chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She bled a little bit; A 'black and blue mark on the arm (as big as a tangerine, and is still there)'; When she vaccination provider put the needle in, it really hurt/soreness; Her arm ached; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that . A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 13:00 as 1st dose, single for covid-19 immunisation. Medical history included for her belly. Concomitant medications included fish oil (OMEGA XL) (Has been taking for years) ongoing and glycopyrrolate [glycopyrronium bromide] taken for her belly, (Once a day) ongoing. On 24Jan2021 the patient experienced Black and Blue mark on arm, when she vaccination provider put the needle in, it really hurt/soreness and her arm ached. On an unknown date the patient experienced she bled a little bit. The patient stated that She got the vaccine on as confirmed Sunday 24Jan2021 and later that day her arm ached. She has heard a lot of people had ache, arm ache after getting the vaccine, but no specific patient details provided.She looked at her arm and she had a black and blue mark as big as a tangerine. She is not too happy that happened. She has to get the second dose of the vaccine 14Feb2021. She is not sure if she wants to get the second one. If this occurred with the first one. She also hurt with getting the vaccine. She is not sure where the needle was placed when getting the vaccine, but it hurt, and she bled a little bit. The nurse had to place a Band-Aid on it. Her arm is still black and blue. She noticed the black and blue mark on the same date she got the vaccine. It was later that day in the evening. She does not know the exact time. The black and blue mark is on her right arm. She noticed her arm ache shortly after she got the shot. It was a few hours after getting the vaccine, but she does not know what time. She stated this seems to be a complaint of a lot of other people, but no other specific patient details provided. It is her right arm that aches. She stated she is wondering if she needs to be concerned about these events. Should she be concerned about what her arm looks like. She is still having soreness. Therapeutic measures were taken as a result of a 'black and blue mark on the arm. The outcome for the events black and blue mark on the arm (as big as a tangerine, and is still there) and her arm ached was recovering. The outcome for the event when she vaccination provider put the needle in, it really hurt/soreness was not recovered. The outcome for the event she bled a little bit was unknown.  Follow-up attempts are completed. No further information is expected.
Red knot at the injection site; Circular red knot at  injection site; Injection site itchy; Injection site warm to touch; Arm was tender to touch; Throbbing Pain in arm; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included nasal polyp.   On 09-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 10-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Red knot at the injection site), injection site lump (Verbatim: Circular red knot at  injection site), injection site itching (Verbatim: Injection site itchy), injection site warmth (Verbatim: Injection site warm to touch), tenderness (Verbatim: Arm was tender to touch), pain in arm (Verbatim: Throbbing Pain in arm) and chills (Verbatim: Chills). The patient was treated with benadryl (nos) (Benadryl) and cefalexin (Cephalexin). The outcome of the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR044358   Additional Information: GSK Receipt Date: 17-MAR-2023 The patient reported that prior to starting nucala therapy for treatment of her nasal polyps, she received Shingrix. The next day she experienced throbbing pain in the left arm and the arm was tender to touch. There was a circular red knot at the injection site, and it was itchy and warm to touch and she experienced chills. She took Benadryl for the reaction, but after 2-3 days, there was not relief and she was prescribed cephalexin. After starting the antibiotic, the injection site returned to normal and the pain resolved. The patient consented to followup with the HCP (healthcare professional) and with herself. This case has been linked to the case US2023AMR044358 reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR044358:Same patient / Shingrix vaccine
Triggered an auto-immune response; Triggered an auto-immune response. Had a strong fever, GI problems after the first shot; Triggered an auto-immune response. Had a strong fever, GI problems after the first shot; This is a spontaneous report from a contactable consumer. A 38-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. On 15May2021, the patient triggered an auto-immune response. He had a strong fever and GI problems after the first shot. The patient was hospitalized and received treatment of colonoscopy and prescription of anti-inflammatory. The outcome of the events was recovering. On 16Jul2021, the patient had nasal swab and showed negative result.  Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951006 same patient/drug, different dose/event
Immediate swelling at injection site.  No discoloration at first.  Severe discomfort in lifting the arm for 48 hours. Bruise still at injection site today.
Information has been received from a medical assistant concerning a 10 year old patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot# not reported). It was reported that the patient developed headache. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
I had an allergic reaction to dose 2 only. Symptoms began roughly 3 hours after injection. I had an itchy red rash on both arms, not at the injection site. I treated with Benadryl, as advised by my dr office. 8 days after injection I experienced acid reflux/heartburn. I treated with Pepcid AC, as advised by on call dr.   Rash moves around my body (arms, legs, trunk, scalp). I've had it for 3 weeks. Treated with Benadryl 3xs a day. The acid reflux/heartburn were bad for 2 days, still experience mild acid reflux 2 weeks later
Tingling sensation from neck to left elbow nauseous feeling. She did state she did not eat anything as of Imz. Did go to inhouse health clinic possible,
12 hours after the injection I started experiencing extreme pain in my all body muscles, high fever (102F), couldn't sleep for 24 hours and experienced swollen lymph nodes. Fever and body pain lasted for 48 hours and then subsided.
MIGRAINE; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine. This report was non-serious.
Ulcer; Dry skin; Chills; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date to MAY-2021 for moderate to severe chronic plaque psoriasis, and psoriatic arthritis. No concomitant medications were reported.  On MAY-2021, the patient experienced chills. On an unspecified date, the patient experienced ulcer, and dry skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from chills on MAY-2021, and had not recovered from ulcer, and dry skin. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
a 14 year old / received the first dose of Twinrix on the 1st May, 2021; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st May 2021, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 1st May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The patient received the 1st dose of Twinrix before he was 18 years old, which led to inappropriate age at vaccine administration. No further information was reported. The reporter consented to follow up.
received Infanrix instead of Boostrix; 11 year-old patient may have received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had received Infanrix dose in error instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration  The reporter clarified after the report of that their investigation showed that the patient who received the Infanrix dose in error could be the patient of or the patient of the case. The reporter consented to follow up. This case is linked to the case US2021149593 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149593:Same reporter
Fever- highest was 103.3.  Gave IB Profin or Tylenol.  Fever continued on an off for two days. As of 8/30/13 has about 30-40 tiny spots all over body. Still has spots as of 9/3/13.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 12:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 12:59 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 25.59 for dose administered on 14-Feb-2021 and 25.59 for dose administered on 21-Mar-2021.  No concomitant medications were reported. Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 to 35 degrees Fahrenheit from 09:00 AM to 3:00 PM. This vial was moved to fridge on 9-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 32 to 34 degrees Fahrenheit from 9:00 AM to 11:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 02Feb2021 as dose 2, single (Lot number: EL9269), in left arm and on 05Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 32030BD) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. Concomitant medication(s) included: BREZTRI AEROSPHERE; MONTELUKAST; VITAMIN C [ASCORBIC ACID]; VITAMIN D [ERGOCALCIFEROL]; CALCIUM. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: Based on reported information, causal association of event vaccination failure, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
11Oct90 pt vax w/ 3rd hepta B; testing on 25Jan91 indicated that vax did not take.
Pt. developed itching, swelling & redness at site at 4PM 5/15/08.
Received VARIVAX 5/4/12. Seen 5/5/12 with Cellulitis. Demarcating from site of injection. Placed on Cefalexin - Cellulitis progressed treated with IV Vancomycin.
Menstrual cycle started 12 days early with heavy bleeding Dizziness//vertigo
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage. Patient experienced mild pain at injection site.
Confirmed Breakthrough  COVID-19 (Moderna) 1 57 Years 9 Months 03/18/2021 Health Centers Moderna 038K20A   COVID-19 (Moderna) 2 57 Years 10 Months 04/16/2021 Health Centers Moderna 037B21A   COVID-19 (Moderna) 3 58 Years 6 Months 12/03/2021 Health Centers Moderna 065F21A
Within 12-14 hours from receiving the 1st dose of the vaccine, I began to have symptoms that initially started as general malaise, fatigue, and muscle and aches and pains. By 2am On 2/09/21, I began having chills and by 6am, I had a fever of 101. F. Pain at the injection site started to develop , which I understood is a normal side effect of vaccines in general, but then over the course of hours to days, the pain began to radiate up my arm to my shoulder, and up my neck, to my head where a severe headache would ensue and render me unable to perform my daily activities. For days I was feeling unwell causing me to call out sick from my job as a nurse more than once. I also feel pain in my axilla and breast tissue adjacent to my arm pit, directly beneath the injection site. I also experienced nausea when the headache and muscle aches were at their worst. The fever eventually subsided after a few days, but the headache has persisted despite taking Ibuprofen as directed by my physician via a telehealth visit on day 3. (I called for an appointment on day 2, but they only had the next day available.) The headache pain is heavy, sharp, piercing, and throbbing, definitely interrupting with my daily activities. I have to go lay down and apply an ice pack to my head and neck area several times a day. These symptoms had been persisting for several days in a row and after being seen by my doctor again on the 8th day because of the symptoms, she recommended I go to the emergency room to address the persisting headaches and rule out any head bleeding and report the symptoms related to the vaccine. I was also advised by my physician to consider skipping the 2nd dose of the vaccine because of my severe reaction to the first one.
Developed redness and swelling at IM site. Generalized itching and SOB with wheezing.
Headache; Calf muscle cramping; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 20Mar2021 at 16:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient was allergic to sulfa and penicillin. Concomitant medications included loryna (YAZ), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO) and loratadine (CLARITIN); all for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Feb2021 at 16:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 06:00, the patient experienced headache and calf muscle cramping. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of headache and calf muscle cramping. The clinical outcome of headache and calf muscle cramping was not resolved at the time of report.  No follow-up attempt is possible. No further information is expected.
Pt recvd DTP/OPV/HIB on 3JUN91; 12JUN slight fever; 13JUN lethargic & sleeping w/fever which responds to APAP; 14JUN seen at clinic virus suspected; APAP recom'd; 15JUN in AM found comatose taken to Hosp; has lt side weakness;
Died of heart attack 10 days after vaccine with no family history or prior indication of heart problems
I received two shot of moderna in March 7, 2021 and second shot on April 4, 2021. I got the Pfizer booster shot on December 23, 2021. Both given at pharmacy locations.   After the booster shot I started to get my period. I have extreme issues with even getting my period due to having PCOS. I typically have 4-5 periods a year. This period was long and heavy. Then I started to get concerned because that period went from Jan 3-9, 2022 followed by another period that started 8 days later on Jan 17 and has not stopped since. This is extremely odd and concerning to me especially after I read the news about Womens menstruation cycles getting messed with due to the vaccine. Please assist or advise. Thank you.
A few days after injection low grade fever - 99-100 degrees F,  fatigue, severe aching neck and back After about 7-8 days intense itching arm, raised red area, swelling at injection site. Still with me today
AFTER 10 OF VACCINATION PATIENT PRESENTED WITH TREMOR, LOWER EXTREMITIES PARALYSIS STARTING AT THE WAIST DOWN AND RESPIRATORY PROBLEMS. THE PATIENT WAS HOSPITALIZED.