chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning her 18 month old daughter who in approximately 1991 was vaccinated with a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). In approximately 1991, when the pt received the vaccine, she developed a measles like rash on the trunk of her body. The rash was limited to the upper portion of her body. Unspecified medical attention was sought. Subsequently, the pt recovered. At the time of the report, on 06MAY2003, the pt was 13 years old and noted to be otherwise healthy. Additional information has been requested.
to be COVID positive (patient was fully vaccinated but not yet received booster); COVID-related pneumonia (Grade 3 lung infection); fever of 102F; hemoglobin was at 5.3 mg/dL (Grade 3 anemia).; to be COVID positive (patient was fully vaccinated but not yet received booster); This is a spontaneous report from a contactable physician.   A 42-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (at the age of 42-year-old) (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (at the age of 42-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced drug ineffective (medically significant) on 21Oct2021 with outcome of unknown, to be covid positive (patient was fully vaccinated but not yet received booster) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown, fever of 102 F (hospitalization) on 21Oct2021 with outcome of unknown, COVID-related pneumonia (grade 3 lung infection) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown, hemoglobin was at 5.3 mg/dl (grade 3 anemia) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown. The patient was hospitalized events from 21Oct2021 to an unknown date.  The patient underwent lab tests and procedures which included:  body temperature: 102 F on 21Oct2021 (Grade 1 fever), chest x-ray: pneumonia (COVID induced) on 21Oct2021, haemoglobin: 5.3 mg/dl on 21Oct2021 (Grade 3  anemia) , sars-cov-2 test: positive on 21Oct2021.  The clinical course of events was as follows: Patient presented to local ED on 10/21/2021 due to having a fever of 102F (Grade 1 fever)at home. Patient evaluated in ED, found to be COVID positive (patient was fully vaccinated but not yet received booster). Chest x-ray showed COVID-related pneumonia (Grade 3 lung infection) and hemoglobin was at 5.3 mg/dL (Grade 3 anemia). Patient was admitted, received blood transfusion and IV antibiotics. Patient was still in the hospital.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "COVID positive", "COVID-related pneumonia" and fever.  The event anemia is considered not related to BNT162B2, but rather intercurrent medical condition. 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.
4 hrs p/vax pt exp pain, swelling in lt upper arm, w/t102.5 & severe pain @ inject site;
Within 10-15 mins of shot patient said he felt dizzy and "couldn't see" lips tingly tongue "feels huge"
This spontaneous report was received from a registered nurse referring to a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-NOV-2016, the patient was vaccinated with a pediatric dose of VAQTA with a lot number M017982 and expiration date of 13-SEP-2017 (strength, dose and route of administration were not provided) for prophylaxis. No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
COVID-19 virus test positive; Lost my sense of taste; Lost my sense of smell; Nasal congestion/runny nose; Arm was sore for 24 hrs; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021. The most recent information was received on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for 24 hrs), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), AGEUSIA (Lost my sense of taste), ANOSMIA (Lost my sense of smell) and NASAL CONGESTION (Nasal congestion/runny nose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o25L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for 24 hrs). On 05-Jan-2021, the patient experienced AGEUSIA (Lost my sense of taste), ANOSMIA (Lost my sense of smell) and NASAL CONGESTION (Nasal congestion/runny nose). On 06-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). The patient was treated with VITAMIN C [ASCORBIC ACID] (oral) from 06-Jan-2021 to 16-Jan-2021 for COVID-19, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) from 06-Jan-2021 to 12-Jan-2021 for COVID-19, at a dose of UNK, bid. On 06-Jan-2021, NASAL CONGESTION (Nasal congestion/runny nose) outcome was unknown. On 10-Jan-2021, AGEUSIA (Lost my sense of taste) and ANOSMIA (Lost my sense of smell) was resolving. At the time of the report, PAIN IN EXTREMITY (Arm was sore for 24 hrs) had resolved and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive (Positive) PCR.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Treatment medications of Vitamin C and Mucinex were reported, nasal congestion and runny nose was reported. Patient reported that she received the second dose of vaccine within the recommended time frame.
very red arm covered area 6" high & 4-6" around upper arm; hot to touch & painful;
Information has been received from a consumer referring to her neighbor's daughter of unknown age. Information about medical history, concurrent condition and concomitant medication was unspecified. On an unknown date, the patient was vaccinated with GARDASIL (lot number, dose and route were unknown). On an unknown date the patient experienced lupus. The outcome and causality of the event were unknown. Upon internal review, the event lupus was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Patient stated tingling of lips and tongue. I asked her to take an antihistamine if she had one. She stated she had claritin and would send her husband to the store to get benadryl. By the time he got back she was feeling better.
Red and hot at site 24 hours after initial injection. Patient stated it was starting to get a little better as of 8-7-2018. Told patient to mark redness and to monitor for 24 hours and if gets worse then call md.  I also contacted md at 11:15 am 8-7-2018 to notify of reaction and what I told patient. Told patient to call pharmacy to follow up tomorrow plus called pt with no response as of 2.59pm 8-7-2018. Entered 2 previous VAERS with wrong lot number and this is an updated correct one with correct information.
Pt recvd DTP/HIB on 28AUG91 & was crying soon as inject was given pt took a deep breath a few sec & appeared like would pass out; by blowing in pt's face did move head & arms; color gray; limp for a few seconds, started shallow breathing;
Patient got Flu vaccine and PNEUMOVAX vaccine on right arm on 10/26, and Tdap vaccine on the left arm. Patient reports the next day about pain, inflammation, and little bumps on the right arm and had fluid discharge came out of the bumps. Patient went to the hospital on 10/29 and the discharged at the same day with the diagnosis is "Right arm cellulitis". Pt was treated with Keflex and doxycycline.
COAGULOPATHY, UNSPECIFIED TYPE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN HYPOTENSION 4/11/2022,  5/18/2022,  6/4/2022,  6/12/2022,  8/7/2022,  8/31/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Records received 12/19/07-11/19/07-11/23/07-patient's words: c/o right upper thigh area reaction to shot given on 11/29/07. We think he had HIB and Hep A given on that side. developed localized redness and induration over the next day which hasn't gotten worse but hasn't gotten better. 11/24/07-Right thigh slightly firm, raised, palpable a nd visible area about 2cm. Mild erythema appears to be withdrawing from the margins. DX: noninfectious, sterile abscess from immunization, from serum leaking back up to surface from needle track. 12/8/07- still has small lump but decreased in size looks like a bruise.
Vaccine was reconstituted with the wrong diluent.  1.3ml of sterile water diluent was used to reconstitute.   no adverse reactions where noted or know at this time
Pt had varicella lesions 10-15- that appeared 3 weeks after vaccine given. No treatment required.
23 Oct 2003 Received vaccinations on this date.  Reports he attended the briefings on smallpox and anthrax vaccinations and received the brochures.No complaints on this date except he had "cold symptoms-runny nose, stuffy head." 28 Oct 2003 Noticed approximately 4 bumps like "zits" on his right thigh.  No itching, no pain.  Went away on their own after a couple of days. 01 Nov 2003 Noticed red streaking from smallpox vaccination site to approximately 2 inches medial to left axillary area.  Also noted tender knot on neck.  No headache, no dizziness.  Neck pain only localized to swollen lymph node.  Had a fever of 102 that normalized after Motrin.  Feels a little more tired than usual.Also noted a canker sore on tip of tongue.Denies any chest pain or palpitations.  Shortness of breath noted only after a long run but not with normal activities or at rest.  No cough. 02 Nov 2003 Continued symptoms as above.  Fever of 99.7 that normalized after Motrin. 03 Nov 2003 Referred to the VHC.  No fever today.  Continued erythematous streaking from SPV to approximately 2 inches medial to left axillary area.  Continued tender, swollen lymph node in posterior cervical neck area and axillary area.  Continued oral canker sore.  No other oral lesions.  No lesions on palms or soles.  Few discrete "bumps" noted on left upper arm and one on chest.  Lesions non-pruritic.  However, patient does complain of itching at SPV site.No complaints of pain, numbness, tingling, or edema at location of anthrax or other vaccinations.  ASSESSMENT:  1. Lymphadenopathy-Left posterior cervical and axillary- Normal side effect associated with smallpox vaccination 2. Lymphangitis-Normal variant associated with smallpox vaccination 3. Robust smallpox vaccination with erythema and edema surrounding vaccination site. 4. Non-viral pustulosis  5. Aphthous ulcer  Treatment Plan: 1. Motrin 800 mg po tid #30 with no refills for comfort. 2. Allegra 180 mg po qd #30 with no refills to relieve itching. 3. Provided patient education and reassurance regarding expected side effects and normal variants of the smallpox vaccination.  Reinforced education on care of the SPV vaccination to prevent transfer of the Vaccinia virus. 4. In a pre-event setting, he should be exempt from all future smallpox vaccinations unless direct exposure occurs. 5. Return visit x 2 days to reassess lymphangitis and lesions. 6. Discussed other symptoms to watch for: instructed patient if he has any chest pain, palpitations, increased shortness of breath, he should go to the emergency room immediately.
Patient had his second covid vaccine on Thursday afternoon, July 28. He had worsening diarrhea (turned liquid from being soft and was darker) the next day on July 29. On Saturday morning July 30, he woke up at 4:30 in the morning with a fever of 103.5. He seemed pretty draggy and uncomfortable all morning, although his fever was responsive to Tylenol. A little later that morning he looked a little blue around his lips, and his hands and feet were dusky with slow capillary refill. He was not in distress, just continued to seem under the weather and have fevers when the medicine wore off.  We took him to an Emergency Room because of lack of availability of a dr's office appointment on Saturday.  They checked his vitals which were normal other than a slightly elevated HR and the fever (back up at 103.4), gave some Motrin, and think he probably had a viral GI bug. They would have tested his stool but he didn't have an episode while we were there. They did a covid and respiratory panel which was negative.  patient's fever and diarrhea resolved over the next couple days and he was quickly back to his normal self.
pt recvd vax, 1 hr later t 101;apap given;t still 103; apap repeated q/ 4 hrs;20jul94 had d;seen by MD 21jul;23jul94 broke out in rash that am & mom called MD;rash appeared on chest, face & arms; rash lasted 1 wk;
Patient experiencing pain, rash, and general soreness in location of the shot. The pain and tingling sensation radiates to the rest of the arm as well. Patient also reports knee pain (where he had the knee implant surgery). This pain started several hours after getting the shot. Also, for the first shot in the series, patient reported similar side effects. The side effects resolved in a few days, but the rash lasted about 3 weeks before resolution.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITINE) for Allergy.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Body temperature: 100.2 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitants included birth control.
This spontaneous report was received from a nurse via Poison and Drug Center (PDC) refers to a patient of unknown gender between the age of 6 years and 12 years old. The patient's relevant medical history, past drug history and concomitant medications were unknown. On 26-May-2015, the single dose vial of PROQUAD (Merck) underwent temperature excursions 5.3 degrees Celsius for 2 hours and 8 minutes. On 02-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K014798 and expiration date 12-MAR-2016) via injection (dose, frequency and indication were unknown). The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. As of 05-AUG-2015, it was unknown if the patient continues on PROQUAD (Merck). This is one of the eight reports received from the same source. Additional information has been requested.
COULD NOT SLEEP; HANDS HURT SO BAD; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis. 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 covid-19 prophylaxis. 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 experienced could not sleep, and hands hurt so bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hands hurt so bad and could not sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20221222529.
broke out w/hives all over face, back, chest, stomach-everywhere, but legs;there was no resp compromise;treated w/DPH;
This spontaneous report as received from a medical assistant refers to an adult patient of an unknown age and gender who on 01-JUN-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (expiration date, dose and route not reported) that was exposed to only one temperature excursion of 63 hours. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
ActHIB was administered with sterile water to the patient / No AE; Initial information was received on 28-May-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 19 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] with sterile water (product preparation error).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.   On 21-May-2020, the patient received a 0.5 mL fourth dose of suspect HIB (PRP/T) VACCINE (for powder: lot UJ185AA and expiry date 27-Apr-2021 and for diluent lot number U6723AA and expiry date 17-Sep-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong solution used in drug reconstitution.  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 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.
knot in right thigh since administration. no knot at left thigh where flu was administered.
Varicella (VARIVAX) given on Tuesday 7/22/14. Pt. presented to clinic with hypersensitivity (skin rash) to injection site. Recommended antihistamine, ice, ibuprofen/TYLENOL.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date It was reported that the patient received her first dose of the Pfizer COVID-19 vaccine, but she became sick between her first and second dose. The patient wanted to know who she needs to call in order to schedule her second dose appointment. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient states about 30 minutes after vaccine was administered she felt nausea and had diarrhea that has not resolved for 4 days .
red local reaction at the shot site on the right thigh.  return tomorrow for a follow up appointment
Hives, inflammation, and itching at injection site 1 week following injection.  Arm soreness for 2 days post injection.
Itching. Burning. Swelling in arm of injection. Patient took a BENADRYL and it has helped with symptoms.
pt recv 1 dose varivax on 4/14/98 2 wks following pt rpt being exhausted, feelings of malaise, headache & chills. 4/18 pt devel ``a few lesions on right arm, chest/left knee.
Fever 98.5 degrees F, body aches, tired hot/red/swollen injection site. Received injection 9-29-10. Temperature reached 100 F on 10-1-10.
Rash, Lip and mouth swelling, face drooping, and throat tightness.
On 8/4/98 the pt experienced nausea, aches and pains at the injection site in the right deltoid, redness at the injection in the right deltoid and flu-like symptoms. The pt recovered on 8/10/98. Additional information is not expected.
Severe headache, body aches, joint pain, sinus inflammation, fever, nausea, fatigue, chills  Still having side effects two days later
Patient experienced warmth and tingling at injection site of Zostavax vaccine. Patient was sent to Dr after 30 minutes.
Patient received the shingrix vaccine yesterday and called today to report that he experienced pain and soreness at the injection site. He also reported pain on his lower back and lower leg(s).  He did take Tylenol yesterday. I advised him to take another dose of Tylenol and to contact his doctor to report his symptoms.  I informed him that the injection site pain is common side effect but the per manufacturer the lower back and leg pain are rare adverse effects that needs to be reported to the doctor immediately. He said he will call his PCP. I also called the MDO and spoke to nurse who said she will send a message to his PCP to contact the patient.
patient is immunocompromised, and received 0.25 mL dose; 1st dose of J&J and 2nd dose Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient is immunocompromised, and received 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of J&J and 2nd dose Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: J & J Vaccine (Received 1st dose.) on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with J & J Vaccine.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 27-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient is immunocompromised, and received 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of J&J and 2nd dose Moderna). On 27-Oct-2021, ACCIDENTAL UNDERDOSE (patient is immunocompromised, and received 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of J&J and 2nd dose Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported.