chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: May2021), via an unspecified route of administration in left arm 03Feb2021, at 10:50 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Prediabetes (5 years ago) and obviously overweight and had cat bite. The concomitant medication was not reported. The patient previously took historical vaccine, on an unknown date in Jan2021 (she got the first dose three weeks before on a Wednesday), first dose of bnt162b2 for COVID-19 immunisation and had no reaction. On 03Feb2021 (early evening) the patient experienced a bad headache and was very tired. Caller says where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that. She says she also had muscle aches and pains. The patient took Aspirin (UPC 9629513147, LOT: P115130, EXP: May 2021) for the event muscle aches and pains at a dose of 325mg, one before bed, took three during night total. The patient reported that she slept and slept and slept on an unknown date in Feb2021. It was reported that patient lots of bloodwork done over the years but if she eats correctly it goes away, then if she gets into the sugar, it comes back. The outcome of the events, where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that and she also slept and slept and slept was unknown while for other events was recovered on an unknown date in Feb2021.
Dizzy, lightheaded, faintness, rapid heartbeat, sweating, blurry vision  Later in day: severe headache,  103 temp, severe joint pain making ambulation difficult
itching; This is a spontaneous report from a contactable nurse reported for herself. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date unknown), via an unspecified route of administration on the right upper arm deltoid on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history included Gallbladder removal from 2019 to 2019, asthma but grew out of it which the last time she had an attack was when she was 12 years old, C-sections for her kids. The patient concomitant medications reported as none. The patient was got the COVID vaccine, the first shot and she experienced itching that's why she took the Benadryl 50 mg. She didn't know if that was normal for people who had the covid vaccine to experience this. The vaccine was received on Monday, 28Dec2020 and the itching started Tuesday on 29Dec2020. She was ok on Wednesday 30Dec2020 but today she is itching again. She took Benadryl 50mg the day the itching started, just once and the next day she was fine. It is explained that the itching was not severe and she was not scratching her skin, she just feel itchy like something was crawling on her skin. She has no known allergies but does remember when C sections had for her kids, she had severe itching with the epidural, she experienced this with but it happens every time she gets an epidural. She has had no adverse events or allergic reactions to any other vaccines. The vaccine was administered on the right upper arm deltoid. The outcome of the event was not recovered.
No adverse events were noted; It was not noted until the patient arrived to receive her 4 month shots that it appears she had received 2 polio vaccinations with her 2 month vaccine series.
No swelling FR (R) deltoid muscle today but swelling and redness has gone down to lower anterior arm. Swelling/induration around 10x12 cm, redness 12x15 cm. Pt also C/O itching. RX: KEFLEX x 7 days, Triamcinolone CR.
This spontaneous case, initially received on 01-Dec-2016, was reported by a non health professional and concerns a 48-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 10-OCT-2016 to 10-OCT-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: 12649211A, Site: Right deltoid. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced injection site reaction - the upper arm is forming blisters (outcome: not recovered / not resolved), injection site reaction - the upper arm is red (outcome: not recovered / not resolved), injection site reaction - the upper arm is swollen (outcome: not recovered / not resolved).
granuloma  on the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site granuloma in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 47CX9, expiry date 29th May 2002) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2020, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st December 2020, less than a day after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced injection site granuloma. On an unknown date, the outcome of the injection site granuloma was not recovered/not resolved.   It was unknown if the reporter considered the injection site granuloma to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient administered Pediarix to left thigh and developed a granuloma  on the injection site on on same day. The Vaccine Administration Facility is the same as Primary Reporter. No patient initials provided. The reporter consent to follow up.  Error correction was performed on 12th January 2021: The classification Exclude from Regulatory Authority was removed from general tab.
redness, pruritis of right arm, along w/ axillary pain, and erythema of bilateral cheeks, headache, onset next day
Fever all day Saturday and into Sunday morning. Hot , then fever would break, sweating, then fever would rise again. Took Ibuprofen to help lower fever.  Hip pain in right hip is still very uncomfortable. Red and swollen at the injection site.
Pt recvd vax 16MAR93 & exp flushed skin, heart palpitations, chest discomfort & difficulty breathing; sx persisted for several hrs; BP @ the time of exp was nl; By the next day, asymptomatic; No further details were provided;
Within 10 minutes of receiving flu shot for 1st time, pt was gasping and c/o SOB. Respirations were labored. 911 was called.  Epi .5ml was given IM.  VS  BP180/110, P98, R28. Pt's skin was pale and clammy.  Pt wheezed for 2 minutes, then started to talk. EMS arrived 3:23; pt was able to walk to ems cot.  Pt transported to Hosp.
Low grade fever; Fatigue; Body aches; Chills; Swelling on the juncture of neck/shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (Body aches), CHILLS (Chills) and SWELLING (Swelling on the juncture of neck/shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (Body aches), CHILLS (Chills) and SWELLING (Swelling on the juncture of neck/shoulder). At the time of the report, PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (Body aches), CHILLS (Chills) and SWELLING (Swelling on the juncture of neck/shoulder) outcome was unknown. Not Provided    No relevant concomitant medications were reported.  Treatment was not provided.
Guillain Barre syndrome; she can hardly walk without any assistance; Condition worsened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced GAIT INABILITY (she can hardly walk without any assistance) and CONDITION AGGRAVATED (Condition worsened). On 04-May-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), GAIT INABILITY (she can hardly walk without any assistance) and CONDITION AGGRAVATED (Condition worsened) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Nerve conduction studies: inconclusive (Inconclusive) Inconclusive. On 11-May-2021, Physical examination: inconclusive (Inconclusive) Inconclusive.         The concomitant medications were not reported.  After the 2nd Moderna vaccine the patient reported that her condition had worsened. She can hardly walk without any assistance.  On 04-May-2021, she went in to see her doctor and was told she could possibly have Guillain Barre Syndrome from  the Moderna Covid-19 Vaccine.  She had a Nerve Conduction Test and full physical examination done on 11-May2021,  but is to undergo additional tests yet to rule out other conditions and to confirm Gillian Barre Syndrome coming from the Moderna Vaccine.  She will be having her Next Office Visit on Tuesday and yet had to schedule a Magnetic resonance imaging (MRI,) unspecified spinal test and an electroencephalogram  (EEG).  The doctor wants to get all tests done yet before starting treatments or drawing up a conclusion.  The treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-128666 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
c/o dizzy 15 min after shot - 10-15 min BP 120/80. Patient remained at office extra 15 min and dizziness resolved before leaving.
almost died from the flu; Initial information received on 29-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographics) who almost died from the flu (feeling abnormal) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date of 1984, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient almost died from the flu (feeling abnormal) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
More than 24 hours after vaccination in right deltoid, pt developed 2 erythematous papules (0.5cm each) on anterior deltoid and red streaking from deltoid to axilla.  No fever.  No area of induration or fluctuance in deltoid.  Pt sent home with Keflex.
A parent reported that her 2 year old son received his first dose of Prevnar on 08/22/00. On 08/30/00, he experienced a seizure. Twenty-two days later, he experienced a second seizure. The seizure is considered a medically important event. The reporter stated that she submitted this report directly to VAERS. Follow up information was received from the child's neurologist on 11/14/00, who stated that an EEG was performed and that the results were "abnormal."
Patient received Fluzone vaccine at pharmacy. Approximately 15 minutes later, pt returned to pharmacy stating that her throat felt swollen, and she had redness on her neck/upper chest area. RPh gave her 50mg diphenhydramine, and she sat in the consult room for 15 minutes for observation. Pt said her throat swelling had improved and she felt okay to go home. RPh talked to pt on the phone approx 50 minutes later (to follow up after pt got home). Pt said that she felt itchy, the redness on neck and chest had spread and was looking like hives. She has prednisone on hand at home which she was going to take. She also has an epi-pen at home if she should need it. RPh recommended pt to take another dose of benadryl at home around 6:30pm and at bedtime today, then re-assess tomorrow. RPh also advised her to use the epi-pen and/or go to the ER if symptoms continue to escalate and she agreed.
Date: 3/23/2021  Problem: Syncope Notes: Client requested a bottle of water upon returning with the water client noted to fall out of his chair. Staff was able to reach him before he hit the ground, guiding his head downward off setting some of the impact from the fall. Client states he does not remember the fall. He also states he has a history of fainting when he gives blood. AAOx3 T 97.4 P68 R18 BP 124/72 O2 97% RA Client monitored for an additional 30 minutes. States he feels fine after 30  mins. T98.0 P72 R20 BP 126/70 O2 98% RA. Client left facility AAOx3 via personal vehicle.
This spontaneous report as received from a 71 year old female consumer on herself with none pertinent medical history and non reaction/ allergies. On 14-MAR-2013 the patient was vaccinated with ZOSTAVAX (Lot # not provided) upper left arm (dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. On 17-MAR-2013, the patient developed a big red,  hot, itchy 8 mm area at the injection site. The patient reported that a couple a days later, the area grew to 17 mm (1/2 dollar size) and was swollen down to her elbow and up to her armpit. The patient reported that went to urgent care and was prescribed BENADRYL, CORTIZONE (dose and manufacturer not specified). Labs diagnostics were not performed. The outcome of the patient had developed a big red at the injection site, was swollen down to her elbow and up to her armpit, itchy 8 mm area at the injection site and hot at the injection site was reported as recovering/resolving. Additional information has been requested.
I am listing all of the doctors we have been to and I will start with our family doctor who is an Internal Medicine doctor where I had the worst symptoms. He had a neck X-ray and an MRI of the head and brains to rule out that area of real concern. Then I went to a Gastroenterologist and had a gastroscopy and Endoscopy. Then I went to an Infectious Disease doctor and then I went to a Rheumatologist. After all of the doctors and all the tests were completed; all were negative. This all started on 12/01/00, when my wife and I went to MD for our Flu shot at 08:30 AM and at 18:00PM, that night, I started and the next day my wife started with the same symptoms I had. At that time we were both eating roast duck which we bought at a public store. These ducks came pre-cooked and frozen (you just cook them for 45 minutes). We had been eating them for some time. When we went to buy more they stated the store had a recall on them. After a time of being sick, I asked the store manager what the recall was for. He checked and could not find what the cause was, for the recall. We tried to think what we both done and the only thing was the Flu shot and the duck where there was a recall on them. I wonder if you and your associates could please help us if possible to get to the bottom of this nightmare. It has been hell on earth with all the symptoms of violent headaches (both front and rear), sore muscles, raw stomach, dry mouth, metallic test in the mouth and we feel like we are dehydrating with all the water we are drinking, runny nose, perfuse sweating and neck pains. I thank you people for anything you can do for us and will do whatever it takes.
AM after administration, patient awoke with following symptoms swollen sinus, eyes and lips with difficulty in breathing. She has also continued with diarrhea for past 3 days. Patient took BENADRYL and will try IMODIUM for diarrhea may contact her PCP.
"Got a really bad headache, shortness of breath, began swelling, fluid up, nausea." Went to ED and given 1 day off work.
Pneumonia; tested positive to covid; Bronchitis; Low grade fever; A spontaneous report was received from a 74 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) was tested positive for Covid and experienced pneumonia, had a little bit of phlegm, bronchitis, and low grade fever.  Patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 16 JAN 2021, the patient tested positive for Covid. He also experienced pneumonia, bronchitis, low grade fever and had a little bit of phlegm. He took antibiotics and was quarantined for 14 days. He went back to his doctor for a second round of amoxicillin after 14 days.  On an unknown date, the patient was tested negative for Covid.  On 10 FEB 2021, he went back to receive second dose of Moderna vaccine and was told to wait for 90 days, although he said he was tested negative from Covid.  Action taken with mRNA-1273 in response to the events was not provided.  The event, tested positive for Covid was considered resolved and outcome of the events pneumonia, had a little bit of phlegm, bronchitis, and low grade fever was not provided.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of pneumonia, bronchitis and positive for SARS-CoV-2, are assessed as unlikely related.  The event of pyrexia is an expected event.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. The physician reported for her son. A 3 year-old male patient received four doses of PREVENAR 13 single dose, on an unknown date, for immunization. Relevant medical history included chronic sinusitis (he was constantly sick with chronic sinusitis before receiving pneumococcal 13-val conj vac (dipht crm197 protein)). Concomitant medications were unknown. It was reported that on 29Dec2016 his titer levels were checked and they showed no response despite receiving all four doses of (PREVENAR 13. After the titer level did not show response to PREVENAR 13, the physician tried PNEUMOVAX on 12Jan2017 but the results back were the same (on 22Feb2017). PNEUMOVAX was not considered successful either.
Had 1st stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose 1, single (Lot number: EN6200, Expiration Date: 30Jun2021) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Cholesterol abnormal" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 10Mar2021 at 13:00, outcome "recovered with sequelae", described as "Had 1st stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)). The event "had 1st stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive; (Jan2023) Negative. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical Course: Patient had 1st dosage of Pfizer Covid 19 vaccine on 09Mar2021, then had 1st stroke 10Mar2021. Went to Hospital Emergency Room. Was advised of stroke, given meds, then med-flighted to a Hospital and was admitted for 3 days. Adverse event treatment: treatment: Medications, testing, observation. Other medications in two weeks: YES, Facility type vaccine: Public Health Clinic.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143181 Same patient, same product, same event (Dose 2);
mouth no taste or smell; mouth no taste or smell; Mouth appears to be inflamed and beet red; Mouth appears to be inflamed and beet red; cold symptoms/Worst cold she has had in her life; sneezy; headache; foggy; Woke up in the morning not feeling well; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), via an unspecified route of administration, administered in arm left on 04May2021 10:30 (at the age of 57-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient had cold symptoms and described as the worst cold she has had in her life, and experienced sneezy, headache and foggy. On 12May2021, the patient experienced mouth no taste or smell, and was concerned about her mouth appears to be inflamed and beet red. It was also reported that the patient woke up in the morning not feeling well on May2021. Therapeutic measures were taken as a result of the events as patient was treated with Claritin. The outcome of the cold symptom/worst cold she has had in her life, mouth no taste or smell and mouth appears to be inflamed and beet red was not recovered; outcome of sneezy, headache, foggy and woke up in the morning not feeling well was unknown. The events did not require a visit to emergency room or physician office. Reporter seriousness for the events was medically significant. Relatedness of drug to reactions/events: Reaction assessed: cold symptoms, mouth appears to be inflamed and beet red and no taste or smell. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179),  to reported events is possible based on temporal association and known profile of the product.