chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller said that after she took the second shot  on 20Jan2021, she noticed the rash came back on 20Jan2021; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient of weight 83.91 kilograms and height 160 centimetres received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283 and expiry date: Apr2021) via intramuscular route of administration at arm left on 20Jan2021 as single dose for COVID-19 immunisation. The patient medical history was not reported, and concomitant therapy was reported as no. The patient previously received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899), via intramuscular route of administration at arm left on 30Dec2021 for Covid-19 and experienced rash, sore arm for a day and a slight headache. On 20Jan2021, the patient experienced rash came back which required treatment with over the counter product (Cetraphil cleanser (Lot: 316776), Dove peak moisture bath wash (Lot: 08280JU41), Witch hazel astringent (Lot: 53849), Benadryl cream (lot: 2910LV/1, Expiration: Sep2022) and tablets (Lot: SMF075, Expiration: Jul2022), Triderma eczema fast healing face and body cream (Lot: 05440289, Expiration: Oct2023) and calamine lotion (Lot: 541128, Expiration: Nov2017)) which was later spread to a much larger area. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Left Deltoid is still sore. IM injection was given correctly, but my arm still hurts enough I need to take Tylenol for the discomfort and the pain wakes me up at night.
Injection site is hot; Rash on her left arm since she received the vaccination but that the rash is getting brighter and; Fever; Chills; Normal sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Normal sore arm for a couple of days), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE RASH (Rash on her left arm since she received the vaccination but that the rash is getting brighter and), PYREXIA (Fever) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Normal sore arm for a couple of days), VACCINATION SITE RASH (Rash on her left arm since she received the vaccination but that the rash is getting brighter and), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site is hot). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 15-Apr-2021, PAIN IN EXTREMITY (Normal sore arm for a couple of days), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE RASH (Rash on her left arm since she received the vaccination but that the rash is getting brighter and) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Vaccine expiration date was given as 01Jan1900.
hearing loss and tinnitus in left ear. Currently being treated with steroids: I got an injection of steroid in the left ear and I'm taking 60 mg/day of prednisone for 1 week.
Patient experienced severe muscle pain and temporary loss of mobility of injected arm, not just pain at injection site. Self limiting without treatment within 14 days. No reaction on previous dosage.
running high fever; chills; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        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.   No concomitant medication was provided  No Treatment medication was provided.
Swelling in given area and in left leg for five (5) days starting on day one.
15 minutes after shots, she had difficulty breathing, lips swollen, whelps on chest, bilateral expiratory wheezing and crackles. She was given Epinephrine 1:1000 1mg 1 ml - 1 ml given subcutaneous, 8 mg Decadron IM, Albuterol 2.5mg nebulized treatment and given - with subsequent resolution of symptoms. Sent home with Prednisone pack and Epipen. To return for f/u the next day.
right arm developed a knot and had a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (right arm developed a knot and had a lot of pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MASS (right arm developed a knot and had a lot of pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, VACCINATION SITE MASS (right arm developed a knot and had a lot of pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment : Azaprocin   Reporter did not allow further contact
Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was not provided.  The patient had trouble conceiving and was scheduled for an ultrasound procedure with water and was recommend to take Motrin or Advil before procedure. Wanted to know if it is ok to take medication before procedure.
fainted; disoriented; dizzy / felt dizzy; weak; This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 10th December 2021) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix (injection) and PNEUMOVAX 23. On 26th September 2020, 1 days after receiving Shingrix, the patient experienced fainting (serious criteria hospitalization and GSK medically significant), disorientation (serious criteria hospitalization), dizziness (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the fainting, disorientation, dizziness and weakness were recovered/resolved.   It was unknown if the reporter considered the fainting, disorientation, dizziness and weakness to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received Shingrix and a pneumonia vaccine on the same day. It was reported that the next day that the patient got weak, disoriented, dizzy, and fainted. The patient was taken to the hospital where he remained for three days. The patient was recovered and the HCP wanted to know if the Shingrix followed by the pneumonia vaccine would have caused this to happen.   The reporter did not consent to follow-up. There was discrepancy in vaccination date of pneumovax 13, it was captured as 25th September 2020.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198013:same reporter
a 64 year old patient stated she was 65 years old received the FLUZONE HIGH DOSE QUADRIVALENT with no AE; a 64 year old patient stated she was 65 years old received the FLUZONE HIGH DOSE QUADRIVALENT with no AE; Initial information received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 64-year-old female patient for whom it was reported "64 year old patient stated she was 65 years old received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]" (product administered to patient of inappropriate age and overdose).   The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE).    On 07-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ750AB, expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was case of actual medication error due to product administered to patient of inappropriate age and overdose [Latency: on the same day].   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 10 minutes after receiving 2nd dose of Moderna vaccine, pt c/o flushing, dizziness, heart "racing", and itchiness to left hand; VS taken; physician notified.
First Moderna vaccine #1 on 3/8/21 and second Moderna vaccine #2 on 4/8/21. About 4 weeks after receiving vaccine dose #2, patient (who was previously  healthy) presented to the hospital with about 3-4 weeks of acutely altered mental status and rapid decline in cognitive function and ability to perform ADLs after previously having normal cognitive function. Also found to have new, acute left arm weakness with new isolated radiculopathy and de-innervation on neurologic testing. See by multiple specialists at hospital, including neurologist, rheumatologist, and hematologist. Definitive diagnosis still unclear but on the differential diagnosis discussed by medical team is secondary Sjogren's Syndrome with CNS involvement accelerated by immune activation soon after receiving  2nd Moderna dose. Unclear if there is actual relationship with vaccine but could be possible given the timing of vaccine administration and onset of patient's symptoms.
In June of 2022, I noticed some swelling on the right side of my neck. I went to my PCP to have it checked out. I was referred to a specialist who scheduled a biopsy. The results came back and they said it looked suspicious so they scheduled a surgery to have my thyroid on the right side removed on September 23rd, 2022.
Got the vaccine and still got it / hospitalized two months / almost killed her / Suspected vaccination failure; Got the vaccine and still got it / hospitalized two months / almost killed her; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening) and meningococcal infection (serious criteria hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown.   It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to Meningococcal B vaccine.  Additional details were reported as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received the Meningococcal B vaccine and got meningococcal infection and was hospitalized for two months at the hospital.  Reporter stated that it had almost killed her. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
On 2/14/03 pt exposed to military recruit recently vaccinated for smallpox. (Identity of recruit unknown). Noted lesions (2/14 and 2/19). Pt has three skin and locular lesion. Eval by opthalmologist 2/25 for conjunctivitis. Tx in local ER 2/26 for skin infection. Tx with Keflex CDC recommended topical antiviral for eye-d/c Rodtex (trifluridine opthalmico). Inadvertent inoculation. Peri-ocular/ocular vaccinia Follow up information states that the information is not availale , as the pt's contact is unknown (she does not know his name). The contact has since been deployed.
Had bright red rash on face and trunk. Left deltoid had large reddened area. Patient had itching. Patient was given Benadryl, Pepcid, Solumedrol and was discharged with prescription for Pepcid and Methyl Prednisolone.
experiencing night sweats, she notice it when she wakes up and; Slight headache during all day; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (experiencing night sweats, she notice it when she wakes up and) and HEADACHE (Slight headache during all day) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 046B21A and 0078(or B)21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (experiencing night sweats, she notice it when she wakes up and) and HEADACHE (Slight headache during all day). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Headache, at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (experiencing night sweats, she notice it when she wakes up and) and HEADACHE (Slight headache during all day) had not resolved.      Concomitant medication: patient takes some medications but was unable to provide that information.  It was reported that the symptoms started on 06Jan2022 or 07Jan2022, three or two days after the shot.   This case was linked to MOD-2022-445052, MOD-2022-445070 (Patient Link).
Information has been received from a physician concerning a 7 year old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed a rash which was reported as questionable chickenpox and also described as breakthrough chickenpox. Unspecified medical attention was sought and it was reported as a mild case, if it was chickenpox. AT the time of this report the child was recovered. No product quality complaint was involved. Additional information has been requested.
A high fever of 104 that did not respond to treatment. Severe upset and irritability.
Area became markedly swollen and red 2 days after injection.  Did not required antibiotics. or imaging.  Pt still has clinically significant induration at site of injection after 4 weeks.
Vaccine adm at about 1:38, felt dizzy, lightheaded - sat down drank water. Cont. to work although still lightheaded. Did not tell MSA. Left center with a friend driving. At about 3 PM began having trouble breathing -took 1 puff ALBUTEROL inhaler and fell asleep. Still feels light headed today. R deltoid with no tenderness, redness or swelling. Offered him the oppty to seek medical advice. Left for home by bus.
Urgent care on 3/24 with trouble breathing, had albuterol breathing treatment and prescribed prednisone medication to pick up the next day. Following early morning 3/25 couldn't breath and went to hospital ER. Was intubated and and admitted to ICU. Diagnosed with acute respiratory failure due to delayed hypersensitivity reaction type IV to the covid vaccine. After release was on albuterol breathing treatments at home as well as prednisone which she is still on. Severe joint pain and fatigue still an issue.
Painful at site for 5 to 6 days. Then started itching. Then large red area at site. Still red on day 8 from vaccination.
This spontaneous report as received from a physician refers to an unspecified number of patients. The patients concurrent conditions and medical history were not reported. On an unspecified dates, an unspecified number of patients received an improperly stored dose of VARIVAX (dose, route of administration, lot number and expiration date were not reported). No concomitant medications were reported. No adverse effect was reported. No further details were provided. This is one of two reports received from the same reporter. Additional information has been requested.
On 7/2/20 presented to Clinic with left thigh with 14x10 cm slightly raised, erythematous circular lesion.  There is mild induration in the center without palpable fluctuance.  Mild tenderness to palpation.  Compartments are soft without pain or compression.  No purulent drainage.  Slight limp with ambulation.  Prescribed Clindamycin (208.5 mg) by mouth 3 times a day for 5 days.  Seen on 7/3/20 at Hospital and prescribed diphenhydramine prn.  At time of this visit patient had cough/fever and CoVid19 testing was performed.
I had a headache for 10 days; 5 days were migraine-like'; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 56-year-old female (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration on 23-MAR-2021 as single dose for covid-19 immunization. The patient medical history and concomitant medication were not reported.Caller reported that  'When I recieved the 1st vaccine, I had a headache for 10 days, 5 days were migraine-like'. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt developed widespread urticaria on his body, increased secretions, headache, and diarrhea 48 hours after the vaccinations. Symptoms improved with solumedrol, cimetidine and benadry. Previous history of urticaria/angioedema with nsaids.
Mother states 2 hrs p/immun child broke out in hives & a rash soon p/she began w/vomiting & diarrhea & had temp to 105 rectally. Mother did not seek medical attention.
I had cellulitis in my arm. Swelling, redness and heat on the shot site. I have hemorrhaging menstrual periods that last 2 weeks. Causing me extreme weakness, fatigue and depression. Periods are getting worse. I waited 4 months to report to make sure the symptoms were vaccine relatares and I know for certain they are.
Hot, swollen very sore arm with an angry red silver dollar sized uproar within 24 hours, mostly dissipated after 3-4 days except for a 2 1/2 inch circular bruise which exists to this day. Couldn't even sleep on that arm. About 2 weeks later, joints are sore, muscles are sore, having intermittent shooting pain headaches (I never get headaches), feel run down and tired. I will NOT be getting the second dose. I was already scheduled for back surgery to occur one week after the second shot. Don't need the grief of side effects (possible even stronger, OMG) while trying to recover from surgery.
Baby was fussy and very gassy for 2 days following vaccine.  Day 3 brought diarrhea 10-15 times a day, watery, green, positive for occult blood, no frank blood seen.  All stool studies were negative.  Diarrhea lasted for 6 days.
Headache, Myalgia, Fever, BODY ACHES, HEAD ACHE, CHILLS, FATIGUE Narrative:
She also mentioned that he took 4 motrins 2 weeks prior for back pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "She also mentioned that he took 4 motrins 2 weeks prior for back pain".  Additional information: Reporter was asking how long before vaccination would it be considered not okay to take over the counter medications like ibuprofen, aspirin and tylenol. She mentioned that the articles she has read were very vague on this. She mentioned that he took 4 motrins 2 weeks prior for back pain as his doctor advised that it would be safe. Mentioned to reporter that usually, low dose aspirin would be used as a blood thinner and that OTC Medications typically evacuate the body fast but that would depend on the person.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On day one, runny nose. Day 2 after 12 hours, achy, chills, sweats, nausea and lightheaded. Took Tylenol to help. In evening of day 2 chest pains in center of chest running through to back. Felt like gas pains not sure if related to vaccine. Took tums and rested. Woke up 3rd day symptoms gone. On 4th day feeling a little light headed, again not sure if related to vaccine. I?m staying hydrated.
Chronic Bloody diarrhea, which I never had in my whole life. I had that for about a month or longer but subsided with medication. Then a severe auto immune disorder called Polymyalgia Rheumatica. And Glaucoma and shingles. This has continued through-out the time until now. After the second dose the other symptoms became more severe and I had that vaccine on April 6,2021.
A report was received from a health care professional on 11/10/03 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.