chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can't swim; No longer sit in the sun; Late allergic reaction to the Moderna Covid 19 vaccine; After the 2nd dose started itching very badly on upper left arm and shoulder/ by summer itching started happen in the evening and also moved to the right arm; A very bad rash; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't swim), PHOTOSENSITIVITY REACTION (No longer sit in the sun), TYPE IV HYPERSENSITIVITY REACTION (Late allergic reaction to the Moderna Covid 19 vaccine), PRURITUS (After the 2nd dose started itching very badly on upper left arm and shoulder/ by summer itching started happen in the evening and also moved to the right arm) and RASH (A very bad rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-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 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't swim), PHOTOSENSITIVITY REACTION (No longer sit in the sun) and TYPE IV HYPERSENSITIVITY REACTION (Late allergic reaction to the Moderna Covid 19 vaccine). an unknown date, the patient experienced PRURITUS (After the 2nd dose started itching very badly on upper left arm and shoulder/ by summer itching started happen in the evening and also moved to the right arm) and RASH (A very bad rash). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't swim), PHOTOSENSITIVITY REACTION (No longer sit in the sun), TYPE IV HYPERSENSITIVITY REACTION (Late allergic reaction to the Moderna Covid 19 vaccine) and RASH (A very bad rash) outcome was unknown and PRURITUS (After the 2nd dose started itching very badly on upper left arm and shoulder/ by summer itching started happen in the evening and also moved to the right arm) had not resolved.            No concomitant medications were reported.  Treatment details included steroid ointment to relieve itching topically. Patient stated that she visited several dermatologist. The first one diagnoses was a late allergic reaction to the Moderna COVID-19 vaccine, the second doctor disapproved the diagnosis of previous doctor that stated it was related to Moderna. Dermatologist recommended stay out of the sun.   This case was linked to MOD-2021-404428 (Patient Link).
received both vaccines of Pfizer little to no response only sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "received both vaccines of Pfizer little to no response only sore arm".  Additional information: It was reported that: 16 year old son one year post Heart Transplant received both vaccines of Pfizer little to no response only sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the patient did not receive a full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: the patient did not receive a full dose).The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter reported that while she was administering a dose of Shingrix, some of the vaccine squirted out of the junction between the needle and syringe and the patient did not receive a full dose, which led to incomplete dose administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
System failure at clinic led to client receiving wrong manufacturer as second dose. Client was informed they received Moderna 1st dose and Pfizer 2nd dose.
one of his sons experienced a break through infection; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Reporter's son) that.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that one of his sons experienced a breakthrough infection after being vaccinated with Comirnaty and that his other son experienced fatigue and flu-like symptoms after being vaccinated. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Caller mentioned that patient was 6 months pregnant, and had a "transverse myelitis" attack after the vaccine; Caller mentioned that Patient is 6 months pregnant, and had a "transverse myelitis" attack after the vaccine; This is a spontaneous report received from a contactable consumer (patient's caregiver). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller mentioned she was asking on behalf of a patient advocacy organization for a young pregnant woman (Patient).  Caller mentioned that patient was 6 months pregnant, and had a "transverse myelitis" attack after the vaccine. Caller disconnected remotely before being able to offer Safety transfer, ask for other questions, offer survey, and closing. Outcome of the events was unknown.  Information about lot/batch number has been requested.
I developed a tightness in my throat that is still present today (May 24, 2021) The same arm that I received the vaccine in has now developed a soreness all the way down to the elbow.  This developed on May 23, 2021- 2 weeks after the vaccine. There has been no know injury to this arm other than receiving the shot which caused extreme soreness for two day afterwards.   I also had severe chills and body aches for 24 hours afterwards.  The most concerning is the lump in my throat and when I swallow now for going into the 3rd week, I have had this ailment.   I'm very concerned.
Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 01Jun2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "MS and history of breast cancer" (unspecified if ongoing), notes: MS and history of breast cancer; "MS and history of breast cancer" (unspecified if ongoing), notes: MS and history of breast cancer; "Known allergies: Sulfa and Copaxone" (unspecified if ongoing), notes: Known allergies: Sulfa and Copaxone. The patient's concomitant medications were not reported. Past drug history included: Known allergies: sulfa and copaxone, reaction(s): "Allergy_Copaxone", notes: Known allergies: Sulfa and Copaxone. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive six days after finishing Paxlovid; (Dec2022) Negative, notes: Tested positive six days after finishing Paxlovid and negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria was reported as disabling/incapacitating. Antiviral details included brand: PAXLOVID, treatment start date was 22Nov2022 and treatment stop date was 26Nov2022. Treatment received for the adverse event included antibiotics and nasal spray.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
maybe just sore arm, that was it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2021 (Lot number: EN6200, Expiration Date: 30Jun2021) as dose 2, single and administered in arm right, administration date 01Feb2021 (Lot number: EN5318, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "maybe just sore arm, that was it".  Additional information: With the first two vaccine shots, she was fine and had no reaction, maybe just sore arm, that was it. First time speaking with Pfizer's Safety Department in regards to her experience.she had all three vaccines in right arm because she had an implant in her left arm and she didn't know how it would interact. Patient did not require visit to Emergency Room for any AE  Follow-up attempts are completed. No further information is expected.
One day post vax he developed a fever of 103 F and trembling all over his body.
Feeling achy; shivering; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX with an associated reaction of pain (received 1st dose in October 2019, For the tolerance of 1st dose refer case US2020AMR041605). Concomitant products included acyclovir.   On 4th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced general body pain, shivering and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, shivering and influenza-like symptoms were unknown.   It was unknown if the reporter considered the general body pain, shivering and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and woke up around 2:00 am in morning with feeling achy, shivering and flu like symptoms. For the tolerance of 1st dose refer case US2020AMR041605, reported by same reporter for same patient. This case has been linked with case US2020040957, reported for the patient's husband. Consented to follow up.
Rash -Information has been received from a healthcare professional concerning a female child who was vaccinated with one dose of varicella virus vaccine live.  It was noted that the patient had developed a varicella like lesion on the top of her head the day prior to vaccination.  Within a few hours post vaccination, the patient broke out in a rash all over her body and was taken to the hospital.
Mild varicella-like rash - Rt upper arm 3 clustered vesicles erupting 1 wk ago, now crusted and 2 1-2 mm erythematous papules on ant. chest.  + URI Sx, no fever.
T98.1 parents states has had no temp c/o hoarseness that began around 4PM 7JUL98 p/vax;around 10PM small sl pink area on lt deltoid @ DPT inj site;lt arm dark pink area @ site of MMR inj;warm to touch;red area noted below inj site 3"x1" ;
12-18 hours after receiving shot #3, experienced sore arm, mild head ache, and very mild body ache. Was able to go to work and function without issue. No other side-effects until a week later. Experienced itching around the groin area  in the morning that I diagnosed as jock itch. Applied OTC medication antifungal cream and medicated powder. 24 hours later, palms on left and right hands, groin, and lower abdomen (below navel) was very itchy - again in morning. Irritated infected area from scratching. Red rash and raised skin in areas where scratching occurred. Applied hydrocortisone that had a positive effect, as did leaving affected area alone. Rash spread to arm pits and areas of the chest, sides, wrists and forearms. Still occurring as of this report. The only other food type that I consumed was beets purchased from a farm market and cooked/ingested on 11/3/2021. No known allergies to beets.
Headache, Myalgia & Fever Narrative: Fever, chills, headache, aches, sore throat for 12 hrs post vaccine
Sweating/perspiration, discoloration (pallor), dizziness, disorientation. BP 100/62 patient laid down ammonia capsule administered.
A temperature excursion because the dial in the refrigerator was turned too low, reached up to Negative 3.4 Celsius for a total of 17 hours, 7 minutes, and 30 seconds/no AE;Initial information was received on 09-Sep-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Medical Information (Reference number- 00762504).   This case involves vaccines that undergoes a temperature excursion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (lot UJ414AAA, expiry date 12-MAR-2022), HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ405AAA, expiry date 08-OCT-2021  ) and IPV (VERO) [IPOL] (lot R1G101M, expiry date 08-OCT-2021) because the dial in the refrigerator was turned too low reached up to negative 3.4 Celsius for a total of 17 hours, 7 minutes, and 30 seconds (product storage error).  It was reported, "caller states that a temperature excursion occurred because the dial in the refrigerator was turned too low. The lowest temperature reached was Negative 3.4C for a total of 17 hours, 7 minutes, and 30 seconds. The products involved were a punctured MDV of IPOL as well as unopened: ACTHIB, IPOL, and PENTACEL. Caller requested stability information for these products".  It was a case potential medication error due to product storage error temperature too low (same day).  At time of reporting no adverse was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
NO adverse events occurred. Expired vaccine was given as the expiration date on box and vial was confusing. Listed as 18OCT17 and thought to expire October 17, 2018 BUT actually expired October 18, 2017.
patient received an expired dose of VARIVAX; No known adverse effects.; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 18-SEP-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (strength, dose, frequency and route of administration were not reported; lot number R024023 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck) with an expiration date on 22-AUG-2020) (expired vaccine used ). No known adverse effects were reported. The outcome of expired vaccine used was unknown.
allergic reaction; itching; rush all over their body; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), PRURITUS (itching) and RASH (rush all over their body) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), PRURITUS (itching) and RASH (rush all over their body). At the time of the report, HYPERSENSITIVITY (allergic reaction), PRURITUS (itching) and RASH (rush all over their body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
10.5 x 9.0 area of erythema near area of injection site. With mild induration. Afebrile.
This case was reported by a other health professional via call center representative and described the occurrence of pain localized in a adult 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 pain localized, localized itching and localized erythema. On an unknown date, the outcome of the pain localized, localized itching and localized erythema were unknown. It was unknown if the reporter considered the pain localized, localized itching and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that, the patient had a localized reaction which included pain, redness and pruritus. The HCP did not report any patient or vaccine information. No other details about the adverse events were reported. The HCP did not specify what type of HCP they were nor gave an address of their location.
Tested positive for Covid 19 after receiving the vaccine/illness; Tested positive for Covid 19 after receiving the vaccine/illness; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program, Pfizer First Connect. A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL0140, expiration date: 31Mar2021), via an unspecified route of administration on the upper left arm on 22Dec2020 at a single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient received her first dose of the COVID-19 vaccine on 22Dec2020. On 31Dec2020, the patient tested positive for COVID-19. The patient was scheduled to receive her second dose and wanted to know if it is okay to get it, clarified that she was supposed to receive her second shot on 12Jan2021 (the day before the report). The doctor gave her a script that showed that she clinically recovered from illness and okay to get the second vaccine (dose). No treatment was administered for the event. The event "tested positive for COVID-19 after receiving the vaccine/illness" resolved on 13Jan2021.
Pruritic plaque approximately 1 inch in diameter directly at injection site,  Monitored lesion and spontaneously went away sometime in late afternoon.
Pt. developed case of zoster within 12 hrs. of receiving ZOSTAVAX.
4 1/2hr p/vax pt c/o swollen lip & one side of face;pt advised to go to ER;approx 1hr later pt stated was having trouble breathing;pt advised to go to ER immed;
Nausea, vomiting, dizziness -30 minute recovery with fluids and ice packs.  Has history of vasovagal symptoms following immunizations.  Was able to ambulate to go home.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 55 year old white Not Hispanic/Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: complex regional pain syndrome (RSD/CRPS), diabetes mellitus, lung disease, Reynold's syndrome, connective tissue disease, mild facial pain syndrome, psoriasis, degenerative disc disease, stenosis, non-alcohol user, smoker, and other pre-existing medical conditions included: the patient did not have any history of drug abuse or illicit drug use except marijuana. The patient was not pregnant at the time of vaccination. The patient has allergy to any medicine ends with zine. The patient experienced drug allergy when treated with morphine, Propofol, oxycontin, injectable Benadryl. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total, administered on 14-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative, SARS-CoV-2 IgM antibody test (NR: not provided) negative, and SARS-CoV-2 IgA antibody test (NR: not provided) negative. The patient wanted an exemption letter to get a booster shot as her doctor recommended (she could not afford to get Covid-19). Her health care professional wanted her to get Pfizer Covid-19 Vaccine. She was frustrated at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189771; Sender's Comments: V0: 20210832576-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Upper arm swollen and painful. Patient advised to take anti-inflammatory and go/call to doctor.