chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lots of pain in arm; could not lift my arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 4 weeks ago and experienced lots of pain in arm and could not lift arm. The reporter consented to follow up.
Nausea, vomiting, diarrhea, dehydration, stiff/painful neck, lack of focus, extreme sleepiness. Starting getting ill on Monday, May 14, 2018, and got progressively worse through Wednesday, May 16th. Could tolerate light food beginning Thursday, May 17th. Did not leave the house for a week. Last vomiting was Friday, May 18th. Diarrhea subsided Sunday, May 20th.
Patient states receiving the first dose of her shingrix vaccine on 6/28/2019 with symptoms starting on 6/30/2019.  Patient states that initially she had symptoms of nausea, vomiting, diarrhea, muscle pain, fatigue, and headaches that were severe and limited her ability to preform normal daily activities.  Reports that she still has some symptoms 2 weeks later but has been getting better.
SWEATING; NAUSEA; EXTREME FATIGUE; This spontaneous report received from a parent concerned a 19 year old female. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced extreme fatigue. On 08-APR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, extreme fatigue, and sweating. This report was non-serious.
Spreading rash that occurred after second dose of Pfizer Covid19 vaccine. Rash appeared approx. 3 hours after administration of the covid19 vaccine...red raised rash with small bumps on torso, quadriceps, inner thighs, both arms at biceps with extreme itchiness and dryness of skin. Also noted change in skin texture at areas affected.
Patient expired 48 hours after immunization (Cardiopulmonary arrest). Autopsy Report received on 1/20/2005 states SIDS. - Review of medical records on 11/10/04 indicate the office visit of 9/30/04 was for nasal congestion and fussiness. TMs were clear and there was no fever or cough. Given NS drops and suggested use of vaporizer. Visit of 10/7/04 was for continued congestion, gassiness and fussiness. Temp was 100 rectally and 98.9 on repeat. Diagnosed with colic.
Enlarged lymph node in armpit on side of injection. Became sore and tender for 24hrs then started to resolve. Now 72 hours after injection and continues to improve. Had similar reaction to flu shot in September but not as severe.
Information has been received from a registered nurse (RN) concerning a 34-year-old female with hypertension and no allergies who in January 2005, was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3).  In January 2005, following vaccination, the patient experienced a cellulitis reaction.  The injection site was red, warm to touch and painful.  Medical attention was sought.  The patient was treated with cephalexin (Keflex), ibuprofen and heat.  Subsequently, the patient recovered.  No product complaint was involved.  Additional information is not expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Products were reported. No Treatment information was reported.   This case was linked to MOD-2021-405033, MOD-2021-404296 (Patient Link).
On 11-26 7 days after JE vaccine patient stood began to feel like this was really bad used handrail for support. Then had 10 seconds shaking both extremities. Patient awake/aware but unable to stop. Post itch state. No treatment given.
their daughter, was diagnosed with a COVID-19 infection between her first and second dose of the Pfizer COVID-19 vaccine; their daughter, was diagnosed with a COVID-19 infection between her first and second dose of the Pfizer COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "their daughter, was diagnosed with a COVID-19 infection between her first and second dose of the Pfizer COVID-19 vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a child. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Dec-2011, the patient received expired FLUMIST. The product expired on 04-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This spontaneous report was received from a nurse and refers to 17 patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB lot # L038018, expiration date 13-SEP-2017 (dose and route of administration were not reported). The vaccines underwent a temperature excursion at 59.7 degrees Fahrenheit for 17 hours and 40 minutes. No adverse event reported. Additional information has been requested.
Pts vaccinated with Engerix-B had no titers post 3rd dose. Non-responder.
Hospitalization for COVID-19 symptoms  on dates 5/25/2022- 5/28/2022. Treated with Vitamin C 1000mg PO daily, Vitamin D3 1 tab PO daily, budesonide 3mg PO daily.
First dose: Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8737) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back pain" (ongoing), notes: Verbatim: Back pain, Caller reported that she began experiencing back pain years ago.; "Arthralgia" (ongoing), notes: Verbatim: Knee pain, Caller reported that she has been experiencing knee pain for a few years.; "Diabetes mellitus" (ongoing), notes: Verbatim: Diabetes, Caller reported that she was diagnosed with diabetes 10-15 years ago. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); GABAPENTIN (ongoing); ATORVASTATIN (ongoing); WELLBUTRIN (ongoing); TRAZODONE (ongoing); LEVOTHYROXINE (ongoing). The following information was reported: FATIGUE (non-serious) with onset 02Apr2021, outcome "recovered" (03Apr2021), described as "First dose: Tired".  Additional information: The patient reported that she did pretty good with the first dose, her arm was not really sore or anything, she was tired and that was about it. First dose: Tired: She reported that she was always tired but she was extra tired. The patient reported that the physician that she had been seeing left the practice and she does not know who the replacement was. Adverse event did not require a visit to emergency room, or physician office. The patient did not receive any vaccinations within 4 weeks prior to COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Significant fatigue, slight head ache, lump and itchy arm at point of vaccination.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient stayed in the store after receiving vaccine shopping. An hour after patient had received her shot, we were notified she was unresponsive sitting in her walker with a chair seat. Patient was breathing, good pulse but not responsive. Paramedics that were called to scene stated good airway. Blood glucose was at 25 mg/dL.
Contracted COVID on 12Aug2021; Contracted COVID on 12Aug2021; This is a spontaneous report from a contactable consumer (patient).  A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: F7484) via an unspecified route of administration on 04Aug2021 (at the age of 47-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient received unknown concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with covid-19. The patient contracted covid on 12aug2021 (coded to covid-19 and drug ineffective). The patient underwent lab tests and procedures which included sars-cov-2 test (PCE nasal swab): positive on 11Aug2021. The patient did not receive any treatment. The outcome of both the events was resolving.  Follow-up attempts are completed. No further information is expected.
Pt is 16 yo female here for rash. Had 16 yo immunizations - that night had some redness and swelling at injection site on (L) arm. Progressively worsened. Now has increased pain, erythema and swelling. Pain when moves left arm,
fever gen itching and rash for 4 days;began 28hr p/inj;
She work up with a rash on her face. Face was red, had 4 blister type area on right side of face about the size of a sunflower seed. Not sure if itchy. No other rash to body. Is eating and playing OK.
The patient experienced a syncope episode while in the office; This spontaneous report was received from a nurse, via company representative, referring to a 11 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. Her previous drug reactions or allergies included amoxicillin.  On 29-OCT-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration and anatomical injection site were not reported) as prophylaxis (lot number 1637641 expiration date not reported, but upon internal validation established as 16-FEB-2022). On the same day, while in the office, the patient experienced syncope for 20 seconds and then recovered.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of syncope was not provided.  Upon internal review, the event of syncope was determined to be medically significant.
felt achy after his first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "felt achy after his first dose of the Pfizer COVID-19 vaccine".  Additional information: The patient also reported that he had mild side effects that were "kind of like hers (his granddaughter)" and felt achy after his first dose of the Pfizer COVID-19 vaccine but did not experience any side effects after his second dose and the booster dose. Responded per attached document and referred the reporter to granddaughter's HCP if symptoms do not improve or become worrisome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have been in remission with my RA since 2010, after the injection I had such a bad flare up of my RA that I went to the rheumatologist and was suggested to get back on medication,  my RA did calm down after 5 months but I just got the Booster 12/13/2021 and again I have flared to the point my pain is disrupting my sleep.  My RA had been under control with no medication since 2010 and the vaccine has just caused me to go backwards with my health.
Headache, fever (100) with chills, body aches, fatigue.  Felt a lot like I had the flu.
swollen throat; rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) on 06Aug2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Two days later, on 08Aug2021, she mentioned that she could breath but had a swollen throat and a rash. She would like to know when the rash would go away. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
It started with a sore throat-felt like needles. That evening, it progressed into body aches. The next couple of days I developed fatigue, headache, coughing, congestion. This lasted for a few days. I could feel I was getting stronger and having more energy. Today, I have a lingering cough.
Information was received from a registered nurse regarding an adult female patient, age unknown, who recently had her antibody levels checked and was found to have a negative measles titer. The nurse was not sure if the patient had received MMR II (albumin status unknown) in the past because she did not have the patient's chart available at the time of the report. Additional information has been requested.
exacerbation of cryptogenic organizing pneumonia; fever; malaise; wheezing; This is a spontaneous report from a contactable physician reported for himself. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration from an unspecified date at single dose for Covid-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced having fever and malaise after vaccination and then a few days later he has been wheezing. The patient believed it was an exacerbation of cryptogenic organizing pneumonia. The outcome of the events exacerbation of cryptogenic organizing pneumonia, fever, malaise and wheezing was unknown.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: The association between the event cryptogenic organizing pneumonia with BNT162b2 can not be fully excluded.  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.
Rash develop about 6 hrs after vaccine was given, 3x3cm in size at left anterior aspect of thigh, no fever, then grew bigger to 7x6cm, mild swing, warm but not tender, no improving.
Asthma symptom of wheezing (only) and then a bad headache and redness of eyes.
Patient presented to the ED on 4/12/2021 for RUQ pain. Patient hospitalized on 4/20/2021 for lumbar laminectomy. These visits are within 6 weeks of receiving COVID vaccination.
RN administered MMR vaccine to toddler in left thigh at 1145. At 1146 RN and mother notes erythema around injection site and 2-3 red raised bumps jsut below injection site. RN visually assessed patient and noted no respiratory distress but localized reaction to the MMR vaccine. RN notified provider Dr. of suspected localized reaction to vaccine at 1147. Dr. assessed the patient and confirmed suspected localized allergy reaction to MMR vaccine. Provider confirmed that the patient's reaction was only localized however transferred patient to urgent care for continued monitoring. Patient discharged from urgent care after monitoring with resolved localized reaction. Patient playful, alert and with no concerns at time of discharge per urgent care provider note.
Patient given second dose of pfizer for 5-11 year olds 6 days after turning 12 years old
shakiness; lack of appetite but not necessarily nausea; syncope; headache; low grade temperature of 99F.
Pt received pneumococcal vaccine right deltoid on 11/06/2001. 11/08/2001 telephoned PHN, notes induration  (5 cm by 3 cm) erythema, warmth, tenderness, chills w/o fever. PHN referred to MD, diagnosed with cellulitis and placed on Keflex 500mg bid for 10 days. No prior reactions to vaccines.
The patient is under age and was given the wrong manufacture during covid vaccine administration. She was given moderna when she was suppose to be vaccinated with Pfizer
Patient received the shot and was fine.  Afterwards, she stood up and fainted.  Patient came to on the floor and was offered water.  Patient stated she was ok and we continued to monitor for 15 minutes at which time she said she believed she was fine to leave.
Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. A nurse injected expired Moderna COVID-19 vaccine to 10 patients on 23-Feb-2022. Vaccine was stored in refrigerator at the time of excursion with a temperature range 38F to 40F. On 24-jan-2022, the vial was moved from freezer to refrigerator. It was reported that Vial location was in a nursing home and reporter was not sure if they discarded the vial or they still had it in the refrigerator.  Total number of vials/doses impacted were 1 vial = 7.5 ml (14 dose each), only 10 doses administered (9 booster and 1 second dose).The vial was not previously punctured nor undergone any excursion. !0 vaccine recipients had been monitored by the nursing staff at the skilled nursing facility. No adverse events reported at all. No treatment medications were reported.
Patient said after receiving her flu shot, she had pain in her right shoulder blade and neck. She tried using a tens unit at home to stimulate the area, putting ice on it, putting heat on it, arthritis cream and taking Ibuprofen. She called her doctor's office and the nurse asked her to make an appointment to come in to be seen. Patient has not done that yet. I (the pharmacist) also recommended she see the dr for follow-up. I also suggested she continue with Ibuprofen.
He got hives after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (He got hives after the vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (He got hives after the vaccine). At the time of the report, URTICARIA (He got hives after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medications was reported.