chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intense vomiting; muscle aches; no ability to get up and stand on her legs, legs were too weak; her legs were too weak; Headache; Enlargement of lymph nodes; This is a spontaneous report from Pfizer-sponsored program.  A contactable physician (patient) reported that a 70-year-old female patient (age at vaccination: 70-year-old) received bnt162b2 (BNT162B2, lot EW0150) intramuscularly in left deltoid on 16Oct2021 14:00 as dose 3 (booster), single, for Covid-19 immunisation. Medical history included blood pressure high hypertension. She had her dose 1, single of Pfizer Covid-19 vaccine BNT162B2 (lot EM9809; expiry date unknown) via unknown route on 20Feb2021 and had her dose 2, single of Pfizer Covid-19 vaccine BNT162B2 (lot AM6306; expiry date: unknown) via unknown route on 12Mar2021 at age of 70-year-old. Concomitant medication included labetalol for blood pressure high. The patient received her booster on 16Oct2021 and within 12 hours, she was unable to get up and stand on her legs/legs were too weak, had intense vomiting, muscle aches and also had a headache, all were reported as serious disabling. On Oct2021, she reported of enlargement of lymphnodes (also reported as same adverse events happened after she took her second shot). The outcome of vomiting was recovered on 17Oct2021; for other events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events vomiting, myalgia, muscular weakness, dysstasia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Post vax the patient developed a very large local reaction with significant upper extremity edema and erythema. The patient was treated with Motrin, Benadryl and Keflex.
Pain in the injection site in his left arm/shoulder; This is a spontaneous report from a contactable consumer or other non-health care professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 05Aug2021 (at the age of 73-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced pain in his left shoulder at the injection site and asked if it was normal to feel this pain. Among the Pfizer-BioNTech COVID-19 Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction", that approximately 84% of clinical trial recipients experienced pain at the injection site as well. Patient wanted to know why was that he still felt the pain in the injection site in his left arm/shoulder in his first dose. Outcome of the event was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Elevated temperatures; Tiredness; Trouble sleeping; Achiness; Late dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in October 2019, refer case US2020AMR125327).   On 6th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 6th July 2020, less than a day after receiving Shingrix, the patient experienced fever, tiredness, difficulty sleeping, general body pain and drug dose administration interval too long. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, tiredness, difficulty sleeping and general body pain were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, tiredness, difficulty sleeping and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had elevated temperatures, tiredness, trouble sleeping and achiness. The reporter did not had lot number or expiration date information to provide for either dose of Shingrix. This case linked with US2020124819 and US2020AMR125323, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020124819:Wife's case 2nd dose US-GLAXOSMITHKLINE-US2020AMR125323:Wife's case 1st dose
Headache Bodyaches Very weak Chills (not sure if feverish - I didn?t take my temp.) Sore muscles (back of legs) Hazy/Foggy mindset  Stuffy nose on morning of second day
Within 48 hours of injection of DTaP red swelling, heat, tenderness developed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: ER8730) and in Nov2021 as dose 2, single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression. Concomitant medication(s) included: WELLBUTRIN XL. 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.  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.
Pain and warmth surrounding needle at time of FIRST injection. Subsequent:  Fell soundly asleep 1 hour after shot for 8 hours. (4pm-midnite), woke for 3 hrs, slept again 'til noon. Each day for 3 weeks fell asleep 2ce/day (very unusual) 8 or 4 hours at a time, never being awake for more than 4-5 hours. (still occurring, but lessening a bit).
feeling sick to her stomach; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient got the first dose of the covid vaccine and reported feeling sick to her stomach afterward (Jan2021). The patient also had a question about the dosing schedule, and was asking if the second dose should be scheduled for earlier than 21 days. She reported that she got her first dose on 17Jan2021 and was scheduled to have her second dose on 04Feb2021. Outcome of the event feeling sick to her stomach was unknown.  Information on the lot/batch number has been requested.
After my second dose of vaccination I was experiencing Chills , fever and headache on May 8th . I had 2 Tylenol tablets and after chills , fever got reduced. Headache alone I was experiencing until May 10th on and off.  From May 10th evening itching has started and hives has been developed in face , head , neck , back and near hip. On May 11th I had 2 Benadryl tablets. Still I am having this allergy problem alone.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 42 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
No adverse event; Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 11-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Apr-2023, the patient experienced EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Administered second bivalent Moderna COVID-19 vaccine at 1:30 today after a previous dose of the Moderna Bivalent vaccine).    No concomitant medications were reported.    It was reported that [patient was administered second bivalent Moderna COVID-19 vaccine at 1:30 on 11-Apr-2023 after a previous dose of the Moderna Bivalent vaccine. No reported symptoms. No additional doses, medications or treatments administered in response.  This case contains information for the 2nd of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719301 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719301:
SWOLLEN AND RED. DELAYED TYPE HYPERSENSITIVITY REACTION. TOLD TO PROVIDER ON SUNDAY AND THEN RESOLVED ON MONDAY.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-JUN-2015 the patient was vaccinated with improperly stored a single dose of ZOSTAVAX injection, subcutaneously (lot number, strength and dose were not reported). No adverse effects were reported. The outcome of the patient's event was not reported. Additional information has been requested.
MUSCLE PA IN LOW BACK &LEGS,SWELLING TO INJECTION SITE (NO ERYTHMA, HEADACHE,FEVER.  TREATED WITH TYLENOL/MOTRIN COMBO,HYDRATION WITH RESOLUTION.
Discomfort in the left fore arm that has lasted for 1 month. Increasing discomfort with use. Noticeable at rest.
Information has been received from a 78 year old female consumer, with an allergy to shrimp and no medical history, who either at the "end of January 2008 or beginning of February 2008" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown). Concomitant therapy included alendroanate sodium (MSD), esomeprazole magnesium (NEXIUM), metoprolol succinate (TOPROL XL TABLETS), aspirin (unspecified), pravastatin Na (PRAVACHOL) and zolpidem tartrate (AMBIEN). One day later the consumer experienced terrible chills, a temperature and hands shaking. The consumer sought unspecified medical attention. No diagnostic studies were performed. The consumer also reported that the symptoms she experienced lasted for a few hours before subsiding. Two days after the vaccination the patient recovered. No product quality complaint was involved. Additional information is not expected.
Shingles; Felling of burning skin on a spot in my back; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and SKIN BURNING SENSATION (Felling of burning skin on a spot in my back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles) and SKIN BURNING SENSATION (Felling of burning skin on a spot in my back). At the time of the report, HERPES ZOSTER (Shingles) and SKIN BURNING SENSATION (Felling of burning skin on a spot in my back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
presented with acute hypoxic respiratory failure due to COVID 19 pneumonia. CXR unremarkable  Tx:  Rocephin, Zithromax, Decadron, nebs, lovenox, oxygen,  Remdisivir, singulair, zinc. Weaned off oxygen and is on room air at d/c
Information has been received from a registered nurse (R.N.) concerning a 78 year old female with no past medical history , who on 21-NOV-2005 at 14:0 PM was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot# 650330/0748P). There was no concomitant medication. On the morning of 22-NOV-2005, the patient developed swelling of her arm to her wrist and complained of numbness. It was reported that the patient recovered. Additional information has been requested.
Pain at injection site, redness and a red bump at injection site, itching at injection site, arm pain, unable to lift arm, fever, muscle aches, lethargic.
swollen arm; minor itch; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), INJECTION SITE PRURITUS (minor itch) and INJECTION SITE ERYTHEMA (redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), INJECTION SITE PRURITUS (minor itch) and INJECTION SITE ERYTHEMA (redness at injection site). At the time of the report, PERIPHERAL SWELLING (swollen arm), INJECTION SITE PRURITUS (minor itch) and INJECTION SITE ERYTHEMA (redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and treatment medications information was reported.
The evening after her vaccination, pt developed chills, possible fever but didn't check temperature.  The following morning she felt weak, achy, fatigued and vomited x 1.  Temp of 99 that day, continued to have chills.  Developed bulky left axillary lymphadenopathy on 1/9, "size of an ice cream scoop".  Injection site redness up to 4x6 inches which gradually improved.  Symptoms improved by 1/13/22 other than lymphadenopathy.  I saw her in clinic on 1/22 and she reported feeling nearly back to her baseline, still slightly more tired than usual and had had two nights of night sweats, but had ongoing bulky left axillary lymphadenopathy measuring  about 4cm x 7cm - firm, non-tender, mobile node.   Of note, the patient had a similar reaction after her second dose of Moderna  vaccine during her primary series, and her lymphadenopathy lasted 6 weeks that time.
13 People, who were applied the vaccine previously, were corona positive after a week; 13 People, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 6th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.
3cm X 3cm area of induration at injection site overlayed by a 8.5cm X 8.5 cm area of pruritic erythema; afebrile.  Rxn began 05/15/08, worse on 05/16/08, seen in our office on 05/16/08.  Advised Motrin PRN for discomfort.  Area circled, mom to call if it enlarged, no call from mom after visit.
HORRIBLE HEALTH PROBLEMS; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced horrible health problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible health problems was not reported. This report was non-serious.
Pfizer-BioNTech Bivalent COVID-19 Vaccine EUA: case resulting in invalid dose given  Patient has previously received Moderna Vaccines on 3/4/2021, 4/1/2021, and 1/28/2022. Patient received Pfizer-BioNTech Bivalent vaccine on 3/13/2023 at 08:45AM. Pt inadvertently received vaccine from vial opened on 03/10/2023 since 15:30PM. Error was found while documenting on 3/13/2023. No harm came to patient. Patient has been contacted, is doing well, and will return for revaccination per Pfizer and CDC recommendations.
Information has been received from a physician concerning an 8 year old male who on an unknown date was vaccinated with a dose of MMR II (route, site, dose and lot number not reported). On 25-NOV-2009, the patient experienced mumps (diagnosed on 29-NOV-2009). The patient was afebrile and had R parotitis. The outcome for mumps was not reported. No further information is available.
Cellulitis developed in forearm at injection site - treating with KEFLEX & steroids.
By that night I had pain and limited use of my left arm. Have had physical therapy for 6 weeks. The doctor said it impacted a nerve and caused some muscles to atrophy - it is getting better.
Sudden onset of fever, chills, body aches, vomiting, shortness of breath.
mom states p/shot arm was swollen; started having a rash that went away; states had to go to ER 24AUG95 because of rash & swelling; states ER MD stated was having rxn to MMR; given DPH & Methylprednisolone; broke out in welts;
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from an nurse. This case involves 13 year old female patient who received FLUBLOK QIV (batch number QFAA1805, expiry date, 02 June 2019) intramuscularly in left deltoid on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to Inappropriate age at vaccine administration as inadvertently gave FLUBLOCK 0.5 ml IM left Deltoid today to a 13 year old patient. It was reported that the patient did not experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
01/15/22 presents to EC ED for "worsening sob and cough". PMHx of "A-fib on AC, HLD, hypothyroidism, GERD, anxiety/depression"