chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "heart" (unspecified if ongoing); "deaf" (unspecified if ongoing); "gastric" (unspecified if ongoing); "Known allergis: Peanuts" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid, Treatment start date was 18Jul2022 and stop date was 23Jul2022. it was unknown that patient took other medications in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
LIMB DISCOMFORT NOS; ARTHRALGIA; BACK PAIN. Information has been received from a registered nurse concerning a 36 year old female CMA employee with no medical history and no allergies who on 23-APR-2003 at a nursing home was vaccinated intramuscularly in the left arm with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #15360). There was no illness at the time of vaccination. On the afternoon of 25-APR-2003 the patient developed achiness in the knees, back and arm. Unspecified medical attention was sought. On 28-APR-2003, the patient recovered. It was reported on 13-JUN-2003 that the employee has since quit the nursing home. No product quality complaint was involved. No further information is expected.
Pt started developing rash on Sunday 2/1/15. Was seen at hospital and was Dx with skin viral infection. Mother stated rash got worse and brought him to clinic on 2/3/15 where he was Dx w/ measles.
I had a headache for about a day after receiving the vaccine. I have history of hearing loss in the left ear that required a hearing aid. on 09/23/2022, I woke up with complete hearing loss in my left ear. I thought I needed to replace the battery but that didn't help. I went to my doctor in 10/2022 and he referred me to an ENT.  The ENT started me on a medication hoping that it would help me regain my hearing, but it did not work. At this point, I am adjusting to the hearing lost.
2FEB98 pt recv vax & 3FEB97 mom called & reported red, raised, swollen area over inj site on lt thigh;
sore arm; fever; chills; body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, fever, chills and general body pain. On an unknown date, the outcome of the pain in arm, fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 76 or 77 year. The patient received 1st dose of shingrix and experienced arm soreess, body aches, fever and chills. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2020AMR237450.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR237450:same reporter
worse side effects with the second dose than with the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (worse side effects with the second dose than with the first 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (worse side effects with the second dose than with the first dose). At the time of the report, ADVERSE EVENT (worse side effects with the second dose than with the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-095578, MOD-2021-095663 (Patient Link).
After patient receive meningococcal vaccine, she became pale, dizzy, diaphoretic, and nauseous.  She was placed in a recliner with her feet elevated and then proceeded to vomit up clear fluid.  Cool compress was applied to nape of neck and patient remained in recliner for 15 minutes.  Patient was placed in sitting position for several minutes without symptoms and then was able to stand without symptoms and ambulate out of the clinic area without further complications.
Information has been received from a registered nurse concerning an approximately 6 year old female who was vaccinated with a dose of varicella virus vaccine live.  The RN reported that the patient subsequently developed a mild case of breakthrough varicella.  Unspecified medical attention was sought and the patient subsequently recovered.  Additional information has been requested. '
rashes; rep / pink rash on the inside of the injection forearm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rashes) and RASH (rep / pink rash on the inside of the injection forearm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INJECTION SITE RASH (rashes) and RASH (rep / pink rash on the inside of the injection forearm). At the time of the report, INJECTION SITE RASH (rashes) and RASH (rep / pink rash on the inside of the injection forearm) outcome was unknown.
Moderna COVID-19 Vaccine EUA: nausea, fatigue, muscle and joint pain especially in shoulder and neck on side of injection, fever, headache, diarrhea, dizziness, swollen and painful lymph nodes under arm on side of injection. Persistent dizziness and nausea.
Information has been received from a physician concerning an over 80 year old female patient who on 18-MAY-2007 was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included PLAVIX. It was reported that on 22-MAY-2007 the patient developed 3 welts, 4 inches long, one on her torso and two on her arms. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
sore arm 31MAY94 PM; onset of fever (?) 1030PM 31MAY94; rash over entire body, including extremities 1JUN94; s/s cont 2JUN94;
Swelling to injection site - approximately the size of an orange Rash to arm, face, neck area and swelling of face Did not loose airway due to swelling
SECOND DOSE Vaccine administered on 10/29/21. Vial expired 10/11/21. Vial was kept in freezer until 10/28/2021 and removed to fridge on 10/28/2021 for administration on 10/29/2021.
Mother reported patient felt sick and passed out for a second after leaving vaccination area. No treatment symptoms has resolved by the time reported.
About 1 minute following the administration of the two vaccines, the patient had an episode of syncope and recovered quickly and symptoms resolved. The patient fainted for a few seconds while seated in a chair and then her symptoms resolved quickly.
Pt administered Moderna on 03/29/2021 and Pfizer on 4/19/2021
I had a sore arm shortly after receiving the vaccine. At 1:00am on 12/22/21 I started to run a fever and had intense body aches. This continued for the next 16 hours even with the use of ibuprofen. I continued to feel sore and fatigued but stopped running a fever for a couple of hours. Around 6pm on 12/22/21 I began to feel much worse. I started vomiting at 8pm on 12/22/21 and continued vomiting until 4 am on 12/23/21. My fever broke around 6am and I am currently fever free but have a strong headache and am very fatigued.
Information has been received from a physician concerning a patient who in 1996 was vaccinated with a dose of VARIVAX (Merck). Several weeks ago in approximately June 2010 the patient did the titer test and resulted in negative titer. Additional information has been requested.
Fever, chills, head ache, nausea and cigarette taste in mouth, body ache
pt recvd vax & devel ful-like sx w/no temp & an achy back w/more severe pain thatn 1st dose; Lodine & Robaxin may have been given to alleviate back pain according to reporter;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 14:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 at 13:15 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Dec2021 at 14:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 2 negative Covid tests and no symptoms after 5 days of paxlovid; Negative, notes: 2 negative Covid tests and no symptoms after 5 days of paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies and no other medical history. The patient received COVID 19 Treatment with Paxlovid from 29Oct2022 to 02Nov2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
26 hours post vaccination I had a grand mal seizure lasting 30-45 seconds. My husband stabilized me and drove me to the nearest emergency room.  After tests listed below and observation, I left a little dazed but feeling fine. Note: My initial vaccination was one Johnson & Johnson; this was my booster shot and I chose Moderna.
the same evening as vaccination had tinnitus thru the night. Beginning the next afternoon ran a low grade fever (100 ish) off and on thru the next day. Also have experience some nausea and slight headache in the days since the vaccination. Sore injection site for 2 days also. Took ibuprofen for the headaches.
-rash with blisters on bilateral arms &  face -vaccine administered at a   Hospital -
Information has been received from an approximately 72 year old female patient with very sensitive skin and codeine and morphine allergy who "at least 5 years ago", in approximately 2007 and in January 2011 was respectively vaccinated SC with a dose of ZOSTAVAX (Merck), 0.65ml. Concomitant therapy included prednisone, 5 mg tablet and PROZAC. The patient mentioned that she had received ZOSTAVAX (Merck) "at least five years ago", in approximately 2007 and had developed shingles after had the vaccine. In January 2011, the patient received ZOSTAVAX (Merck). In addition to her developing shingles she explained that "around the time" she received the vaccine she experienced a drop in her blood sodium level, to a level 17, this drop in blood sodium required hospitalization for about a week, with rehab for about 3 weeks. The patient was hospitalized at this time. Unspecified antiviral pills, unspecified ointments and fluororacil (+) mitomycin (+) vincristine sulfate were given for the patient. The patient explained that the only treatment that gave her some relief is the muscle relaxant fluorouracil (+) mitomycin (+) vincristine sulfate, which was mostly because it put her to sleep. Unspecified tests had been performed including a biopsy and an allergy patch test. At the time of the report, the patient was still suffering with severe case of shingles. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 14, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had peripheral swelling (swollen arm after first vaccination shot), with outcome of unknown. The event occurred 3 days after vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Malaise; loss of appetite; chills; fever; was down for a day; A spontaneous report was received from a consumer concerning his wife a 59-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events malaise/ vaccination complication, loss of appetite/ decreased appetite, chills, fever/pyrexia and was down for a day/asthenia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced Malaise, had a loss of appetite, chills, fever, and was down for a day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was Not applicable.   On 15 Feb 2021, the outcome of events, malaise, loss of appetite, chills, fever and was down for a day were considered resolved.
Unable to sleep; brain fog; confusion; muscle aches; Fatigue/exhaustion; headaches; This spontaneous case was reported by a physician and describes the occurrence of INSOMNIA (Unable to sleep), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confusion), MYALGIA (muscle aches) and FATIGUE (Fatigue/exhaustion) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a and 022c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Grass allergy, Dust allergy and Allergy to plants. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) from 01-Jan-2000 to an unknown date and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) from 01-Jan-2000 to an unknown date for Allergy, ALBUTEROL SULFATE from 01-Jan-2000 to an unknown date for Asthma NOS, ONE A DAY WOMEN'S from 01-Jan-2000 to an unknown date for Vitamin supplementation, RUBUS IDAEUS LEAF, SAMBUCUS NIGRA FLOWER, SAMBUCUS NIGRA FRUIT (ELDERBERRY [RUBUS IDAEUS LEAF;SAMBUCUS NIGRA FLOWER;SAMBUCUS NIGRA FRUIT]) from 25-Feb-2021 to an unknown date for Zinc supplementation.   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Unable to sleep), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confusion), MYALGIA (muscle aches), FATIGUE (Fatigue/exhaustion) and HEADACHE (headaches). At the time of the report, INSOMNIA (Unable to sleep), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confusion), MYALGIA (muscle aches), FATIGUE (Fatigue/exhaustion) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, the patient was struggling, can't work, can't live life and no one knows what to do to help the patient.  No treatment medications were reported.   This case was linked to MOD-2021-214782 (Patient Link).
Sudden onset of numbness and tingling in Left arm at 11pm (arm that received injection). Arm appeared to be mottled as well.
golf ball size lump under skin, redness, swelling, pain, growing rash over 10 days
HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID VACCINE SERIES.
Patient complained about feeling  faint and tired. RPH continued to track progression and engage patient, there was no loss of consciousness. Patient remained alert and responsive. Then complained about "lump in throat" and feeling more tired. Called EMS. Administered epinephrine 0.3mg auto-injector once. Shortly after, about two to three minutes, she said she was starting to feel better but warm. EMS arrived shortly after. She said she was feeling better and may not need to go to ER. She was convinced to go by staff and EMS personnel since she had received epinephrine.
This spontaneous report was received from a nurse referring to a 24 year old patient, gender not provided.  No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On 07-AUG-2012, the patient was vaccinated with GARDASIL or CERVARIX as a first dose (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (product origin unknown). On 14-NOV-2018,  the patient received a dose of GARDASIL 9 lot number N035957, expiration date on 10-OCT-2020 (strength, dose, route of administration, and anatomical location, were not reported) for prophylaxis.(interchange of vaccine products).  No adverse effects were reported.  The outcome of product origin unknown was not reported. The reporter did not assess the causal relationship between suspect vaccines with the event of product origin unknown .
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patients information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
placed in refrigerator after the expire date; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (placed in refrigerator after the expire date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (placed in refrigerator after the expire date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (placed in refrigerator after the expire date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 17Nov2021. Patient did not experience temp excursion and any adverse event   No treatment medication was provided by reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain and intramuscular formulation administered by other route. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and intramuscular formulation administered by other route were unknown.  It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, a female the patient inadvertently received a dose of Shingrix vaccine via subcutaneously injection, which led to inappropriate route of vaccination, and as a result, the patient developed arm swelling and pain along with redness at the injection site.  The patient was treated with prednisone taper. No further information was available at the time of reporting. This case has been linked with case US2018110644, reported by the same reporter.
Pt requested FluMist & nurse gave it without looking at age on consent.  No adverse reactions known.