chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with drug hypersensitivity and drug hypersensitivity. On 23-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # N009167 for prophylaxis. Other suspect therapies included sterile diluent. On 24-AUG-2017, 2 days after onset of therapy the patient experienced injection site erythema and injection site warmth. The outcome of injection site erythema and injection site warmth was reported as not recovered/not resolved.
Malaise, 99.4 F temperature, backache, chills, minimal nausea
Initial report was received from a consumer on 17 June 2013. This case involved a cluster of 13 patients who received IMOVAX, lot number D1177-1, and had low titers. Thirteen unidentified patients had received injections of IMOVAX, lot number D1177-1, on 07 September 2011, 14 September 2011 and 05 October 2011. Titers were checked on 14 May 2013 and 15 May 2013 and were low indicating need for a booster prior to the 2 year booster dose indication. No other information was available. Outcome was not reported. Follow-up information was received on 05 August 2013 from a health care professional. Upon internal review it was determined this case did not meet seriousness criteria and has therefore been down grade from serious to non-serious. A 24 year-old  male patient had received dose one intramuscular left deltoid injection of IMOVAX, lot number D1177-1, on 21 September 2010, dose two intramuscular left deltoid injection of IMOVAX, lot number on an unspecified date and dose three intramuscular left deltoid injection of IMOVAX, lot number D1177-1. The patient had no illness at the time of the event and had a history of allergy to Amoxil. No further information was available at the time of the report. The patient's outcome was unknown. The reporter for this case is the same as for case 2013-08317 and 2013-08318. Documents held by sender: None.
VACCINE DID NOT WORK; This spontaneous report received from a patient via media through a company representative concerned a male of unspecified age, race and ethnicity. 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 administration, and batch number were not reported) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient reported vaccine did not work (Lack of drug effect). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine did not work was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product quality complaint: 90000216653. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from department on 16-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: This follow up version was created to update following information: Product quality complaint investigation result. This added information does not alter the causality of previous reported event. 20220220931-COVID-19 VACCINE AD26.COV2.S-Vaccine didn't work. Follow-up received regarding Clinical Details. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Left arm got sore red rash moved around to front of arm pain went down into elbow causing numbness and bottom fingers on my hand. It caused a knot on my shoulder Then my shoulder got hot where red rash was
Patient experienced a mild case of shingles even though she was administered 2 shots of Shingrix
HEART RACING, FLUCTUATING BLOOD PRESSURE SINCE THE PFIZER VACCINE, SWEATS, LOW BLOOD PRESSURE, LOW HEART RATE, 96% OXYGEN LEVELS, THEN RACING HEART AND THEN EXTREMELY ELEVATED BLOOD PRESSURE, DIZZINESS, CHEST TIGHTENING IN THE HEART AREA, CHEST PAINS IN GENERAL BOTH RIGHT AND LEFT,  MUSCLE ACHES ALL OVER WITH PRIMARY ACHES IN LIMBS, CHEST AND BACK, HEADACHES, AGITATION, LOW-GRADE FEVER, SWEATS AND FEELING HOT AND UNABLE TO COOL CORE TEMP TO STABLE WITHOUT FEELING OVER HEATED, ALL OF THESE SYMPTOMS STARTED BY THE 3RD DAY BEFORE THE 72 HOUR MARK AT 1:00 AM 11/22/2021 AFTER PFIZER VACCINE DATE 11/19/2021 AT 12:30PM. THIS HAS CONTINUED TO WORSEN OVER THE LAST 72 HOURS. LOSING CONSCIOUSNESS AND AWARENESS WHILE FAINTING TODAY AROUND 9AM THIS MORNING 12/2/2021 -  AFTER WAKING 30 MINS TO 1 HOUR PRIOR TO THE FAINTING OCCURRENCE. DECREASED APPETITE COUPLED  WITH INCREASE THIRST IN THE LAST 48 TO 72 HOURS.
Patient reports that within 24 hours after the Moderna Bivalent booster, he developed a very large bruise; Patient also had a red rash below the bruise (2"X3") on upper left arm; Patient also had a red rash below the bruise (2"X3") on upper left arm.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (Patient reports that within 24 hours after the Moderna Bivalent booster, he developed a very large bruise), VACCINATION SITE RASH (Patient also had a red rash below the bruise (2"X3") on upper left arm.) and VACCINATION SITE ERYTHEMA (Patient also had a red rash below the bruise (2"X3") on upper left arm) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 23-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 19-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 13-Oct-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 4) on 18-Apr-2022 and PFIZER BIONTECH COVID-19 VACCINE (Dose 5) on 18-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 02-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE RASH (Patient also had a red rash below the bruise (2"X3") on upper left arm.). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Patient reports that within 24 hours after the Moderna Bivalent booster, he developed a very large bruise) and VACCINATION SITE ERYTHEMA (Patient also had a red rash below the bruise (2"X3") on upper left arm). At the time of the report, VACCINATION SITE BRUISING (Patient reports that within 24 hours after the Moderna Bivalent booster, he developed a very large bruise) and VACCINATION SITE ERYTHEMA (Patient also had a red rash below the bruise (2"X3") on upper left arm) outcome was unknown and VACCINATION SITE RASH (Patient also had a red rash below the bruise (2"X3") on upper left arm.) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
About 12 hours post vax, the pt complained of tongue and throat swelling and states it felt like it was all numb. She states she could hardly breath or swallow. She took an Atarax pill and it helped but her tongue and mouth are still numb.
feels like something inside; he was not normal; feel a little bit dizzy; he was just uncomfortable; This is a spontaneous report from a contactable consumer (patient). This case is for dose 1 of 2. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9464, Expiry date: unknown), intramuscularly, administered in left arm on 28Jan2021 (at the age of 72 years) as dose 1, single for COVID-19 immunization. Patient took second dose of bnt162b2 (Lot number: EM6198, expiry date: 30Jun2021) intramuscularly, administered in left arm on 23Feb2021 as dose 2, single for COVID-19 immunization. Patient had no medical history (including any illness at time of vaccination). More or less, he was in good health and may be his condition was too good. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Patient previously received flu vaccine in Oct2020, which he takes every year, the last one he had was sometime in late Oct2020. On an unknown date, the patient felt like it was something inside. He clarified for about a day or day and a half, he was not normal, and it felt the same way as any flu shot. He thought it was normal to feel a little bit dizzy or feel a little "this". Patient explained that he was just uncomfortable. He felt like there was something inside him for about a day or day and a half. Patient wanted to know if he had to do a test in 3 or 4 weeks to be sure of the COVID-19 vaccine. He wanted to know what degree he has immunization. He knows the vaccine was supposed to be around 94 or 95% effective, but maybe he was in the 5% that is not. The outcome of all the events were unknown.  No follow-up attempts are possible. No further information is expected.
she was diagnosed with Covid; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient 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 on 27Apr2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, on 07May2021, she was diagnosed with COVID and the pharmacist told her to wait 90 days to get her second dose. Her second dose was scheduled for 19May2021. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Swelling; Pain in the arm; Heat in arm; Itching/it was not hot to touch but was itchy; Redness, local/a 2- 2.5 inch red area on her arm at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included SYNTHROID for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS and VACCINATION SITE ERYTHEMA. On an unknown date, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN outcome was unknown and VACCINATION SITE PRURITUS and VACCINATION SITE ERYTHEMA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information updated, onset date and outcome of the events updated. Sender's Comments: This case concerns a 72-year-old patient of unknown gender who had nonserious events of unexpected injection site warmth and expected erythema, injection site pain, injection site pruritus, injection site swelling. Event onset occurred with unknown latency after the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PTE PRESENTA MAREOS Y BP ELEVADA. POR LO QUE REQUIERE SER EVALUADA POR MD DE TURNO.
Arm pain 3 weeks post vaccine. Initial arm pain faded after 4 days. New pain started after 19 days. Hurts to lift or put pressure on the left arm at all. Getting worse by the day. Pain is directly at vaccination site and slightly below.  Was told by doctor to come back in if I develop a fever and take ibuprofen in the meantime.
exposed to a chemical; his hand started hurting, swelling, and became red; his hand started hurting, swelling, and became red; his hand started hurting, swelling, and became red; allergic reaction; This is a spontaneous report from a contactable consumer or other non-HCP (reporter's husband) via medical information team. A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL9264), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient exposed to a chemical, his hand started hurting, swelling, and became red, allergic reaction. Reporter calling for 69-year-old husband who received his first Pfizer COVID vaccine on 29Jan2021. Patient will receive his second Pfizer COVID vaccine on 27Feb2021. Patient works as a janitor and was exposed to a chemical (unsure of name) while cleaning. His hands became painful, swollen & red. Pt received one Kenalog 40 mxl injections in his hip when seen by his provider. Wife asking if it's okay to take the COVID vaccine after have the Kenalog injection. Reporter is a consumer that was calling about6 the covid-19 Vaccine. The reporter reported that her husband, (Name), had the first vaccine on 29Jan2021 and did wonderful. Patient was scheduled for his second shot, but because of snow and the vaccine getting there it was rescheduled for this Saturday, 27Feb2021. Reporter said that he is a janitor for a park and was cleaning up and he got into some chemicals and his hand started hurting, swelling, and became red. They do not know exactly what caused it and she said that he is assuming that he came into contact with some chemicals. She said that he typically wears gloves when he is cleaning, but for this particular job he did not wear any gloves. The reporter said that the doctor told him it was an allergic reaction and treated him with Kenalog 40MXL and told him to take Tylenol and Ibuprofen. Can he still take his Covid vaccine in Saturday without a problem or is it contraindicated because he had the Kenalog 40MXL. The patient received Kenalog 40MXL injection as treatment for all the events. Outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Hot arm; Very itchy; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Red arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Covid-19 vaccine at 3 pm. She reports symptoms of throat feeling "funny" at 3: 40 pm. She noted she may be "psyching herself" due to history of anaphylaxis after shellfish with tongue swollen; was a frightening experience. No issues breathing, able to swallow. Felt had mild headache right after shot; better now. BP 142/80, pulse 74, p ox 98%. Gave water, monitoring. Concerned about husband waiting; might be worried. 3: 45 pm: BP 160/90, pulse 68; feels throat a bit better. Did not feel needed to go to ED. Notes has high BP; took meds today; forgot yesterday. Did not eat as of yet. Gave water. 3: 55 pm Felt now little headache; concerned husband texting and worried. BP 158/88, pulse 69. Patient felt ready to leave; felt stable. Reviewed if symptoms worsened to seek medical attention; may want to call doctor and update. Nurse accompanied to lobby where husband waiting.
It was reported that a pt received a TD Adult vaccination that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further info is being requested.
devel rash the day p/vax; also immun given 14JUL94 came to clinic 19JUL94; ran fever until 18JUL94;
itchy rash at injection site, started on Feb 6, still present as of Feb 8.
Two weeks of abdominal discomfort, followed by onset of extreme abdominal pain  Followed by diagnosis of blood clot at kidney artery
Information has been received from a nurse concerning her 19 year old daughter who in 2007 was vaccinated with three dose series (0.5 ml) of GARDASIL (No lot numbers were provided). The patient experienced dizziness after each dose of the three doses series of GARDASIL. The dizziness only lasted approximately 24 hours after each injection. Medical attention was not sought. Patient outcome was recovered on an unspecified date. No product quality complaint was involved. No further information is available.
Itching in hands, arms, fingers, legs and sometimes ankles:; tiny bumps in both arms; arm was a little tiny sore; hives; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).  A 64-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection Batch No: not available/Lot Number: ER8736) via an unspecified route of administration, administered in Left Arm on 21Apr2021 at 15:15 (at the age of 64 years old) as dose 2, single for covid-19 immunization. Medical history included ongoing hypertension from an unknown date. The patient's Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from an unspecified start date and ongoing; acetylsalicylic acid, ascorbic acid (ASPIRIN C) taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection Batch No: not available/Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 64 years old) as dose 1, single for covid-19 immunization. No other vaccinations administered within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations was unknown. No Family Medical History Relevant to AE(s). No other Additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that patient was calling about the Pfizer, and that she took two vaccine shots for the Pfizer Covid 19 vaccine. On an unspecified date in APR2021 (about the end of the month of April) for the last 2 weeks, patient experienced hives, has had itching at night. She had itching in her hands, arms, and sometimes ankles and feet. There are tiny bumps in both arms and it was weird and cannot see them or itch during the day. They are still the same but sometimes there will be tiny little bumps and can barely see them. Looks like they maybe rubbing them all of the time. Her arm was a little tiny sore, got over that and was feeling fine. The itching was at night and then she feels it and starts itching. For the last 2 weeks, she started itching all the time that lasted 2 weeks and felt little fine. She stated that, her breathing and everything was okay. She had no fever or anything, just itching. AE did not require visit to physician room or emergency room. The relevant test was none. Treatment was tried Cortisone cream and has tried some Rapid Relief Gold Bond Anti-itch Cream for the itching in hands, arms, fingers, legs and sometimes ankles which was persisting. Was trying to see if it would help stop itching. Was itching for 2 weeks, has had enough and was sked anything there to take or help with the itching. The outcome of the events "arm was a little tiny sore" was recovered and all other events was not recovered.  No follow-up attempts are needed. No further information is expected.