chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported very sore arm starting about a week after flu shot in right arm. Patient reported sharp shooting pain in arm at times that lasted about an hour. She said this lasted about a week. She said she did not see a doctor and it resolved in about a week.
Chills, local swelling at site of injection with tenderness and redness and mild auxiliary neuropathy.
Very high fever of 107 that would not go down with Tylenol or Motrin. Persisted and baby seemed to be very uncomfortable. We rushed to the emergency room after giving another dose of Tylenol. Fever only went down to 105. We went to facility for a week and then were moved to another facility for another week.
joint pain; muscle pain; headache; chills; pains in her back; tremendous amount of aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 16Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 13Oct2021, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 13Oct2021, outcome "not recovered", described as "muscle pain"; HEADACHE (non-serious) with onset 13Oct2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 13Oct2021, outcome "not recovered", described as "chills"; BACK PAIN (non-serious) with onset 13Oct2021, outcome "not recovered", described as "pains in her back"; PAIN (non-serious) with onset 13Oct2021, outcome "not recovered", described as "tremendous amount of aches and pains".  Additional information: Caller stated that patient received the second dose of the Pfizer covid 19 vaccine on 16Sep2021. 2 days ago, 13Oct2021, she started to get the symptoms that were similar to those that got the vaccine and asked could these be side effects of the vaccine after 4 weeks and if so how long would they last. it was reported that patient had joint pain, muscle pain, headache and chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
EXPERIENCED EXTREME DIZZINESS AND FAINTING SYMPTOMS WITHIN MINUTES OF ADMINISTRATION. PATIENT WAS VERBALLY RESPONSIVE.
Within minutes after immunization coughing, c/o difficulty breathing, audible wheezing, red rash over entire body, welts on entire body. Hospital ER IV-gave BENADRYL and steroids IVP-released after 1 1/2 hour
Fatigue; injection site pain; muscle ache; acute pain in lower back; This is a spontaneous report from a non-contactable consumer. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 18:00, the patient experienced fatigue, injection site pain, muscle ache with acute pain in lower back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fatigue, injection site pain, muscle ache with acute pain in lower back and included treatment with TYLENOL. The clinical outcome of the events fatigue, injection site pain, muscle ache with acute pain in lower back were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Unable to go up and down stairs due to severe pain in joints, ligaments, and muscles. Extreme weakness, fatigue. Generalized pain throughout body.
This spontaneous report was received from a nurse regarding to unspecified number of patients of unknown age and gender. Patient demographics were not provided. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L044707, expiry date 06-OCT-2018 (dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Vaccine was stored at cumulative minimum temperature of -40.3 degree Fahrenheit for 193 hours. There was no previous temperature excursion performed. This is one of the several reports received from the same reporter. Additional information has been requested.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: all the skin peeled from hands and black spots appeared on skin, recommended follow up with physician before admin 2nd dose
Fever (101); aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9269) via an unspecified route of administration on 15Feb2021 at 11:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes and osteoporosis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not have allergies to any medications, food, or other products. The patient previously received dose 1 of BNT162B2 (lot EL9261) on 25Jan2021 at 15:00 as a single dose in the left arm for COVID-19 immunization. On 15Feb2021 at 19:00 after the second dose of BNT162B2 the patient experienced fever of 101, aches, chills, and fatigue all night and into the morning. The events were reported as non-serious. The patient was not hospitalized for the events. The outcomes of fever of 101, aches, chills, and fatigue all night and into the morning were recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Arm was just a little sore; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 25Apr2021 at 13:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The medical history included depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fish oil (OMEGA-3), sertraline (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. On 26Apr2021 at 13:00, the patient's arm was just a little sore after. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm was just a little sore was recovered on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
IM injection of Rotarix; received a dose diluted with sterile water; received a dose diluted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong route of administration in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 6973H, expiry date 2nd April 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong route of administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were 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: 28-Mar-2022 Reporter's comment: The nurse reported that a female patient received Rotarix by intramuscular route which was diluted with sterile water, which led to wrong route of vaccination, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. Additional Supportive Information: This case was found to be duplicate of case US2022055949 reported by same reporter for same patient. Hence, present case would be kept as case of record and the US2022055949 would be deleted. All the future information corresponding to the case would be submitted to the case of record.
Severe body ache, lethargic, short of breath, took NYQUIL, was taking daily mega man vitamin, loss of appetite.
5ml syringes that had been provided Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.3ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Patient was given adult pfizer dose by mistake and noted by administering pharmacist immediately afterward. Parent was notified by phone and advised about possible adverse reactions and asked to follow up as needed with pharmacy manager First dose administered correctly as Pfizer Pediatric
Patient experienced perspiration, dizziness, lack of strength, lack of coordination, over heated, blurred vision, breath restriction ?could not get a rhythm to my breath, muscle weakness ?could not stand?, nausea
Less than two minutes after J & J vaccine I was unconscious and unable to move my entire body.  I could not move my eyelids, mouth, arms, legs...entire body . Upon becoming mentally alert it was more than two hours until I could move all of my body.   I was taken by ambulance to an emergency room.  IV fluids, potassium, and released 3 hours later.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 29 years old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) with frequency time 1 total, dose was not reported, administered on an unspecified date earlier this year (2021) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date in OCT-2021, the patient had started to experience mild minimal symptoms after testing positive for Covid-19 (suspected Covid-19 infection), which indicates suspected clinical vaccination failure. Further it is reported that this is a case of breakthrough infection. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211061474-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Pt had glass of Mescal. Body aches, headache, no chills, started when he went to bed, just felt terrible. Very sore arm. No medical treatment needed.
COVID-19; COVID-19; body aches; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4448417-00.  A 24-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160838), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Solicited report by a consumer of an adult female with events of non-serious COVID-19 and BODY ACHES with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced COVID-19 and BODY ACHES. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB) for the event(s) of COVID-19 and BODY ACHES was not provided. The reporter's causality for the event(s) of HIDRADENITIS SUPPURATIVA FLARE UP ON ARMS with HUMIRA(ADALIMUMAB) was a reasonable possibility. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; PAIN (non-serious), outcome "unknown", described as "body aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The reporter considered "covid-19" and "body aches" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events "covid-19" and "body aches"  and the suspect drug BNT162b2.
Pfizer / BioNTech Dose Number: 2 / Treatment of COVID-19 5-AUG-2022; Pfizer / BioNTech Dose Number: 2 / Treatment of COVID-19 5-AUG-2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE, taken in 2 weeks, start date: 05Aug2022, stop date: 12Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech Dose Number: 2 / Treatment of COVID-19 5-AUG-2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive, notes: Rebound symptoms 6 days after ending treatment. Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included treatment with Paxlovid from 05Aug2022 to 09Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 5T943, expiry date 30th June 2019). On 26th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 26th September 2018, immediately after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On 27th September 2018, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the injection site pain was not reported. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. Pharmacist reported that they had been giving FLUARIX QUADRIVALENT at work for years. However, this year they had been seeing a lot of local reaction which was not normal. The pharmacist reported this case for herself. A day before the date of reporting at around 3 or 4 pm, the patient was vaccinated with FLUARIX QUADRIVALENT. The injection site was sore right away after vaccination. The patient noticed injection site redness on the morning of reporting date. She had raised round area and redness at the injection site of about 1.5 inches in diameter. The patient had denied permission to contact their physician. This case was linked with case US2018176518 and US2018176519 reported by the same reporter.
LEG PAIN, ONE WORSE THAN THE OTHER; HEART BEATING FAST; COLD SWEAT; THROAT CLOSING UP; HANDS AND FEET SWOLLEN; BLOOD PRESSURE UP A LOT; BODY ACHE; DIZZY; FELT VERY BAD; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 202A21A, and expiry: 31-DEC-2069) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 12-APR-2021, the patient experienced heart beating fast, cold sweat, throat closing up, hands and feet swollen, blood pressure up a lot, body ache, dizzy and felt very bad shortly after vaccination approximately within 5 to 10 minutes. In the 15 minutes of post vaccine observation, emergency services were called and the ambulance/EMTs came and helped stabilize the patient. The patient conveyed when she had arrived home that day after receiving emergency services she did not felt well at all and felt very bad. The patient was still had same symptoms at home that experienced shortly after vaccination, the symptoms did not resolve. The symptoms had lasted for two weeks. On 19-APR-2021, the only symptom patient had was strong leg pain in both legs, one worse than the other and was hospitalized (date unspecified). The patient's legs get swollen still and the pain remained to be intense. The patient's HCP was aware and was monitoring the patient. On 04-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Results pending to rule out blood clots in the leg. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Cleared, CT scan (NR: not provided) Cyst, but she complained no pain there and Urinalysis (NR: not provided) Cleared. The patient was told to go to clinic and the patient had followed up with clinic, then the patient was told to visit hospital as no appointment. The patient needed to be seen at a hospital and that was when she returned back to hospital a couple days after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating fast, cold sweat, throat closing up, blood pressure up a lot, and dizzy on 19-APR-2021, and body ache on APR-2021, had not recovered from leg pain, one worse than the other, and hands and feet swollen, and the outcome of felt very bad was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210513962 -covid-19 vaccine ad26.cov2.s-Pain in extremity. This event(s) is labeled per RSI and is therefore considered potentially related.
Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-419407, MOD-2021-419262 (Patient Link).
Seen on 12/16/01 after hours with increased swelling (5cm X 8cm) and redness with itching over the past 24 hours. Left arm is swollen from the shoulder to the elbow and hot to touch. Dx'd with a large local reaction and questionable cellulitis. The area was marked and parents were instructed to call if there is an increase in swelling or any fever.
rash all over body that itched, became worried and went to ER.  Rash appeared 30 minutes after leaving clinic
Pediatric dose of Hep A given when it should have been Hep A adult dose.  No adverse reactions noted