chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bump at vaccination site and it was itchy; bump at vaccination site and it was itchy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age:70, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 14Jan2021 and still has a bump at vaccination site and it was itchy. The patient wanted to know if it was normal. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
2/17/21 at 7:00pm; extreme fatigue, massive headache, chills, nausea; couldn?t stay awake, slept for 12 hours.   2/18/21 at 7:00am; difficulty waking; fatigue, muscle and joint pain; moderate headache; nausea; diarrhea; dizziness, minimal relief with Tylenol and Tums. Continued all day.   2/19/21 all day; muscle and joint pain, fatigue, chills; dizziness  2/20/21 all day; headache at least twice and dizzy spells at least four times; fatigue, chills; temperature ranged between 95.4-96.2; nausea; lost of taste  2/21/21 all day, no headache; chills; inability to stay warm, inability to taste (even tried straight sugar and daughters sour candy), dizzy spells so far three times. No loss of smell.
Moments after the vaccine administration, pt started to experience difficulty breathing, lightheadedness, flushing of the face, swelling of lips. Epinephrine 0.3 mg IM was administered, 911 contacted. A few minutes after the epinephrine administration, pt started to breath better. EMT came in within 5-10 minutes. Checked pt's vitals, administered required care and took the pt to the ER.
A nurse reported that a pt received tetanus toxoid approx. 15 years ago and subsequently, experienced chest pain, "lock jaw" and neck swelling. The pt was hospitalized; he recovered. As of 11/21/00, no further information was available.
Patient reported palpitations beginning in the evening of the day she received her vaccine. She said they persisted for two more days following vaccination. She said she is now feeling better and no longer experiencing palpitations. She did not seek treatment for this side effect. She reported it to the pharmacy on 2/19/21.
first dose of Shingrix 9 months ago / has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, 9 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist refused to answer any questions.
This spontaneous report as received from a medical assistant refers to a 9 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009323:Original Case : 1902USA009323 .-009507513-1902USA009326:Original Case : 1902USA009323.
Had vacc on 5/11/15, reaction occurred later that day. Fever 103 degrees, leg pain, swelling, redness around site. Dr saw pt. on 5/13/15, fever 103 degrees, sweating-inj area red/swollen 6.5 inches vertically x 8 inches horizontally, splotchy red raised patches. Tx with KEFLEX: Dexamethasone.
Significant bone pain in both legs from hip to toes without any associated injury.  Symptoms came on over a couple of hours on Wedsday evening and disappeared as suddenly Sunday morning
Patient found to have large pericardial effusion without tamponade. He is now status post sub-xiphoid pericardial window with subsequent drainage of effusions. Pericardial pathology showed hemorrhagic pericardial tissue with marked acute and chronic inflammation and adherent fibrin consistent with fibrinous pericarditis. Patient endorses improved symptoms post-operatively, remains afebrile, and is without leukocytosis. Minimal residual pain is likely secondary to his recently removed chest tube. Medical team plans to discharge patient today.
Patient reported that within seconds of getting the vaccine (1st dose), he had immense pain and rush to back of head with swelling. Could only walk 10 feet before getting short of breath and lightheaded. Noted throat swelling. Sharp sensation in arms, numbness and tingling in hands. Noted tachycardia until next day. Continues to have lower abdominal pain that started evening after his injection.
Within 2 to 3 hours of the first vaccine I developed ringing in both ears.; This is a spontaneous report from a contactable consumer. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 08:00 (Lot number: ER8729) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: VIACTIV [CALCIUM]; VITAMIN D [VITAMIN D NOS]. The following information was reported: TINNITUS (non-serious) with onset 14Apr2021 11:00, outcome "not recovered", described as "Within 2 to 3 hours of the first vaccine I developed ringing in both ears.". The event "within 2 to 3 hours of the first vaccine i developed ringing in both ears." was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Facility type vaccine was other. There was not any other vaccine in four weeks. Other medications in two weeks were Multi vitamin, vitamin D, Viactiv and cholesterol. On 14Apr2021 at 11:00, within 2 to 3 hours of the first vaccine patient developed ringing in both ears. The physician said there was no treatment for tinnitus. Patient did not experience covid prior vaccination. Patient did not test covid post vaccination. On 05May2021, patient took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0172; Expiration date: not provided) via an unspecified route of administration in left arm as dose 2, single for Covid-19 immunization.  No follow-up attempts are possible. No further information is expected.
A week and a day later from vaccine given I woke up with my deltoid area swollen, red and warm. Quarter size at first and then continued to increase in size to about 3 inches round.
She received the first dose of the Moderna vaccine on 4/16.  She reports last night she developed a half dollar sized raised, warm, red rash just below the injection site on her left arm. It has now spread to the size of an iphone and her neck also has patches of scattered red dots that just appeared today. She denies pain or itching.  Denies swelling of the neck or face.  Denies fever. Saw PCP on 4/28-diagnosed with "COVID arm" Zyrtec, Benadryl, famotidine and ice TO call if symptoms worsen
Ongoing chills and fever, body aches and arthritis pain going on 7 days.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
On 04/09/2022 around 12:00, I started to have a tickle in my throat and a dry cough. I knew I had been exposed to a positive case and that is initially why I tested. I took two at-home tests that were negative. On the 10th, my cough got worse and I had a headache, On the 11th, I got congested and ran a fever for two days. I was very fatigued the whole time. The only other symptoms was on the 11th or the 12th I had terrible joint paint in the knuckles on the right hand only. I spoke with my PCP and my Pulmonologist by phone. My PCP told me to continue to take Ibuprofen for fever and take Robitussin for cough. I take Flovent PRN for my mild asthma but my Pulmonologist advised me to take it regularly twice a day for a couple of weeks. I haven't tested again but I would say I am still easily fatigued and have dry cough.
Worsened fatigue; Inability to eat; Pain in her bladder; Foul smelling urine; Arthritis worsened; Knees were swollen; Vaccine site bruise; hypotension; Fever of 100.4; Reoccurring headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Worsened fatigue), FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine) and ARTHRITIS (Arthritis worsened) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Influenza: Influenza (severe connective tissue disease flare) in 2020. Concurrent medical conditions included Clotting disorder since 2004, Sleep apnea since 1996, Degenerative joint disease (Worsening) since 1976 and Neurological disorder NOS (intermittent symptomatic worsening) since 2019. Concomitant products included WARFARIN for Clotting disorder, CANDESARTAN from an unknown date to 07-Mar-2021 for Hypertension, FOLINIC ACID and METHYLCOBALAMIN for Neurological disorder NOS.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Worsened fatigue), FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine), ARTHRITIS (Arthritis worsened), JOINT SWELLING (Knees were swollen), VACCINATION SITE BRUISING (Vaccine site bruise), HYPOTENSION (hypotension), PYREXIA (Fever of 100.4) and HEADACHE (Reoccurring headache). At the time of the report, FATIGUE (Worsened fatigue) and JOINT SWELLING (Knees were swollen) was resolving and FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine), ARTHRITIS (Arthritis worsened), VACCINATION SITE BRUISING (Vaccine site bruise), HYPOTENSION (hypotension), PYREXIA (Fever of 100.4) and HEADACHE (Reoccurring headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100.4 (Inconclusive) Fever at 100.4. On 06-Mar-2021, International normalised ratio: 5.4 (High) INR went up to 5.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-058249.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: F/u received on 24-MAY-2021 , patient demographic details was updated, patient medical history was updated , events was updated, concomitant medications was updated.
Patient received the  Pfizer Pediatric Bivalent COVID vaccine, 0.2mL undiluted. Patient was stable during the 30 mins observation and no further treatment was needed at time of discharge. Patient's parents were advised to inform their PCP and follow up with them for any other concerns.
Fever above 101 for more than 6 hrs. Also high pitched scream & unconsolable for 6-8 hrs.
DELIRIUM; SEVERE NAUSEA; NUMBNESS IN LEFT ARM; This spontaneous report received from a patient concerned a 24 year old male. 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, and batch number were not reported) dose was not reported, 1 total, administered on left arm, on around an unspecified date of AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 24 years old. No concomitant medications were reported.  On AUG-2021, evening of vaccination, the patient experienced delirium, severe nausea and numbness in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from delirium and severe nausea after 3 days, and from numbness in left arm after about a week.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220901837- Covid-19 vaccine ad26.cov2.s- Delirium. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Chest pains that woke me up on during a weekend night (either Saturday or Sunday). Pain went away about an hour later. Occasional chest pains continued. Went to ER on Tuesday, and was admitted. Primary diagnosis was acute myocarditis. Also had a fever (around 101 degrees, but varied) for 2 days following the vaccine, but no fever after those 2 days. I also had arm soreness for about 2 days following the vaccine.
NAUSEA/VOMITING BEGAN 03/05/2021 IN THE PM
Paxlovid Rebound; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Paxlovid Rebound) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced IMMUNISATION REACTION (Paxlovid Rebound) (seriousness criterion life threatening). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, IMMUNISATION REACTION (Paxlovid Rebound) was resolving.            No concomitant medication information was reported.  Unknown if any treatment medication was provided.  It was unknown whether the patient took any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.  Paxlovid Rebound device date was 28-May-2022  Company comment: This is a spontaneous case concerning a 27-year-old male patient with no reported medical history, who experienced the unexpected serious (seriousness criterion life threatening) event of immunization reaction. It was reported that immunization reaction described as Paxlovid Rebound which occurred 6 days after the patient completed a 5-day course of Paxlovid. The patient had received a third dose of mRNA-1273 (Spikevax) 6 month 20 days before the event of immunization reaction. Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 27-year-old male patient with no reported medical history, who experienced the unexpected serious (seriousness criterion life threatening) event of immunization reaction. It was reported that immunization reaction described as Paxlovid Rebound which occurred 6 days after the patient completed a 5-day course of Paxlovid. The patient had received a third dose of mRNA-1273 (Spikevax) 6 month 20 days before the event of immunization reaction. Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Client presented to  Vaccine Unit on May 3, 2021 and received the Janssen vaccine. He did not bring his vaccine card back and presented again on May 24, 2021 and received another Janssen vaccine. When he filled out the patient information sheet he marked that he had not ever received a COVID-19 vaccine in the past. The vaccinator proceeded with his Janssen vaccine. It was not known that he received an additional vaccine until the information was input into the vaccine program. There is no way to notify the patient because he did not list a phone number or address of record. The vaccinator, upon query, remembers him having the appearance of possibly being transient. In summary, the client received 2 Janssen vaccines, 21 days apart and is lost to follow up.
Extreme headache; Jaw pain; This is a spontaneous report from a contactable consumer reported that a 54-year-old male patient that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that his brother received the first dose of Pfizer vaccine and developed extreme headache and jaw pain for 1 week. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
angiodema; face / became swollen; lips became swollen; tongue started swelling; throat / started swelling; Fever; This case was reported by a consumer via call center representative and described the occurrence of angioedema in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2020, less than a day after receiving Shingrix, the patient experienced fever. On 13th October 2020, the patient experienced swollen tongue and throat swelling. On 26th October 2020, the patient experienced facial swelling and lip swelling. On 28th October 2020, the patient experienced angioedema (serious criteria GSK medically significant). The patient was treated with prednisone. On 28th October 2020, the outcome of the swollen tongue and throat swelling were recovered/resolved. On an unknown date, the outcome of the angioedema, facial swelling and lip swelling were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the angioedema, swollen tongue, throat swelling, facial swelling, lip swelling and fever to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself. The patient experiencing angioedema.  The patient stated his throat and tongue started swelling up about a week after the injection. After about 4 weeks, his face and lips became swollen. The patient went to the emergency room on day before reporting and received prednisone.  The patient's health care professional would have him follow up with an allergist.  The patient still experiencing some swelling of his face and lips. The reporter consented to follow up.
EXTREME CHILLS, HEADACHE, WEAKNESS & TINGLING IN BOTH ARMS & LEGS, DIZZY, NAUSEA, FATIGUE.
mom states redness & sl swelling of rt thigh noted yesterday 7APR93; area of inject site red & skin warm to touch; mom to take pt to MD for eval; only sm hard area noted @ site;
Approximately 6 hours after receiving the injection, chills began.  Then headache, low grade fever, neck ache. Then nausea and vomiting.  I couldn't keep anything down.  About 24 hours after the side effects began, I started to feel better.
Injection site is warm to the touch; Injection site itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to the touch) and VACCINATION SITE PRURITUS (Injection site itches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to the touch) and VACCINATION SITE PRURITUS (Injection site itches). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to the touch) and VACCINATION SITE PRURITUS (Injection site itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Reporter did not allow further contact
Stable after vaccine administration. 10 days later, presented in extremis to the Emergency Department - sepsis / respiratory failure. Transferred to higher level of care (PICU), where the patient died 4 days later of COVID pneumonia.
SUDDEN DEATH - PULMONARY EMBOLUS DUE TO DEEP VEIN THROMBOSIS RIGHT POPLITEAL VEIN
02/01/00, vaccines given and pt developed a papular rash on both legs and took 6 days to go away.
Body ache, chills/sweats, headache, sore throat, fatigue, diarrhea for seven days. And lasting fatigue into the 10th day following.
expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Gave patient KINRIX to RD/IM on 5/04/10. Patient came back to the office 5/06/10 w/ a reaction, there was inflammation to the ( R ) arm. It measured @ 60 mm. Treatment is to apply warm compresses & monitor arm/site.