chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around December 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered hearing loss. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, hearing loss was determined to be medically significant. Hearing loss was considered disabling. Additional information has been requested.
Within 5 minutes of receiving the vaccine she complained of numbness/tingling in her right arm.  She then also complained of being short of breath and feeling dizzy.  She then started demanding to leave the room because she couldn't breathe with her mask on and wanted to go outside for "fresh air."  I called the emergent response team and escorted her outside.  Her vitals were taken and were all normal.  The emergent response team arrived and she settled down once they were there.  Her oxygen was completely normal and she refused oxygen supplementation.  After another 5 minutes she said she was feeling better and left.  She was given a single dose of Benadryl 50mg IM prior to the response team arriving.  On 8/23/2021 she came to see me in person and said that a few hours after leaving she had developed hives and was feeling short of breath again but had not gone to see a doctor.  She stated that she was going to be seen on Wednesday 8/25/21 to follow-up to her reaction and get treatment for the hives.  I could visibly see that she had hives on her left arm.  She said that she hadn't done or tried anything new that could have caused the hives.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on 12Oct2016, at single dose, for immunisation. The patient's medical history included leukaemia. Concomitant medications were not reported. The patient experienced lips turning blue on 12Oct2016, 30 minutes after vaccination. Patient was wearing purple lipstick and lips just appeared a bit darker. Outcome of the event was unknown.
CRAMPS IN BOTH LEGS FROM KNEE TO ANKLE; SEVERE ARM PAIN THAT RADIATES FROM SHOULDER TO ELBOW LIKE HAD SURGERY ON IT; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was not reported and height was 61 inches. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no any seasonal allergies, medications and previous medical history, no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 23-AUG-2021 11:30 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced cramps in both legs from knee to ankle. On 24-AUG-2021, the patient experienced severe arm pain that radiates from shoulder to elbow like had surgery on it. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe arm pain that radiates from shoulder to elbow like had surgery on it, and cramps in both legs from knee to ankle. This report was non-serious.
The pt was dx'd with cellulitis of the left thigh and left arm with ER visit on 1/8/02. He was given Benadryl and Oxacillin X 2 with IV. Discharged from the hospital on 1/10/02 AM. At 13:00, he had swelling at both sites has reoccurred with complaints of itching from the child. Will return to hospital for further evaluation. An annual follow up report received 6/4/2003 adds: Pt seems fine now but still taking pruritis medication as prescribed.
Vaccine was administered approximately 2 in away from where there was a hemangioma. Next day patient noticed significant swelling of the hemangioma.
Dose 2 she said hurt not as bad/ Pain in arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2020AMR003903).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient's injection hurted but not as bad as after the 1st dose and lasted for 3 days. The reporter stated all pain in arm resolved.  The reporter consented to follow up. For the tolerances of 1st dose, refer case US2020AMR003903, reported by same reporter for the same patient.
Rash from 2nd Shingrix shot, 50 MCG/0.5ML INJ GLAX Rx 1st shot 02/07/2020 Rx 04/16/2020 Fever to 100.5 04/23/2020 to present 06/06/2020 - Slow, progressing bilateral rash to forehead and hairline. Redness, tenderness, with tight skin feeling, warm to touch, itchy and flaky bumps.
Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125. There are a total of 82 patients involved. The healthcare provider wanted to know if the vaccine administered on 15-MAR-2023 would be considered as valid for the patients.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time. The second potential lot was confirmed to not be used.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Husband received the vaccine as well and only his arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Husband received the vaccine as well and only his arm hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Husband received the vaccine as well and only his arm hurt). At the time of the report, VACCINATION SITE PAIN (Husband received the vaccine as well and only his arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-060269 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant Follow-up received on 09-AUG-2021.  events updated from initial version, events experienced by female patient were deleted and event experienced by male patient was retained.
Broken hip; Broken arm; currently immobile; This is a spontaneous report received rom a Pfizer sponsored program . A contactable consumer (patient sister)reported that a 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The Caller reported that her sister who had the first shot of the Pfizer vaccine. Her sister had surgery on a broken hip and arm. The broken hip and arm happened just this week (unspecified date in Mar2021). Her second shot scheduled for tomorrow (27Mar2021). Her sister was currently immobile and unable to come in for the shot. The 21 days was up tomorrow (27Mar2021). The reporter was concerned about the efficacy of the shot if it was not given within the 21 days. Outcome of the events broken hip and arm was not recovered and that for currently immobile was unknown.  Follow-up (26Mar2021): This is a spontaneous report received from a Pfizer sponsored program.  Information on patient second shot of vaccine was reported.  Information on the lot/batch number has been requested.
Chills after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills after 2nd dose). At the time of the report, CHILLS (Chills after 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-384017 (Patient Link).
This spontaneous report was received from a nurse practitioner refers to a 29 year old female patient. There was no drug reactions or allergies. On 04-SEP-2013, the patient was vaccinated with 0.1 ml PNEUMOVAX23, (lot number, expiry date was not reported and route was subdermal) instead of the TB (tuberculosis skin test). On 06-SEP-2013, the patient stated that injection site was having a local reaction. She stated that it ws sore and tender to touch. Thee was no treatment rendered for the event. There was no laboratory tests performed. At the time of the event the patient was recovering from the reported events. The patient sought medical attention. Additional information has been requested.
Case number PHEH2013US013956, is an initial spontaneous report received from the nurse on 26 JUN 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: A12097) reconstituted with sterile water intramuscularly on 26 JUN 2013. No adverse reaction was reported following this administration error.
1-9-21 fever of 101.0 at 10:18pm and fever on 1/10/21 at 12:16 am
Information has been received from a registered nurse, for GARDASIL, a pregnancy registry product, concerning a 16 year old female who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL IM (lot#658563/1063U). The nurse reported the patient was in the office on 03-JUN-2008 for a physical and her blood pressure was ok, however she had gained 30 pounds in 1 year. The patient's weight was 256 pounds at the time of visit. On 25-AUG-2008 the patient was vaccinated with the second dose of GARDASIL IM (lot# 660553/0070X). On 27-JAN-2009 the patient was vaccinated with the third dose of GARDASIL IM (lot# 660553/0080X). The patient was seen on 25-MAR-2009 for laryngitis, her blood pressure was 157/115 in one arm and 146/91 in the other arm. She was prescribed Bactrim and told to come back in 2 weeks for a follow up on her blood pressure-no treatment was noted. She was 307 pounds at this time and she reported her "last menstrual period" started on 24-MAR-2009. She never made it back in for the two week follow up as she delivered a baby on 09-APR-2009 in her bathroom. The patient went to the hospital after delivery. She had no knowledge of any complications, or any congenital anomalies, she heard the baby weighted over 9 pounds, she received no prenatal care. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a 69 year old female patient. The patient's pertinent medical history and concomitant therapies were not reported. The patient had no drug reactions or allergies. On 09-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously, dose was not reported, lot # L037797, expiration ate 03-DEC-2016). On 10-FEB-2016, the patient experienced a "red patch" at the site of the injection. On an unspecified day in February 2016, the patient came to the pharmacy to show the pharmacist the "red patch". The area around the injection site "red and warm to the touch." There were no raised areas nor rash present. The patient informed she would apply an unspecified steroid cream to the "red patch". The patient's outcome was not recovered/not resolved. The relatedness between the events and the ZOSTAVAX was not provided. Additional information has been requested.
After getting a Tetanus shot, I had a red, hot, swollen place at the injection site that worsened over 4 days after receiving the injection. It was the size of a half dollar and had a large hard center. For two days following the injection, I also felt extreme fatigue and at one point experienced noticeable cognitive issues (words were mixed up).
I started having pretty bad pain in the knuckles of my hand, both hands and the wrist. Then I was having joint pains in my knees and ankles. So I went to the Dr. arthritis does run in my family so I was thinking my it was starting to kick up. Dr. did bloodwork. Rheumatoid levels were normal. ANA levels were elevated. Dr. said they were not really really high but that they were elevated. She wanted me to see a rheumatologist who can't see me for months.  I have days now where its better and days when it is worse. It is not as bad consistently
Localized rx at time of injection on 9/9/19 and then on 9/14/19 noted inc in pain,swelling,redness,heat and firm tissue to Rt arm from shoulder to elbow. Presented to wlc on 9/16/19 with ongoing pain although decreased some,swelling, redness and heat with firm tissue from rt deltoid to elbow.
Guardian stated that patient had not eaten all day and had arrived this morning from being on an airplane for 15 hours. Patient was given lollipop and began to lick on it. Immediately after all immunizations were given, patient turned greenish and leaned back in the chair, broke out in sweat, and closed eyes. Nurse immediately got cold wet paper towels and began to wipe face and arms. Other nurse brought cold water bottle, cold packs and applied to neck and arms. Patient felt sick at stomach and attempted to vomit in the trash can. Guardian assisted patient with taking small sips of cold water. At no time did patient fall or hit head on anything. Patient drifted in and out of semi-consciousness for about 20 minutes. Patient remained seated in treatment room for at least 45 minutes, then stated that she felt ok. Patient was assisted by nurse as she ambulated to waiting area and was assisted by guardian and husband out of the waiting area. Guardian stated that they would watch her closely and get her something to eat.
04May2021: Dose #1/ 10Sep2021: Dose #2; 04May2021: Dose #1/ 10Sep2021: Dose #2; Seven hours after dose experienced pain; shingles; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 10Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, administered on 04May2021 as dose 1, single for covid-19 immunisation and got sick with Covid and following symptoms: No fever but extreme chills, no taste, sore, can't really move, GI issues, headache, and slight cough from 06Aug2021. The patient received dose 1 on 04may2021 and dose 2 on 10Sep2021 and seven hours after dose experienced pain and shingles on Sep2021. Therapeutic measure (treated with Valtrex) was taken as a result of pain and shingles. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265495 Same patient and drug, different event and dose
cold; tired; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: NASOPHARYNGITIS (non-serious) with onset 02Apr2021, outcome "unknown", described as "cold"; FATIGUE (non-serious) with onset 02Apr2021, outcome "unknown", described as "tired".  Additional information: Reporter reported that reporter's son had the Pfizer vaccine last Saturday and at day of reporting he was so cold. They have 2 blankets on him and a heater. He was really tired. Reporter asked if other reports like this. Reporter scared for son to get the second dose. Reporter asked If vaccine building an immunity for him.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Thirty minutes after 1st vaccine administered mental foggiest and headache and acrid taste in mouth.  Then three days post vaccine return of brain fog and headache.  Gradually headaches subsided within ten days.
an hour ago food allergy reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 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: FOOD ALLERGY (non-serious), outcome "unknown", described as "an hour ago food allergy reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt ran t104 19AGU92, vomiting, prolong crying & irritability, swelling of face;
Redness at site of injection (L). Ice pack given will return if worsens. Redness about 2.5 in.
Polyarthritis nodosa 9/20/18 previous Hx of brachial neuritis + Lymphocytic vasculitis Dx at other facility
I got my first dose of the Moderna vaccine while unknowingly  having Covid. Covid symptoms started the next evening. I was sick for 3 weeks with symptoms. One that was a symptom within a day or two of vaccination was dizziness. I am still suffering with vertigo 3 months later caused by vestibular neuritis.
Left arm pain started the next morning after my 2nd injection. The pain started off achy at first and has gotten much worse. I saw a PA at my PCP office on 6/10/21 and was told that the pain I was having was because of the administration of the vaccine. He told me to put heat on it and use it normally. Follow up with them if it doesn't get better. I am on disability and cannot afford to have tests or physical therapy or injections done because I cannot afford it. That is the only reason I have not yet been seen a 2nd time. The pain goes into my elbow and is much worse than in June.
stuffy nose; fever; headache; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100.2 f (High) 100.2 F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Pain in arm - muscle weakness in arm continuing for over 3 weeks. Achy left arm from shoulder to elbow. Some tingling in the fingers. Only left arm.