chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5/13/04 Call from school nurse says child arm swollen, red and has heat. Child sitter called and said area was a little red & swollen last night but child kept scratching area.
Dizziness, Headache, Arthralgia, CoughWheeze, injection site pain, chills, chest tightness Narrative:
tongue and roof of her mouth went numb; tingly feeling around lips and face; This is a spontaneous report from a contactable consumer. A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Feb2021 (at the age of 54-year-old) as dose 1, single for covid-19 immunisation. Facility type vaccine was unknown. The patient medical history and concomitant medications were not reported. Known allergies were unknown. Unknown allergies to medications, food, or other products. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received any vaccines within four weeks prior to the vaccination was unknown. No prior vaccination. On Feb2021, patient experienced tongue and roof of her mouth went numb and had a tingly feeling around lips and face. No idea on timing of the event, almost immediately after the 1st dose. Patient then went into ER Emergency room (unknown location) for 3 hours after the shot (1st dose). Reporter was informed that patient was waiting on an infectious disease specialist to contact her. Her 2nd shot was supposed to occur 02Apr2021, no idea on specific date on 1st dose. The patient received any treatment for the event was unknown. Reporter did not have additional details like ER hospital location, location of dose 1, batch number etc. The outcome of all events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had the same reaction after the second shot that I had with the first  it started with slight numbing in my face and then 2 days of severe flu like symptoms including aches from head to toe and freezing and not being able to get warm I was very tired and stayed in bed for a day and a half and then it went away with no further problems
5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lightheaded.  Patient has a history of anaphylaxis and had Epi Pens with her.    1600 Vitals: BP: 184/72 P: 117 SaO2: 100%  Epi Pen self-administered.  1605 Vitals: BP: 125/74 P:103 SaO2: 100%  Nurse transferred patient to ER in wheelchair for further treatment and evaluation.
Patient called on 12/19/2022 reporting hives on her back and spreading that started  on 12/9/22.  Said it is on arms now too.
Pt's father reported red skin with fine pruritic rash around inj. site to elbow up to shoulder. Given two BENADRYL at HS (9/21/10). Awoke 9/22/10 with slight pruritus, rash cleared. Given one BENADRYL by parent, sent to school.
This spontaneous report was received from a health care professional refers to unspecified patient of unknown age and gender. On 25-MAR-2016 the patient was vaccinated with first dose of improperly stored (Oka/Merck) VARIVAX injection (dosing regimen unspecified) (lot # L000456, expiry 06-JAN-2017). Excursion details are as follows, which were exposed to the following conditions, were administered to the patient: temperature: 14.7 F, Time frame: 6 hours 42 minutes, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved upon arrival to ED. no further intervention. - observed for 4 hrs, d/c to home
herpes zoster; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions or concomitant medications. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of herpes zoster was not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown ages and genders. She reported that PNEUMOVAX 23, GARDASIL (1406USA004040) and ROTATEQ (1406USA005480) were exposed to temperatures outside the recommended range at 30.6F for 36 hours. She stated that the exposure occurred on 23-MAY-2014, and that since then, the unspecified number of patients had received doses of all three vaccine (lot#, dose and route not reported). M-M-R II was involved. But M-M-R II did not go out of temperature range in this case. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient inadvertently given rotavirus (Rotarix) 1ml po at the age of twenty one weeks and six days.  Protocol states do not start the series on or after the age of 15 weeks. No patient impact.
Mild headache in left upper corner of head. started day of shot and is continuing through the next day atleast.
Fever 101 to 102 for past 24 hours.  Started 12 hours after injection.
1 hour post vaccine: drunken state, headache 24-48 hours post vaccine: headache, fever  120 hours post vaccine: unresponsive and altered mental state
Forty hours after the vaccination, I developed a blotchy, flat ,red rash covering my entire trunk  - up to my neck and down to my where my legs meet my trunk(front and back).  The rash continued to develop on both forearms(worse on the left side) and upper arms as well(inside).  Doctors on my unit suggested I take 20mg famotidine, 10mg loratidine, 38mg Benadryl, 400mg ibuprofen. I took those medications at 4:30pm on 2/5/2021. Today, 2/6/2021, the rash is resolving. It is still visible, but definitely fading.
Dizziness and nausea, fever peaking at 101.4 deg, chills lasted for 2 days. Severe muscle aches, strong joint pain, persistent tiredness, bowel irritation lasted for more than 3 weeks so far. Examined by doctor but no treatment prescribed. Rash in right arm was visible on fourth day, below shoulder where second shot was received. Severe pain in left shoulder on third day, where first vaccine shot was received 3 weeks before second shot. Most symptoms are improved at this time, but still some tiredness and muscle and joint pain.
Deep vein thrombosis.  Developed on 12/11 or 12/12, came to see me in office with it on 12/16. Ultrasound diagnosed DVT same day.
she did not know if the patient's inability to walk was due to Guillain-Barre; Unable to walk; This is a spontaneous report from a contactable Pharmacist. A female patient in her 20's received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Apr2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The pharmacist reported that she did not have a lot of information but the incident prompted her to reach out to Pfizer. There was a situation with a young female that received her first dose of the Covid-19 vaccine last week that was unable to walk on 19Apr2021. She was unsure of where the patient received her Covid-19 vaccine. She was unsure if there were any co-factors that could have contributed to the patient's inability to walk. She reported that she did not know if the patient's inability to walk was due to Guillain-Barre. Her number one concern was that the patient was not walking. The pharmacist inquired if there was any help that Pfizer could provide. She reported that she did not know if IViG, intravenous immunoglobin, had a place in therapy for the patient. The patient was going to be admitted to the hospital at the time of the report on 19Apr2021. Clarified that the patient was not hospitalized yet and that she believed that the patient was en route to the caller's facility at time of call on 19Apr2021. The event unable to walk was reported as serious due to Medically significant. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on limited information provided, a possible relation for BNT162B2 injection and serious Guillain-Barre syndrome with secondary walking inability cannot be completely excluded, only supported by plausible drug/event chronological sequence. Other evidence or argument, indicating a contributory role in development of reported events cannot be established. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Dark thoughts; Constant shaking; Unable to get out of bed; This is a spontaneous report from a non-contactable consumer, the patient. A patient of an unknown gender and age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 09:30 as a single dose for COVID-19 immunisation. Medical history included chronic back pain and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 15:00, the patient experienced dark thoughts, constant shaking and was unable to get out of bed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dark thoughts, constant shaking and unable to get out of bed was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 20MAY97 & 29MAY97 pt exp sl pain in both feet which worsened over a period of a few days;1JUN97 pt also exp pain in hands;3JUN97 wrists & hands were so painful & swollen that pt was unable to use them;diff walking;
. Admitted to the local Hospital on 10/29/2022 for Hyponatremia:  COVID positive: 10/29/2022
Reported Symptoms: 10013963:DYSPNEA: 10043528:THROAT TIGHTNESS;  Narrative:  A 54yo female with PMH of multiple medical problems which included, Bilateral Sensorineural Hearing Loss, Knee Pain, lumbosacral spondylosis, Cervicalgia, Generalized Anxiety Disorder, Asymptomatic diverticulosis, Pain of right shoulder, GERD, Chronic PTSD, Insomnia, and Sleep Apnea.  Pharmacist reported on December 13.
chest palpitations; This is a spontaneous report from a contactable reporter. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. This consumer (Patient's wife) reported for a 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered in left arm on 26Feb2021 at 13:00 (at the age of 73 years) as dose 1, single for covid-19 immunisation. No details regarding products, patient history and investigation assessment. Declined to provide concomitant medications. The vaccination received at pharmacy/drug store type facility. The patient took Covid-19 vaccine for Covid protection. On 26Feb2021, the patient got chest palpitations but his were much more milder compare to his wife and only lasted a few hours (lasted for 4-5 hours). It was reported that he had palpitations and his went away and didn't come back on same day. Reporter and her husband didn't talk about the palpitations. It was mentioned later that night. Event did not require emergency room or physician office visit. The outcome of the event was recovered on 26Feb2021.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021252324 same reporter/drug/AE, different patient
Information has been received from a pharmacist concerning his 11 week old son with no pertinent medical history, drug reactions or allergies who on 05-FEB-2008 was vaccinated orally with a a "single dose" of ROTATEQ. There was no concomitant medication. The pharmacist reported that the patient had been experiencing 5-6 loose stools per day since 21-FEB-2008, 16 days after receiving his first dose of ROTATEQ. On 29 FEB 2008 the pharmacist contacted the physician by phones, who recommended switching the patient to a lactose free infant formula. The patient started the lactose free formula on 02 MAR 2008. At the time of reporting the patient had not yet recovered, and his symptoms were unchanged. No lab diagnostic studies were performed. There was no product quality complaint. Additional information has been requested.
8 hours after vaccine chills and shivering uncontrollably;  13 hours after vaccine got up and went to another room to get a drink and fainted.  Day after vaccine felt tired/weak and headache.  All symptoms gone the following day
Fever, Papular rash with buccal Petechiae, starting about 10 days post ProQuad administration.
Patient was given Flu Mist vaccine 6 Dec 04. Later that evening he began to have some itching and came to the medical clinic the next morning where he was examined and assessment of urticaria was made.  He was treated with Benadryl. All treatment provided was outpatient.
Both arms and hands went numb, started to tingle, then felt like they started to burn and then felt cold.  Did this for a couple of hours. Started at 4:13pm
A few days after the normal second injection reactions of fever, chills, exhaustion, saw a rapid and extreme gastro disorder. Started with significant diarrhea for several weeks, and progressed to severe cramping and very odd lower abdominal pain, as well as generally mild nausea and lethargy. Family doctor ordered blood and stool analyses, which both came back negative. Doctor prescribed anti-diarrhea meds which worked within several days, and condition improved gradually until at this time am almost back to normal. Doc also recommended gastrointerologist(?) if conditions did not improve. Of course this entire sequence of events may have nothing to do at all with the vaccine, but it is unprecedented for me.
Site is red, swollen, pt states tender to touch. Soft to palpation. Site border marked in pen, warm moist compresses QID.
fever 104 degrees Fahrenheit; headache; lost about 40 pounds; hard to walk; Muscle weakness, whole body; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In MAR-2019, the patient received the 2nd dose of Shingrix (intramuscular). In MAR-2019, immediately after receiving Shingrix, the patient experienced headache (Verbatim: headache), weight loss (Verbatim: lost about 40 pounds), walking difficulty (Verbatim: hard to walk), generalized muscle weakness (Verbatim: Muscle weakness, whole body) and fatigue (Verbatim: fatigue). On an unknown date, the patient experienced fever (Verbatim: fever 104 degrees Fahrenheit). The outcome of the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue to be related to Shingrix.     It was unknown if the company considered the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2023 The case was reported by the patient's wife. The patient received both Shingrix vaccinations in 2019, and almost immediately after the 2nd shot of Shingrix, the patient began feeling symptoms such as headache, fatigue, muscle weakness to whole body, hard to walk and fever of 104 degrees Fahrenheit. From that time to present, the patient had lost about 40 pounds, and currently weighs 108 pounds. The reporter believed that it could be a Guillain Barre Syndrome (GBS).  The reporter was contacting the patient's doctor to request testing for GBS. The reporter stated that doctors have administered many tests and scans, with no answers.  The reporter was not specific as to what tests were administered. The reporter mentioned talking with a lawyer about her husband's case, and he told her he did not have enough information to pursue a lawsuit at that time. Referred her back to her husband's physician.  The symptoms had never completely disappeared, and they reported that the symptoms exacerbate every year at about the same time (March). The reporter reported that it was a potential legal case. The reporter consented to follow up.
Severe shaking (not shivers), tongue curving at rear. Felt like I would swallow my tongue if I lay down. Lasted about 10 minutes.  I had the Moderna Booster after receiving the single J&J vaccine in April.
High fever, redness all over body, very red, swollen, lumpy right upper arm, dizziness, low blood pressure (104/65) aching joints and muscles, extreme thirst, dry mouth, confusion, nightmares.
8 am the following morning after the vaccine, I became very flushed and hot and don't remember leaving my seat at the breakfast table. I found myself on the floor on the other side of the table.  I had fainted which has never happened  to me in my lifetime.  I was drenched in sweat, and nauseous, and a headache began and lasted the day.  I spent the day resting and was fine the following day.  I do have an occasional hot flash, even at 71 years old.   I was alert, oriented, and had a bruise on my shoulder.  I had now reoccurring issues .
Left deltoid 13 1/2 x 12 cm reddened swollen and warm to touch. Rub area 2 Hrs. and apply ice pack for 15 min. for 24 Hrs - then warm compress.
Soreness, redness at injection site and underneath injection site, achy, nausea, headache and fever.
Moderna .25ml administered booster on 11/18/21 dose when it should have been .5ml b/c it was Dose #1 in the primary series.  On 11/19 Moderna .5ml administer
Fever of 104 for 72 hours that did not respond to acetaminophen/ibuprofen. Severe/debilitating body aches for 5 days. Headaches with auras that was not responsive to OTC pain medication.
About two and a half days after receiving the injection (2nd dose), I began feeling a tingling feeling and then numbness and dull pain in my left thumb.  Within the next day the feeling had expanded up my left arm to my elbow, and I began feeling the same effect in my lower left leg and left foot ... especially in the big toe.  A day later, it had expanded into the inside of my right foot ; that's when I reported it to my doctor.  He said to monitor the condition and to come in to be checked if it got worse.  After ~ 3 months, it has not gotten any worse, but the tingling/numbness and dull pain remain in my left thumb area and the inside of the left foot and big toe.
Anaphylaxis 20 mins after receiving the first dose of Pfizer covid vaccine (throat swelling, difficulty swallowing, dizziness, shortness of breath). Epinephrine 0.3mg given Intramuscular 10 mins after symptoms of anaphylaxis. EMS called and went to hospital via ambulance.
lightheadedness, dizziness immediately after vaccination; patient lay on exam table for 30 minutes after vaccination. once assessed as clinically stable, sent home. within 2 hours of receiving vaccine, developed nausea, intractable vomiting, weakness, diaphoresis. was returned to clinic where vital signs and initial assessment and evaluation/treatment performed., increase in fever 100.4 F to tmax 101.3F, lower back pain.  Brother received same vaccines without any incident.
Pt is disabled, after giving vaccine about 10 minutes, patient threw up. no other aderse reaction reported
Fatigue/Tiredness/I was tired that I could hardly get out the bed the next day; Nausea; Headache; Muscle paining; Chills; Feeling unwell; upset stomach; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), both intramuscular on an unspecified date (three weeks apart) at single dose (0.3 mL) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient wanted to know if the reaction to the vaccine after the second dose is expected to be the same than as for the first dose. She also wanted to know if the second dose of the vaccine is stronger or the same as the first dose of the Pfizer BioNtech Covid 19 vaccine. She also wanted to know if your immune system is compromised because of a heart transplant should you receive the Pfizer-BioNtech Covid-19 vaccine or follow your HCP recommendations if they know this information. The patient experienced fatigue and nausea after her first dose of the COVID Vaccine. It was further reported that "It was the Pfizer vaccine for virus (further not clarified hence, captured as Unspecified vaccine" (pending clarification). The patient reacted but not seriously, she had most of the symptoms like upset stomach, tiredness. She didn't have the injection site pain, she was tired that she could hardly get out the bed the next day and then headache, muscle paining, some chills and no fever and some nausea. Just kind of feeling unwell. And she was just wondering a little bit about the second dose that they get. She was asking if she reacted to this that way will she react even worse to the next one or do they know that. Unknown if treatment was given. Limited information was available over the call. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.