chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 39-year-old female patient who received FLUARIX quadrivalent (batch number 4A5K3, expiry date 22nd June 2016). On 24th September 2015, the patient received FLUARIX quadrivalent (intramuscular) .5 ml. On an unknown date, less than a month after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details provided were as follows: The patient received FLUARIX quadrivalent in left arm. The patient experienced soreness in the left arm, which remained ongoing until 5th October 2015. The outcome of the reported event was unknown to the reporter.
This spontaneous report was received from an epidemiologist referring to unspecified patients of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with doses of improperly stored (incorrect product storage) ZOSTAVAX (dose and routed unspecified) (lot# L028282, expiration date 28-OCT-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT CAME IN TODAY AND AFTER VACCINE WAS GIVEN HE HAD RECEIVED THE OTHER MRNA VACCINE (MODERNA). DUE TO CDC GUIDANCE PT IS CONSIDERED FULLY VACCINATED AFTER 14 DAYS. PT IS AWARE HE RECEIVED PFIZER TODAY AND HIS FIRST DOSE WAS MODERNA
Sore Arm for a couple of days.  Chills around 12 hours after.  A little achey but not bad.
Within 24 hours: fever of 101.2 that lasted around 24 hours, visible bruising and red patch at injection site that lasted one week.   One week after injection: Red, bumpy rash spreading from injection site down left arm that lasted around 24 hours.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient' s concurrent conditions, drug reactions/allergies and medical history were not reported. On 07-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017 (strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Inappropriate schedule of vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 21-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  Patient was claiming that he was not given a vaccine so another pharmacist gave another dose.
patient developed unexplained diplopia and vertigo; extensive diagnostic workup including mris and LP. Felt to have aseptic meningitis with vestibular neuronitis
Had a fever, shivering, abdominal pain, myalgia, and headache the night after 2nd dose.
Flu-like symptoms.  Low fever, congestion, cough, 5 days, no treatment.
Case number PHEH2013US007860 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This case refers to 12-yer-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12009, expiration date: Feb 2014) at a dose of 0.5ml intramuscularly on 18 Mar 2013. The reporter stated that the administered MENVEO was stored at 34 F for 12 hours, but was not frozen. No adverse event was reported following this drug administration error.
big red spot; doesn't hurt badly only had little achiness; all red (right arm); felt warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (all red (right arm)), INJECTION SITE WARMTH (felt warm), RASH MACULAR (big red spot) and INJECTION SITE PAIN (doesn't hurt badly only had little achiness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (all red (right arm)) and INJECTION SITE WARMTH (felt warm). On an unknown date, the patient experienced RASH MACULAR (big red spot) and INJECTION SITE PAIN (doesn't hurt badly only had little achiness). At the time of the report, INJECTION SITE ERYTHEMA (all red (right arm)), INJECTION SITE WARMTH (felt warm), RASH MACULAR (big red spot) and INJECTION SITE PAIN (doesn't hurt badly only had little achiness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications reported were medication for condition of her heart for many years.  No treatment information was provided.    Reporter did not allow further contact
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50-year-old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: unknown) dose was not reported, dose number in series was 01, 01 total was administered at right deltoid region on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in DEC-2021, the patient experienced symptoms of body aching and fever and suspected coronavirus disease-19 (COVID-19) infection. On 31-DEC-2021, patient took a COVID-19 home test [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid diagnostic test] and the result was positive, and hence the event of suspected clinical vaccination failure. On an unspecified date, patient experienced other symptoms of cough, stuffy, runny nose, fatigue and was experiencing them at the time of report (04-JAN-2022) (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected COVID-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210057.; Sender's Comments: V0:20220104395-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Anaphylactic reaction; Redness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed redness and anaphylactic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed redness and anaphylactic reaction. She took ibuprofen post vaccination and diphenhydramine for the anaphylactic reaction. Her physician assistant also ordered epinephrine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, redness and anaphylactic reaction, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient with urticarial lesion below where received MMRV. developed within 5 min of receiving shot. no respiratory distress or compromise noted to ascultation. mother advised to give patient 1 teaspoon of benadryl elixir every 6 hours. (patient's weight 28 pounds)
Contracted varicella zoster on 03/16/2002. Received varicella vaccination on 04/02/1996.
Now i am very anemic for the first time in my life; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Jan2021 at 18:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included liraglutide (SAXENDA) and dicycloverine (DICYCLOMINE) for unknown indications from unknown start date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 00:00 the patient had new blood work (blood test) in June 2021, then patient was very anemic for the first time in her life. patient thought it had something to do with the vaccine. On an unknown date in Dec2020, the patient underwent Blood test and the result was normal results. On an unknown date in Jun2021, the patient underwent Blood test and the result was diagnosed with anemia. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the reported event. The clinical outcome of the events very anemic for the first-time in-patient life was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Received shot in upper right arm and it was painful.  My arm grew more painful throughout the day.  I became very tired as the day went on.  Went to bed for the evening, Monday 4/26/2021 and woke up at 1:50am on Tuesday morning, 4/27/2021 in full body sweats, dripping with sweat.  So weak I couldn't get up or lift my head.  My husband took my temperature which was 103.  Massive headaches, full body aches and pains, chills which made my body shake uncontrollably.   My whole body hurt.  Could not get up to use the restroom, tried and fainted back into the bed.  Heart felt like it was beating out of my chest.  My husband wanted to call 911 but I didn't want to.  Felt like I had COVID again.
- 5 hours post-injection, felt extreme fatigue, mild fever and muscle soreness. Fretful sleep, woke up with a headache.  Took two Excedrin, headache went away.  Soreness in arm lasted a few more days then dissipated. - 1 week post-injection, injection site swelled  and itched like a spider bite.  That dissipated within 2 days. - Low level fatigue continued constantly - A week and 5 days after injection, experienced a repeat of the same extreme fatigue, mild fever and bad headache that had initially followed on the same day as injection. Passed a day later. - Two weeks and one day post-injection, I went to the gym and worked out pretty hard.  The next day felt excessive fatigue again and continued headache.  called pcp who advised COVID test.  Took test same day, came back negative. - Today is two weeks and two days post-injection.  Continued headache, not relieved with Excedrin or Vicodin (at night), and low level fatigue remains.  Also continued achiness in all of upper left arm, where injection was done. This is definitely out of the norm for me.
Information was received for a case for live (Merck) VARIVAX (MARRS # 1301USA005117) from medical records concerning an approximately nine year old female. Vaccination records indicated the female was vaccinated with PNEUMOVAX23 on 15-FEB-2004 (lot number 647039/0604N; expiration date 17-APR-2005) (site of vaccination illegible) and 26-JUN-2012 in the left arm (lot number 672962/0025AE; expiration date 18-OCT-2013). Medical record date 15-DEC-2012 indicated that the female had a history of low PNEUMOVAX23 titers in 2005 "with adequate response to PNEUMOVAX." She again had low titers in 2012 with subsequent PNEUMOVAX23 titers. The outcome was not specified. All available medical records will be provided upon request. Additional information is not expected.
Approximately 4 days after receiving the vaccine, I began experiencing deep pain in my upper back (left side). This progressed to a painful blistering rash which spread to my left arm and my left breast. On 2/13/21, I was diagnosed with shingles. I have received both the Zostavax vaccine and both doses of the Shingrix vaccine. I am 7 days post antiviral treatment and am still suffering from stabbing pain at the rash sites.
after receiving the vaccine, we walked around the store for about 10 minutes before i then became lightheaded, dizzy and passed out. i regained consciousness a few seconds later but continued to feel like i?d pass out again, and i threw up. an ambulance was called, i had a blood pressure of 80/40 and was taken to the hospital
neck popping; ache neck and scull; dizziness; headache; fatigue; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (neck popping), PAIN (ache neck and scull), DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 19-Feb-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (Pain at injection site). On 21-Feb-2021, the patient experienced PAIN (ache neck and scull). On 23-Feb-2021, the patient experienced MUSCLE SPASMS (neck popping). On 21-Feb-2021, HEADACHE (headache) had resolved. On 23-Feb-2021, MUSCLE SPASMS (neck popping) had resolved. On 24-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PAIN (ache neck and scull), DIZZINESS (dizziness) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
Patient was vaccinated on 11/29/2021 with 0.3ml of Pfizer. Patient was vaccinated on 4/9/2022 with a 0.5ml  of Moderna. Patient presented to COVID clinic on 7/27/2022 seeking vaccination to complete her primary series. The above discrepancy was discovered via an search since patient did not have her COVID card.  No side effects reported by patient related to mixing primary series doses. Vaccines were not provided on 7/27/2022. Inquiry made with immunize.org and was instructed that patient is considered to have a completed primary series.  Called and spoke with patient 7/28/2022 and notified her that she had completed her primary series and she did not need any further vaccinations at this time. Notified that she would be due for a booster dose 5 months after her last vaccine dose.
Watery diarrhea and rash. Diarrhea persisted for 2 days. Rash persisted for 1 day.
Nausea/ vomiting/ dehydration/ malnutrition/ hypotention/ severe/ all required hosp still numbness/ left side/ instability walking-blood pressure. The discharge summary received on 3/31/04 states weakness, blurred vision, headache, photophobia and GI reflux. The medical record received on 3/31/04 states weight loss, and hypokalemia. Information from Annual Follow-up report states permanent disability/nerve damage, numbness left and right side.
Erectile dysfunction; very low libido; This is a spontaneous report from a contactable consumer (patient's son). The consumer reported similar events for two patients. This is the second of two reports. A male patient of unspecified age received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced erectile dysfunction and very low libido on an unspecified date. He was experiencing the exact same problem after his 2nd Pfizer shot. The outcome of the events was unknown.  Information about the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101299845 Same reporter/vaccine, similar events, different patient
Information has been received from a 60 year old female patient with nickel, neomycin and "THERMISEROL" and no pertinent medical history who on 10-AUG-2010 was vaccinated with 0.65 ml dose of ZOSTAVAX (Merck) (route and Lot# Not reported). Concomitant therapy included FLONASE, thyroid medicine, "e-strain" and vitamins (manufacturer unspecified). The caller stated that she had received the ZOSTAVAX (Merck) and "about 4 to 5 weeks later". "About mid-September" on approximately 15-SEP-2010, broke out in a pimply, acne-like rash accompanied with bad itching and hive-like rash on her trunk, upper leg and thigh and backside. Three biopsies were performed as a laboratories diagnostics studies to determine cause of rash (results not reported). At the time of the report the patient's outcome was recovering. The patient sought unspecified medical attention. Follow-up information has been received from the physician who reported that retired female patient with no allergies at the time of vaccination and nickel, AUGMENTIN, erythromycin, formaldehyde, neomycin and thimerosal pre-existing allergies. Concomitant therapy included PRILOSEC, aspirin, levothyroxine sodium.  The physician stated that in October 2010 the patient experienced a very pruritic rash on trunk and proximal to thighs. Two skin biopsies were performed that were unremarkable. The physician also stated that the rash lasted 2 to 3 months. The physician claimed that the patient was seen by two separate dermatologists and he did not have those records. In February 2011, the patient recovered. No further information is available.
husband is breaking out in cold chills, and his bones are still sore.; inflamed liver; arm is still sore; Nauseated; has no energy; sick; no appetite; he is sweating; he is tired.; husband is breaking out in cold chills, and his bones are still sore.; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration on 19Jan2021 08:00 at single dose on left arm for COVID-19 prevention. The medical history and concomitant medications were not reported. The patient got the shot on 19Jan2021. Since Jan2021, his arm was still sore, but he had been nauseated since then. He has no energy. He has had it almost four days. He was fine until he got it and his arm is sore and he is nauseated. He is usually on the go. The patient also has an inflamed liver. He has been sick since. The patient has no appetite, he is sweating, his bones are hurting, and he is tired. The consumer took her husband to his doctor, and they tested him for COVID, and it came back negative, but the consumer does not think the PA did the test right. The consumer doesn't know what to do with him, because he is still tired, and has no appetite. The patient is breaking out in cold chills, and his bones are still sore. When the patient got the vaccine, he was walking and talking, and by 11 AM that day, he was in bed. The patient had some labs done, and was being told that his liver is big, so the consumer did not know if the vaccine went to his liver. The outcome of the events was unknown.
L upper arm surrounding site of IPV injection with 5cm area of warmth and erythema,mild induration.
Hardness at the site of injection; Itchy at the site of injection; Redness at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (Hardness at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Hardness at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This spontaneous report as received from a nurse refers to a 30 years old patient. The patient was vaccinated with RECOMBIVAX HB about 2 years ago. No other co-suspects were reported. No concomitant medications were reported. On 27-NOV-2012 the patient experienced borderline anti-HBs titer. No treatment information was reported. The outcome of hepatitis b antibody abnormal is unknown. The relatedness for RECOMBIVAX HB. Additional information has been requested.
30 mins after vaccine, patient felt sore a few weeks later, pain increased and MRI performed. MRI showed inflammation and strain in affected area. Provided steroids and ibuprofen. Patient unable to raise left arm due to pain and swelling.