chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe headache; major rash with prickle feeling on face, chest, both arms; major rash with prickle feeling on face, chest, both arms; lethargic; This is a spontaneous report from a contactable other-healthcare professional (patient) reported for herself. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6202, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 03Mar2021 11:45 AM (at the age of 60-year-old) as 2 ND DOSE, SINGLE for COVID-19 immunisation at public health clinic. The patient medical history included tachy-Brady syndrome, thyroid, gout and umbilical hernis. The patient had no known allergies. The patient previously received her first shot of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN9810, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 10Feb2021 (at the age of 60-year-old) as 1 ST DOSE, SINGLE for COVID-19 immunisation and had severe chills, severe soreness in shot area, lethargic. The patient received the medication within 2 weeks included Synthroid, Allupurinol and Digitex. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 03Mar2021 at around 15:00, the patient had experienced severe headache, major rash with prickle feeling on face, chest, both arms and lethargic. The patient did not received treatment for adverse events. The outcome of all events was resolving.  No follow-up attempts are possible. No further information is expected.
Pain and swelling at injection site, high temperature, fever, muscle aches, migraine, dizziness.
Pt stated about 10 mins after administration she had itching in her arms, Waited 5 min then requested  Benadryl.  Redness  on face and arms. 25 mg's of Benadryl given at 10:28AM. Caregiver discarded to home at 11:15 am.
Lip is huge; Right arm is in so much pain; Feels like her body is inflamed; Her elbow hurts; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunization. Medical history included Crohn's disease, Ganglion cyst and immunocompromised from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced body ache, fast heart rate, sneezing and joint pain. Patient stated she was on day 9 of the second vaccine, she had Crohn's disease, so she was already immunocompromised. She stated but then after the second vaccine, on an unspecified date in 2021, her lip was huge, her right arm was in so much pain which she has had a Ganglion Cyst in her wrist, but she felt like her body was inflamed and her elbow hurts because she thought the cyst is pressing on it. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning an approximately 12 week old male who on 01-JAN-2008 was vaccinated with a first dose of ROTATEQ. On approximately 06-JAN-2008, or earlier, it was reported that the patient developed vomiting. On 07-JAN-2008 the patient was seen by the physician for nasal congestion and vomiting. It was noted that on 08 JAN 2008, the child was fussy and still had vomiting. On 08 JAN 2008 the patient was taken to the emergency room where they were diagnosed with intussusception and hospitalized. The patient underwent surgery on either 08 January or 09 January. It was noted that "there was no dissection". At the time of reporting the patient was recovered, date unspecified. Additional information has been requested.  2/6/08-records received for DOS 1/9-1/10/08-Air contrast enema partially reduced intussusception. Laparotomy reduction of ileo-colic intussusception and suture of multiple tears peri ileo-colic band. Intussusception in hepatic flexure.  10/2/09 Surgical report received DOS 1/9/08. Assessment: Ileocolic intussusception. Procedures: Laparotomy, reduction of ileocecal intussusception, resection of peri-ileocolic bands, suture repair of several serosal tears.
EXPIRED DOSE OF VACCINE WERE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced expired dose of vaccine were administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of vaccine were administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211012114, 20211012141 and 20211012209.
2 weeks ago she was diagnosed with covid. She was started on medication but had n/v and could not keep her medication down. She was then diagnosed with pneumonia and started on azithromycin. She started to have chest pain over the last couple of days. She presented to the ER today and was found to be in a-fib with rates in the 140s. She states she has been very fatigued lately. Her PPM was interrogated and she has been in a-fib for about 50% of the time. She continues on eliquis and has not missed any doses. Her ER workup was positive for elevated WBC, BNP of 5659, potassium and magnesium WNL, troponins flat. She was started on a diltiazem drip. She will be admitted to cardiology for further treatment.    Currently in the hospital (not in ICU on 06/20/2022).
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (lot numbers: L026602, Expiry date: 19-FEB-2017; lot numbers: L036301, Expiry date: 20-DEC-2017; lot numbers: M026306, Expiry date: 30-APR-2018) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
device or device component malfunction; no additional AE details; TE vaccine administered; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-APR-2022, the patient was vaccinated with an improperly stored first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date reported and established as 19-AUG-2023, administered subcutaneously (dose and site of administration not provided) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for a total of 3 hours and a temperature excursion of -10 degrees Celsius up to 8 degrees Celsius for 1 hour 30 minutes. There were no previous temperature excursions. Additionally, a device or device component malfunction was reported (unspecified, conflicting information, varicella virus vaccine live [Oka/Merck] [VARIVAX] is not manufactured/ provided with a device component). The patient experienced no additional  adverse event (AE).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA007852: US-009507513-2205USA007821:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL0140), in left arm, on 03Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FF2566), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications in 2weeks. Past drug history included: Tetracycline, reaction(s): "Allergy", notes: known allergies: Allergic to tetracycline. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive, notes: Tested positive on July 26 with severe sore throat and fatigue; (04Aug2022) Negative, notes: tested negative on August 4; (07Aug2022) Positive, notes: August 7, I felt very congested and fatigued. Tested positive that evening. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: She felt ill 25July. Tested positive on 26July with severe sore throat and fatigue. Was prescribed Paxlovid which she started on 26July and finished on 31July. Recovered and tested negative on 04August. 07August, she felt very congested and fatigued. Tested positive that evening.
Gave meningitis vaccine. Patient was fine. About 5 minutes later, gave PPD intradermal and patient fainted. We lowered her to floor. She did not fall. BP 70/0. After 30 minutes BP 98/64. Went home. Called patient at home 06/14/2002. Has been fine since incident.
Arm was sore in the area of injection; A spontaneous report was received from a consumer concerning a female patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced arm soreness in the area of injection.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced a sore arm in the area of injection. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.; Reporter's Comments: This case concerns a female patient of unspecified age, who experienced a non-serious expected event of Injection site pain. The event occurred on unknown date after first dose of mRNA-1273, (lot unknown).  Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
This case was reported by a other health professional via call center representative and described the occurrence of headache in a 11-year-old male patient who received MENVEO for prophylaxis. In August 2018, the patient received MENVEO. In August 2018, less than a week after receiving MENVEO, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO about one week ago and experienced headache for about 4 to 5 days.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. A month after receiving Shingles vaccine, the patient got shingles again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
This spontaneous report as received from a female patient of unknown age regards herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, frequency, route and site of administration were not reported). On an unknown date the patient developed a rash the size of a softball around the injection-site, where she received ZOSTAVAX. The outcome of rash the size of a softball around the injection-site was not reported. The relatedness between therapy with ZOSTAVAX and rash the size of a softball around the injection-site was not reported. Additional information is not expected.
patient received an expired dose of vaccine/ No side effects were mentioned.; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 31 months old patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5202AA via intramuscular route in the left deltoid on 24-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.   Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  No side effects were mentioned.  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.  Documents held by sender: none.
Patient received DTaP on 12/17/02 in left deltoid. Came to clinic on 12/19/02 with large area of redness, warmth at site of injection. Treated with oral antibiotics for cellulitis.
Primary pox bursted. Went from 3 pox to 11 pox.
Patient later states it was less painful than her flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (134184). The reporter is the patient.  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lyrica. Vaccination history included: Flu shot, for immunisation, reaction(s): "pain". The following information was reported: PAIN (non-serious), outcome "unknown", described as "Patient later states it was less painful than her flu shot". Additional information: The patient also received the second dose of BNT162B2 and stated that both doses were less painful then the flu shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given Bivalent as first dose in the Pfizer covid series, I spoke with the manufacturer, they referred me to the CDC for dosing recommendations. The CDC recommendation is to count the Bivalent given by mistake as the first dose in the regular series, do the monovalent as the second dose and the 3rd dose Bivalent on the regularly recommended time intervals. Patient's parent notified of the recommendations.
rash and hives after first week, got worse after second shot.  two days after second shot, rash and bumps under breast, about  50 of them.  since then rashes and welts on arms, breast, stomach, back, buttocks, neck, head, legs. tried local over counter creams, stop itch for a few hours,  finally went to doctor on 5/21/21 doctor subscribed Famotidine 40 mg, take one tablet twice a day, allergy relief tablet once a day.  rash went away for about a week.  it is coming back, but not as bad
Parent states child had reaction to vaccine at 12 months of age - see attached letter. I am writing today to report an adverse side effect to vaccines given to my child back in 2017. My son, was seen at Pediatrics on April 26th, 2017 for his 12 month well check. At this visit, he received the Hep A, MMR, Varicella and Pneumo vaccines. On this date, son was a little over 12 months old. We had no concerns about his development; he was hitting milestones early and his vocabulary was growing. He frequently used simple words, such as Mom, Dad, more, no, and "more bites" just to list some examples. On April 27th, the day after his 12 month doctor visit, we noticed a very sudden change. All of the words he used to say and use properly were now all pronounced as "Buh." His dad and I noticed this immediately, but did not get too concerned until a few days had gone by and his normal speaking habits did not return. Multiple family members noticed this change as well. Son was over 18 months old when he began using simple words again. For over 6 months, the only thing he said was "Buh." After this incident, we have been very reluctant to have any more vaccines administered. Son is now 3 years old and his speech is no longer concern; he has a wide vocabulary and can speak in full sentences. Son's dad and I both believe that his speech regression was a direct effect of one or more of his 12 month vaccines. Please feel free to reach out to me with any questions you may have.
pain is "swimming" and it feels like its on the bone or nerve; cannot sleep well; Swelling; Pain of the left arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021. The most recent information was received on 22-Jul-2021 and was forwarded to Moderna on 22-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (pain is "swimming" and it feels like its on the bone or nerve), POOR QUALITY SLEEP (cannot sleep well), SWELLING (Swelling) and PAIN IN EXTREMITY (Pain of the left arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced NEURALGIA (pain is "swimming" and it feels like its on the bone or nerve), POOR QUALITY SLEEP (cannot sleep well), SWELLING (Swelling) and PAIN IN EXTREMITY (Pain of the left arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, NEURALGIA (pain is "swimming" and it feels like its on the bone or nerve), POOR QUALITY SLEEP (cannot sleep well), SWELLING (Swelling) and PAIN IN EXTREMITY (Pain of the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR Received-Event Outcome  Updated. Denied Followup.
My arm felt sore around the deltoid muscle, which swelled.  This started to resolve, but returned on Monday, along with more swelling.  I saw PA on the 13th.  I could no longer fully extend or flex that arm.  It wasn't warm, or red - just swollen.  PA ordered an ultrasound which was done that afternoon.  The results were normal (no clots).  At this writing, the arm is still swollen, still painful on attempting full flexion or extension.
Left arm tenderness and knot on 10/7/10 (B) hand tingling (pin and needles) lasted for seconds every 15 - 20 minutes - starting 10/8/10.
Initial report received from a nurse on 17 Mar 2010: This patient was vaccinated with FLUVIRIN (batch no 1009231p), intramuscular, 0.5 ml, on an unspecified date. The patient was vaccinated with expired vaccine (date unspecified). The reporter stated she didn't know of any adverse events. The outcome of the event, seriousness criteria and causality were not reported.
Patient was fussy with fitfull sleep.  He had a fever to 102 deg.  He was crying which was somewhat high pitched and was unconsoleable at times.  When he was up this morning he had a fever and did not seem to know or respond well.  He could not use his right arm to pick up his pacifier.  He crawled very slowly and could not pull to a stand, something he routinely does otherwise.  In retrospect mom thinks he was fussy and not very consolable for previous vaccines as well.
severe headaches; Body ache; Extreme body chills; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6205), via an unspecified route of administration in the left arm on 19Mar2021 at 11:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included occasional bronchitis. The patient received unspecified medications within two weeks of COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6205), via an unspecified route of administration in the left arm on 26Feb2021 at 13:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 20Mar2021 at 03:30, the patient experienced severe headaches, extreme body chills, body ache and slight fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome for events severe headaches, extreme body chills, body ache and slight fever were recovering at the time of this reporting.   No follow-up attempts are needed. No further information is expected.
Left hand pain, tingling and numbness for last 5 days following injection.   After injection left arm was painful from injection site to hand. Arm pain resolved 2 full days later, but hand pain remains.
Patient has been experiencing tingling and pain at different times of the day in the upper arm (the same arm she received her vaccination) since the day of the injection. Its been two months and she experiences them at different time of the day in that location.