chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said a small rash (round) started on her Right arm on Sunday 10/7/18. It became larger and itchy and started to spread down. It's itchy. So she went to see Dr. today. She was prescribed Prednisone 10mg BID x5days. Also BENADRYL cream apply on rash, Also BENADRYL 25mg twice a day for itching. She says the rash is getting better. She had been putting ice on it and will start medicine today. She says it's starting to improve now. I asked Pt to call us and the MD if it's getting worse.
Covid arm: red lesion on left arm injection site. Hot to the touch, firm, itchy, sore. Spot the size of a large lemon or deck of cards. Showed up  8 days after getting dose 1. Red spot lasted 5 days. Itching lasted 1 day. Still mildly sore today (day 14).
No additional AE reported; Improperly stored vaccine was administered to patient; This spontaneous report was received from a medical assistant referring to a 4 years old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 27-DEC-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) in the right thigh for prophylaxis (lot # W019628, expiration date: 19-DEC-2023; strength, dose and route of administration were not reported) (product storage error). According to digital data logger, the vaccine had a temperature excursion on 10-DEC-2022 (also reported as 05-DEC-2022) that it was stored under -14 to -10 degrees Celsius for 1 hour. The vaccine was stored in the clinical practice, it was unknown if there was previous temperature excursion. No additional adverse event was reported.
L shoulder pain immediately after vaccine that persisted and worsened over the subsequent weeks. Reduced ROM and pain persisting  at visits 10/9 and 10/17
sore arm; Felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (Felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (Felt tired) outcome was unknown.            No concomitant medications were reported.  It was reported that, after the first dose of vaccine patient had no side effects. On 07-Feb-2021, after receiving second dose, the patient felt fine for rest of the day.   On an unspecified date, the patient received two booster doses and did not have any problems but a sore arm. Further it was stated that, the patient never got sick.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-685585 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685585:MOD-2022-685585  (case for husband)
severe asthma; still cannot taste anything; still cannot smell anything; Initial information received on 20-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional under reference number: US-SA-SAC20211127000140 in   This case involves Elderly and unknown gender patient who experienced severe asthma (asthma), still cannot taste anything (taste disorder) and still cannot smell anything (anosmia)  after receiving INFLUENZA VACCINE and while treated with TOZINAMERAN [PFIZER BIONTECH COVID-19 VACCINE].  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient started taking PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) formulation unknown dosage unknown route unknown (with an unknown batch number) for Prophylactic vaccination. a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date  not reported via unknown route in unknown administration site for Prophylactic vaccination respectively.  On an unknown date the patient developed a non-serious severe asthma (asthma), still cannot taste anything (taste disorder) and still cannot smell anything (anosmia)  (unknown latency) following the first dose intake and (unknown latency) INFLUENZA VACCINE and  following the last dose intake of TOZINAMERAN.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of the events was reported as unknown.   There was be no information on the batch number for this case.
Initially I was fine but then by the next morning I had some stuffiness, congestion, and I didn't have the nausea right away because I wasn't in the hospital until August 10. I think a couple of days before 08/10 I was having the nausea and my DR said to sip ginger ale and I did that for two days and it didn't cut it. I went to ER on 08/10 and he treated me with anti-nausea medicine, and they ran all kinds of tests to include my heart and after many hours they got me well enough that I could leave. They sent some Zofran 4 mg every 8 hours as needed for Nausea and they said I had colitis and they sent me to gastroenterology and they didn't feel I had colitis. I had severe nausea and it was something I couldn't treat on my own and I had also tried Pepto Bismol and that didn't help either. Altogether this lasted for 3-4 days. I was on the lansoprazole at the time. I did have to go to the pharmacy to get the Zofran and protonix delayed release. ER Visit was at the Hospital.
This case was reported by a healthcare professional via a sales representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with Infanrix, GlaxoSmithKline for prophylaxis. On an unspecified date the subject received 5th dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, on or before 30 August 2006, the subject experienced cellulitis from the shoulder to the elbow. The nurse was trying to determine "if there is an issue with the lot or if the injections were given subcutaneously rather than intramuscularly. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting the events were resolved.
9/14/2022- I felt a little lightheaded and a sore arm after the vaccine. On 9/22/2022 I went to an indoor concert, I was standing in the back, and I was wearing a mask, but I think it was then that I was exposed. Three nights later, I felt really lightheaded, my throat was rather sore. When I woke up that Monday, 9/26/2022, I was coughing, very sore throat, lightheaded, fluish, bad cold. I just felt off. I took a home test and it was positive, bright red. I called my doctor that morning and he prescribed me Paxlovid. I am probably 90 percent better. I still have a sore throat and I am feeling tired.  This past Monday, day 8, 10/3/2022, I took a home test and it was faintly positive. As of today, I am completely negative.
no reaction to the Pfizer shots other than fever for first one; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "no reaction to the Pfizer shots other than fever for first one".  Additional information: Patient reportedly received Pfizer on 30May2021, 21Nov2021, and on 12Apr2022. She also received Moderna Spikevax Bivalent BA.1 Covid-19 Lot # 017F22A booster on 28Sep2022 at 12 pm. She had pain throughout the night, hard to sleep. Pain was more tolerable but swelling continued. It subsided by Sunday 02Oct2022. She also reported having similar swelling with shingles vaccine.   No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My COVID-19 infection symptoms started on 03/05/2023. I had mild cough and headaches. The next day I wasn't feeling well at all. I had no energy. mild cough , and  severe headaches.  On 03/06/2023 I did a home COVID-19 test which was positive. On 03/07/2023 in the afternoon I did a telehealth with my doctor who then prescribe me with Paxlovid for 5 days. According to CDC website I will be doing another COVID-19 home test tomorrow to see if  I am negative for COVID-19 since I have no symptoms.
redness at injection site; shivering; sweating; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax and Shingrix (1st dose received in January 2019).   On 29th April 2019, the patient received the 2nd dose of Shingrix. On 30th April 2019, 1 days after receiving Shingrix, the patient experienced sweating. On 1st May 2019, the patient experienced shivering. On an unknown date, the patient experienced injection site erythema. On 5th May 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the sweating was not recovered/not resolved and the outcome of the injection site erythema was unknown.   The reporter considered the sweating and shivering to be related to Shingrix. It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: In January 2019, the patient had his first Shingrix shot and did not have any side effects from that shot. The patient had 2nd shot was administered. The next day patient started to experience severe sweating. The next night he awoke during the night experiencing both shivering and sweating. It had continued each night since then. Last night, he experienced only the sweating which does not seem to be improving. However he did not experience the shivering last night. On an unknown date, less than a week after receiving Shingrix, the patient had redness at the injection site. The patient had continued with his normal activities during the day. The reporter consented to follow up.
Felt lethargic and feverish for a week after the booster. Last week of December I was exposed to Covid. Fever, lethargic, deep chest cough. I went to urgent care New Years Day and had a negative PCR test. I was given cough medicine and decongestant medicine.  Returned to the same urgent care a week later and tested positive on January 8, 2022.  I was given brom-phed for my cough and congestion and told to take Mucinex DM and alternate the Bromphed with the Tessalon Perles I was prescribed the previous week. Still had frequent coughing fits that resulted in either coughing up discolored mucus (green/brown) or gasping for breath. Also, discolored (green/brown) nasal discharge. I saw my pulmonologist the first week of February and he said it developed into bronchitis, sinusitis, and bacterial overgrowth. He prescribed me antibiotics, steroids, and 2 decongestants. A month later (March) I was still unwell and went to urgent care and was given more Brom-phed after a chest x-ray showed inflamed airways. Also, dizziness upon standing due to fluid behind the ears.
This spontaneous report as received from a pharmacist refers to a 1 unspecified infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-JUL-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 and expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other: Moderna/vaccine administration date: 08Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 54 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: En6205), on 26Mar2021 as dose 2, single (Lot number: Er8727) and on 11Oct2021 as dose 3 (booster), single (Lot number: Fd0810) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Lot number: 084j21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "vaccine brand other: Moderna/vaccine administration date: 08Apr2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient has vaccine was received  and Other medication in 2weeks Yes. patient received Paxlovid treatment for event.
Evening of injection, patient complains of constant upper L shoulder pain at injection site.  When he wakes up in the morning he had tightening of L elbow that sometimes experiences numbness.  The pain, still to this day is a constant sharp pain.  Pt believes that injection was given too high at the site and may have hit a nerve.  Wife has is expecting (EDD 11/02/12), pt is concerned that he is unable to carry newborn due to constant numbness and pain.
Pt states her entire L arm is very sore. She denies redness or swelling. She did not check her temperatur, but had body aches and fatigue that resolved by day 2 after getting the vaccine.
barely get out of bed; super weak/It only lasted about 12 hours or so, but it was extreme.; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (barely get out of bed) and ASTHENIA (super weak/It only lasted about 12 hours or so, but it was extreme.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Atrial fibrillation.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (barely get out of bed) and ASTHENIA (super weak/It only lasted about 12 hours or so, but it was extreme.). At the time of the report, BEDRIDDEN (barely get out of bed) outcome was unknown and ASTHENIA (super weak/It only lasted about 12 hours or so, but it was extreme.) had resolved.            No concomitant medications were reported. No treatment information was provided. The patient had a severe reaction on the last one. The doctor told him it might be best not to take the booster.   This case was linked to MOD-2022-546734 (Patient Link).
Pt called 5 hours after receiving shot complaining severe sore throat, swollen eyes, & swollen lips. Pt was seen in ER & given BENADRYL. Pt also had severe flu-like sx (fever, body aches, malaise) for few days after receiving shot. Per last phone conversation, 4 days after shot, pt felt better.
Information has been received from a physician concerning a 22 year old female patient who on unspecified date received three doses of GARDASIL (Lot# not reported), IM. The physician stated that the patient experienced test results that determined the woman to be in high risk for Human Papillomavirus (HPV) with mild dysplasia after being administered GARDASIL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. This is one from several reports received from the same source. Additional information has been requested.
Back pain, Arthralgia, Influenza like illness, Paraesthesia, Migraine. This report described the occurrence of low back pain in a female patient who received Lyme disease vaccine recombinant OapA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patent received injections of LYMErix "between April and May of 2001 according to the client." On 03 September 2003. the patient's attorney alleged that the patient "suffered low back pain, right hip pain, flu-like symptoms, tingling of her fingers and toes, and migraine headaches beginning in September of 2001 according to the client." Treatment and outcomes of the alleged events were not reported.
Tylenol was given by mother at 5 pm. Woke up with a high fever and fussiness. Mother took baby to the Emergency Room. Temperature was 105.4 at hospital then temp declined to 98.9 prior to leaving. Mother stopped by the clinic today so doctor could look at the injection site, the site where Prevnar was given was ecchymotic.
Report of pain at injection site about 12 hours after injection.  Next day developed swelling at injection site with continuing pain.  Next day developed decreased ability to move left shoulder due to pain at injection site.
Sweating, turned "rosey", SOB, rapid heart beat, nausea w/out vomit, fatigue.
received the fluzone hd qiv to 58 years old with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old male patient who had received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ924AD and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunization.  On 17-Oct-2022 the patient developed a non-serious event of received the fluzone hd qiv to 58 years old with no reported adverse event (product administered to patient of inappropriate age)(Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: was not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient was given Influenza vaccine x 2 d/t documentation error on list. Patient given Influenza vaccine on 10/12/16 and 10/20/16.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 33-year old male consumer who experienced 24 hour flu, nose, sinus and ear congestion. At 33 years of age, the patient received a dose on 15-Dec-2003. Medical History: The patient had a "slight cold" prior to receiving Flumist on 15- Dec-2003, with a past history of ear infections. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details : On 22-Dec-2003, 1 week post-immunization, the patient experienced a "24 hour flu", for which he took Nyquil (detromethorphan hydrobromide and doxylamine succinate and ephedrine sulfate and ethanol and paracetamol). The "24 hour flu" continued as nose, sinus and ear congestion. He was scheduled to see the physician in 1 week. No additional information was available at the time of this report.
Patient called 9/16/20 in the AM. She saw her MD who asked her to call us to check if any other patients were having symptoms from their flu shot or if it was a new brand. I said no.  She is having tingling in her arms and legs (kind of like goose bumps) on and off every day since she has received her flu shot. She received her shot on 9/11/2020.
I have not had a period since receiving my first vaccine and am not pregnant (verified by blood test by my doctor). So far I have skipped 2 cycles. I also have restless legs and joint pain in my hips and knees.
Approx. 45 min after vaccines were administered pt c/o ears burning. Mom noted both outer ears bright red and he started to breakout in hives. Left eye very swollen face puffy. Lungs clear in all lobe when returned to office in 10 minutes. .15cc epi given and 40 mg Kenalog
Pt c/o dizziness 15 mins after receiving vaccine. She noted that her last meal was at 8pm last night and she had a cup of black coffee at 7am this morning. She reported no other complaints and noted that she has no past medical history.
warm red area below injection site; war at injection site; injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 6th November 2019, the patient experienced erythema and feeling of warmth. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the erythema was not recovered/not resolved and the outcome of the feeling of warmth was unknown.   It was unknown if the reporter considered the injection site pain, erythema and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a sore injection site that day.  The patient had warm, red, area that was huge below the injection site,described as 3.5 inches by 2 inches.He states the arm soreness has resolved, only the red area below remains at this time.  The reporter consented to follow up. The reporter has no further details for this adverse event, declines follow up.