chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial 2 days sore arm and nausea. Nausea continued for next few days. Day 4 Friday 4/30/21 lost taste so had COVID test which came back negative. Saturday 5/1/21 had headache and high blood pressure. Had video visit with doctor who told to take Motrin/Advil.Headache did not go away even after medicine. Sunday 5/2/21 high bp and numbness in face and limbs. Had tingling in body.Went to  ER. Did EKG,Blood work, CT of skull ,CT of Spine which came back normal. No medications given and came back home. Er suggested to visit Neurologist in few days.Was feeling tingling and bp was still high and headache. Wednesday evening 5/5/21 had chest pain and sweating so went to ER again. Done EKG,Bloodwork and Chest X Ray which came back normal. No medicines given and sent back home. Thursday 5/6/21 visited primary care doctor as headache was still there on and off and tingling. Bloodwork done which was okay. Sunday 5/9/21 visited Urgent Care due to pain in Legs. Monday 5/10/21 Leg ultrasound done as ordered by doctor. Reports mentioned mild muscle spasms. Started to feel better. Still had tingling feeling and headache on and off. Tuesday 5/18/21 visited Neurologist as recommended by ER. She checked reports and said looked good. Need to take Migraine medicine if heavy headache. Follow up after two months to see if MRI would be required. Headache has now reduced but still it is on and off.
Pain/arm was very painful/pain goes all the way down her left arm through her elbow to her hand; Cannot move arm; Uncomfortable to Sleep; lumpy in her arm; Wrong Injection Technique; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received the 1st dose of Shingrix (left arm). In MAY-2023, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain/arm was very painful/pain goes all the way down her left arm through her elbow to her hand), movement disorder (Verbatim: Cannot move arm), sleep disorder (Verbatim: Uncomfortable to Sleep), upper extremity mass (Verbatim: lumpy in her arm) and vaccine administered at inappropriate site (Verbatim: Wrong Injection Technique). The patient was treated with paracetamol (Tylenol). The outcome of the pain in arm, movement disorder, upper extremity mass and vaccine administered at inappropriate site were not resolved and the outcome of the sleep disorder was unknown.   It was unknown if the reporter considered the pain in arm, movement disorder, sleep disorder and upper extremity mass to be related to Shingrix.     It was unknown if the company considered the pain in arm, movement disorder, sleep disorder and upper extremity mass to be related to Shingrix.   Additional Information: GSK receipt date: 24-JUL-2023 The reporter was a patient that reported that she received her 1st dose of Shingrix either 7th May 2023 or 9th MAY 2023 (she could not remember which date specifically), and that when the pharmacist administered the vaccine, it was very high on her arm like up where the socket was and it was very painful when the pharmacist was pushing the syringe into her arm. The patient reported when she got home from receiving the 1st dose of Shingrix, that it felt like there was something lumpy in her arm (specifics were not provided), her arm was very painful, it was uncomfortable to sleep, but she did not think she had a fever; however, she took Tylenol (specifics about product unknown) that evening.  The patient reported that she had to keep rubbing her arm for the pain, cannot move her left arm freely, this pain went all the way down her left arm through her elbow to her hand, and she was still having all of this till on the day of reporting. The reporter did not consent to follow-up.  The patient received Shingrix vaccine very high on her arm like up where the socket was, which led to vaccine administered at inappropriate site.
1st dose in Jan2022, 2nd in 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 13th Jan 2022).   On 05-JAN-2023, the patient received the 2nd dose of Shingrix. On 05-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in Jan2022, 2nd in 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 4-Apr-2023 The nurse did not want the information stored in their database but agreed to follow-up by safety. The reporter consented to follow-up. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: 01Aug2022, stop date: 01Aug2022; METHOTREXATE, start date: 04Aug2022, stop date: 04Aug2022. 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: (06Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Symptoms began 05Aug and tested positive on 06Aug. Patient did not had any known allergies. Patient received Paxlovid from 23Jul2022 to 27Jul2022 for covid 19 treatment.
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 30 month old female vaccinee was inadvertently administered Fluvirin IM on 12Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200805, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
My throat started to feel dry, scratchy about 20 minutes after I received my second Moderna dose. These symptoms continued and my throat gradually started to swell, as well. I took a Benadryl after about 30-35 minutes, which made the symptoms go away. My throat started to swell again after about five hours, so I took another dose of Benadryl.  Throat symptoms feel very similar to when I am stung by a bee, which I am allergic to. So far, have not needed to use epinephrine.
Pt has had rotavirus twice now-1st time on 6/21/17 and 2nd time on 8/28/17. A few hours after vaccine, pt had bloody stools and treated for intussusception that same day.
allergic reaction of hives all over the body; throat started to close; arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (allergic reaction of hives all over the body), OROPHARYNGEAL DISCOMFORT (throat started to close) and INJECTION SITE PAIN (arm pain at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced URTICARIA (allergic reaction of hives all over the body), OROPHARYNGEAL DISCOMFORT (throat started to close) and INJECTION SITE PAIN (arm pain at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, URTICARIA (allergic reaction of hives all over the body), OROPHARYNGEAL DISCOMFORT (throat started to close) and INJECTION SITE PAIN (arm pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees of one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 6 of 6 (see case IDs A0952647A, A0952653A-A0952656A for details of the other reports).
Losing his eyesight; After the second dose, he is like gradually he is losing it; Started seeing a floater in his eyes, then he was like seeing all the blank, black things; This is a spontaneous report from a contactable consumer reporting for her husband. A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot/batch number: EW0173) via unspecified route in the left arm on 06May2021 (at the age of 67-years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported but reporter stated that patient was on several medications like hypertension, but reporter did not want to give full medical history here. Patient previously received first dose of BNT162B2 for COVID-19 Immunization. Patient did have underlying conditions (history). Reporter concern was, something had to be done with the vaccine because after few weeks, patient started seeing a floater in his eyes, then he was like seeing all the blank, black things. Within couple of weeks (second or third week) (in May2021), patient started losing his eyesight. Reporter meant it was pretty gradually. Patient went to optometrist and ophthalmologist right away, they went to 'retinopathy' and they were trying to figure it out why all of sudden patient experienced it and then they realized that it just happened after couple of weeks, after the vaccine. The clinical outcome for the events was unknown. Patient had a lab test like a month ago or something.  Follow-up attempts are completed. No further information is expected.
Difficulty breathing, pain and weakness all over. Felt as if my lungs were bruised, dizzy and unable to keep food down. I was given steroids and fluids along with a shot of ketorolac
PETECHIAE RASH NOTED 12-04-2009 ON PALMS OF HANDS.  BY 12-05-2009 BODY WIDE RASH NOTED ON ENTIRE BODY (TRUNK, FACE, LIMBS) ALSO HAD DIFFICULT WEIGHT-BEARING ON LEFT LEG WHERE INJECTION WAS ADMINISTERED.  SX/SZ RESOLVED BY 12-06-2009 AND MOTHER REPORTED APPROPRIATE RESPONSE TO ANELGESICS AND ANTIHISTAMINES WHEN GIVEN.
2000-2004 - Experienced Arthritis pain   1/04 - TINGLING, PINS & NEEDLES AND QUITE SEVERE PAIN IN LOWER EXTREMITIES   1/04 to Present - aches and pains all over My body
The mom called stating arm was sore for 1st day or two post vax. Now has red ring around injection site with golf ball size lump. Child is acting normal.
This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in a 25-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 22 February 2008 at 10:30 the subject received 3rd dose of Engerix B at 1.0 ml in the left arm.  On 22 February 2008, after vaccination with Engerix B, it was noted that the vaccine administered to the subject had expired.  The healthcare professional considered the event was clinically significant (or requiring intervention).  No adverse events were reported.
Rash, itching, hard swollen redness from top of shoulder to elbow, blisters at bandaid adhesive
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient's pertinent medical history, concurrent conditions and concomitant medications were not known. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage, lot and expiry date unspecified). A week ago, in approximately 14-OCT-2016, the patient was diagnosed with skin cancer. The pharmacist could not confirm if skin cancer was present prior to administration of ZOSTAVAX. Patient was treated for the event. The outcome of skin cancer was unknown. Causality assessment was not provided by the reporter. No Product Quality Complaint (PQC) was involved. Upon internal review, the event of skin cancer was considered to be medically significant. Additional information has been requested.
SICK A DAY; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported.  On an unspecified date, the patient experienced sick a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick a day. This report was non-serious. This case, from the same reporter is linked to 20210815700 and 20210815667.
Missed dose; left knee swollen; can barely move right arm due to soreness; can barely move right arm due to soreness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (left knee swollen), PAIN IN EXTREMITY (can barely move right arm due to soreness), MOBILITY DECREASED (can barely move right arm due to soreness) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced JOINT SWELLING (left knee swollen), PAIN IN EXTREMITY (can barely move right arm due to soreness) and MOBILITY DECREASED (can barely move right arm due to soreness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (left knee swollen), PAIN IN EXTREMITY (can barely move right arm due to soreness) and MOBILITY DECREASED (can barely move right arm due to soreness) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI On 25-Jun-2021: TCR received on 25 JUNE 2021 updated with Email address.
Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 23 Feb 2022; Patient received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received  an expired vaccine for a booster dose) and PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 23 Feb 2022) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A5) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 23 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received  an expired vaccine for a booster dose) and PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 23 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated she received dosages in January with the same lot number, 045L21A that expired, on the 20-Jan-2022, they were put in the freezer and from 23-Feb-2022 until 12-May-2022 they administer them to 13 patients. The vaccine was initially stored in the refrigerator on 20-Jan-2022. Lot number and Expiration Date reported as 045L21A5, Jul 2022. Maximum or minimum temperatures reached- Maximum 44.6 degree F, minimum 38.8 degree F. Excursion duration were reported as 3 months.  No treatment medications were reported.   This case was linked to MOD-2022-572778 (Patient Link).
Left arm pain at the site of the injection; Body aches; Fever; Chills; Nausea; Splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included IRBESARTAN, ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE, XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY ) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Splitting headache). At the time of the report, VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Splitting headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medicines were reported
Pt developed atopic dermatitis, progressing to 75% of body surface area. Severity increasing with Anthrax shot #2 and #3. Diagnosed at a dermatology clinic as contact dermatitis (no patch or allergy testing). Condition severe enough to require treatment by private MD.
This case was reported by a physician and described the occurrence of neck spasm in a 41 year old female subject who was vaccinated with hepatitis A vaccine for prophylaxis. On an unspecified date in November 2004, the subject received first dose of hepatitis A vaccine at a dose of 1440 ELISA units. In November 2004, at an unspecified time after vaccination with hepatitis A vaccine, the subject experienced neck spasm. The subject was seen at a local ER and treated with IV diazepam. The physician stated the subject "...had problems four to six weeks afterwards and lost time from work." The event was considered persistently incapacitating because the subject was unable to work. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with hepatitis A vaccine.
45 mins p/vax pt devel pain, pressure across upper chest, could not breath deeply; became warm & flushed; face felt like it was swelling, tongue thick & dry; dizzy & lightheaded, sl nausea; seen in ER given Vistaril;
Severe Pain radiating down the arm for a period of three days followed by aching pain in shoulder over the next 3-4 days.
Pt stated she felt dizzy,was placed in a reclining patient chair and lost consciousness. Pt regained consciousness, A&O x4, pt stated continued nausea.
Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  No concomitant medications were provided.  No treatment information was reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.