chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild soreness at injection site; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable Female consumer reported.  A 71-year-old female consumer (patient) who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number ER2613, Expiration date unknown), via an intramuscular route of administration in upper left arm on 17Mar2021 at a single dose for covid-19 immunization. The patient's medical history was not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number EN6202, Expiration date unknown), via an intramuscular route of administration in upper left arm on24Feb2021, as a single dose for covid-19 immunization. The patient did not receive prior vaccination within 4 weeks. Patient's concomitant medications included METOPROLOL taken for hypertension, LEVOTHYROXINE for thyroid, SIMVASTATIN for lipase, all are taken via oral route. The patient took 400 mg acyclovir for herpes simplex on or around the 3-week time frame of receiving the Pfizer covid vaccine. The patient did not consume acyclovir whether the 2 weeks prior to or during vaccination for covid. On an unspecified date, the patient had no side effects to where vaccine administrations other than mild soreness at injection site. The outcome of event was unknown.  Information on the lot/batch number has been requested.  No follow-up attempts are needed. No further information is expected.
Here for flu shot. See VAR; 1025- Flu shot given in left leg - laying on exam table-; 1027 sat up and was talking and crying to mom. Note face becoming pale and lips becoming pale. O2 placed nasal cannula at 1.5 liters - Called for help. O2 sats 94%-95% at 1 1/2 liter - HR - 70 - responded to pain and mom's voice - X 2 IV attempts unsuccessful on hands and X1 #24 jilco Left antecubital by RN - fluids bolus started by NS. Epi Jr given at 1032. 911 -called 1045. at this time sats 98-99% and heart rate 120, and crying and fighting with IV starts. 1050 ambulance personnel here - information given - and transferred to ER by ambulance - parent in attendance. Assisted dad to ran to go and meet wife and son in ER.: Addendum: History and events as above. Past history in May '07 of similar incident post - Hep A vaccine. Heart Rate went down very low (a 10 or so, very bradycardia): Color was just very pale, including buccal mucosa. Skin was cold and clammy. The eyes were closed. patient responsive to Mom's voice and pain stimuli with attempted I.V. insertions. After Epi Pen given and NSS started, color slowly returned to normal and EMT bought patient to ER where he was given Benadryl and Steroid. Vitals were stable and patient was transferred to Peds. Dx - Vasonagal reaction vs Anaphylactic Shock.   12/19/2007 MR received for ER visit 11/14/2007 who presented after a reaction to flu vaccine with the impression: Vasovagal reaction. Child received vaccine and became pale, hypotensive  and bradycardic with loss of consciousness.  Had previous rxn of hypotension to Hep A vax. EpiPen and IV fluids administered in PMD's office and transported. Child improved promptly with tx.  No local rxn.
Had febrile seizure p/receiving DTP vax; had shot @ 1PM sz occurred @ 1AM; called 911 taken to ER: had febrile sz when was 15 months old; fever;
This spontaneous report was received from a pharmacist via a market research program on 01-SEP-2015, and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) (lot number, expiration dates, dates of vaccination, dose and route of administration were not reported). There was no concomitant medication reported. The reporter stated that on an unspecified dates, the patients had coming up to him, and reported that they still had shingles (herpes zoster) after receiving the vaccine. The reporter stated that the patients had a vaccination failure. At the reporting time, the outcome of herpes zoster and vaccination failure was unknown. Additionally, the reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (manufacturer unknown). Additional information is not expected because the reporter did not consent for new follow up attempts.
Development of sever, painful and  blistering distribution zoster rash 24 hours after Administration
Patient now has gotten pleurisy. Reporter describes pleurisy as meaning patient is now having a tough time breathing deeply, and patient has pain in her diaphragm area; Patient now has gotten pleurisy. Reporter describes pleurisy as meaning patient is now having a tough time breathing deeply, and patient has pain in her diaphragm area; Patient now has gotten pleurisy. Reporter describes pleurisy as meaning patient is now having a tough time breathing deeply, and patient has pain in her diaphragm area; Patient had the covid vaccine on Sunday afternoon. Patient has been feeling very ill since; Reported as worsened; This is a spontaneous report from a contactable consumer (patient's father) (primary care physician). A 25-year-old female patient (reporter's daughter) received first dose of BNT162B2 (Solution for injection) via an unspecified route of administration, administered to her right arm on 06Jun2021 14:30 (Lot number: EW0182, NDC number/Expiry date: Unknown) as single dose for COVID-19 immunization. The patient was taking Pfizer Covid vaccine as required to take it for college. The patient's medical history included ongoing bouts of diarrhea (had bouts of diarrhea prior to receiving the Covid vaccine). Patient had been having bouts of diarrhea. Reporter stated that patient has been having bouts of diarrhea prior to receiving the Covid vaccine. Age at the time of vaccination: 25-year-old. Concomitant medications were not reported. On 09Jun2021, patient now had gotten pleurisy. Reporter described pleurisy as meaning patient was having a tough time breathing deeply, and patient had pain in her diaphragm area. It was reported as worsened. Reporter was calling about the first dose of the Pfizer Covid vaccine. Reporter's daughter was the patient. Patient had the Covid vaccine on Sunday afternoon. Patient had been feeling very ill since. Patient had gotten pleurisy. Reporter provided spelling for pleurisy. Reporter describes pleurisy as meaning patient was having a tough time breathing deeply, and patient has pain in her diaphragm area. Began yesterday morning, Wednesday, 09Jun2021. Reporter was asking had Pfizer seen pleurisy as a side effect after the Covid vaccine. Reporter already took patient to the emergency room once before. The emergency room gave patient Maalox. Reporter had been trying to take patient to see her doctor, but reporter was having a hard time getting an appointment for patient. Outcome of the event reported as worsened was unknown, whereas other events was not recovered.  Follow up attempts are needed. Further information has been requested.
After 7 hrs of post Tdap injection, notice itchiness of chin and neck. The next morning woke up with rashes of Rt side face, eye, neck and chest and gen. rashes to back and abdomen. Redness to injection site with chest tightness and short of breath. Went to Emerg. Dept, prescribed with SOLUMEDROL IV, PEPCID, BENADRYL and IV hydration.
Chills, sweats, nausea, vomiting, body aches, headache, stomach ache, sore arm
I started feeling bad on February 14th of 2023.  I test in the early evening of that day and tested positive. On the 15th I was prescribed Paxlovid I took it for the 5 days.  After the 5th day I started my symptoms again and I was back in the bed again. I kept testing positive again for a while then it tested negative, but it was a faint little line.  I had symptoms for over a month. Coughing, runny nose, fever, aches all over, pressure in ears and pain, night sweats, tightness in chest thru to back, sore throat, headache, and my tongue felt like little cuts all over.  The last vaccine I felt sick a high fever of 102 degrees. I felt sick for about 2 days.
Shivering; High fever like spike fever; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported the female patient (wife) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation. Relevant history was none. Relevant concomitant drug was not reported. The patient got the second shot of the Pfizer Vaccine and after couple of hours the patient experienced shivering, high fever may be like spike fever. The patient was trying to figure out may be like she was shivering, so what could be next step. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
i received a johnson  covid 19 vaccine on monday 03/29/2021 i felt very tired and no appetite for first two days then i started experiencing dizziness to the point that i felt i was going to collapse my head inside like a spinning i had to sit all the time when i got up i felt the same. i also felt disbalance  and unable to walk balance and straight i kept experiecing to the point that i had to go to urgent care on friday 04/02/2019 the physician said i needed a ct scan of my head and bloodworks i had to go to the Emergency room is two weeks later and iam still dizzy and disbalanced  all this after receiving the johnson covid 19 vaccinei had called johnson vaccine hotline left my number and no one returned my call or left a message. This caused a large copay for the test and emergency room visit.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccines received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 92 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
bad nausea, fever, headache, sporadic chills, sore throat, fatigue on Saturday 11/20/2010 coughing started
After receiving vaccines, patient was sitting in her chair, slumped over, and passed out. The Rapid Response team was called and patient was lowered to the floor, evaluated by MD, and given oxygen 2 liters per nasal cannula. Symptoms resolved and patient was alert and oriented within 2 minutes.
Papular urticaria.  Patient presented to office on 12/17/07 with onset of rash on 11/27/07 - still with diffuse, pruritic papular urticaria.  Had been self-treated with Benadryl.  Today started on Prednisone and Xyzal.
Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose  - 1/8/2021 AM of 1/10/2021 had small patch of hives on ankle, took zyrtec resolved 1/11/2021 felt ok no symptoms 1/11 to 1/12 night  "woke up and had massive allergic reaction everywhere - patches of redness on leg, arms, belly, back, face-sparing" -- took zyrtec and the reaction improved somewhat. Was in clinic so went up stairs and spoke to our dermatologist who thought this was likely reaction to vaccine. Prednisone RX given but has not taken. Takes 1-2 zyrtec daily.  Spoke to me on the phone 1/12 at night, increased zyrtec to 4 pills daily, added pepcid and decided to speak today. Did not take atarax or benadryl bc she was on call. Improves with triamcinolone    Presents today with worsening rash, she will upload pics in Epic. Areas of urticarial patches from yesterday now have left non blanching purple rash/bruising. More urticarial plaques today. No angioedema. Feels hot has not take temperature. No joint pain or swelling. No oral or vaginal mucosal involvement.  No issues with respiration generally but maybe a little tight. >75% BSA involved    Allergy history  - chronic rhinitis, no known triggers or patterns No history of asthma, eczema, food allergy or drug allergies
Patient called and stated her throat swelled up however she had no trouble breathing. She took an antihistamine after contacting pharmacy. She complained of severe dizziness through the night and fever which persisted into the next day.
Onset of pain began 2 days after injection given. Pain is constant from 5-10 - radiates from injection site to palm of hand on (L) side. Aspirin & acetaminophen provide minimal relief.
Pain is radiating down left arm; Site of injection is swelling; Swelling of the lymph nodes in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain is radiating down left arm), VACCINATION SITE SWELLING (Site of injection is swelling) and VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes in the arm of the injection) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Site of injection is swelling) and VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes in the arm of the injection). On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain is radiating down left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain is radiating down left arm), VACCINATION SITE SWELLING (Site of injection is swelling) and VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
vaccine dripped out of the syringe; dripped out, made her pants wet; dripped out, made her pants wet; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 07-Jul-2022 Reporter's Comments: The reporter was a HCP, stated that he/she was administrating the 1st round of the Shingrix vaccine to a patient and some of the vaccine dripped out of the syringe, enough that it made her pants wet, but could not tell how much was not given. The reporter wanted to know what would be the recommended course of action in this case The HCP who did not provide any additional information. Email address provided for follow up although follow up permission was not obtained due to the nature of the request. Additional Supportive Information: While administrating the 1st round of the Shingrix vaccine to a patient some of the vaccine dripped out of the syringe, enough that it made her pants wet, but could not tell how much was not given, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine.
post herpetic neuralgia; shingles; This spontaneous legal report was received from a lawyer referring to a 68 year old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 23-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported). As a result of vaccination, in 2012, the patient was caused to suffer shingles, including any and all of its sequalae. As a result of vaccination, the patient was caused to suffer serious and dangerous side effects including postherpetic neuralgia, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.  The reporter considered postherpetic neuralgia as serious (medically significant).
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in September 2018, refer case US2019005998). On 9th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Wednesday, the patient's arm started out sore not to bad but then got progressively worse. The patient's arm was swollen and got a fever with headaches and shivers like he had the flu. The reporter stated that he could not get out of bed for 2 days and just got back to his self this morning.
Weakness, dizziness with near syncopal episode, headache, blurred vision, nausea, fever, rigors, swelling at the site of injection, arm pain, joint pain, shortness of breath
fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 months ago from the date of reporting). Concurrent medical conditions included tooth abscess (started on 8th April 20, for which she was taking an antibiotic and that antibiotic was making her nauseous and was also making her feel tired).   On 15th April 2020, the patient received the 2nd dose of Shingrix. On 15th April 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The patient received second dose of the Shingrix in her left arm (second dose received within six months of the first dose of the Shingrix vaccine). The reporter did not specified, the date of the first Shingrix vaccine. Before receiving the second dose of the Shingrix vaccine, the customer was being treated with antibiotics for a tooth abscess, after experiencing events from antibiotics, at the day of reporting, she went to the pharmacy to get another medication filled, at which time she received the second dose of the Shingrix vaccine.  The reporter stated she started to experience fever a few hours after receiving the vaccine. The reporter did not consented to follow up.  The reporter did not want to provide her address, the doctor's information or the pharmacy information.
Though previously very active/athletic and in good health, I began experiencing noticable muscle and joint stiffness/pain in neck, hips, lower back, knees, thighs, hamstrings in June 2021. Stiffness/pain became progressively worse over the next few months and eventually spread to shoulders/upper back and upper arms.  Bloodwork ordered by my PCP in September 2001 suggested an autoimmune disorder. PCP suspected Polymyalgia Rheumatica, but noted that this would be very unusual for someone under 50.  She referred me to a rheumatologist for further evaluation and diagnosis. I had my initial rheumatologist visit in December 2021, and medical team confirmed the diagnosis of Polymyalgia Rheumatica (though noted that this is highly unusual in someone my age). I began a course of Prednisone treatment (15 mg/day) on December 29, 2021 and am currently at the start of a taper.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Psoriatic arthritis" (unspecified if ongoing), notes: Other medical history: Psoriatic arthritis; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: METHOTREXATE, start date: 10Jul2022, stop date: 24Jul2022. Past drug history included: Guaifenesin for known allergies: guafenesin, notes: Known allergies: Guaifenesin. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Strong positive antigen test result. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Post vax, the patient developed an 8cm area of redness and warmth at the injection site.
severe diarrhea all night; severe vomiting all night; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea all night) and VOMITING (severe vomiting all night) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced DIARRHOEA (severe diarrhea all night) and VOMITING (severe vomiting all night). On 20-Apr-2021, VOMITING (severe vomiting all night) had resolved. At the time of the report, DIARRHOEA (severe diarrhea all night) was resolving. Not Provided          No concomitant medication was reported. No treatment was provided.
Patient stated she had tingly of lips, bp was 170/92. Patient checked by medical officer, opted to stay and be observed another 30 minutes. B/p rechecked 163/85. Patient discharged to home at 13:05. Advised to call PCP with any further problems.
swollen and warm to touch with cellulitis treated with zithromax X,s 5 days