chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown age and gender. The concurrent conditions and medical history of the patients were not mentioned by the reporter. On an unknown date the patients were vaccinated with M-M-R II of lot # K018990, expiry date: 15-OCT-2016 (strength, dose #, route, site of administration and indication not reported) which had been improperly stored (incorrect product storage). No adverse effects were reported. Product Quality Complaint was not filed. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
pt recvd vax & 31AUG92 lab eval showed a pos test for Hep B; No further details were provided;
Headache, Myalgia, pain of upper legs and arms and slight headache Narrative:
Total 10-12 erythematous papular vesicular lesions, some excoriated, on the left scalp, back, arms, right knee, chest and left temple.
This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). On an unspecified date, a few hours after vaccination with FLUARIX, the subject experienced injection site redness, swelling injection site and injection site soreness. The events occurred within "possibly a few hours after vaccination." At the time of reporting the outcome of the events were unspecified. The pharmacist reported another subject with same events. See case A1002923A for details on the other subject.
Pt recvd vax on 30JUL92 & 4AUG92 devel nausea & vomiting; seen by MD dx viral illness; devel muscle weakness & pain in lt leg; virus infection is settled in muscle of leg;
dizziness; vertigo; try not to move my head because if I move it I feel worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 at 14:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No, Known allergies: No. The patient took concomitant medications. Vaccination history included: jansenn (DOSE 1, SINGLE; Batch/Lot No: Unknown. Unable to locate or read the details; Location of injection: Arm Left; Vaccine Administration Time: 04:00 PM), administration date: 27Mar2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2 (INITIAL PFIZER DOSE), SINGLE; Batch/Lot No: Unknown. Unable to locate or read the details; Location of injection: Arm Left; Vaccine Administration Time: 06:00 PM), administration date: 12Nov2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 26Nov2022 at 08:00, outcome "not recovered"; CONDITION AGGRAVATED (non-serious) with onset 26Nov2022 at 08:00, outcome "not recovered", described as "try not to move my head because if I move it I feel worse"; VERTIGO (non-serious) with onset 26Nov2022 at 08:00, outcome "not recovered". Therapeutic measures were not taken as a result of dizziness, vertigo, condition aggravated.  Additional information: Patient had dizziness, vertigo. It had improved but it did not go away. Patient don't know what to do. Patient tried not to move her head because if she move it feel worse. Patient did not had COVID prior to vaccination. Patient had not tested for covid post vaccination. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient vomited both the 1st and now 2nd vaccine. Several times during a 6 hr period.
Pt. has had prolonged pain in the muscle that extends both above and below the elbow. One day had a shooting pain down to thumb, but only happened once. Currently experiencing an aching pain right above elbow. Can't lift anything without pain.
open heart surgery; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC OPERATION (open heart surgery) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 0H7A21A) for COVID-19 vaccination.    Co-suspect products included non-company products METFORMIN for an unknown indication and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    Concomitant products included AMLODIPINE, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE, ATORVASTATIN, FERROUS SULFATE, SIMETHICONE, METHIMAZOLE, ASCORBIC ACID and Tylenol PRN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, METFORMIN (unknown route) 500 mg once a day and MULTIVITAMINS & MINERALS PLUS LUTEIN (unknown route) dosage form. On 08-Mar-2021, the patient experienced CARDIAC OPERATION (open heart surgery). At the time of the report, CARDIAC OPERATION (open heart surgery) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medicines include Amlodipine, Metoprolol, Aspirin  ,Omeprazole, Atorvastatin, Ferrous Sulfate, Simethicone Methimazole  Metformin, Ascorbic Acid, Tylenol , Multivitamins  Treatment drugs were not provided  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-061260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non significant follow up received on 13-MAY-2021, AE contact information updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061260:2nd dose
Bronchitis Started with a sore throat on the 3rd.  Stuffy nose and head started on the 4th and then cough and chest congestion on Thursday night.  Started as a dry cough but moved to a productive cough on Friday afternoon.  Also had a bad headache.  Sought medical care and was diagnosed with Bronchitis.  Received a steroid shot, liquid for cough and congestion (Bromphen), Albuterol, and an antibiotic.  Today, I'm feeling better but the cough is still lingering.  It is fairly productive.
Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting.   The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure.  On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection.   On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia
Information has been received from a health professional concerning her niece who on 04JAN1999 was vaccinated SC in the left leg with a dose of varicella virus vaccine live (lot 624724/1327R). There was no illness at the time of vaccination. Subsequently the patient had a mild case of chicken pox break through two weeks after her sister. Unspecified medical attention was sought. The patient recovered. No product quality complaint was involved. The patient's sister was also vaccinated with varicella virus vaccine live and developed chicken pox and another patient was vaccinated with varicella virus vaccine live and developed shingles. Additional information has been requested  Follow up information frim a health care professional indicated that the child broke out with chicken pox 1 week after her sibling, on Feb 4 2004, and that she was heavily covered with pox. No labs or diagnostic test were done. She was out of school one week and recovered fully on approximately 02/11/2004. The patients sister (WAES0403USA00668) was vaccinated with varicella virus vaccine live (lot 624734/1327E) and developed chicken pox and another patient (WAES0402USA01796) was vaccinated with varicella virus vaccine live (lot 624724/1327E) and developed shingles.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 59-year-old female patient who received Shingrix for prophylaxis. On 24th April 2018, the patient received the 1st dose of Shingrix. In April 2018, less than a day after receiving Shingrix, the patient experienced bedridden, mobility decreased, muscle pain, joint pain and ligament pain. On 24th April 2018, the patient experienced general body pain. On an unknown date, the outcome of the general body pain, bedridden and mobility decreased were recovered/resolved and the outcome of the muscle pain, joint pain and ligament pain were unknown. It was unknown if the reporter considered the general body pain, bedridden, mobility decreased, muscle pain, joint pain and ligament pain to be related to Shingrix. Additional details were provided as follows: The caller reported that less than a day after receiving Shingrix, the patient experienced whole body hurt, except her face. By midnight of the day of the vaccination, the patient could not lift her arm. The patient's every muscle, joint and ligament in her body ached and she could not get out of bed for 3 days. By the 4th day, the patient felt better and was up and about.
Narrative: Patient previously had a Pfizer 1st dose at a pharmacy when traveling in May. He had a reaction with shortness of breath, hives, itching. He administered his epi pen and took lots of Benadryl per his report. He has previous reactions to injected and oral meds along with tomatoes. He requires a Covid vaccination per his work protocol. A provider reviewed his case 9/21/21 and they decided to give him the J&J vaccine for his 2nd dose. The patient was monitored for 30min without problems. RN called pt at home later - he reported taking Benadryl prior to the injection and the itching had decreased. No additional Benadryl needed.
received dose today after 3 weeks of receiving last dose of pfizer covid vaccine, received J&J in March 2021,  Monitored for 30 minutes after receiving, no adverse events today, advised patient to hydrate, will followup with patient on 12/15/21. She was instructed to seek medical attention if having severe  adverse advents.
Pt developed a red indurated area at the site of injection and rash all over body 48 hrs post vaccine.
Chills followed by high fever (105), severe generalized joint and muscle pain, severe headache, nausea, inappetence.  Started several hours after the vaccine and lasted for about 24 hours followed by marked weakness and dizziness that persisted for another 24 hours and lessened in the next 24 hours.
Severe thrombocytopenia. Administration of dexamethasone and IVIG immune globulin. Petechiae over bilateral lower extremities and feet. Ecchymosis.
got the flu; Initial information received on 12-Nov-2020 regarding this unsolicited valid non-serious social media case from a consumer (patient).   This case involved a patient with unknown demographics who got the flu (Influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (Influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that patient would stay home and take care of himself/herself.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown. Not Provided          No concomitant medication was provided by the reporter .  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Source document received on 9/5/2021 does not contain any new information On 10-May-2021: Source document received on 10/5/2021 does not contain any new information
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Mild
cheek swelled up like he had mumps; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; body aches; low grade fever; dull ache was causing some headaches; sensitive area in lower right portion of jaw; parotid salivary gland infection; This is a spontaneous report received from a contactable consumer (patient himself). A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and lot number: EL9369), via an unspecified route of administration on 10Feb2021 as a single dose in the left arm for COVID-19 immunisation. Patient had no medical history and concomitant medications. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL3246), on 20Jan2021 in left arm for COVID-19 immunization. On 10Feb2021 (about 6-8 hours after second dose), the patient developed body aches and low-grade fever. It was reported that at same time as body aches, he had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only. Stated everything went away after 36 hours except the ache in his jaw and ear, states it became very low grade, thought it was his ear and after a week, the dull ache was caused some headaches in 2021 and he went to doctor who told him to see an ENT, states he saw an ENT, they looked deeply, it was fine, states they did find there was a sensitive spot down by his jaw, told him to just take Ibuprofen. On 21Mar2021, patient cheek swelled up like he had mumps and went to the periodontist, he probed and found no infection, did find a sensitive area in lower right portion of jaw, prescribed cefalexin. Swelling went down, and then suddenly it came back and told him to go to oral surgeon specialist, oral surgeon did a CT, did not find an evidence of tumours or anything in 2021, based on symptoms he said he had parotid salivary gland infection in 2021, when it gets infected it creates a mump like condition and prescribed amoxicillin. Clarified the jaw pain started out severe dropped down to low grade annoying pain and stayed that way. then on the 21Mar2021 it got severe again with the swelling. Stated today, it seems to have gone away, still has 5 days of amoxicillin left. Outcome of body aches, low grade fever was recovered on 11Feb2021, dull ache was causing some headaches, cheek swelled up like he had mumps, sensitive area in lower right portion of jaw and parotid salivary gland infection was unknown and had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 12 year old female with no known allergies and no pertinent medical history who on 15-DEC-2006 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil. On 12-FEB-2007 the patient was vaccinated intramuscularly with a second 0.5 mL dose of Gardasil. There was no concomitant medication. Since March 2007, the patient experienced debilitating fatigue. The patient was unable to attend school and could barely get out of bed. The patient also experienced weakened hand grip, abdominal pain and nausea. A gastrointestinal work-up, including endoscopy was negative. On 14-JUN-2007 the patient was vaccinated intramuscularly with a third 0.5 mL dose of Gardasil. The physician reported that the patient's symptoms worsened after the third dose of Gardasil. As of 22-OCT-2007 the patient's debilitating fatigue, weakened hand grip, abdominal pain and nausea persisted. Debilitating fatigue, weakened hand grip, abdominal pain and nausea were considered to be disabling by the reporting physician. Additional information is not expected.
phlebitis in left calf two weeks and 3 days after vaccine. I had phlebitis in that calf 3 years prior,, provoked by a splint, which resolved with treatment and has been a non issue until this recurrence.  I had no events in the last 3 weeks that would provoke phlebitis, other than possibly the vaccine. Since Covid is thrombogenic, and the Astra-Zenica vaccine has been held for possible thrombogenic concerns, I am reporting this with the possibility that the vaccine provoked my phlebitis.
Swollen and painful lymph nodes in right axilla; Swollen and painful lymph nodes in right axilla; DOSE 1: 09Feb2021;  DOSE 2: 26Feb2021; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 26Feb2021 at 11:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 09Feb2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 13:00, the patient experienced swollen and painful lymph nodes in right axilla. Therapeutic measures were not taken as a result of the events.. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of the events swollen and painful lymph nodes in right axilla was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever/is getting more often than it was; Booster dose; Booster dose; Feeling very weak; Pain started after her booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Aug2021 (Lot number: FC3180) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; immunoglobulin human normal (HIZENTRA), administration date 20Aug2021 (Batch/Lot number: unknown) as 8 g. Relevant medical history included: "Wears hearing aids" (unspecified if ongoing), notes: Verbatim: Caller wears hearing aids; "Immunodeficiency", start date: 2013 (ongoing). Concomitant medication(s) included: DOXYCYCLINE MONOHYDRATE, start date: 16Jul2021. Past drug history included: Hizentra, notes: A couple years ago. Vaccination history included: Bnt162b2 (First dose, lot E1926S, Dose #1 on 31Jan2021 in her muscle of arm at 10:55), administration date: 31Jan2021, when the patient was 65 years old, for Covid-19 Immunisation, reaction(s): "Cramping/locking started in July"; Bnt162b2 (Second dose, Dose #2 on 20Feb2021 in her arm at 14:15), administration date: 20Feb2021, when the patient was 65 years old, for Covid-19 Immunisation, reaction(s): "Cramping/locking started in July"; Flu vaccine (Flu shot as a child around 7 years), for Immunization, reaction(s): "rash". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "Booster dose"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Feeling very weak"; PYREXIA (non-serious) with onset 12Sep2021, outcome "unknown", described as "Fever/is getting more often than it was"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain started after her booster dose". The events "feeling very weak", "fever/is getting more often than it was" and "pain started after her booster dose" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She did her infusion (Hizentra) 2 hours ahead of her Covid vaccine,3rd dose. The lot number of dose 2 was EL1926, it was hard to tell or EL9267 and stated 31May2021 under it; Dose 3 was taken in her arm, she doesn't recall which arm or what time. Patient stated that she was seeing like 19 doctors and has many papers and is behind. Vaccine Administered at Facility: No.  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.