chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 3 years plans to receive second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago from the date of reporting, in the dose of 0.5 ml, intramuscularly in unknown deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. At the time of reporting, the patient planned to receive 2nd dose. The patient declined to provide demographics and provide information. The reporter did not consent to follow up.
3 hours after receiving the flu vaccine in my left upper arm, I began to experience extreme pain and limited mobility in my left shoulder.  I was unable to move my arm more than 3-4 inches away from my body.  This severe pain lasted for 4 days and kept me from sleeping at night. The pain has slowly been diminishing but has not gone away, and now, 3 1/2 weeks later I still do not have full range of motion, certain arm movements cause moderate pain, and I can not sleep well at night due to pain. I saw a doctor 13 days after the injury and was diagnosed with shoulder impingement and was prescribed anti-inflammatories and physical therapy.  I start PT tomorrow 12/7.
This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced injection site pain. The pharmacist stated that "the vaccine was administered at her pharmacy so she could not verify." At the time of reporting the outcome of the event was unspecified. The pharmacist reported another case with FLULAVAL. See A1051252A for details on the other case.
5 min after dose got dizzy. 20 min after dose experienced difficult breathing. Used inhaler.  30min after vaccine continued difficulty breathing.  My throat started narrowing.  Breathing continued to get worse took two Benadryl capsules and compressed oxygen an our and a half after the shot.  It helped.  Half hour after, it was easier to breathe and swallow.  I probably should have used my epi pen when this started...but I was not thing straight.
Covid-19; Covid-19; Colonoscopy: active colitis; Fatigue; This is a solicited report based on the information from a non-contactable consumer (patient) received by Pfizer.  Solicited report from the USA by a consumer of an adult 59-year-old female patient with events of non-serious COVID-19 and FATIGUED with HUMIRA (ADALIMUMAB). The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), intramuscularly on an unspecified date at single dose for COVID-19 immunisation/COVID-19 Vaccination; adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneously from an unspecified date to an unspecified date at unknown dose, single for Moderate to Severe Ulcerative Colitis. There was no reported medical history. Concomitant drugs not reported. On unknown dates, the patient experienced COVID-19 and FATIGUED. On an unknown date, COVID-19 resolved. COVID-19 VACCINE was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient received COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab test and procedure, which included Colonoscopy: active colitis on an unspecified date. The action taken in response to the events for adalimumab was permanently withdrawn on an unspecified date. The outcome of the events COVID-19 was recovered on an unspecified date, outcome of the other events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information currently available the causal association of the reported events lack of efficacy, covid-19, ulcerative colitis and fatigue with the usage of the vaccine BNT162B2 cannot be meaningfully assessed. Also take into consideration the contributory role of the usage of the drug adalimumab. The case will be reassessed once the information regarding date of vaccination, onset of the events, patient's medical history and concomitant medications is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Client stated: redness and warmth at injection site. Had jitters in bed that night with mild dizziness some SOB, headache and heart racing. He stated that he checked his Blood Pressure and that his BP was normal. Highest HR=109 at 6:25am on 10/2 and decreased to 84 at 11:00am same day. On 10/2/20 he also stated a headache, sore red and swollen shoulder area (LA) and around to armpit. He stated that symptoms subsided throughout the next couple of days.
Chicken pox all over my body; Getting new blisters daily; This case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced chickenpox and blister. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the chickenpox and blister were recovering/resolving.   It was unknown if the reporter considered the chickenpox and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-Jun-2022. Reporter's comment: This case was reported by patient via  interactive digital media. The patient got the Shingrix vaccine and 2 days later had full blown Chicken pox all over body. It went on for 10 days and was getting new blisters all over body daily. The patient had to get an antiviral to make it stop. Finally on week 3, the patient was better.
Starting about 5 hours after injection, fatigue, followed by extreme headache, followed by chills and aches. Lasting about 24 hours, treated with extra strength tylenol.  I couldn't sleep due to the chills, and muscle aches during the night so I slept most of the next day until late afternoon. Kept taking Tylenol through the day and evening. Felt ok the following day.
Moderna COVID-19 Vaccine EUA. A week after receiving the vaccine I woke up to my arm knotted up, red, itching and hot to the touch.  The symptoms begin to fade then come back. I have not received any treatment for the symptoms.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt fainted and sezied for 10 seconds, this was 3 minutes after vaccine. After 2 minutes this repeated again. Pt was okay after talking to her, given her cold water, orange juice, and juice drink x2. Took her 30 mins to recover
Two doses of Shingrix, 20 days apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received two doses of Shingrix vaccine about 20 days apart. The reporter wanted to remain anonymous and had not provided details to provide about this adverse event. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix early than recommended time frame, which led to shortening of vaccination schedule.
Unspecified number of doses of MMRII were improperly administered subcutaneously "in the outer aspect of leg" to unspecified children younger than 12 months of age at unknown times; This spontaneous report was received from a nurse and refers to a unspecified children younger than 12 months old. No information was provided regarding the patient's concurrent condition, concomitant medication, pertinent medical history and drug reactions/allergies.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) by subcutaneous in the outer aspect of leg (Vaccine administered at inappropriate site), for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported).   The nurse stated, she was not feel comfortable to provided any information.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4382442-00. A 58-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 26Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160186) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Moderate to severe rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; PAIN (non-serious), outcome "unknown", described as "achiness following Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. The reporter considered "Covid-19" related to BNT162b2. The reporter's assessment of the causal relationship of "achiness following Covid vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event drug ineffective, suspected Covid-19, pain cannot be completely excluded.
Welt on arm; Nausea; vomiting; Fatigue.; Normal activity affected; In bed for 4-5 days. Normal activity affected.; This case was reported by a nurse via sales rep and described the occurrence of welts in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis.   Concurrent medical conditions included immunocompromised (immunocompromised due to medication).   On an unknown date, the patient received the 2nd dose of Shingrix and PREVNAR 20. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired. On an unknown date, the outcome of the welts, nausea, vomiting, fatigue and activities of daily living impaired were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK receipt date: 08-Nov-2022 Reporter's comment: The patient received Shingrix co-administered with Prevnar 20. 4 hours after Prevnar 20 the symptoms began, the patient had welt on arm. Nausea and vomiting. In bed for 4 to 5 days. Normal activity affected.  The patient experienced fatigue. Patient was immunocompromised due to medication on two biologics. Less than a week, after Shingrix and Prevnar 20 the patient was bedridden and activities of daily living impaired. It was unknown if the reporter considered the welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired to be related to Prevenar 20.
Rapid heart beat, feels like elephant sitting on my chest, arm pain, overall body aches & pain, nausea & migraine headache
purple knot on her arm; purple knot on her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (purple knot on her arm) and SKIN DISCOLOURATION (purple knot on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (purple knot on her arm) and SKIN DISCOLOURATION (purple knot on her arm). At the time of the report, VACCINATION SITE INDURATION (purple knot on her arm) and SKIN DISCOLOURATION (purple knot on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
No adverse effects; the patient received an improperly store dose ofVARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.    On 10-OCT-2019, the patient was vaccinated with a dose of improperly store varicella virus vaccine live (oka/merck) (VARIVAX) lot # S005078, expiration date 19-FEB-2021 (exact dose, frequency, route of administration and anatomical location were not reported) reconstituted in sterile diluent (lot # and expiration date were not reported). It was not provided whether the diluent was properly stored. Administered dose of vaccine experienced the temperature excursion between minus 14 degrees Celsius to minus 10 degrees Celsius for 45 minutes and minus 9 degrees Celsius to 8 (minus 5) degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Fatigue, chills fever joint aches and pains along with femur bones aching/hurting as well as my rib cage sore and achey.  Fever went as high as 102.4.  Plus have noticed a small cough.   I received the vaccine on Monday morning and by that evening I could not move with fever and pain. The symptoms started to subside around 4:00 am Wednesday 1/6/2021. Currently it is 18:30 and I feel better temp is  99.1. No joint aches but with a small cough.
A non-serious spontaneous report of red throat, 104 fever, and sneezing has been received from a consumer concerning a four-year old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 02-Aug-2010. On 04-Aug-2010, the patient developed symptoms of red throat, "104 fever", and sneezing. She went to the emergency room where she was treated and released. The symptoms were decreased on 05-Aug-2010. The outcome of the events was unknown; the patient's symptoms were lessening.
excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The pharmacist reported that an excursion happened during shipping of Hiberix from an external wholesaler on the way to the pharmacist's facility, which led to incorrect storage of drug. The pharmacist stated, feel comfortable using the product now. The pharmacist had been provided extended stability data which does not apply to shipping.
Site: Pain at Injection Site-Mild, Additional Details: Patient called on 11/22, states that starting the night after his Moderna booster (11/17) that his heart was racing and chest was painful "like an elephant was sitting on his chest". It is now feeling somewhat better, reduced pain but still painful during the day and racing heart. Pt states he is not the picture of his and that night of vaccination 11/17 he spoke to friend  said they knew someone  had this happen and it lasted 3 months. He has not gotten any F/u, I recc calling dr or going to ER
Information has been received from a physician concerning a 13 year old female patient who on unspecified dates was vaccinated with 3 doses of GARDASIL (no lot number given). The physician reported that the patient experienced injection site reactions after all 3 doses with the third dose being the most painful. The patient sought unspecified medical attention. This is one of two reports received from the same source. No further information is available.
Pain started the evening of injection, Redness started 48 hours after injection with more pain, Symptoms resolved 5 days after injection
Within 72 hrs of receiving seasonal influenza vaccine- child had episode of acute R.D. - requiring episode of acute R.D. - requiring OREPRED, PULMICORT and reported- Child had an uneventful recovery.
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. Information regarding medical history or concurrent conditions were not reported. On unknown dates, the patients were vaccinated with 5 improperly store doses of VARIVAX (which had the lot number of M002061, expiration date 12-JAN-2018 (dose, route and anatomical site of vaccination were not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. And there was not product quality complaint involved. This is one of two cases from the same reporter. Additional information has been requested.
Tired, confusion while driving home, shortness of Breath.  While sitting at the desk the day following the vaccination, heart started racing, got light headed and almost passed out. This happened 3 days in a row. Felt like heart was going to explode. Very scary experience filled with anxiety and panic.  Shortness of Breath and weak heart beat followed for the last 3 weeks. Still is here off and on.
Dizzy, throwing up, sore arm, chills, sweats, headaches, loss of appetite, could not stand due to dizzy or open eyes, temperature variance from 97 to 100.
pt recvd vax & devel severe burning, lower back pain; a burning sensation when urinating; ovary pain & lower abdo pain w/ 1st dose; when 2nd dose admin, pt exp same symptoms;
Vaso vagal syncope with seizure. Had severe lethargy and  arm pain for 3 days afterward. Diarrhea and headache started day after injection and lasted for 2 days. Saw doctor for follow up, as encouraged by the clinic's staff, on Friday, April 16th and she needed to get more information before making a decision on whether or not to get a second dose. The following Monday she messaged me via "mychart" through the healthcare that I would be fine to get a second dose but wouldn't be reporting the incident. I asked her to report the incident and she refused.
Transient nausea; Chills; Debilitating nausea; A rash on back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash on back), NAUSEA (Transient nausea), CHILLS (Chills) and NAUSEA (Debilitating nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (A rash on back). On 03-Mar-2021, the patient experienced CHILLS (Chills) and NAUSEA (Debilitating nausea). On an unknown date, the patient experienced NAUSEA (Transient nausea). At the time of the report, RASH (A rash on back), NAUSEA (Transient nausea), CHILLS (Chills) and NAUSEA (Debilitating nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-032000, MOD-2021-032170, MOD-2021-032170 (Patient Link).
Patient presented day after vaccination with redness and swelling to site of shot administration on right thigh (MMR injection site)  Dr. prescribed Zyrtec 1/2 tsp bid and Ceftin 250/5 1/2 tsp bid for 7 days for inflammation and possible infection.