chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "a-fib" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included/Other medication in 2weeks: DEPAKOTE; AMLODIPINE; METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Known allergies: phenobarbital, reaction(s): "Drug Allergy"; Known allergies: codeine, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (01Aug2022) 101.3, notes: fever of 101.3; SARS-CoV-2 test: (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received the treatment with anti-viral details included: Brand: Pfizer, Treatment start date: 27Jul2022, Treatment stop date: 01Aug2022, Indication: Treatment of COVID-19. The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
First a feeling of nausia.  Sycope within minutes of the injections.  Fell and hit head.  Regained consciousness within a few minutes under care of the doctor.  Slightly light headed and weak the rest of the day.  Loss of appetite.
Headache and Nausea started 01/02/2022; Patient found unresponsive 01/06/2022; CT scan and MRI showed massive blood clot in brain leading  to brain hemorrhage Patient died 01/10/2022
A few days after vaccine, my left lymph node in my armpit hurt and was swollen. Then the week of 12/27 my left lymph node in my neck began to swell
I started having pain and limited range of motion in right shoulder. It started by end of spring and by end of summer I had to seek treatment for it. It got so I couldn't wash my hair or get clothes over my head, etc. I did 6 visits with a Chiropractor and got to the point where he thought I had a torn rotator cuff. I made an appointment with an Orthopedic surgeon. I had two steroid injections in it - he gave me one before MRI and then one in a different spot after the MRI. I don't have pain unless I do fast motion or try to stretch the arm beyond where it wants to go. I have started Physical Therapy and it may be helping me stretch more but it is still not great. I just had my initial Physical Therapy last week. I'll have 12 sessions altogether. He talked about surgery, and he said two or three months recovery so it's not an option for me with my work right now.
Extreme dizziness and nausea started 5/1/13 nauseousness 5/2/13 vomited 5/3/13.
Immediately post 1st shot experienced distortion of vision and severe fatigue that both lasted 5 weeks . Seen at urgent care on 8/16/21 due to severity and told it was unrelated to the covid vaccine to still get the second shot . Immediately post 2nd shot I experienced lethargy and was unable to get out of bed for 24 hours . After 24 hours I felt better but upon walking I was falling frequently. Within 6 I started to have severe chest pain, confusion, distortion of vision , right eye droop , fatigue, difficulty reading , walking into walls/ balance issues and continuing to fall. By day 9 I went to the hospital due to symptoms persisting and the chest pain being too severe to tolerate. I was admitted to a local HCF on 9/21/21.
This spontaneous report has been received from a 58 year old female patient referring to herself. The patient had a previous case of shingles. The patient was allergic to gelatin, latex and any derivatives of codeine. The patient had no concomitant medication. In approximately May 2018 (reported as about 6 months ago), the patient was vaccinated with ZOSTAVAX, 1 dose, for prophylaxis (strength, anatomical location, route of administration, batch/lot # and expiration date were not reported). In approximately May 2018 (reported as within 10 minutes of leaving the physician's office), she started going into an anaphylactic shock. Medical attention had been sought for the patient. The patient's husband drove her right back to the physician's office because she couldn't breathe, and her eyes had shut due to the anaphylactic reaction she was experiencing. Treatment was given for the event. At the doctor's office she was given two shots of cortisone to counter-act the anaphylactic reaction. No lab diagnostics/studies were performed. The outcome of anaphylactic shock was reported as recovered within one day post vaccination. No causality assessment was provided. Upon internal review, anaphylactic shock was considered to be medically significant.
poor appetite vomiting tiredness rash on chest on 07-28-11, fast heart rate on 07-28-11
12 minutes after injection, I felt flushed and dizzy.  They hooked me up to a vital sign monitor which showed my heart increasing to 133 bpm, SaO2 98%.  A manual blood pressure check was 168/110.  My heart felt like it was pounding, I was hot and sweating.  After 10 minutes or so, I felt increasingly dizzy and my vision started fading.  VS still showed tachycardia and hypertension.  It became difficult to swallow and my tongue was feeling fat.  A Rapid Response Team was alerted, they started and IV, and took me to the Emergency Department.  I became very cold and shaky.  My hands and feet became a little mottled.  They gave me 50 mg IV benedryl, 20 mg IV pepcid, a dose of solumedrol, and IM epinephrine 0.3mg, and 1 Liter of fluid.  My symptoms resolved and I was discharged home a couple hours later.
pt recv vax 12NOV95 & 23SEP97 pt devel herpes zoster T1-T2 on lt side from the front midline to back midline;the lesions range from 3mm-2cm, confluent & in clusters approx 100 lesions;pt exp moderate to severe pain;
First day: pain at injections site Second day:  Fever, severe joint/muscle ache, headache Third day and continuing:  significant swelling in lymph nodes of collarbone area Fifth day:  light-headeness, pulling-ache down inside of left arm, some chest pain.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 29-JUL-2014, the patient was vaccinated with ZOSTAVAX, SQ, single dose (lot # J003359; Exp Date: 21-JUN-2014). Co-suspect or concomitant therapies were not reported. The vaccine was expired at the time of administration. No adverse effects reported. Additional information is not expected since reporter did not give consent to be contacted.
I received my 2nd dose around 11:15am on Wednesday.  Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started.  Mine weren't nearly as bad as some others have experienced.  I didn't sleep well that night and woke up with a mild headache and body aches.  Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness.  My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm.  The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing.  I sl
Pain / when raising arm; This is a spontaneous report from a contactable consumer. A 64 years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 23Mar2021 at 10:45 (at the age of 64 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021, patient experienced sore right arm and pain when raising the arm. The patient did not receive any treatment for the event. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pain in arm was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Pt with localized redness and blistering at site of injection. Approx. 3 cm dia., NOS.
SHINGRIX Vaccine extravasation into the (L) arm subcutaneous tissue instead of intermuscular (IM).
8 x 8 cm area of erythema and swelling over (L) ant. thigh around site of vaccine. No tenderness no induration.
Patient reports feeling flushed up to 3 minutes, felt her heart was racing and felt her tongue was swollen and was nervous when she received the vaccine. Patient was observed for 15 more minutes and was cleared by EMS.
pain in the knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in the knees) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in the knees). At the time of the report, ARTHRALGIA (pain in the knees) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Twelve hours after receiving first dose, I started experiencing Chills, severe headache, sinus pressure, low grade fever, achy,  This lasted 24 hours. Headache was reoccurring  over the course of two days.  A four days after receiving the vaccine I broke out in multiple cold sores all over my lips.
Since the injection, I've had ongoing tingling and weakness in my arm.  Unable to open a jar with my hands, which I could do previously.  I feel a bit off and this has been going on since I received the shot 2 weeks ago.  Concerned about getting the second dose, which is due 3/15  - I don't want these symptoms to worsen and need guidance.
20SEP bad stiff neck, h/a-back of head, sore shoulder & arm;21SEP all of above-even cheek aches, sore wrist & elbow, sore throat;22SEP visit MD presceibed Amoxil for upper resp;23SEP call MD @ noc feeling worse;26SEP neck swollen-diff to me
Patient was administered Pfizer booster vaccination in left arm on 01/04/2022 at 1:58 pm lot number. Pfizer Vaccination was found to be expired at 1:00 pm that day. Management was contacted, Manufacturer was contacted. Patient was advised "Hospital has received reports that the Pfizer COVID-19 vaccine administered to you on [date of administration] had exceeded its thirty-one day expiration date on Feb 4th, 2022. Hospital has received guidance from the manufacturer, Pfizer, that the lot number you received, FL3198, has extended stability through Feb 18th, 2022. With this extended stability information, no repeat dose is recommended. You should continue to follow the current vaccination schedule for completion of the series. Discussed the above message with the patient. All questions answered and patient has no concerns. No adverse reaction was reported.
Information has been received from a consumer's mother concerning her 18 year old female daughter who in approximately 2008 was vaccinated with a dose of GARDASIL (dose, route and Lot# not reported). The consumer's mother stated that in November 2010, her daughter was diagnosed with cancer after receiving GARDASIL and could no specify what type of cancer it was. A colposcopy was performed (no results reported). At the time of the report the patient's outcome was unknown. Upon internal review cancer was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information was received from the consumer concerning her daughter had the GARDASIL shot's from her pediatrician when she was 15 1/2 to 16 years of age. She became sexually active at the age of 17 1/4 years old. She did not use a condom with this particular partner. She had been with her same boyfriend since 25-MAY-2010. In September her and the consumer went to their family doctor to get her birth control pills so, she had her first pap smear. It came back abnormal, so she went back again and had a second and it came back human papilloma virus test (HPV) positive high risk. They were told to see an obstetrics and Gynecologist (OBGYN) which they did, and the patient did a colposcopy (also reported as colonscopy) which confirmed she had three infected areas.  She was under a loop electrosurgical excision procedure (LEEP) procedure on 24-JAN-2011 (no results reported). She was 5' 8" and 111 Ibs. She started at 117 but she could not eat from nerves as she felt like her life was ruined forever now. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Telephone call from pt. 11/25/05 states he had swelling in axilla right and red welts on right shoulder. Beginning 1 hour after vaccination. He began taking Benadryl. Had some fatigue several days, 11/2//05 wife state "at work feeling better."
Shortly after receipt of the first dose of the Pfizer-BioNTech Covid-19 vaccine, this patient began complaining of palpitations, "warmth" radiating from the center of chest, and anxiety while in the observation area. She was moved to a quieter portion of the vaccine area where she was asked to lay supine on a bed. She did not have any difficulty breathing or swallowing and also did not have any visible rashes or hives. Her vital signs were as follows: 3:00 PM- BP: 148/85 mm Hg, HR: 144 beats/minute, SpO2: 100% 3:05 PM- BP: 148/85 mm Hg, HR: 156 beats/minute, SpO2: 100% 3:11 PM- BP: 120/76 mm Hg, HR: 127 beats/minute, SpO2: 100% 3:17 PM- BP: 120/76 mm Hg, HR: 120 beats/minute, SpO2: 100% 3:22 PM- BP: 130/77 mm Hg, HR: 132 beats/minute, SpO2: 100%  Emergency medical services was called. She stated she felt better around 3:17 pm onwards, however, it was suggested that she visit the Emergency Department due to her ongoing tachycardia. She was subsequently transferred to the Emergency Department for observation and work up. She is awaiting work up currently in the Emergency Department, without any complaints asides from anxiety.
Redness on injection area (2in x 2 1/2in), warm to the touch (left thigh).
nauseated; Rash/all over her body/I woke up in a rash and yesterday it was worst; allergic reaction to something because she just woke up in a rash it didn't itch; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249) injected via an unspecified route of administration in the left arm, on 22Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included blood pressure (disorder). Concomitant medications included losartan for blood pressure, montelukast, estradiol (ESTROGEN), metoprolol, esomeprazole, rosuvastatin calcium (ROSUVA). Patient got the COVID vaccine on Friday (22Jan2021), Saturday (23Jan2021) started breaking out in a rash, all over her body. She woke up in a rash and yesterday (24Jan2021) it was worst and she was nauseated; she was having allergic reaction to something because she just woke up in a rash it didn't itch (Jan2021). This was her first dose of the vaccine. She didn't get the vaccine from her doctor, she called into the hospital, the hospital was giving them out on Friday (pending clarification). She was wondering if there is any way she can get something for the rash. Patient did not have treatment for the events. Outcome of rash was not recovered, outcome of other events was unknown.
CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced chills and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious.
I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; Tiredness; Headache; Nausea; Feeling unwell; Arm pain; Weakness; Short of breath; This is a spontaneous report from a contactable consumer (patient).    A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration, administered in Left arm on 03Jun2021 at 17:00 (at the age of 55-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. and the patient had no known allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, probiotic supplement (PROBIOTICS NOS) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185, Expiration date: unknown), via an unspecified route of administration, administered in Left arm on 13May2021 17:00 at the age of 55-years-old for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04Jun2021 at 11:00, the patient experienced side effect Injections pain, swelling, redness, itching, Tiredness, Headache, Nausea, feeling unwell, Arm pain, Weakness and Short of breath. patient did not received any treatment for adverse events. The outcome of the events was unknown. .
10 days after my vaccine 2/25/15  I had the most severe attack of vertigo that I ever had.  It passed and then I was fine.  Just wondering could this have been caused from the vaccine.  It will be interesting what happens after my second vaccine. Vaccine was Moderna as above
Initial medication error report received on 05 December 2013 from a consumer: A 32 year old male patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route, lot number and site of vaccination was not reported) on an unspecified date. Consumer stated that he received FLUZONE HD and is only 32 years of age. Patient did not have any adverse events. List of documents held by sender: none.
Patient got light headed, was helped to the floor, remained conscious. after about 10 minutes was able to get to chair, offered water, then after a few more minutes was able to leave
Headache, Myalgia, BODY ACHES, CHILLS Narrative:  Reports that at approximate 0230 this morning developed headache, chills, body aches.
18 y.o. female who was initially admitted to Hospital with concern for retropharyngeal phlegmon/developing abscess whose course was complicated by shock (sepsis vs cardiogenic), now thought to have MIS-C.    Four days prior to hospital admission, patient developed sore throat and high fever. This was managed with tylenol. She continued to have daily fever with a Tmax 103F prompting her to begin alternating tylenol with ibuprofen yesterday. Her symptoms progressively worsened and has been accompanied by frontal HA, decreased appetite, two days of non-bloody diarrhea, abdominal pain (periumbilical), 1x NBNB emesis, and overall lethargy. She also developed pain with neck motion, swallowing, and opening of her mouth.  Diagnosis: Principal Problem: Multisystem inflammatory syndrome associated with COVID-19 Active Problems: Retropharyngeal abscess AKI (acute kidney injury)  Elevated liver enzymes Septic shock  Hypoxemia Cardiogenic shock  Acute respiratory failure  Acute hypoactive delirium due to another medical condition Lactic acidosis Generalized anxiety disorder Decreased cardiac ejection fraction Coronary artery abnormality  Treatment: Supplemental Oxygen: Nasal cannula, High Flow Nasal Cannula, Bipap Vasoactive medications:  Norepinephrine, Epinephrine, Dobutamine Steroids Anakinra Aspirin, Plavix Heparin drip, Lovenox IVIG
occurred on 6/25/19 vaccinated, 7/25/19 iritis initially occurred, vaccinated sec; This non-serious case was reported by a physician via call center representative and described the occurrence of iritis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-JUN-2019, the patient received the 1st dose of Shingrix. On 25-JUL-2019, 30 days after receiving Shingrix, the patient experienced iritis (Verbatim: occurred on 6/25/19 vaccinated, 7/25/19 iritis initially occurred, vaccinated sec). The outcome of the iritis was not reported.   It was unknown if the reporter considered the iritis to be related to Shingrix.   It was unknown if the company considered the iritis to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR097564   Additional Information: GSK receipt Date: 14-JUL-2023 The patient was vaccinated with Shingrix and iritis initially occurred, The doctor would like to be contacted by email by medical information to discuss his condition. The reporter agreed to follow up from GlaxoSmithKline. For tolerance of 2nd dose of Shingrix, refer case US2023AMR097564.; Sender's Comments:  US-GSK-US2023AMR097564:Same patient. second dose
After receiving shot on 12/10/19 in the morning, pt developed hives from neck to feet that night and went to the ER at 1am.  Pt was given steroids for treatment.  Pt spoke with her MD, but first contacted the pharmacy on 12/16/19 about the event. As of 12/117/19, patient has yet to fully recover.  Still has rash on legs.
Patient was given the following vaccines: Hep B pediatric, MMR, Polio, and HPV.  After vaccination, patient began to look pale in color and complained of feeling faint, but did not faint. Patient was advised to put her head down between her legs and given water and a snack.  Patient left after 15 minutes after verbalizing feeling better.
Diagnosed with COVID July 2, 2022.  Stayed home until I felt better.
Received COVID-19 Moderna vaccine 02/03/2021. At return appt on 03/03/21, pt reported that her hands peeled. Visible peeling noted at time of 2nd vaccination.
Tenderness of left arm began at 4:00 pm, worsening to disabling pain by 10:00 pm. By 8:00 pm felt very chilled. By 11:00 pm very cold and began shivering, head / sinuses felt clogged and swollen, eyes swollen, tender, joints achy. Temperature at 11:00 pm: 100.5. Went to bed with heating pad, after taking 2 - 325 mg aspirin + 100mg trazedone. At 1:00 still awake, warmer, temperature of 102. Temperature remained at 102 for at least 4 - 6 hours, returning to 100 at 9:30 am 7/3 without any remaining sinus congestion. Continued with 100 degrees fever, aches, tiredness, until 10:00 pm 7/3, when temp returned to normal. Left arm remains tender at 6:00 pm 7/4, but all other symptoms subsided.