chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient).  This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old.  Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided.  On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship.  It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization.  The case will be reassessed should additional information become available. 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.
Anaphylactic Shock; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic Shock) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds and Allergy NOS (other things).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic Shock) (seriousness criterion medically significant). On 31-Mar-2021, ANAPHYLACTIC SHOCK (Anaphylactic Shock) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   One minute after vaccination, he was in anaphylactic shock.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to INC.-MOD-2021-132953 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. INC.-MOD-2021-132953:
6 hours after immunizations, fussy, crying, lump, pale, CPR-EMS activated-normal by hospital arrival.
Really fatigued; Seizure for 15 minutes; Puffiness in lip; Puffiness in throat; Uncontrollable jerking  for 15 minutes; Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure for 15 minutes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure. Concurrent medical conditions included Allergy. Concomitant products included CLONIDINE, ROSUVASTATIN, LEVOTHYROXINE, PANTOPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ALBUTEROL [SALBUTAMOL], FLUTICASONE, MULTIVITAMIN [VITAMINS NOS], APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.  On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced SEIZURE (Seizure for 15 minutes) (seriousness criterion medically significant), LIP SWELLING (Puffiness in lip), PHARYNGEAL SWELLING (Puffiness in throat), DYSKINESIA (Uncontrollable jerking  for 15 minutes) and GAIT DISTURBANCE (Could not walk). On 19-Sep-2021, the patient experienced FATIGUE (Really fatigued). At the time of the report, SEIZURE (Seizure for 15 minutes) and DYSKINESIA (Uncontrollable jerking  for 15 minutes) had resolved, LIP SWELLING (Puffiness in lip), PHARYNGEAL SWELLING (Puffiness in throat) and GAIT DISTURBANCE (Could not walk) outcome was unknown and FATIGUE (Really fatigued) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included cavatelli 25mg.  Treatment information was not provided.  Company Comment - This case concerns a 74-year-old, female patient with relevant medical history of drug allergy and seizure, who experienced the unexpected event of Seizure. The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. However, patient's medical history remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, female patient with relevant medical history of drug allergy and seizure, who experienced the unexpected event of Seizure. The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. However, patient's medical history remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
This spontaneous report as received from a registered nurse refers to a unspecified patients of unknown age and unknown gender. The nurse reported that frequency unspecified patients returned to the office to complete GARDASIL (dose, frequency, route and lot # were not reported) series on alternate dose schedule. Nurse stated sometimes the second dose of GARDASIL was given to unspecified patients on the fifth month after the first dose of GARDASIL. No adverse effects were reported. Additional information is not expected as the reporter did not wish to contact.
headaches / headache never went away it increased so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "headaches / headache never went away it increased so bad ". The event "headaches / headache never went away it increased so bad " required emergency room visit.  Course of events: Caller states when it first came out she got the Pfizer covid vaccine shot and says she is current up to now. Caller states when she first got the shot all the normal things happened, headaches and everything but her headache never went away it increased so bad that she went to the ER. She had no health problems and the ER didn't say why she had the headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She described that she started a rash a couple days after her shot. She also showed me that she had a bruise from the shingrix. Lastly she showed me that she had a bruise like or stretch mark looking rash on her hip. And I could still see that 8 days after she received the vaccine.
At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a reaction including itchiness all over my body, redness all over my body, abdominal discomfort, diarrhea, vocal changes, lightheadedness, felt hot (but didn't have a temperature, 97.4 degrees Fahrenheit), joint pain.  Took Benadryl, and symptoms resolved after about an hour.
Gave child PEDIARIX (DTAP, IPV, HEP B) and Hep B instead of HIB.
Chills; Body aches; Fever; Cough; Fatigued; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included esomeprazole magnesium and ibuprofen, both from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 25Mar2021 at 11:15 (at the age of 55-years-old) for COVID-19 immunisation. The patient reported that 24 hours post injection she experienced chills, body aches, fever and a cough; further reporting the fever peaked at 100.7 and her symptoms lasted about 24 hours. She also reported she was fatigued for 72 hours after that. The clinical outcomes of chills, body aches, fever and a cough were recovered on 18Apr2021 at 12:00, the outcome of fatigue was recovered in Apr2021. It was also reported the patient was not tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
Information has been received from a public health nurse concerning a 5 year old female child who in 2004 was vaccinated with her first dose of VARIVAX (Merck). The child received her second dose of VARIVAX (Merck) in November 2008. The child developed chickenpox in the first week of January 2009. The child was seen by a nurse for medical attention. This is one of the 4 children from the same source. One of the 4 children developed 50 to 200 lesions and was prescribed Valtrex. No further information is available.
still feeling body shocks; randomly break out in to sweats just lying here; Shaky; Week; with headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SHOCK SYMPTOM (still feeling body shocks), HYPERHIDROSIS (randomly break out in to sweats just lying here), TREMOR (Shaky), ASTHENIA (Week) and HEADACHE (with headaches) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SHOCK SYMPTOM (still feeling body shocks), HYPERHIDROSIS (randomly break out in to sweats just lying here), TREMOR (Shaky), ASTHENIA (Week) and HEADACHE (with headaches). At the time of the report, SHOCK SYMPTOM (still feeling body shocks), HYPERHIDROSIS (randomly break out in to sweats just lying here), TREMOR (Shaky), ASTHENIA (Week) and HEADACHE (with headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. SD Text: AE submitted: Its the 2nd day after and Im still feeling body shocks and randomly break out in to sweats just lying here.and Im shaky and week with headaches. Will this hi away soon  Treatment information not reported.  Limited information regarding the events in this unidentified patient has been provided at this time and a causal relationship cannot be excluded.  The reported "body shocks" do not appear to be describing an actual event of "shock", but rather the impact of the other symptoms on the patient, so this event is downgraded via override function.; Sender's Comments: Limited information regarding the events in this unidentified patient has been provided at this time and a causal relationship cannot be excluded.  The reported "body shocks" do not appear to be describing an actual event of "shock", but rather the impact of the other symptoms on the patient, so this event is downgraded via override function.
Pt has a cough, body aches, chills, nausea, and vomiting for 10 days. She is admitted with COVID-19 with acute hypoxic respiratory failure, secondary bacterial pneumonia, and MS.
Strong heart Palpitations.  PVCs and PACs found later on holster monitor.  Started with only a few waking me at night.  Became more frequent and consistent over time.  Still occurring today all day long now.
Patient received flu vaccine and HPV9 vaccine. In waiting area after vaccine administered and because dizzy, pale & diaphoretic with c/o nausea. Mom picked child up and imms staff pulled a w/c over. Child placed in w/c and brought to treatment room. No LOC. Cool compresses to head and neck. She had an emesis of about 50 ml green fluid. Afterwards she said her stomach felt better but she still felt funny. Assisted to treatment bed with head elevated at 30 degrees. Had not eaten anything today. Took a few sips of water without difficulty. Eating a lollipop. BP 92/58 and per her mom, her BP normally low. Remained lying down for 10 minutes. Slowly sitting up then sitting for 3 minutes. No c/o dizziness or nausea. Skin warm and dry. Color pink. Accompanied to waiting area and allowed to go home after sitting another 15 minutes. Instructed to remind us this happened when she comes for next dose and will administer it with her in the lying down position.
Within a day of receiving my second dose of Pfizer, I have discovered an extreme sudden sensitivity to caffeine. Prior to my second shot, I have never had any issues with caffeine tolerance, no matter the amount of caffeine ingested, but after my second dose, I come down with shakes, heart palpitations, and mild nausea within only a few sips of a caffeinated product/black coffee.
contracted Covid-19 after getting both shots ofModerna vaccine; cough; lack of drug effect; fever; headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches), COUGH (cough) and DRUG INEFFECTIVE (lack of drug effect) in an elderly patient of an unknown gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches), COUGH (cough) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches), COUGH (cough) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.            No concomitant medications reported. The patient was over 80 years old that have been vaccinated with both shots and contracted Covid-19, presenting fever, headaches and cough. No treatment information was provided.
Swollen arm, pain on the arm and the shoulder, fatigue, fever, stomach upset, sever head ache
A 46-year-old female patient has been using DEPO-PROVERA injections for contraception for several years and she usually sneezed immediately after receiving one of them. She was administered her most recent 150mg intramuscular injection on 05Aug03 and, on this occasion, her eyes became puffy, her tongue and throat was tingling and tight, and she started swallowing frequently with an over production of saliva. The patient also received intramuscular BIOTHARX vaccine. The outcome of the event is unknown. The reported considered the reactions to be serious as life-threatening. Submission of a report does not constitute an admission that the medical personnel, user facility, distributor, manufacturer of product caused or contributed to the event.
Total body Aches Dizziness No able to move Extreme soreness at the ejection site Weakness of body
c/o swollen feet, headache, no fever; no local reaction; pt was seen by MD, rheumatologist, dx'd acute condition occured suddenly & cleared spontaneously-probable adverse reaction to flu shot;
- A few hours after vaccine, started to itch. 1 next day red, blotchy hives. Called a triage nurse who recommended BENADRYL and topical hydrocortisone, lasted approx. 3 days. Has hx of localized itch at injection site after seasonal flu shot.
Tingling in mouth, numb tongue and lips; numb tongue and lips; This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 04Jan2021 14:30 at single dose at left arm for COVID-19 immunization. There was no medical history reported. Concomitant medication included pravastatin, levothyroxine, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium, glucose oxidase, lactoferrin, lactoperoxidase, lysozyme, sodium fluorophosphate (BIOTENE [GLUCOSE OXIDASE;LACTOFERRIN;LACTOPEROXIDASE;LYSOZYME;SODIUM FLUOROPHOSPHATE]). On 04Jan2021 14:45, within 15 min observation period, the patient experienced tingling in mouth, numb tongue and lips. No throat swelling. The patient was given 25mg diphenhydramine. Therapeutic measures were taken as a result of tingling in mouth, numb tongue and lips. The outcome of the event was recovered in Jan2021.
sunburn type rash on arms; It was itchy & treated w/Cortisone cream & DPH lotion;
Information has been received from a physician concerning a less than 60 year old patient who was vaccinated with a dose of ZOSTAVAX. The patient had remission of genital herpes outbreaks. No medical attention was sought and no laboratory or diagnostic tests were performed. This is one of several reports from the same source. Additional information has been requested.
Pt developed R ear pressure 2 days after COVID vaccine when she woke up in the morning. Was seen at local UC and found to not have an ear infection. Discharged home. Saw her Ent on 5/12 and was found to have R hearing loss.
Tingling in right-half of tongue, numbness of right tongue, palate and of the neck. I had tongue tingling with all my shots; but not the neck/swallowing issue. After my first 2 shots, I also had abnormal menstrual bleeding (excessive). Shot 3, tingling and numbness of tongue and throat continue today. Abnormal menses since.
Patient given a Kinrix vaccine as well as a polio vaccine on 9/2/22.  Patient received 2 doses of polio. Kinrix was given before the age of 4.
Strong chills, fever (101.8 to 102.5), sweats, strong headache lasted for 48 hours.  Took Tylenol for fever till symptoms ended 48 hours later
C/o shortness of breath  routine oxygen increased cannula changed to mask oxygen sats at 88%
Pt recvd 2nd dose of vax 30DEC87 & 26JAN88 devel rt facial numbness & drooling; pt was taken to ER & dx w/viral synd; 2 days later, dx Bell's Palsy, secondary to viral synd; devel arthritic sx & a flu-like illness; cont facial drooping;
Patient presented to ER with chest pain, trouble breathing after 2nd covid immunization 2 days prior. ER did EKG and chest xray - wnl.  Labs done and unremarkable except CRP =18.92 which was attributed to immune response to vaccine.  Patient treated with albuterol and Toradol 15 mg IV x1.  Patient discharged with albuterol inhaler and follow up with PCM. VH follow up on 7/6 noted that patient doing well, no concerns.  Using albuterol prn and referral entered for allergy consult d/t history of exercise-induced asthma. 8/2 - Patient seen for PFTs and exercise induced asthma not ruled out.  Allergist noted well controlled mild intermittent asthma.  Treatment plan - loratadine for allergic rhinitis and albuterol prn for shortness of breath.  Referred to ENT for sleep study and possible evaluation / tx of apnea.
On 9/15 I went to pharmacy and received the Fluzone high-dose vaccine by Sanofi. I have continued to experience pain at the injection site on my left arm for eleven weeks. It is not constant, and not sharp, but is rather a dull ache that seems to be deep in the muscle or shoulder joint. It is a daily pain that is annoying and sometime lasts for quite a few minutes on end. Raising my arm seems to restart the pain at any time. To me, it feels like the same discomfort that normally lasts only two or three days after a normal vaccine shot. I believe my pain goes well beyond the expected side-effect of "pain at the injection site" that was published in the Sanofi materials.
Patient passed away unrelated to covid vaccination Narrative: The patient had Alzheimer's disease and was placed on hospice care. Patient received his first Pfizer vaccine on 1/16. No adverse reaction was reported. Patient passed away on 1/30. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Started with a slight headache, then became a mildly achy with slight joint stiffness. Later in the evening got the chills. Took 2 Tylenol and went to bed. Was fine the next day.
From initial information received on 10/21/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a cluster of six patients (dates of birth, ages, and genders not reported) inadvertently received a dose of TD ADS ADULT, lot number U0640AA, administered ID instead of TUBERCULIN PPD with three vaccination given on 10/19/04 and three given on 10/20/04. Sites of administration were not reported. An unspecified amount of time later, all six patients developed redness at the site of injection. Two out the six patients also developed injection site pain. In additions, two other patients out of the six also developed injection site induration. It is unknown whether any of the patients recovered from these events. The reporter of this case is the same reporter as cases 200403439 and 200403440.
Injection site swollen, red. Arm is swollen, flu like symptoms. Extreme fatigue, headache