chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Pt was vaccinated at a pharmacy with Moderna MRNA vaccine either 4/9 or 4/12 per notes. Pt reported to have "mini stroke" 2 days later. Pt was seen at a site for this. He did follow up for neurology consult post stroke, but all stroke related medical attention was at another site. Patient stated it was recommended by other provider that he not get 2nd dose of vaccine.
Patient experienced pain at the time injection was administered on 10/11/12. Pain was worst on 10/12/12 in the morning around 8:30am and continued. Rash was noticed next to right armpit. On 10/12/12 pain was 90% better (subsided) by 10/15/12. Patients rash cleared up in 10/14/12 after taking BENADRYL on 10/13/12.
Nightmare outbreak from covid-19 shot; Open sores on legs; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Nightmare outbreak from covid-19 shot) and SKIN ULCER (Open sores on legs) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NIGHTMARE (Nightmare outbreak from covid-19 shot) and SKIN ULCER (Open sores on legs). At the time of the report, NIGHTMARE (Nightmare outbreak from covid-19 shot) and SKIN ULCER (Open sores on legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of NIGHTMARE OUTBREAK FROM COVID-19 SHOT with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of OPEN SORES ON LEGS was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
10 X 10 cm area of erythema induration around DTaP site, good ROM at hip in office gave 1 tsp Motrin and 1/2 tsp Benadryl, parents were instructed to use warm compresses and Benadryl/Motrin. Recheck prn or increase size/swelling.
This spontaneous report was received from the patient's mother referring to a 21 year old female patient. The patient presented drug allergy to Azithromycin and no pertinent medical history. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route and lot number were not provided). No concomitant medications were reported. On 11-JAN-2016, the patient had abnormal cells on her cervix. No product quality complaint was involved. On an unspecified date, PAP smear was performed. At the time of report, the outcome of the adverse event was reported as not recovered. The relatedness between the adverse event and the vaccination with GARDASIL was not reported. Additional information is not expected since no contact details were available.
pain; Chills; Headache; muscle aches and pains; Fatigue; Hot all over; Hard to breathe/shortness of breath/short winded; dizzy/feeling lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded), PAIN (pain), FEELING HOT (Hot all over) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FAMOTIDINE, ROSUVASTATIN, METOPROLOL, SPIRONOLACTONE, ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded) and FEELING HOT (Hot all over). On an unknown date, the patient experienced PAIN (pain). an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle aches and pains) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded), FEELING HOT (Hot all over), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle aches and pains) and FATIGUE (Fatigue) had not resolved and PAIN (pain) outcome was unknown.            Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up document received on 29-May--2021 and does not contain any new information On 28-Jun-2021: follow-up document received on 28-06-2021 and does not contain any new information
Inflammation of airways causing incessant cough unrelieved by 4 rounds of 3 different antibiotics, steroids, codeine cough syrup, tessalon pearls, Zyrtec, monteleukast.
Generalized urticaria, no respiratory symptoms. Seen at hospital.  Had Benadryl.
Case number PHEH2015US027168, is a combined initial spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 03-years-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: not reported) on an unknown date, when the patient was at the age if 03. No adverse event was reported following this mal administration (inappropriate age at vaccine administration).
Typical varicella zoster rash - left T7-8 distribution.  Positive VZ PCR from blister fluid.  Treated with Valtrex.
Information has been received from a medical assistant concerning a female who was vaccinated with a second dose of GARDASIL.  Secondary suspected therapy included INFLUENZA (unspecified).  The patient experienced vomiting 10 minutes after receiving GARDASIL and "flu" vaccination.  Medical attention was received in the office.  At the time of reporting, the outcome was unknown.   Additional information has been requested.
Severe hives and itching beginning 11 days post booster as well as dermatographia.  Has not subsided yet.
Redness at injection site; Feel bad; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included peripheral neuropathy.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site) and feeling bad (Verbatim: Feel bad). The outcome of the injection site erythema and feeling bad were unknown.   It was not reported if the reporter considered the injection site erythema and feeling bad to be related to Shingrix.     It was not reported if the company considered the injection site erythema and feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-02-2023 HCP called on behalf of herself for information regarding if Shingrix was contraindicated in people who had peripheral Neuropathy.  During the call she mentioned that many of her colleagues usually feel bad or had redness at the injection site after receiving the Shingrix.  No additional information provided.  She just mentioned this during the conversation.  The reporter did not consent to follow-up.
Right arm red, painful esp w/movement or lifting, was swollen. Has been icing - used some APAP.
2/9 - 13 - R arm red, swollen, itchy 3/3 - T 101 - L arm swollen, red itchy (shoulder to above elbow) 3/4 -  "                " 3/5, 6, 7, 8, 9- no temp - L arm red,swollen, itchy
Tachycardia Anxiety related to shots Light headed Diaphoretic at 11:35am BP 79/53 P 76  at 12:12pm BP 130/86 P 88 14 98%
Start to have extreme chills the night of immunization. Pt states extreme fatigue for 1 month and developed a rash on both lower extremities. Pt states after scratching one leg it developed into open pustule and now after 3 months started to develop papules near eye and ear.
02/24/2009 Severe Seizures < 3 days Transported by ambulance to renown medical center.  Ongoing seizures until under control with phenoborbitol BID, last seizure 6 months ago, care managed by pediatric neurologist.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 1-Dec-2021 vaccine was moved to fridge and vaccine administrered post 30 days from the initial storage at 2C to 8C.  No concomitant were reported. No treatment were reported.   This case was linked to MOD-2022-496015.
Beining on the 3rd day vision became blurry. Normal natural vision became blurry enough to have to use prestrition glasses more ofen for uprescribed reading. Prescription glasses vision became blurry. and remains so.  Over time vision from directly in front of eyes to several feet has become more blurry. Letters are undescribable.
AFTER VACCINE WAS ADMINISTERED, PATIENT WAS ASKED TO WAIT/SIT FOR 20MINS PER PROTOCOL. AFTER ABOUT 3-5MINS OF ADMIN, PATIENT WAS ON THE FLOOR AND THE PHARMACIST AND 2 OTHER STAFF RUSHED TO HER AID. UPON ASSESSMENT, WITHS SIGNS, FLUSH  ON FACE CLAMY BODY, ETC--SYNCOPE WAS CONFIRMED. HER LEGS WERE ELEVATED. NOT LONG SHESTARTED ASKING QUESTIONS ABOUT HER SITUATION AND EXPLAINED HOW SHE FELT A BIT DIZZY, CLOSED HER EYES AND FINALLY FELL ON THE FLOOR FROM HER CHAIR.   SHE WAS IN LYING POSITION FOR ABOUT 25MIN AND HER DAD CAME TO THE PHARMACY TO PICK HER UP. SHE WAS FINE . DAD AND DAUGHTER LAUGHED ABOUT THE WHOLE THING COS SHE HAS ALWAYS HAD THIS KIND OF EXPERIENCE BEFORE EVEN WITH LAB WORKS PER PATIENT.
It started as a head cold, I was very congested, runny nose, dry cough that progressed to a wet cough that sounded like a croupy cough. I called my sister-in-law who is a doctor for advice. I had a headache, fatigue, body aches, constant coughing, body aches. a lot of congestion. I was advised to take over the counter decongestion, get plenty of rest and fluids. It did take three and half weeks for me to get completely over the health event.
August 2nd felt weak, coughing, flu like, took cover at home test o nWednesday August 4 and tested positive for covid.Called my Doctor who told me they were following CDC guidelines and they could not prescribe anything, and if I felt worse to go to the Emergency room. On August 9 and the 11the I went to the emergency room they took chest X-rays and diagnosed me this Covid Pneumonia, on the 11th after an X-ray they diagnosed me with COPD. On the 11th after the hospital could do nothing for me,  My boyfriend took me to his concierge Doctor who put me on Doxycyline and ivermectin , quarantine , vitamin D3, Zinc, prednisone and Albutrin inhaler. The evening of the 11th my oxygen levels started dropping, so the Doctor wrote a script to  put me on oxygen. To date because of the damage to my lungs I am still on oxygen.
Pt felt her heart was racing.  Taken to medical observation.  Preferred to stay seated in wheelchair.  BP 162/80 HR 65 Pulse oximeter 100.  Heart beat auscultated to be regular in rhythm. Lungs clear 3:36 PM BP 165/78 HR 64 Pulse ox 100 3:40 PM BP 172/91 standing HR 65 Pulse ox 100 3:47 PM Patient discharged via wheelchair to exit in stable condition
woke morning p/vax w/swelling in face & lips;devel rash w/itching on arms & chest;called PMD who called in claritin & Pred dose pace;saw MD 7MAR97;
12 hours after vaccine: fever approx. 102/103.  Chills, body aches, sweating.    15 hours after vaccine: 101.5 fever, continued chills, body aches, sweating.  Nausea.  Dizziness.    Approx 24-30 hours after vaccine (12-18 hours after onset), developed severe headache.   Fever broke approximately 24/30 hours after onset.  Body aches and chills subsided.     Headache worsened.  Took 2 aspirin 48 hours after vaccine.  Headache went away but returned several hours later.  Went away with 2 more aspirin.  Retuned the next day.   Did not respond well to aspirin.  Finally subsided 77 hours after vaccine/65 hours after onset.      Severe night sweats continued for 3 nights after fever broke.  Lessened, but still continue.    Skin reactions: injection site reaction developed within a day.  Large red welt on arm.   6 days after vaccine, developed itchy trash all over back and abdomen.
Herpes zoster diagnosis on 10/13/2015 in a 2-dose varicella vaccine recipient.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 26-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Severe worsening of eczema. Complete uncontrollable body itching causing excessive scratching and bleeding. Rash with raised bumps and redness. Needed to increase steroidal use including oral prednisone and topical steroidal creams, lotions, and ointments. With no resolution for months, started injectable Dupixent giving some relief, but not complete.
Palpitations Pt. felt like she was having palpitations. VS stable. Narrative: c/o dizziness and palpitations about 20 min. after getting covid 19 immunization; described by pt. as a "very fast heartbeat". P. 96 regularly in the 60's normally, per pt. @ 1320, BP 127/64, P 96, R 16, O2Sat 96%; at 1324 BP 124/57, P 88, R 16, O2 sat. 97%; @ 1337, BP 130/67, P 89, R 16, O2 sat..98%. d/c'd back to work at 1350 resolved. Updated in employee record.
Joint pain beginning with left ankle, 1 hour after vaccination. Pain spread to other joints including knees, hips, elbows and wrist.
received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 95-year-old female patient who received Men B NVS (Bexsero) (batch number AVXB39AB, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The follow-up permission was not requested during the call, later, agent will email Safety Team with health care professional's details and follow-up confirmation. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Loss of his short term memory; Rash, his skin is hard and breaky; Itchy; It comes off like pieces of plastic; Fever; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced loss of his short-term memory, rash, itchy and it comes off like pieces of plastic. On an unspecified date, the patient experienced loss of his short-term memory, rash, his skin is hard and breaky, itchy, it comes off like pieces of plastic and fever for a while after the second shot. He was not able to remember anything. He can remember all his past, from when he was 3 years old, but he can't remember if he was doing something. He stated he didn't have a memory problem before. Outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Beginning 9 hours after injection, I experienced severe chills and shaking for approximately two hours. Nausea, severe body aches, loss of appetite, and weakness followed. Fever peaked at 101.8. These symptoms started to diminish about 33 hours after injection. Complete recovery happened approximately 42 hours after injection. Only fluids, clear soup, and popsicles were eaten from 33-42 hours. Nausea prevented taking anything other than fluids before that.
twisted back in a wrong way; This spontaneous case was reported by a consumer and describes the occurrence of BACK INJURY (twisted back in a wrong way) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced BACK INJURY (twisted back in a wrong way). At the time of the report, BACK INJURY (twisted back in a wrong way) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.
Mother called 1-16-08, stating baby's leg was very red & swollen.  Child was sleeping more than normal & cranky.  No oozing or drainage from sites.  Both sites were the same & there was a small scratch by arm 1-17-08.  Swelling was subsiding & site remained red.
pt recvd vax 6APR93 & 16APR93 devel rash that started on face & spread to chest & body; It was a typical measles rash; had no fever; devel enlarged lt submaxillary & posterior cervical lymph nodes; exp itching, irritability, neck pain,
Patient began to feel achy, with Shortness of breath and R sided chest pain, Nausea, and 2 episodes of diarrhea.  "Felt like gonna die" Anxious, flushed, tachycardic, conjunctival injection.  No edema, no rash, no trouble swallowing, no lightheadedness or dizziness.  BP 124/88, RR 20, HR 140 -- 122, Pulse ox 94-95%  Pt given Decadron 8 mg IM with improvement in symptoms. Had normal EKG except for sinus tachycardia.  Pt refused Chest Xray. Pt refused (AMA) transport to Emergency Room and refused to go to Emergency Room.  Discharged in stable condition with prednisone taper from Urgent Care office.
Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.
This spontaneous report was received from a register nurse referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. The nurse reported that improperly stored doses of ROTATEQ lot # M039061 with expiration date of 28-APR-2018; and lot # M035456 with expiration date 01-MAY-2018 (dose, frequency and route were not reported) for prophylaxis, were administered to patients from 01-MAY-2017 to 30-MAY-2017. The vaccines were exposed to temperature excursion of 9° Celsius (°C) to 25°C for a time frame of 1 hour 9 minutes because of data logger. The vaccines had a previous temperature excursion of 9°C to 25°C, for a time frame of 7 hours 50 minutes. Nurse stated that no adverse effects had been reported by any patient and that she was unable to provide any additional patient information for patient who had received supported vaccines. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006155: US-009507513-1706USA000368.
Patient reports pain in arm starting the day he received the vaccine. Describes it as sore to touch and when not being touched a persistent ache like a minor toothache.