chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With every dose of the vaccine caller has had muscle problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (ongoing), notes: in her 30s when started; "Hashimoto's" (ongoing); "Fibromyalgia" (ongoing); "Sjogren's" (ongoing). The patient's family history included: "Rheumatoid arthritis" (ongoing), notes: in her late 30s. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/ lot: EN6205, Anatomical location: Upper left arm, Time: sometime in morning), administration date: 02Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "had muscle problems", "arm irritation", "arm tenderness"; bnt162b2 (DOSE 2, SINGLE, Batch/ lot: ER8727, Anatomical location: Upper left arm, Time: sometime in morning), administration date: 23Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "every muscle in body was bothering patient/ muscle problems", "arm sensitive/ had tenderness", "leg cramps", "very tired", "headache", "sore throat"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot: 30135BA, Anatomical location: Upper left arm, Time: sometime in morning), administration date: 21Oct2021, for Covid-19 immunization, reaction(s): "Pericarditis", "couldn't breathe", "with every dose of the vaccine caller has had muscle problems". The following information was reported: MUSCLE DISORDER (non-serious), outcome "unknown", described as "With every dose of the vaccine caller has had muscle problems". Therapeutic measures were taken as a result of muscle disorder.  Additional information: Patient's rheumatologist prescribed the Prednesol. Reporter's aunt had rheumatoid arthritis. No investigations were carried out. The time of administration of suspect dose 4 was sometime in morning.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337361 same patient/vaccine, different doses/event.;
painful injection, severe headache for 4 days, nauseau, fever, aches and pains, swollen arm at injection sight, extreme pain at injection sight
Pt stated confusion/dizziness shortly after vaccine administration. Pt further stated they had a reaction involving their muscles, pt. unsure if seizures or convulsions. Occurred every 1/2 hour for a while. Did not seek medical advice or consultation. Felt better on 11/27/15 3PM.
Very swollen and painful lymph node in neck on left side; Very swollen and painful lymph node in neck on left side; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included trigeminal neuralgia, hypothyroidism and penicillin allergy. Concomitant medications included oxcarbazepine (TRILEPTAL), levothyroxine (MANUFACTURER UNKNOWN and fluoxetine (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient had a history of allergy to penicillin, erythromycin and yeast. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 15:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation and took Erythromycin and Yeast on unknown date for unspecified indication and experienced drug allergy. 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 08Apr2021 at 21:00 the patient experienced very swollen and painful lymph node in neck on left side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event swollen and painful lymph node in neck on left side was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
severe itching on the palms of her hands; This case was reported by a consumer via call center representative and described the occurrence of itching both hands in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th December 2019, 2 days after receiving Shingrix, the patient experienced itching both hands. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the itching both hands was recovering/resolving.   It was unknown if the reporter considered the itching both hands to be related to Shingrix.  Additional details were received as follows: The patient stated that she got the 2nd dose of Shingrix and had severe itching on the palms of her hands. The patient took some Benedryl and it went away for awhile before coming back. The patient did not consent to follow up.
TEMPERATURE EXCURSION OF RISING TO 9.9 DEGREES C FOR 30 MINUTES; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced temperature excursion of rising to 9.9 degrees c for 30 minutes, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and temperature excursion of rising to 9.9 degrees c for 30 minutes was not reported. This report was non-serious.
I had a swollen lymph node on the left side under my armpit. It was larger than a golf ball. A couple days later I started to get a sinus infection. There was mucus and postnasal drip. It's kind of settled down into a cough/bronchial infection. I have also been feeling fatigue. As of today, I can tell the enlarged lymph node is still there, but not nearly as large as it was after receiving the vaccine.
tingling & pruritus @ site p/vax;allerg rxn to pneumovax;edema of whole arm;
Patient experienced pain from the elbow to shoulder the evening of vaccination (7/22), expanding to include the hand and wrist the following day (7/23).  The 2nd day after vaccination (7/24), patient stated pain worsening to the point that it limited use of his arm.  the 3rd day after vaccination (7/25), patient reported to the emergency room for follow-up,  No X-ray or MRI was performed.  Patient was prescribed a steroid and Norco for treatment, and advised to keep arm in a sling and treat with heat or cold as appropriate, based on symptoms and relief given.
3/19/2021- Dizziness, Abd discomfort, diarrhea, blood glucose greater than 1000 3/20/2021- syncope and collapse resulting in tib/fib fracture, decreased BP ( admitted to local ICU) 3/22/2021- tested COVID positive
first dose > 25 days ago; first dose was not an approved or authorized COVID19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose was not an approved or authorized COVID19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 25 days ago) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002914) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: AstraZeneca (first dose and Lot MT0055) on 20-Apr-2021. Past adverse reactions to the above products included No adverse event with AstraZeneca.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose was not an approved or authorized COVID19 Vaccine). On 15-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 25 days ago). On 20-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose was not an approved or authorized COVID19 Vaccine) had resolved. On 15-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 25 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
This spontaneous report as received from a registered nurse refers to a four patient of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, two patients were vaccinated with a dose of PROQUAD (Merck) injection, lot # L008354, expiration date 11-SEP-2016 (strength, dose and route of administration were not reported) that were improperly stored. On an unknown dates, two patients were vaccinated with a dose of PROQUAD injection, lot # L007230, expiration date 03-SEP-2016 (strength, dose and route of administration were not reported) that were improperly stored. No information on patients concomitant medication was provided. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Patient was seen for routine lab work as an outpatient on 12/2. The patient was found to have a low serum sodium and sent to ED for evaluation. Patient is a daily alcohol drinker. The patient was tested for COVID-19 and found to be positive. The patient is being admitted to the hospital.
The pt experienced an asthma attack, difficulty breathing, brought under control with repeated doses of albuterol inhaler.
Due to COVID outbreak at facility, resident was tested for COVID in house on 6/8/2023, Results were negative. Resident sent to hospital 6/11/2023, was diagnosed with COVID. 77-year-old gentleman with past medical history significant for ischemic heart disease, adult failure to thrive, epilepsy, diabetes mellitus, recurrent falls among others referred to my service having been brought to the ER unresponsive. HPI review of systems unobtainable due to altered mental status Patient passed away prior to my evaluation
vaccine excursion, unknown if administered to any patient; This case was reported by a consumer via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received Engerix B and Rotavirus vaccine. On an unknown date, unknown after receiving Engerix B and Rotavirus vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 09-AUG- 2022 Reporters comment: The reporter reported that had an excursion last week from reporting, the vaccines. Reporter stated that he/she worked on the doctor's office and had Engerix b and rotavirus vaccine. Reporter requested to call the manufacturer to know the viability of Engerix. The reporter did not consent to follow up. Additional Supportive information: Had an excursion last week, the vaccines, which led to incorrect storage of drug.
Chills, fever, headache, muscle aches, dizzy, sore arm. Lasted 5 days.
VARlVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant referring to a 4-year old patient of unknown gender.  The patient's medical history, concurrent condition and concomitant medication were unknown.    On 16-JUL-2021, the varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T028310, expiration date 20-AUG-2022, indication: prophylaxis; strength and dose were unknown) was administered after undergoing a temperature excursion (product storage error).         Temperature excursion of this vaccine was 0.4 degree Celsius for 13 hours and 10 minutes. There was no previous temperature excursion. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2107USA006887: US-009507513-2107USA006957: US-009507513-2107USA007004: US-009507513-2107USA007009: US-009507513-2107USA006981: US-009507513-2107USA007007: US-009507513-2107USA007000:
Information has been received from a registered nurse concerning a 25 year old female with allergies to VICODIN and nuts and no pertinent medical history who on 12-OCT-2010 was vaccinated intramuscularly on her left arm with the first 0.5 ml dose of GARDASIL (lot# 0450Z). Concomitant therapy included DESOGEN. On 23-OCT-2010 "11 days after administration" the patient developed a rash on her left arm. Nurse stated that the patient had sent in a picture of the rash and it looked slightly vesicular. The patient said she would be going to an unspecified dermatologist. No diagnostic laboratory tests were performed. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by office call. Additional information has been requested.
p/having vax pts arm was swollen red, painful & stiff; this prevented pt from using arm; no nausea or other sx; last shot in 1987 had no react;
4 hours after flu  vaccine,  I started having chills and my teeth were chattering. I went to bed at 7:30 and didn?t wake up until 7:30am. I went back to sleep at 8:30Am and didn?t wake up until noon.
Patient received a COVID vaccine. A couple minutes after administration. Patient stated that she was feeling faint and dizzy. Patient mentioned that she was having blurred vision. Pharmacist provided a cool compress to the patient's head, neck, and wrists. Patient was also provided water. Patient's blood pressure was taken several times which read extremely low (90s/ 50s). Patient mentioned that her hands were going numb and stiff.  EMS was called for patient for assessment. Patient was observed by EMS in which it was concluded that patient experienced what appeared to be a panic / anxiety attack. Patient believed that the vaccine was giving the patient covid. Once the EMS told her otherwise, patient was able to calm down. After about 25-30 minutes after the vaccine, patient felt better and left with her mother.
A pt (2 of 6) post vaccine developed fever, inconsolable crying and swelling and induration of injection site that was hot to the touch.
This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 26-SEP-2018, the patient was vaccinated with an expired vaccine of VAQTA 50/1.0 U/ml, lot # N016805 with expiration date on 04-SEP-2018 (route of administration was not reported). However, no adverse event were reported.
Mild dizziness then increased heart rate; Mild dizziness then increased heart rate; tachycardia; high blood pressure; rash on face; This is a spontaneous report from a contactable consumer or other non hcp (herself). A 64-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,Batch/Lot Number: EN6204, expiry date not reported), via an unspecified route of administration, administered in Arm Right on 18Mar2021 12:45 as dose 1, single (age at vaccination 64-year-old) for covid-19 immunisation. Medical history included breast cancer metastatic and Known allergies: Sulfur antibiotics from an unknown date. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 12:45, the patient experienced mild dizziness then increased heart rate, tachycardia, high blood pressure, rash on face. The patient received treatment for the events includes Benadryl injection, steroid injection, EPI pen inj. The patient underwent lab tests and procedures which included blood pressure measurement: high on 18Mar2021, heart rate: increased on 18Mar2021. The clinical outcome for all events was Recovered with lasting effects on an unknown date in 2021.  No follow up attempts are possible. No further information is expected
pt recv vax 18MAY95 & 8JUN95 pt exp 30 to 40 pox marks on the lt front leg, lt front abd & primarily on lt front thigh; No further details were provided; 4 wks p vax dev 30 clusters of pustules, scabbed over, mod hyperpigmentation;
Ischemic stroke from occlusion of Right middle cerebral artery stroke.Ischemic stroke from occlusion of the distal right A2 segment near origin of the callosomarginal artery; This is a spontaneous report from a contactable consumer (patient) received via Regulatory authority. A non-pregnant 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Jul2021 at 12:15 (Lot Number: EW0191) (at the age of 76-year-old) as single dose for COVID-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19; since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  The patient previously took aspirin and experienced upset stomach.  The patient experienced ischemic stroke from occlusion of right middle cerebral artery stroke. Ischemic stroke from occlusion of the distal right A2 segment near origin of the callosomarginal artery on 11Jul2021 11:00. The event was serious, medically significant and caused hospitalization for 14 days.  Unspecified therapeutic measures were taken as a result of the event. The patient outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
I had 3 vaccinations that same day at the same time: flu, pneumo, and meningococcal. This was about 11:00 AM local time. At about 11:00 PM, that same day, I developed muscle aches and a fever and violent shivering. At about 1:00 AM, I began vomiting, which lasted until 4:30 AM. The shivering stopped after that, but the fever continued throughout the next day (Nov 3). By Nov 4, all symptoms were gone.
Really swollen red and itchy at injection site, swollen and red spread throughout her upper arm.
Heart palpitations  Tachycardia Shortness of breath  Migraine Fatigue Lethargy
heat that come and goes at the injection site; Itchy at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat that come and goes at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat that come and goes at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (heat that come and goes at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant list.  Treatment was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Approximately 12 hours post vax, the patient experienced a fever of 104, a headache, nausea, vomiting and body aches. These symptoms lasted 2 days.
Route of administration: IM; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 13-month-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 22-FEB-2023, the patient was vaccinated at a private doctor's office/hospital with varicella virus vaccine live (oka/merck) (VARIVAX) via intramuscular (IM) route at her right thigh (Incorrect route of product administration) as prophylaxis (lot # W006412 and expiration date 23-FEB-2024; dose not provided). It was reported that, on 20-JAN-2023, the vaccine underwent a temperature excursion in the range of 6°F to 14°F (-14°C to -10°C) for 1 hour (Product storage error).   This is one of several cases received from the same reporter.
Last evening complained of shivering, nausea, vomiting and diarrhea last night.
Fever; pain at injection site; joint pain; chills; tiredness; nausea; muscle pain; feeling bad; headache; This is a spontaneous report from a contactable consumer.   A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in arm left on 19Mar2021 13:00 (Batch/Lot Number: EN6207) (at the age of 51) as single dose for covid-19 immunisation. Medical history was not reported. No concomitant medications in two weeks. No other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever on 20Mar2021 01:00, pain at injection site on 20Mar2021 01:00, joint pain on 20Mar2021 01:00, chills on 20Mar2021 01:00, tiredness on 20Mar2021 01:00, nausea on 20Mar2021 01:00, muscle pain on 20Mar2021 01:00, feeling bad on 20Mar2021 01:00, headache on 20Mar2021 01:00. The events were not treated. The events outcome was not recovered.    No follow-up attempts are possible. No further information is expected.
Mother phoned stating about 1 hr after receiving injection, daughter c/o lightheadedness and nausea within short time client c/o "seeing double", feeling icy cold, fingers and toes tingling and burning, "hyperventilating". Dr told mother combination of anxiety, nerves, fear of "shots". Given orange juice and sent home to rest. Client slept 3 hrs-at 6:00pm mom reports client doing well-no problems.