chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had heart palpitations; I had shortness of breath / have breathing issues where it feels difficult to breath/I get out of breath fast; I exert myself a little; This case was reported by a consumer and described the occurrence of palpitation in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In March 2020, the patient received Shingles vaccine. In March 2020, 1 day after receiving Shingles vaccine, the patient experienced palpitation, shortness of breath and fatigue. On an unknown date, the outcome of the palpitation, shortness of breath and fatigue were unknown.   It was unknown if the reporter considered the palpitation, shortness of breath and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 62 or 63 year old. The patient stated that they received a Shingles vaccine about 5 weeks ago. The next day they had heart palpitations and shortness of breath. Anytime they exert themselves even a little, they had breathing issues where it feels difficult to breath as if they was breathing through a towel. If they still exert themselves, they get out of breath fast. Just days before the vaccine, they rode an exercise bike every day with zero issues. The patient took an EKG and it was perfect.
Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Child patient (age and gender not reported) who was vaccinated with expired dose of PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Expired vaccine used. No adverse event 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 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. List of documents held by sender: none.
Caller states both of them contracted Covid-19 19AUG2021; Caller states both of them contracted Covid-19 19AUG2021; pneumonia; This is a spontaneous report from a Pfizer-sponsored program [Regulatory Authority Support]. A contactable consumer reported for himself that a 65-year-old male patient received 1st of BNT162B2 on an unspecific date in 2021 and 2nd dose on an unspecific date in Feb2021 at single dose for covid-19 immunization. Medical history was cancer. Concomitant drug was not reported. Caller states he and his wife had both doses of the Pfizer BioNTech Covid-19 Vaccine in Feb2021. Caller states both of them contracted Covid-19 on 19Aug2021. Caller states they were not hospitalized but were recovering for about 3 weeks. Caller reports having "Covid cough and phlegm." Caller states he was given a "Z-Pak and an inhaler." Caller states he and his wife are now recovered, but would like to get the booster dose of the Pfizer BioNTech Covid-19 Vaccine. Caller states his doctor would not know whether he and his wife should get the booster dose or not, and his doctor would also just ask Pfizer. The caller is 65 years old and they got COVID and now the caller is wondering where they can get and if they are eligible for the booster. He is a cancer survivor. The husband and wife were both hospitalized (as reported) on 19Aug2021 and the caller is the husband. Caller reporting on the Pfizer COVID vaccine and mentioned that he received the two series of the Pfizer shots to prevent COVID earlier in the year around Feb2021, he had the last of the two around Feb2021. On 19Aug2021 he contracted COVID, he wasn't hospitalized (as reported) but had 2 weeks trying to recover. He did have pneumonia too but had the COVID congestion and cough and received the the z-pack inhalers. Outcome of the event was recovered in Sep2021.  The lot number for BNT162b2 was not provided and will be requested during follow up
Fatigue, headache, muscle pain, chills, nausea, vomiting, fever, swollen lymph nodes
2ND DAY AFTER VACCINE, SITE BECAME ITCHY AND SWOLLEN. SITE REMAINED THAT WAY FOR SEVERAL DAYS AND BEGAN TO GO DOWN BY THE 30TH. NO TREATMENT RECEIVED
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 22-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (valid lot #T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, and route of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 12.4 degrees Celsius for 53 minutes; 9.6 degrees Celsius for 34 minutes; 9.5 degrees Celsius for 23 minutes; and 8.5 degrees Celsius for 9 minutes. There was no adverse effect reported.; Sender's Comments:  US-009507513-2112USA007442: US-009507513-2112USA006870: US-009507513-2112USA007443:
exposed over the w/e, then sx 17May2022 PM cold symptoms mild and then tested Ag positive am 18May2022; exposed over the w/e, then sx 17May2022 PM cold symptoms mild and then tested Ag positive am 18May2022; cold symptoms mild; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 17May2022, outcome "unknown", described as "cold symptoms mild"; COVID-19 (medically significant) with onset 18May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "exposed over the w/e, then sx 17May2022 PM cold symptoms mild and then tested Ag positive am 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Nasal Swab. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccination with improperly stored doses of ROTATEQ lot # K014826, expiration date 28-MAY-2016, orally (dose was not reported). No adverse symptoms were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reported to RX on 10/11/16. Had rash on left hip/buttock area. Pt reports it itched but no pain/burning.
On 7/11/00 at 08:00, the pt received his 1st dose of Lymerix. Subsequently, his right arm was "a little sore". He "couldn't get out of bed on 7/12/00 at 08:00. His joints were aching and his neck was hurting "like the flu". Symptoms resolved "a few" days, post vax, without treatment. As of 10/10/00, the outcome of the events is resolved.
This spontaneous report was received from a healthcare worker, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature 6.5 Fahrenheit, for 6 months) doses of ZOSTAVAX , lot # L0146899, expiry date 23-FEB-2017 and lot # L046900, expiry date 23-FEB-2017, (dose, frequency and route of administration not reported). No adverse effects reported. Vaccines were back in range. Previous temperature excursion was reported as no. It was because of a data logger. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
(L) eyelid - excessively; droop of (L) face; decreased strength. Dx'd Bell's Palsy.
Mother states patient reacted the day after vaccine was administered. Swollen and redness was notice around the injection site. Cold compresses for further treatment.
Pt is on a MSD HIB study. Mom noted an unusual high pitched cry at 6hr. Also irritable, gaggy but not vomiting, & pain at inject site. Temps were 6hr 99.6, 24 hrs 99.6.
Nausea, vomiting, diarrhea, bronchitis patient given antibiotics from ER. They said her body rejected the vaccine.
Received Varicella vaccine on 4-4-11, 4-7-11 c/o red arm & tender at injection site. Called on 4/8/11 and stated arm was better. 4-9-11 Pt went to ER with residual rash all over body, itchy, macular papular per ER doctor. Rec'd BENADRYL in ER & sent home.
Patient was ashy and was feeling short of breath.  He had chills and was shaking uncontrolably.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of COMVAX (lot # J013884 and expiration date 19-AUG-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. There was no previous temperature excursion. The temperature of the excursion was 59F and the time frame was 16 hours. This is one of several reports received from the same reporter. Additional information has been requested.
At the six week mark post 2nd vaccine, developed a severe case of Shingles; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 25Feb2021 00:45 (Batch/Lot Number: EN6202) as 2nd dose, single (at the age of 44 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 28Jan2021 07:30 PM (lot number:EL8982), on left arm at the age of 44 years old for COVID-19 immunisation. The patient experienced at the six-week mark post 2nd vaccine, developed a severe case of shingles. The patient had muscular adjustments as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
it is probably more sore than when the patient got the injection; Started to get a little bit of a rash at the injection; it is spreading; 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, lot number: EL0142), via an unspecified route of administration on 07Jan2021 15:40 at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had first dose on 07Jan2021 at 3:40 pm and everything seemed to be fine and then yesterday (17Jan2021), the patient started to get a little bit of a rash at the injection point and today (18Jan2021) it was spreading and it was probably more sore than when the patient got the injection. The outcome of the events was unknown.
had many different vaccines given at the same time and adversely reacted 2 separate times; Initial information was received on 24-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant and unknown gender of patient who reported that had many different vaccines given at the same time and adversely reacted 2 separate times after receiving vaccines Vaxelis and diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (HEPATITIS B VACCIN); POLIO VACCINE (POLIO); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); and HIB VACCINE (HIB).  On an unknown date, the patient received a unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date, the patient received a unknown dose of suspect Vaxelis (Injection) (not produced by Sanofi Pasteur)  (strength, expiry date, lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient developed a non-serious event of had many different vaccines given at the same time and adversely reacted 2 separate times (adverse reaction) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and (unknown latency) following the administration of Vaxelis.  No lab data reported.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (had many different vaccines given at the same time and adversely reacted 2 separate times).  At time of reporting, the outcome was Recovered on an unknown date for the event had many different vaccines given at the same time and adversely reacted 2 separate times.
shingles; This is a spontaneous report from a contactable other HCP via the Pfizer sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 04Jan2021 to 04Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient got her 1st dose of the Covid-19 vaccine dated 04Jan2021. She has a scheduled 2nd dose for the said vaccine this coming Saturday however, she suddenly got shingles and asking if she still can get the second dose. Outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Itching, redness, soreness 24 after injection and then again 9 days after injection
Pt admitted for shortness of breath, and respiratory failure with hypoxia due to COVID pneumonia.
Information has been received from a certified medical assistant concerning an 11 month old female who on 11-JAN-2007 was vaccinated with a dose of Pneumovax 23 (lot 651321/1036P) instead of PREVNAR.  The certified medical assistant reported that the patient was due for a dose of PREVNAR, and the vial of Pneumovax 23 was pulled by mistake due to similarity of the vials.  The patient received unspecified medical attention, and it was confirmed that the patient was "fine".  The medical assistant stated that there was a plan in place to prevent a similar incident from happening again.  No additional information is expected.
Complained of pain in upper arm immediately following receipt of flu shot. Two weeks later still complaining of pain in upper arm and unable to raise arm above shoulder without pain. Patient states it feels like a pulled muscle. No lump at injection site, no loss of sensation distally in hand/fingers, no warmth/swelling at injection site.
Symptom onset: 5/10/21 Symptoms include: altered sense of smell, cough, nasal congestion and runny nose   Moderna 1/22/2021, 12/23/2020
Pt 5 days after vaccine, in area of vaccination began experiencing "nerve pain" radiating to (L) shoulder and occipital area. Waxes and wane. Reports H/O shingles in 2005 in the same area, describes it as similar pain.
Pt vaccinated with DTP experienced a Syncope attack 3-4 hrs after vaccination lasting 30-40 secs. without any after effect.
swollen face; allergic reaction to her first dose; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 74-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 19Jan2021 as SINGLE DOSE for covid-19 immunization. Medical history included eye operation and diabetes from an unknown date and unknown if ongoing. No concomitant medications were not reported. It was reported that she received the first dose of the pfizer covid 19 three weeks ago and her second dose is tomorrow. she reported that she experienced a swollen face 3 days after the vaccine and wants to know if she should get the second dose. She also wanted to know if the second shot had to be in the same arm as the first. Upon date 09Feb2021 iI was reported that she had an allergic reaction to her first dose, where her face was swollen, so her primary care doctor gave her some antihistamines, and now she feels fine. She was worried about getting the second dose after what happened with the first, and she is wondering if there are recommendations for if people should get the second dose after an allergic reaction to the first. Patent received treatment for the events with antihistamines. The outcome for the events was reported as unknown.   Follow-up attempts completed. No further information expected.
Patient described fever, soreness, stiffness, and pain in arm, upper back, and into neck area.
prone to strokes; both her legs felt numb; This is a spontaneous report received from a contactable consumer (patient reported for herself). An elderly female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving Pfizer covid vax, 4 days later (date unspecified), the patient reported that both her legs felt numb. She was elderly and prone to strokes so they rushed her to hospital (dates unknown). All tests were negative (date unspecified) so now they suspect it may be related to the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
CHILLS; SHOULDER PAIN; HEADACHE; NAUSEATED; PASSED OUT; HEARING LOSS GETTING WORSE; CHEST PAINS; SWELLED UP; RINGING IN LEFT EAR; TREMBLING; BRAIN FOG; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes and arthritis in the lower back. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, and expiry: unknown) dose was not reported, administered on left arm on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, 30 minutes post-vaccination, the patient passed out and was rushed to the hospital and later she recovered. On the same day, the patient also experienced chest pains, chills, brain fog, trembling, nausea, shoulder pain that was shooting up and down between shoulder and elbow, ringing in left ear, developed swelling; headache and hearing loss in left ear that got worse. Electrocardiogram (EKG) was performed for chest pains (result unknown). At the hospital, she was given treatment that included Benadryl (diphenhydramine hydrochloride), many different shots (unspecified) and 'intravenous' (IV). The patient was at the hospital for about 8 hours. The patient was sent to a hearing specialist for her hearing loss. On 21-MAR-2021, the patient recovered from the events chest pains, chills, swelled up', nausea and trembling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains, chills, swelled up, nauseated, trembling and passed out, and had not recovered from brain fog, shoulder pain, headache, left ear hearing loss, and ringing in left ear. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409641- covid-19 vaccine ad26.cov2.s - passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
given a shot of expired Daptacel; Initial information received on 26-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of an unknown demographics who received expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used. Caller stated that she has given a shot of expired Daptacel.   It was unknown whether the patient had 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.  Information on the batch number was requested.  Documents held by sender: none.
red blotches (hives) all over patient stated appeared day after receiving vaccinations and patient feels continue to appear. Itchy in some spots. No reported difficulty breathing, swelling of face/tongue/throat, heart palpitations, sweating. no other vaccine history on file