chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atrial Fibrillation; increase in heart rate; fatigue; Headache; muscle pain; This is a spontaneous report received from a Pfizer sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 reported as Pfizer COVID-19 Vaccine), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he was experiencing atrial fibrillation, an increase in heart rate, fatigue, headache, and muscle pain on Mar2021. He mentioned that he is scheduled for the second dose on 26Mar2021 and inquired if he can still continue the 2nd dose of the vaccine. He also inquired if the symptoms would worsen after the second dose of the vaccine. The outcome of the events was unknown.   Information on lot/batch number was requested.
I have a rash with itchy red bumps from under both my arms and on  my upper back.
DID NOT KEEP VIVOTIF IN REFRIGERATOR BEFORE COMPLETING THE DOSES; This spontaneous case (PVX2019-1497) was received from a pharmacist on 10-Jun-2019. It describes a 17-year-old adolescent male consumer who "did not keep Vivotif in refrigerator before completing the doses". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not keep Vivotif doses in the refrigerator and took all the doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not keep Vivotif in refrigerator before completing the doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not keep Vivotif in refrigerator before completing the doses" was considered as not applicable.
Status post immunization right arm became warm to touch, itchy, swollen, with skin discoloration, and blister like formations at the site of injection.
TOOK FIRST DOSE YESTERDAY AND TRAVELLING TOMORROW; This spontaneous case report was received from a pharmacist (PVX2019-118) on 14-Jan-2019. The report describes a 20-year-old male consumer who "took first dose yesterday and travelling tomorrow". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif yesterday and he was leaving tomorrow.  The action taken with Vivotif with respect to the event "took first dose yesterday and travelling tomorrow" was not applicable.  The clinical outcome of the event "took first dose yesterday and travelling tomorrow" was unknown.  Company's Comment: The causality of the event "took first dose yesterday and travelling tomorrow" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose yesterday and travelling tomorrow" was considered as not applicable
Palpitations of a hard heart beat that started 5 days after the vaccine and then got less severe throughout the day.
Fever, headache, skin rashes 2 hrs after received TYPHIM Vi shot. Rashes all over the body included face eye pain, lethargy, body ache, sweating and fever more than 2 days. Itching on day 5th. Resolving with antihistamine BENADRYL.
Initial report of a cluster involving Fluzone was received from a nurse on 10/17/2005. It was reported that pts (specific number involved, gender and age not reported) complained of nausea and vomiting, fever, diarrhea and burning at the injection site after receiving the injection of Fluzone. Route site, lot number and date of administration not reported. Treatment and recovery status was not reported. Follow up information received on 3/24/06 from a health care provider. At the time of this report, the pt had recovered from the events. The case was reviewed, and no additional information was available. Same reporter in case 2005-02131.
Severe muscle aches- crying, swelling in lips and gums, some soreness at injection site.
Patient stated she received the MMR on 5/9/2006 and on 5/18/2006 she started having a temperature of 103F which lasted until 5/22/06. On 5/22/2006 she broke out in a rash over her entire body. Pt stated that a doctor told her she had the measles.
bones hurt; headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt) and HEADACHE (headache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bones hurt) and HEADACHE (headache). At the time of the report, BONE PAIN (bones hurt) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Patient's daughter stated the reaction was a hot red rash (patient stated: not itchy or burning or painful) when first noticed. Family took her to ER to have injection site looked at. Was prescribed antibiotic and kept overnight and blood drawn. Was discharged on Clindamycin 300mg capsules three times daily for 7 days.
Rash-MMR rash vs other viral  Exanthem was described by Children's ER doctor as "measles rash"
fever & difficulty to breath 3 days previous hosp admission & 2 days after recv vax tx w/ meds
Patient is very angry due to his left leg got paralyzed after receiving the 2nd dose of Pfizer COVID 19 vaccine; He has been experiencing extreme pain on left leg; Severe muscle pain on the back of his thigh; This is a spontaneous report received from a Pfizer sponsored program A male contactable consumer (patient) reported for himself that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 on an unspecified date for COVID-19 immunization. Patient was very angry due to his left leg got paralyzed on an unspecified date after receiving the 2nd dose of Pfizer COVID 19 vaccine. He mentioned that next week will be the 7th week from the time he received the 2nd dose. He had been experiencing extreme pain on left leg, severe muscle pain on the back of his thigh. He always used heat pad to ease the pain. Prior to vaccination he could do 7000 steps, now it was just 4000 steps. He also mentioned that he already went to (withheld) and his doctor and told him that there were numerous complaints about Pfizer COVID 19 vaccine. The outcome of events was unknown.   Information on the lot/batch number has been requested. Additional information has been requested.
pt recv vax 23OCT97 & 24OCT97 pt devel many itchy, non-erythematous soft tissue swellings, nodules & lumps;dx eczema;
A 15 month-old child receive a 4th dose ADACEL instead of DAPTACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (HCP) via Medical Information (Reference number- 00667485).  This case involves a 15-month-old patient who received a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of 4th dose DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On 02-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Injection, lot C5689AA and expiry date: 10-April-2021) instead of fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) via intramuscular route in the right thigh for prophylactic vaccination (wrong product administered).  It was an actual medication error case due to wrong vaccine administered (latency: same day).  A nurse stated that today a 15-month-old child was supposed to receive a 4th dose of DAPTACEL. Instead ADACEL was administered. No adverse effects reported. Nurse states that this child is a twin and HCP initially reported that both children received the vaccine. But she was unable to find documentation of the second child's vaccination today.  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. 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.
Hives developed 2-3 days following vaccination lasting several days. Steroids and antihistamine treatments.
Swelling of arm, severe redness, rash, fever, flu-like symptoms, nausea, headache.
COVID Pfizer 6mo-4yr vaccine given instead of COVID Pfizer 5-11yr
Developed weakness and feeling unwell on 4/27/23. Presented to ER on 4/30 with difficulty ambulating and wife not able to care for him.
Patient was given immunization  not in the deltoid muscle. It was given low. There is an injection site reaction. (Redness/ swelling/ pain/ itching). The red area was a large area.
Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 with expiration date of 23-APR-2018 administered intramuscularly for prophylaxis (dose was not provided). It was reported that the vaccine had been stored for 5 hours at 59 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008023: US-009507513-1702USA008024: US-009507513-1702USA008022.
Patient received FLUZONE HD 3:45-4:00 pm on 10/07/16. 10/08/16 at 9:15 am patient called and said he developed hives around 11 pm last night so he went to the ER. He got prescriptions for prednisone 60 mg for 4 days and BENADRYL as needed. As of this morning he said he has no more hives and feeling fine back to normal. He wanted to know if he still needs to take the prednisone.
Patient had her covid vaccine at 7:22am. Around 7:35 am she said she was flushed, diaphoretic, and weak. I took her bp. It was 136/102. Her HR was 97. RR 16. Pulse ox 99%.  Patient reports a hx of anxiety. She also did not eat breakfast. We got her juice, water, and a breakfast bar. At 7:50, she started feeling a lot better. BP was 137/95 with HR of 79. At 8am, her bp was 124/96. Her HR was 91. Her husband took her home.
3 hrs after Day 7 Rabies vaccine pt developed hives, nausea, vomiting, SOB, racing heart. Prescribed BENADRYL and prednisone 20 mg 2 x D. On day 3 visit, pt c/o nausea and vomiting and rash but was also on AUGMENTIN for dog bites to hands. Was advised to call primary MD. On 11/1/16 patient had contacted MD who attributed rash to AUGMENTIN. Felt better but still had rash.
I tested positive. Even though I was asymptomatic I called a provider. They said since I am 72 years old they wanted to  put me on PAXLOVID. I had no symptoms throughout the time I was positive.
Client states that friday eve he started with slightly raised red patchy like area on his mid abdomen, buttocks & thighs. Today it is also on his mid and lower arms. He takes prilosec & ibuprofen. He has also ate cookies on friday 11-30-2006 & poss before that were sent to him by his mother from which contain powdered milk which he states he allergic to. States he has been taking benadryl for the itching & hives but no real relief. States no difficulty breathing or swallowing.
No other AE reported; Temperature excursion on MMR II and Varivax. The vaccines were administered; This spontaneous report has been received from a non health care professional concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the following vaccines:  -  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II)  formulation not reported but defaulted to subcutaneous injection, 0.5 ml,  Lot # S006051, expiration date 27-FEB-2021 ( a second Lot # was reported: S015427, expiration date 20-MAY-2021) for prophylaxis (dosage regimen and anatomical location was not reported).    - varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection, 0.5 ml, Lot # S002740, expiration date 28-JAN-2021( a second Lot # was reported: S031494, expiration date 07-OCT-2021) for prophylaxis (dosage regimen and anatomical location was not reported).    On 28-SEP-2020, it was identified that the aforementioned vaccines had been involved in a temperature excursion.   The storage temperature for both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) and  varicella virus vaccine live (oka/merck)(VARIVAX)  was reported to had been at 5.7 °Fahrenheit (F) for a period of 14 hours.    No other adverse event was reported, there was digital data logger involved and no previous temperature excursion was reported.; Sender's Comments:  US-009507513-2012USA001631:
I do not drink, so I do not have liver problems but my liver enzymes were very high. My joints  start to swell. My legs, ankles, calf, hands are stiff as well. I am unable to get wedding ring on. Joints hurt to the touch.
Developed 9.5 x 10.0 cm redden area around (Dtap) injection site. Warm moist heat recommended. area resolved by day 2.
Patient was give the wrong dosage of Moderna vaccine.  She was originally given 0.3ML.  I realized she was given the wrong dosage, and we gave her 0.2ML to make a total of 0.5ML of the vaccine.
Acute appendicitis; This is a spontaneous report from a contactable physician reporting for herself. A 31-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), intramuscular in the left arm, on 16Jan2021 at 18:30, at single dose, for COVID-19 immunisation. Medical history included iron deficiency anaemia, migraine and drug allergy to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included multivitamin and ferrous sulfate (unknown manufacturer). Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), on 26Dec2020 at 04:15 PM, intramuscular in left arm for COVID-19 immunisation. The patient experienced acute appendicitis on 20Jan2021 at 09:00 with outcome of recovering. The patient went to the emergency room and was hospitalized due to the event in Jan2021 for 1 day. Therapeutic measures were taken as a result of the event and included laparoscopic appendectomy. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 20Jan2021.; Sender's Comments: Given the nature of the medical condition and the overall clinical picture, the event appendicitis is most likely an intercurrent medical condition and is assessed as unrelated to bnt162b2. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
I loss my sense of taste and smell; fever; fatigue; nasal congestion and  cough for 7 days  Contacted Urgent Care and was prescribed a 5 day course of Paxlovid.
The exact time of the administration is actually unknown, however the computer system would not let me go on without entering something in that field.  Likewise the exact date and time of the onset of adverse symptoms in not known.  The patient only told me that the symptoms began "right after I got the immunizations".  It is worth noting that the Anthrax was the 6th in the series for this individual.  The adverse reaction is subjective, diffuse arthralgias and myalgias.
Chills, headaches, fever, soreness, body aches. Used Dayquil and Nyquil to relieve symptoms. Received the vaccine on Friday, felt the symptoms late that night and throughout Saturday, but felt better later that evening.
4 months old received Flulaval; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2022, the patient received the 1st dose of FluLaval Quadrivalent 2022-2023 season .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 14th December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-DEC-2022 Reporter's comment: The medical assistant reported that the patient under the recommended age received a dose of FluLaval. Information for adverse event was given and specific information about vaccine was relayed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The four months old patient received a dose of FluLaval, which led to inappropriate age at vaccine administration.
Itching all over body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced PRURITUS (Itching all over body). At the time of the report, PRURITUS (Itching all over body) outcome was unknown.            Concomitant product information was not provided.   Reporter stated they were vaccinated a couple months ago with Moderna COVID-19 Vaccine. Reporter experienced itching all over body with no rash twice.  Treatment information was not provided.
pt recvd vax & 2 hrs later devel twitching of the rt lower eyelid; twitching has partially subsided, however continues slightly;
Weakness, swelling , fatigue joint pain mild fever chills for 4 days; Most worrisome is impact on two artificial knee joints; Can?t stand without assistance.
Within a half an hour on my way home I developed a 2" circle perfect circle red spot  at injection site.  It was a large painful lump. I developed an irregular rash below that between my spot and my elbow.  That part went away by the end of the day.  I give myself a Rebif injection in my legs twice a week.  When I did that the spot on my arm would get redder and warm and I would feel worse.  It would flare and symptoms would reappear. I had tremendous fatigue for two weeks.  My red spot is now very faint.
Initially experienced expected aches and weakness about 6 hours after shot.  Just felt bad and tired.  Expected that.   Then I experienced extreme chills approx. 18 hours after shot, where I tensed up so hard over most of my body that my legs hurts, my sides and under my rib cage cramped and it became hard to breathe then I started shaking and could not stop.  I gained control after about 10 minutes of resting.  It just came over me unexpectedly.   Also got the Flu shot at the same time.  I get it every year never experienced any reactions..
About 10 days past vaccination I started to experience a muscle burning sensation when lifting my arm causing quite discomfort. It?s a muscle pain that is limiting the range of motion, coming from my upper arm (below shoulder facing outwards) and traveling down in my entire arm when I am lifting my arm. I didn?t pay attention to it as I thought I just pulled a muscle. Meanwhile the pain is still present and it seems to be getting worse. There is also a certain degree of hotness to the skin when touched by the injection site.
Patient is complaining of arm numbness and pain for 4 weeks after getting the flu shot. He does not have full mobility or grip of his left arm/hand. He is going to follow up with a doctor for further review.
the patient experienced "general cold like symptoms" /fever / being sick; The patient experienced myalgia,; This spontaneous report was received from a physician via company representative referring to a non-pregnant female patient of unspecified age. Her medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered intramuscularly (strength, lot #, expiry date and anatomical location were not provided) used as directed to prevent human papilloma virus infection.  On an unknown date, the patient was out of school due to being sick for a week. She experienced myalgia and fever. It was stated that the patient experienced "general cold like symptoms" and was "in bed for a week". At the time of reporting, she was recovered from the events.  The causal relationship between myalgia,cold symptoms and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Diffuse rash that did not improve over 2 weeks, required prednisone course
Patient got the Moderna vaccine 2 days ago this was her third shot.  Last night after eating she noticed some sores in her mouth and this morning they got larger and were blisters.  She also states she noticed some blood in both her urine and in her stool.  Otherwise patient states she has been feeling well has no fevers.  She had a mild headache this morning that has since resolved.  No other new medications that she started recently no recent travel or tick bites. On examination patient has a sending petechiae to both legs extending up to her thighs.  She states that these were not there when she put her socks on this morning at 9 AM.
Right EAR PAIN, NUMBNESS,TINGLING,BURNING  TO HEAD, EAR , CHEEK, TOUNGE,(RIGHT SIDE)  LIPS
pt recv vax approx 320PM;pt was very apprehensive before & p/recv shots;pt sibling was then checked for a rash by MD;at approx 345PM pt fainted & hit the back of head;pt was kept @ office for several hr for observation;