eczema or psoriasis. The patient did not have lot/expiry date of both of the doses. The patient gave consent to follow up with HCP (healthcare professional).  The contact information to HCP had been collected.  The patient gave email address for an acknowledgement letter. The reporter consented to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2022AMR183527 and US2022AMR183527, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR183520:same reporter
About 4 hours after the vaccine I was so tired i went to bed.   After midnight i had fever which over the next two days rose to 101.4.  My usual temperature is 97.7.  I had severe neck ache and head ache extreme fatigue,  and was bed ridden for 4 days.  My fever started to decrease on the third day.   I had roving pains which lasted 3-4 hours in each place:  first the right back above the waist where the kidneys are, then just below my right breast, then the left side of the top of my head.  Throughout I had to have a wet cloth on my head.  About a week later I had a relapse.... my temperature rose to 98 and I had the same headache place and neck ache at the bottom back of my head along with extreme fatigue and brain fog.  It lasted at least two days.   Of course as expected my arm was sore, but very swollen like a goose egg,  red, and impossible to move.    I still feel the same fatigue, and have to go to be very early but have insomnia and extreme anxiety.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
flat,blotchy, red, tender rash entire upper 1/2 of lt arm;beginning am of 29OCT97;
Shortly after injection, patient developed L sided neck and shoulder pain which has evolved into a neuropathic chronic pain radiating down to her lower arm.   Has been for 6 months w/o improvement.  Also had associated weight loss and night sweats during this time which have stablized.
p/vax pt exp pain in knees w/prevents pt from sleeping & stiffness in legs;
The night of the vaccine I developed a bad headache, diarrhea, and had no energy.
Subsequent to receiving the first dose of varicella virus vaccine live the pt developed breakthrough varicella that consisted of 20 small vesicular lesions on her chest and back with an erythematous base and some crusting.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017) (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
At 1208 patient reports feeling dizzy and feeling like fainting. Assisted client along with parent to cot in EMS room.  Client skin pale. Snack and bottled water given prior to injection. Cold moist was cloths applied to back of neck and forehead. 1216 client reports feeling good at this time .  Color returned to face; cheeks pink. Client finished full bottle of water. Client later reports she has a history of fainting with injections and forgot to inform nursing staff. Symptoms subsided and resolved.
patient of 23 years received pediatric dose; patient of 23 years received pediatric dose; Date of vaccination 2nd dose of Engerix- B: 8/03/2021 (adult dose) and Date of vaccination 3rd dose of Engerix-B:  09/07/2021 (pediatric dose); first dose of EngerixB was administered in 11/13/1998.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number 5295P, expiry date 27th December 2022) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B pediatric (received first dose on 13th November 1998).   On 7th September 2021, the patient received the 3rd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 3rd August 2021, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 3rd August 2021, not applicable after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 7th September 2021, the patient experienced underdose, adult use of a child product and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product, drug dose administration interval too long and drug dose administration interval too short were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical Assistant reported that the patient was vaccinated with second dose of Engerix B adult, later than the recommended interval, which led to lengthening of vaccination schedule. The patient was tested for Hepatitis antibodies 28th July 2021 and it showed that they did not have immunity to Hepatitis B so they restarted the series. The patient then received the third dose with Engerix B pediatric earlier than the recommended interval as per Engerix B schedule, which led to underdose, adult use of a child product and shortening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021190995:duplicate deleted case
The morning after the injection, the patient had severe vertigo for several hours .   It improved during the day but did not completely resolve.  The second day after the injection, the severe vertigo returned, lasting several hours and waning as the day progressed. Since then, the vertigo has been mild, and as of today has almost completely resolved.   The patient is aware of another person who had a flu vaccination at pharmacy around the same time and also experienced vertigo .
a 17 year old patient received an expired dose of Ipol vaccine yesterday/No AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who was vaccinated with an expired 0.5 ml dose of IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS-B), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLULAVAL).  On 19-Nov-2019, the patient received an expired dose of suspect IPV (VERO) (lot number: N1K93 and expiry date: 18-Nov-2019) via subcutaneous route in the right deltoid.  It was actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
VOMITING; SORE THROAT; COUGH; CONGESTION; RUNNY NOSE; CHILLS; FEVER; SINUS INFECTION; SEVERE  ALLERGY SYMPTOMS; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and coughing for four months, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sinus infection. On MAR-2021, the subject experienced severe allergy symptoms. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced congestion. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced vomiting. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, cough, congestion, runny nose, and sore throat, and the outcome of vomiting, sinus infection and severe allergy symptoms was not reported. This report was non-serious.