chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash starting at nape of neck, spreading into scalp, then to chest, shoulders, back, legs and arms. So far lasting four and 1/2 months.  Terrific itching in all areas.  Have had two, three week courses of Prednisone.  Using Betamethasone Lotion, Pimecrolimus Cream, Clobetasol Propionate Cream.  Two injections of Dupixent, 01/19/2022.   Rash is begiinning to get better at the moment.
20 min sz 5hrs p/DTP; 25 min sz 17hrs p/DTP;
Fatigue. Soreness at site. Swelling of bicep around puncture site. Redness and heat at injection site. Cough. Sore throat. Nasal drainage. Fever greater than 101. Weakness.   Pain and swelling began about 6-7 hours after injection.  Cough fatigue onset 12 hours after injection.  Nasal congestion and fever onset 24 hours after injection.   Treatment: otc tylenol, ibuprofen, trazadone to sleep. Increased fluid intake. Increased rest.   Outcome: 48 hours post injection- still febrile. Head congestion. Cough. Weakness and body aches. Swelling decreased at injection site.
Janssen COVID-19 Vaccine EUA  Extreme chills and quaking, despite 3 blankets and two heating pads, occasional jerks of my body -within 7 hours.  Lasted 20 hours or more.  Fatigue- unable to walk myself to bathroom within 8 hours, lasted two or more days. Very weak.  VERY Severe Headache, including facial pain, neck pain, temple pain and eye sockets , stared 7 hrs, lasted two days  Severe nausea, I actually thought of food poisoning (but it wasn't). Approx. onset 9 hours.  Very painful body aches and muscle spasms throughout my body but especially my Back, underarms, legs, feet. Approx. onset 7 hours. lasted 48 to 60 hour  Diabetic Ketoacidosis approx 30 hours after. Wasn't able to eat, blood sugar remained in the 150 to 180 area. Managed to eat 2 TBsp of applesauce to reduce ketones, (which worked)  Fatigue unable to work until 5 days later.
Large left upper arm cellulitis around left upper arm to left axillae.  Went to ER.  Received 48 hours of IV antibiotics then 10 days of oral antibiotics.
I noticed after my first shot that I was getting random muscle pain/cramps in different parts of my body. They would last a few seconds up to a minute. My hand, arm, leg, chest and neck mostly.  I just got my second shot so we will see if it continues.  I put "unknown" on item 20 since I don't know if it will continue yet.
Fever 103-104.7, vomiting, seizure-seen in ER. Swelling, tenderness L thigh
Fever 102.3 after 15 hrs. Aches, chills. Disappeared after several doses of ibuprofen . Fever and aches resumed after 28 hrs and is continuing through 36 hrs post dose.
Patient came into pharmacy on 7/15/18. She said she had called her MD and was told it was not due to the vaccine. She called GlaxoSmithKline and was told one in six react this way. Her description.... about 3 hours after receiving vaccine she had been napping and awoke with shivering, chills, nausea, and vertigo. She couldn't stand. She went to bathroom and threw up black liquid. Next morning she couldn't get up. She had diarrhea, and muscle weakness. She sat in chair all day Tuesday 7/10/18. Wed Am she felt a little better but was still shaky and sleepy. By Wednesday evening she felt that she was better but still had diarrhea and cramps until Saturday. She said she reported to Glaxo on Thursday and her physician on Tuesday. Physician's office told her it may be the flu. She doesn't think she wants the 2nd vaccine.
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered with improperly stored PEDVAXHIB (lot # M001813, expiration date 14-OCT-2018, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I got the first shot of the moderna vaccine on February 27. After 5 days, I started to feel as if I were under the weather (headache, tiredness, running nose and a lot of sneeze, very occasional cough). Days have passed by and the symptoms don't go away (except for the headache). Yesterday and today have been the worst days, with my symptoms worsen and headache again. Today, I felt very cold all day and I had low grade fever 99.1 (my normal temperature is 97.5)
Arm very red & hot; Pt had inc temp; ?abscess; TC 28MAY91 swelling all gone no further problems;
Patient is a staff member and received her booster dose during the clinic hosted by pharmacy.  She told clinic staff she completed the initial series at least 6 months ago. She provided a CDC card and the handwritten entry for the 2nd dose appeared to be April 2021. When the team returned to the store to bill and process, it was revealed that the 2nd dose was actually given on 6/21/21 and patient would have been due for booster dose on 12/18/21.  Patient was experiencing no adverse effects at the end of the observation period.
Pt received 2 immunizations on 9/25/21 (pneumovax 23 and pfizer covid 19) in the right arm.  Pt presented to pharmacy tonight about 6 or 630pm 9/27/21 with swelling/edema down by her elbow and forearm.  Pt wanted to know our opinion of the reaction.  She did not have any other injection site reaction symptoms and only other compliant was soreness into the arm but has since resolved. I told her it may be immunization related and that the concern is swelling into a joint or compressing on a nerve.  When asked if she had numbness or tingling she denied but did state that it felt like a rubber band around her forearm/elbow.  I told her to follow up with her pcp and to let us know what was going on and to let us know.
Headache started within 30 minutes of the vaccine. Fatigue started aobut 6 hours after the vaccine and severe body aches about 24 hours after the vaccine.
I took the vaccine on 14th April, at 1:30pm, on that night I started having vaginal spotting as well as cramping which felt like period cramps, on 15th night I started having my periods. My periods were supposed to be on 28th April, also it?s my third day of period and my period hasn?t been this heavy in a long time.
high heart rate; Respiratory Rate in the mid twenties,; fever of 102.9 degrees Farenheight/high fever,; weak/patient reports being extremely weak; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (high heart rate), RESPIRATORY RATE INCREASED (Respiratory Rate in the mid twenties,), ASTHENIA (weak/patient reports being extremely weak) and PYREXIA (fever of 102.9 degrees Farenheight/high fever,) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (weak/patient reports being extremely weak) (seriousness criterion hospitalization). On 09-Mar-2021, the patient experienced HEART RATE INCREASED (high heart rate) (seriousness criterion hospitalization), RESPIRATORY RATE INCREASED (Respiratory Rate in the mid twenties,) (seriousness criterion hospitalization) and PYREXIA (fever of 102.9 degrees Farenheight/high fever,) (seriousness criterion hospitalization). At the time of the report, HEART RATE INCREASED (high heart rate), RESPIRATORY RATE INCREASED (Respiratory Rate in the mid twenties,), ASTHENIA (weak/patient reports being extremely weak) and PYREXIA (fever of 102.9 degrees Farenheight/high fever,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: high (High) 102.9 degrees Farenheight. On 09-Mar-2021, Heart rate: high (High) High. On 09-Mar-2021, Respiratory rate: high (High) High.     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.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 76-year-old male patient with no reported medical history, who experienced the serious unexpected events of heart rate increased, respiratory rate increased, asthenia and pyrexia. The events occurred within first 2 days after the first dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 76-year-old male patient with no reported medical history, who experienced the serious unexpected events of heart rate increased, respiratory rate increased, asthenia and pyrexia. The events occurred within first 2 days after the first dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
Patient was given the regular Pfizer 12+ as abooster dose instead of the new Pfizer Bivalent booster
48 patients have received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
she administered the Covid shot to. 3 of her patients died; This spontaneous case was reported by a physician and describes the occurrence of DEATH (she administered the Covid shot to. 3 of her patients died) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   This case refers to the patient 1 out of 3 patients died as per the reporter.  Concomitant medication was not reported. The vaccine lot number was not reported.  Treatment medication was not reported.  Company Comment: This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273.815 vaccine.  Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750271, US-MODERNATX, INC.-MOD-2023-750269, US-MODERNATX, INC.-MOD-2023-750261, US-MODERNATX, INC.-MOD-2023-750261, US-MODERNATX, INC.-MOD-2023-750264 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750271:Invalid Case US-MODERNATX, INC.-MOD-2023-750269:4th Stroke case US-MODERNATX, INC.-MOD-2023-750261:2nd Death case US-MODERNATX, INC.-MOD-2023-750264:Master Case US-MODERNATX, INC.-MOD-2023-750261:Master case; Reported Cause(s) of Death: Unknown cause of death
The first shot: sore arm and really tired Second shot: sore arm (less sore than after first shot), about 3 days later I started to notice itchiness back, legs, arms, stomach, breasts
Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM-108 14:00 p.m. symptoms continuing, symptom improvement beginning at 13:00 p.m.
Saturday - Asthma got triggered, chills, achy joints, fever, eyeballs burning, tired, fatigued, headache, lymph nodes swollen under armpit of left arm Monday - Developed an itch rash, headache Lingering - fatigue
pt recv vax 18NOV95 & 2 days p/vax pt exp nausea, vomiting, & diarrhea;tx Imodium;
Child complained of HA at 10:30, approximately at 11 am had seizure.
Mom reported noted some swelling 10/4 in arm and seen in ER that night and given cephalexin. Seen again 10/5 and L upper arm significantly swollen, warm to touch and reddened, min tender. Due to fact he also has a sinus infection at this time that had not been disclosed at the time of the vaccination and did not need the cepahlexin, was changed to AUGMENTIN ES.
I broke out in Hives on Lower Arms (Including palms & fingers), Lower Legs (including top and bottom of feet), mid-section of my body as well as the crotch area.  It was incredible itching.
Nausea, chills & fever, headache and muscle aches which lasted for 2 days
Had chills the night of the vaccine from 8:30-10:30. The following day I was extremely exhausted and had to rest the majority of the day.  Also was sore at th injection site.  No treatment required except tylenol and rest.
Patient is reporting feeling unwell, low grade fever and body aches.  Still has a sore arm.
I had chills that afternoon and felt achy.  i woke up the next day fatigued and had sores  in mouth and 2 white spots on my tongue.  I gargled and used orajel on the mouth sores. That didn't help.  It hurt to eat and drink.  I saw the doctor on 2/1/2021. He did the examination and the dx was Oral Thrush.  I was given Magic Mouthwash and Lidocaine 10 ml.  I had it for 10 days.
Hospitalization: 2/20/2023 - 2/23/2023 (3 days) Presentation to the ED: lightheadedness weakness  COVID + date: 2/20/2023 Treatment: asymptomatic requiring no oxygen Discharge to: home.   001A21A 2/27/2021 048A21A 3/27/2021
At approximately 10 minutes post-vaccination, pateint reported to wife in car that he felt faint and nauseated, At arrival of RN, patient was near-syncope vocalizing nausea and not feeling well. Per wife, 'this always happens."   Symptoms self-resolved after approximately 1 min of nursing supervision and assessment.  Vitals: Temp 98.1 HR 70, RR 18 BP 112/58
She doesn't remember exactly when it started, approximately within 24 hours of vaccination Nerve pain in hands and feet, pins and needles feeling Worse after second vaccine  Stiffness ongoing PCP started on Gabapentin to help with pain
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 11-AUG-2016, the patient was vaccinated with a dose of M-M-R II (lot # L040961, expiration date 19-OCT-2017) subcutaneously, which was inadvertently reconstituted with a dose of VAQTA (lot# L023232, expiration date 25-FEB-2017) instead of sterile water diluent (manufacture unknown). It was reported that the patient was intended to receive both M-M-R Ii and VAQTA. The reporting medical assistant stated that the error occurred because VAQTA was mistaken for sterile water diluent (manufacture unknown) as the label colors were the same. No adverse effect was reported. Additional information has been requested.
Pt came in 11/20 w/local site reaction - (L) upper arm was red, swollen, warm to touch and painful (approximately 8 x 6 in) she reported the reaction developed the 2nd day after administration. Rph on duty sent her to urgent care nearby where she received injectable antibiotic and was sent home w/antibiotic prescription. Dx: cellulitis.
(After second dose)she felt very weak.; (After second dose)loss of appetite; (After second dose)had mostly fatigue; (After second dose)headache; (After second dose)chills; (After second dose)fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache) and CHILLS ((After second dose)chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache), CHILLS ((After second dose)chills) and PYREXIA ((After second dose)fever). At the time of the report, ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache), CHILLS ((After second dose)chills) and PYREXIA ((After second dose)fever) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-378262 (Patient Link).
Information regarding Flumist nasal solution was received from a consumer regarding a 15 year old female patient who experienced headache and body aches. At 15 years of age, the patient received a dose on 12/15/03. The patient has no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. The patient experienced headache and body aches on 12/15/03. The patient's sister developed headache and body aches following receipt of Flumist on 12/15/03, at 13 years of age. No additional information was available at the date of this report.
after client was given both vaccine she said i feel week so i sat here down and she went into a 10 sec seizure with left arm jerking
Information has been received from a health professional concerning a 7 year old white male with no known allergies who on 03-JUN-1999 was vaccinated SC in the right thigh with a first dose of Varivax (lot # 630037/0290J). Concomitant therapy included a first dose in the right thigh SC of MMR (lot # 630101/0117J). There was no illness at the time of vaccination. On 10-MAY-2006 the patient's mother reported that he had little red dots on his shoulders and a few on his back. He complained of itchiness. Some spots were crusted over. It was a "very light case" per mom. No labs were done and no medical attention was sought. Subsequently the patient recovered. Additional information has been requested.
After flu shot complained she "felt funny", pain in both arms, BP 140/90, heart rate 88 irregular. Gave juice & nitro without relief. Ambulance to ER. spoke to her 7 hours later at home said didn't have a heart attack but needs stress test and already had appt with heart dr 11-1-07.
after 1st vaccine had adverse event of pink eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (ongoing); "Bone Health" (ongoing); "Antidepressant" (ongoing). Concomitant medication(s) included: ARIMIDEX oral taken for neoplasm malignant, start date: 2018 (ongoing); CALTRATE PLUS D oral taken for bone disorder, start date: 2020 (ongoing); LEXAPRO oral taken for antidepressant therapy, start date: 2017 (ongoing). The following information was reported: CONJUNCTIVITIS (non-serious) with onset Jan2021, outcome "recovered", described as "after 1st vaccine had adverse event of pink eye". The event "after 1st vaccine had adverse event of pink eye" required emergency room visit. Therapeutic measures were taken as a result of conjunctivitis.  Additional information: The patient received eye drop for pink eye.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a healthcare worker referring to a 6 patients of unknown ages and genders. The concurrent conditions and medical histories were not provided. Since 13-JAN-2016, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (route and dose were not provided) lot # L013067, expiration date on 14-APR-2017. Concomitant therapies were not provided. Names of vaccines involved (including lot/exp): VARIVAX (Merck), lot # L013067/ Exp. 04/14/2017 - Temperature 7F - Time frame: 10 minutes - Previous temperature excursion? Yes, supported defrost cycles. No doses of ZOSTAVAX were administered. M-M-R II remained in recommended storage range. No adverse events were reported. No product quality issue was involved. Additional information has been requested.
had telehealth with a provider he told me to get tested for Covid which I did and the result is negative Headache, nausea, lightheadedness, and swollen neck lymph nodes
This spontaneous report as received from a pharmacist refers to a 38 year old patient. On an unknown date in June 2016, the patient was vaccinated with first dose of RECOMBIVAX HB. On 13-SEP-2016, the patient was in the pharmacy to receive a second dose of RECOMBIVAX HB. No adverse effect was reported. No PQC involved. Additional information has been requested.
developed chest pain; Troponin level greater than 1000; This is a spontaneous report from a contactable consumer. A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 08May2021, 6 days after receiving 2nd dose, patient developed chest pain. He was admitted to hospital for 2 days. Troponin level was greater than 1000 on 08May2021. Cardiologist believes this may be a severe reaction to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 via Nasal Swab (Coronavirus PCR) with negative result. The outcome of events was unknown.   Follow-up attempts are completed. The following information on the batch number has been requested.
Prolonged fever 99.5 - 100.6 joint & aches fatigue. Note: exposed to varicella 1 week prior to immunization. I.D. MD says not related.