chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown) and experienced decreased therapeutic response. The pharmacist reported that four subjects in a row were non-reactive with a count less than 2.89. At the time of the report no additional information was provided. This is one of four cases reported by the pharmacist, please see cases A0975396A, A0975398A and A09755399A. Follow-up information was received on 23 May 2012 via healthcare professional who reported on 27 January 2012, 26 August 2011 and 29 July 2011 the subject received 3rd doe, 2nd dose and 1st dose of ENGERIX B (1 ml, unknown, right deltoid). The lot number for the last dose of ENGERIX B was noted to be "AHBV94BB". On 12 April 2012, 76 days after vaccination with 3rd dose of ENGERIX B, 8 months after vaccination with 2nd dose of ENGERIX B, 9 months after vaccination with 1st dose of ENGERIX B, the subject experienced decreased therapeutic response. On 12 April 2012 Hepatitis B titer results were less than 2.80 (9.99 or less is negative 10 or more is positive). The subject received a booster dose of ENGERIX B on 16 April 2012. The lot number was reported as AHBV94BB from the reporter; however, based on a safety lot number review, the lot number was updated to AHBVB944BB.
pt began having tremors of head, hands, arms approx 2 days p/vax; temp was not taken; occurs when pt is eating; no other time; stops when nipple removed from mouth;
Patient received ZOSTAVAX vaccine 8/19/15. Area was raised, warm, red that day. Progressively got more severe. Patient saw physician 8/21/15 was given antibiotic. Area was now approximately 6 in long by 2 in wide.
testing positive for Covid; sore throat; trouble swallowing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (trouble swallowing) and SARS-COV-2 TEST POSITIVE (testing positive for Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and DYSPHAGIA (trouble swallowing). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (testing positive for Covid). At the time of the report, OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (trouble swallowing) and SARS-COV-2 TEST POSITIVE (testing positive for Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It is reported that the consumer believed she had a head cold but she tested positive for Covid-19. Information pertaining to the Covid-19 test, such as date, and type of test were not provided. No concomitant medications or treatment medications were reported.
Experienced rash/hives starting at mid neck line - then continued to jawline and then ears and towards eyes - did not itch or feel painful.
Information has been received from a physician concerning a 9 year old female who on 30-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 657403/0715U). On 02-JUL-2007, the patient developed a golf ball lump around the injection site that was tender. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
anaphylaxis w/gen pruritus, hoarseness, wheezing & possible hypotension 20-30min p/vax;tx w/inhaled racemic epi & DPH & kept on oral allegra bid for 3 days;
Pt vax w/ 3 hepta B & did not respond. Given on 2Oct, 2Nov, 2Dec, 1990.
This spontaneous report refers to a 61 year old female patient concern to herself with penicillin allergy, allergy to narcotic medication and latex sensitivity. On 05-MAY-2014, the patient was vaccination with ZOSTAVAX for vaccine, injection for prevention shingles (dose and route not reported). Concomitant therapies included losartan potassium (manufacturer unknown) and WELLBUTRIN. It was reported that the patient began having severe nerve pain on 05-MAY-2014 (reported as last night), that went from her breastbone to her back. On 06-MAY-2014 (reported as this morning), when the patient was showering she noticed a rash similar to chickenpox under her breasts, under her arms, all over her back, and down her face. Her body was warm all over. The patient was not treated. The patient did not sought medical attention. The patient would be calling her physician on 06-MAY-2014 (reported as today). Patient's present status was not improved. Additional information has been requested.
Transient global amnesia. I am a neurologist and my wife lost a sense of time, where she was, where she was parked app. 15 minutesd after m-RNA injection without systemic problems. Even was followed in ten minutes by esophageal spasm and then resolved without residue. No history of similar events
Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an over 65 years old patient who experienced flu-like symptoms, while he/she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. In 2017, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a non-serious flu-like symptoms following the administration of INFLUENZA VACCINE. Patient went to the hospital. Lab test not reported. Final diagnosis was flu-like symptoms. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for flu-like symptoms.
Palm size rash on left thigh (inject site), swelling, no fever. MD gave antibiotics and Benadryl.
Rapidly progressing hive like rash. Given BENADRYL 25 mg PO with nominal alleviation. No facial swelling. No respiratory involvement.
Admitted on 2/16/2021 with ascending weakness/ possible Guillain Barre. Patient was readmitted a month later with severe dehydration, colitis, sepsis and metabolic acidosis
pt recv vax & exp arthralgia;the reporter felt there was a problem w/the  particular lot of vax;no further details were provided;
Injection pain; Extreme fatigue; headache; muscle pain; Chills; fever 101.1; Feeling unwell; dizziness; weakness,; nausea; joint pain; This is a spontaneous report from a contactable consumer. This 66-Year-old elderly male consumer (patient) reported that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown as Unable to locate or read the details), dose 1 via an unspecified route of administration on 01Mar2021 at 04: 15 pm in left arm (at the age of 66-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was unknown. Patient's medical history cardiac history, Polycystic kidney disease, diabetes, hypo thyroid, auto immune and covid-19 from an unspecified date to unknown if ongoing. There were no known allergies. No other vaccine were given in four weeks. Concomitant medications (in two weeks) included omeprazole, Amlodipine, thiamine hydrochloride (THIAMINE HYDROCHLORIDE), Metformin hcl, all from an unspecified date to an unspecified date at unspecified dosage for an unknown indication. On 01Mar2021 at 1:00 pm, patient experienced injection pain, extreme fatigue, headache, muscle pain, chills, fever 101.1, joint pain, feeling unwell, dizziness and weakness, nausea. The AEs did not result in emergency room visit or physician's office visit. No treatment was given for the AEs. Patient had covid prior vaccination and was not tested for covid post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient developed bleeding from the gums soon after the first shot, did not notify medical personnel until his second vaccine. Platelet count was found to be 3000 on March 2
Chest pain started kind of mild; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain started kind of mild) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced CHEST PAIN (Chest pain started kind of mild). At the time of the report, CHEST PAIN (Chest pain started kind of mild) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-385727 (Patient Link).
Shoulder pain following immunization. Described as moderate in severity, severe, constant, dull, aching, and certain movements cause sharp/stabbing pain. Pain increases with abduction and nonspecific arm movement such as buckling seatbelt. Patient has decreased range of motion and pain with range of motion.
Pt  ambulated w/ assistance into observation area, upon sitting down in observation, Pt appeared faint, almost losing consciousness, Pt never lost consciousness, Dr. called, Dr. and more staff arrived, Pt was assisted to the floor, O2 began @ 8L, then lowered to 4 L, vitals taken BP 145/80, HR 76, O2 98%, O2 sat flucuated btw 84%-98%, AXOX4, EMS arrived within minutes and took over, Pt observed by EMS for 30mins. stable and released to go home per Pt request.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 5/19/2022 Discharge Date: May 21, 2022  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE:  Patient is a 84 y.o. female with PMH significant for CAD, carotid stenosis, a fib, HTN, hypothyroidism, and HLD who presented to the ED on 5/19/22 due to worsening cough and SOB. Patient was initially diagnosed with COVID on 5/16 while visiting friends. She then drove 2.5 hours back.  Patient had appointment with her PCP on the day of admission and was found to have spO2 of 87% and was referred to the ED.    In the ED, spO2 fluctuated, at times requiring 2L and at times stable on RA. She was also tachycardic in 100-110 range. VS otherwise stable. Labs notable for Cr 1.3 at baseline, mild transaminitis, WBC 12. COVID PCR was repeated and positive. CXR showed patchy indistinct hazy opacities without focal consolidation. She was started on decadron and is being admitted to Blodgett for hypoxia 2/2 covid pneumonia.   Patient continued to have fluctuating oxygen saturations with saturating stable on room air at rest but requiring supplemental oxygen with activity.  Patient was continued on oral dexamethasone awaiting clinical improvement. She was weaned to room air and discharged to home in stable condition. Will complete 10 days of Decadron.
Patient has had chronic headaches and stomach aches in the last year since the last vacccine.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 8 weeks old child patient of unknown gender. On 26-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Pt recv vax on 10/13/98; on 10/14/98 pt exp lump on left jaw
Grandmother had trouble breathing the night she got the vaccine. She went to the hospital. They found pneumonia and a partial bowel obstruction. The obstruction cleared but she died from the pneumonia on 2/16/21.
Redness presented a couple of days following; Experienced soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2021, the patient received the 1st dose of Shingrix. On 22nd March 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  Immediately after receiving 1st dose of Shingrix, patient experienced injection site soreness and couple of days following, experienced redness, which lasted for week. The reporter mentioned that,patient has not received the second dose yet. The reporter consent to follow up.
Large swelling,dark red circle at injection site 2 inches in diameter, bruising, still present after 10 days. Heavy chest. Joint pain. 2 days later itching injection site with mild rash on same arm, stomach, red itching heel of same foot. Injection site still itching 10 days after.
95 Year old came to pharmacy for Booster vaccine.  Filled consent form.  RPh checked face of vaccine card, it had been 6 months and the patient was eligible.  Patient got booster shot.  The next day pharmacy got a call from friend/family saying that she had received booster while visiting family in another state.  Perhaps patient did not remember receiving  it.   Rph verified with family member that booster was received.  There was a possibility that patient could have had a second vaccine card not presented or the booster could have been written on the back of the vaccine card.  Called patient she stated she had diarrhea the following day after the vaccination, but attributed it to something she ate.  On Sunday, 2 days after the vaccination patient was fine she went to the store, went to mass/church, went for coffee.  RPh told patient to seek out medical assistance if experiences any side effects.  Called patients prescriber and they are aware and had no concerns at this time.
patient was administered a dose of the vaccine from punctured vial that was punctured for more; A spontaneous report was received from a pharmacist  concerning a patient who experienced patient had been administered a dose from a punctured vial that had been punctured for more than hours.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced nonserious unexpected event of Expired product administered with mRNA-1273 (Lot # unknown), with no associated adverse events.  Reporter stated that patient was given "vaccine from a punctured vial that had been punctured for more than hours".  The event occurred the same day as the first dose of mRNA-1273. Very limited information has been provided at this time.  Further information has been requested.
tested positive for covid; tested positive for covid; This is a spontaneous report from a non-contactable consumer. This report refers to three patients.  The patient of an unknown age and gender received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Lot Number: E10140 expiry date not reported) via an unspecified route of administration on an unknown date in Jan2021, at a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Lot Number: E10140 expiry date not reported) via an unspecified route of administration on an unknown date in Dec2021, at a single dose for Covid-19 immunization. On an unknown date, all the three patients were tested positive for covid-19 vaccine. The outcome of the events of Covid-19 and drug ineffective was unknown.  No follow-up attempts possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021363887 Same reporter/drug, different patient/event.;US-PFIZER INC-2021361018 Same reporter/drug, different patient/event.
Swelling of arm, tender & lump in arm, redness from shoulder to elbow lasted a~ 1 week, fever/chills for 2 days, HA x 3 days
After receiving the Moderna booster, I had chills for several hours on the day of injection. During the next 5 days I had a swollen and discolored hard knot at my injection site, sore lymph nodes near my arm pit on the injection arm, body aches, and fatigue. My symptoms lasted 6 days.
my left arm hurt for about 2 days; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 05May2021 as single dose for COVID-19 immunisation. Medical history included at the tender age of 40 (unspecified units), diagnosed with chickenpox. The patient had itching and discomfort on the chest and throughout the body. The patient concomitant medications were not reported. The patient previously received shingle shots for immunization. It was reported that 20 years later after chicken pox, the patient heard about shingle shots. Patient learned that people who have had chickenpox carried the same "virus" and decided to get vaccinated. As the pharmacist gave the injection, the patient felt a brief itching sensation, exactly the same location where the patient had the chickenpox, mainly on the chest and all over the body. That lasted only a few minutes and then disappeared. On 05May2021, the patient received first vaccination in left arm. About 8 hours after the vaccination (May2021), left arm hurt for about 2 days and that was all the patient experienced. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Red, swollen rash on upper arm, approximately 6 inches across. Warm to the touch and slightly swollen but no pain or irritation. Pt went to ER before consulting pharmacist.
Chronic Pain med requirements increased after the second dose of the vaccine. 1 week after vaccination previous dose quit working.
Patient presents to ED on 1/14/2021 with respiratory arrest and started around 1300. Per EMS, reportedly told fiance that he had taken some sleeping pills and was going to go to sleep. EMS was called after the patient was found unresponsive about 15 minutes later. Family attempted to do CPR. Upon EMS arrival to the patient's home, patient had a pulse, was in respiratory distress with agonal breathing. They also reported emesis in the airway. EMS performed nasal intubation and administered 10 mg IV Narcan en route. Upon arrival to the hospital, patient was moving arms more and gritting teeth. Patient had movements of decerebrate posturing of arms intermitting with a relaxed posture. GCS was 4 on arrival. Patient is currently still in ICU and has been extubated.
SICK; This spontaneous report received from a patient 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, and batch number were not reported) 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 sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick. This report was non-serious.
He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.).    Concomitant product use was not provided by the reporter.  It was reported that received a shipment of NDC 80777-275--05 after receiving the Bivalent vials.  Treatment information was not provided.
tingling of tongue and lips, numbness of feet/legs.  Started 30 minutes after shot and continued to the next day
As soon as patient received VARIVAX she fainted. I (the physician) came in the room right away; she was alert & oriented O2 sat 96% on R.A. Her lip is pale & hands are sweaty; The rest of physical exam is within normal limit. I think pt has vaso-vagal episode secondary to fear of vaccination
Approx 4 hrs p/recvd vax mom noted pt choking, sat pt up over shoulder & pt became limp & wouldn't shake awake this happened twice; mom shook pt & blew in face; pt was white & stopped breathing; taken to ER;