chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received SHINGRIX. In November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness at the injection site, which began the 1st day the vaccine was administered. The soreness began to spread, the patient could not lift her arm over her head, and was reportedly worsening at the time of the report. The reporter was unsure of the date of administration and reported that it was 6 days to a week ago before the date of reporting. Possibly on 29th November 2018. The reporter gave consent to follow up.
Information has been received from a health professional concerning a 17 year old female patient with history of acne and dyspepsia who on 28-FEB-2007 was vaccinated IM with her first dose of Gardasil lot #655503/0012U. Concomitant therapy included PREVACID, RETIN-A and CLEOCIN. The patient reported that she felt dizzy, nauseated and agitated starting 30 minutes after receiving the infection. The physician advised the patient to rest, monitor symptoms and call the office if no improvement. The patient's outcome was unknown. Additional information has been requested. Intial and follow-up information has been recieved from a health professional concerning a 17 year old female patient with history of acne and dyspeaio who was vaccinated on 28-Feb-2007 at 12:10am in to left deltoid IM with her first dose 0.5mL of GRADASIL, lot #655503/00120. COncomitant therapy included lansoprazole, trtinoin and clindamycin. On 28-FEB-2007 at 12:40AM the patient reported that she felt dizzy, bnauseated and agitated starting 30 minutes after recieving the injection. Yhe patient was lightheaded for approximately 6 hours. The physician advised the patient to rest, monitor symptoms and call the office if no improvement. The patoent's outcome was unknown. in follow-up it was reported that patient recoveredon 28-FEB-2007. Additional information is not expected.
COVID 19 Treatment.; COVID 19 Treatment.; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 at 08:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Aug2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11May2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment.". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid. Clinical course: Patient took paxlovid from 01May2023 to 06May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300187649 same patient, different drug/event;
Narrative: Patient received Dose#2 of the Moderna vaccine and began to feel ill one day later. She began to experience throat soreness, myalgias, fevers, and headaches. Patient stated that she took acetaminophen and diphenhydramine at home. Called the facility and they prescribed amoxicillin and recommended that she go to urgent care. Patient went to ER and tested negative for Covid. Covid vaccine was documented as an allergic response in the database. Per the notes patient did not have anaphylaxis to the vaccine.
20OCT92 pt recvd vax & devel migraine 21OCT92 6AM vomited;
About one week after I took my 2nd Pfizer booster I suffered a stroke. I think the COVID Booster caused the stroke.  I had my Pfizer COVID Vaccines on  5/7/2021, 5/28/2021 and 11/29/2021. The last booster triggered my stroke.
Very tired; Light pain everywhere on his body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Very tired) and MYALGIA (Light pain everywhere on his body) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (Very tired) and MYALGIA (Light pain everywhere on his body). At the time of the report, FATIGUE (Very tired) and MYALGIA (Light pain everywhere on his body) was resolving.            No concomitant medications were reported.  Treatment information was not provided.
Double vision; blurry vision (unable to see clearly with prescribed glasses); swollen lymph nodes under left arm; fever 101; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (fever 101) and HEADACHE (headache). On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under left arm). On 23-Apr-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant) and VISION BLURRED (blurry vision (unable to see clearly with prescribed glasses)). On 23-Apr-2021, PYREXIA (fever 101) had resolved. At the time of the report, DIPLOPIA (Double vision) outcome was unknown, VISION BLURRED (blurry vision (unable to see clearly with prescribed glasses)) was resolving and HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes under left arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 101 (High) High.         Patient received treatment with ibuprofen (Motrin) and acetaminophen (Tylenol).  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; Sender'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
Severe arm pain extending from injection site to fingers; described as burning pain, no bruising, no swelling.
1 day lump X 2 days 1 1/2 dollar size. Itchy/ rash
Information has been received from a 18 year old female with allergy to dust and mold who on 22-MAY-2008 was vaccinated with the first dose of GARDASIL and with the second dose of GARDASIL on 11-JUL-2008. There was no concomitant medication. On 07-AUG-2008 (last Thursday) the patient found out she was pregnant. On 12-JUL-2008 the patient experienced arm soreness which subsided on 13-JUL-2008 and went away on 14-JUL-2008. Therapy with human papilloma virus vaccine was discontinued. Her last menstrual period was approximately on 30-JUN-2008. On 07-AUG-2008, was performed a pregnancy test resulting positive. Estimated date of delivery approximately on 06-APR-2009. The patient sought medical attention by seeing a doctor. Additional information is not available.
pt recvd vax & exp headache; exp myalgia & headache w/ 2nd dose of vax;
Pneumo vaccine was given subcutaneously in left deltoid area and MMR was given subcutaneously in right deltoid area at noon, 1/21/05. Left deltoid area was very tender when she woke up on 1/22/05 and she found that area to be hot to touch, swollen with a red streak extending from injection site to unarm. She was seen in ED at 0800 on 1/22/2005. Doctor diagnosed left deltoid as reaction to pneumo vaccine with cellulitis at sit of injection. She was prescribed Prednisone 10 mg tabs to be taken in decreasing am'ts over 4 days; Hydrocodone/APAP 5/500 PRN pain; and Levaquin 500 mg tabs one a day for 6 days.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a male pt who experienced generalized rash.  The pt received the first dose on 04/03/01.  The pt also received a dose of Varivax, a dose of Comvax, a dose of MMRII, a dose of IPV and a dose of Tripedia on 04/03/01.  Relevant medical history was not provided.  Indication for Prevnar was immunization. Product was administered on 04/03/01.  Dose regimen was 1 dose (IM).  Concomitant medications were not reported.  The pt experienced generalized rash (rash generalized).  Information regarding this report has been forwarded to manufacturers of the concomitantly administered vaccines.  No additional information was available at the time of this report.
1 month later I began acute onset of diffuse crampy ABD pain  bloody pink to red diarrhea weight loss of,30#). CRP eleveated 45+ and CT (-)  stool testing O & P  C&S etc biopsy and colonoscopy early January 2022 after persistent  of symptoms that  found moderate to severe acute onset ulcerative colitis.  now on prednisone and mesalamine without resolution- soon to start Biological Entyvio IV This was my 3rd Moderna and I told pharmacist to ASPIRATE before giving - he did. thank you. I got 2021 Flu vaccine in left deltoid (aspirated as well)  #1 12/22/2020 @ a local Hospital right deltoid (not aspirated) #011J20A  #2 1/20/2021 @ a local Hostpial  left deltoid (not aspirated)  #029k20A
Pt. had received the Gardisil shots in 2008. In 2019 she started to have pain during sex. She thought she had fibroids . She actually had stage 3 cervical cancer . Never thought she could get this due to the shots she got in 2008. Has treatment - proton radiation and chemo , she was clear for a year . After that year the cancer returned. All?s treatments the doctors had given her included more chemo, even newer chemo that was shown to help with cervical cancer . Tivdak. With this she had to have cold packs on her eyes during treatment and see an eye specialist before each treatment . Feb 8, 2023 pt. was in a lot of pain. She went to the hospital and the doctors tried to treat the pain . Pt. ended up on a ventilator and after a little bit her blood pressure wouldn?t stay up and eventually her heart stopped  Time if death 11:28 pm. .
Multiple joint pain, muscle aches, head ache, chills, fatigue lasting 48 hours. Took ibuprofen with relief.
10 cm erythematous area on left lateral thigh. No induration, non-tender.
Information has been received from a physician concerning a 22 month old female who on 7/24/03 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (644788/0328N). In April 2004, the patient developed shingles. Medical attention was sought and the patient was treated with Acyclovir for two weeks. Hospitalization was not required. It was reported that the patient has fully recovered. No product quality complaint was involved. Follow up information from the physician indicated that the onset was 4/04, at 10:00 AM (before 4/14/04) however, it was also reported that she had a fever and anorexia on and off around 3/31/04. There was multiple vesicular rash and scab over the left anterior chest and medial side of the left upper arm. She was seen on 4/14/04 and was treated with Zovirax 1 tsp PO QID for 2 weeks. She did not have a fever in the office, but had a fever on and off at home with questionable itching. She had an appointment on 4/28/04, but she didn't keep it. She was seen on 5/20/04 and there was no more rash. The physician reported that it was one month duration. No other labs or diagnostic tests were done and there was no rash at site of injection or elsewhere within 42 days of the vaccination. There was also no history of chicken pox and there no recent exposure to chicken pox or zoster. Additional information is not expected.
pt recvd vax & inj burned a lot;by next day lt arm red & edematous from deltoid to elbow & cont to swell down into forearm & fingers for 5 days; arm red, hot; had flu like sxs x 4 days;
One big hive underneath injection site. Currently untreated. Will use Benadryl overnight
patient received vaccine on 09/17/21, reports that on 9/26/21 she developed numbness in the left arm, the arm in which she received the vaccine. She developed a rash on that arm on 9/28. She went to a clinic and was diagnosed with shingles
Dose was given SC instead of IM   No signs/symptoms  Researched it and CDC states it is an administration error Dose does not need to be repeated.
Ringing in ears; Still ringing, has gotten louder; This is a spontaneous report received from contactable reporter (Consumer), Program ID: The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: which he takes medicine for; "Ringing in ears", start date: 22Mar2021 (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6198, Dosage text: First shot, left arm), administration date: 01Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, LOT: EN6198, NDC, EXP: Unknown), administration date: 22Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Ringing in ears". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Ringing in ears"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Still ringing, has gotten louder". Therapeutic measures were taken as a result of tinnitus, condition aggravated.  Additional information: Ringing in ears: Started about 6 months after getting first Covid shot. Ringing in ears: Right after he took first shot, about 6 months after, started ringing in ears. Still ringing, has gotten louder. Bought over the counter stuff, that isn't helping him. Fourth Shot Covid shot, Moderna: 24May2022. Sender's Comments: Linked Report(s): US-PFIZER INC-202300168958 same reporter/patient/event, different dose number;
Approximately 2 hours after the vaccine was injected into my right upper arm, I noticed that my dentures felt different.   The right side of my face from just below my nose to just above my chin was mostly numb.  The right front (my perspective) of my tongue was also mostly numb.  I could feel touch but it was not as clearly as normally felt.  After removing my dentures, the numbness was also in my gums and a section of the right inner cheek.  I went to the ER at about 7:00 that day, as advised by my medical clinic, and was examined by a nurse and a physician.  No swelling was seen in my tongue though it felt larger on the right side (due to numbness, apparently).   The doctor diagnosed a general allergic reaction and I was given one dose of Benadryl 25mg, Zyrtec 10mg and Pepcid 20mg.   I was advised to purchase these over-the-counter medications and use them for about 1 week.  I decided that since the reaction was very mild and not getting worse after more than 4 hours, to hold off on the meds and get them if there was a change for the worse.  The numbness lasted for several days, progressively improving each day.  By Sunday, there was no numbness left.
returned from lunch at approx 1410 and at approx 1430 developed symptoms of anaphylactic reaction: angioedema (lips and slight eyes) throat swelling to include change in voice and ability to speak, red and tingly palms, diarrhea
A child pulled the arm away awhile being vaccinated and only got around 1/3 of the vaccine; 1/3 leaked to the arm; This spontaneous case was received on 26-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04265) and concerned a male child patient. Discrepant information about the age was provided. Reporter stated that the patient was 5 years-old.  The patient had no relevant medical history and was not taking any concomitant medications.  On 25-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: unknown, route of administration: intramuscular, anatomical location: arm and indication: not reported) for flu prevention. The child pulled the arm away while being vaccinated and only got around 1/3 of the vaccine, 1/3 leaked to the arm and 1/3 was still inside of the syringe (explicitly coded as 'Incomplete dose administered' and 'Accidental exposure to product'). The batch number was reported as 279839 and expiry date was reported as 30-Jun-2021.  At the time of initial reporting on 26-Oct-2020, it was not reported if the patient experienced any adverse event after Flucelvax QIV administration.  The reporter assessed the events as non-serious.  Company comment: The child was vaccinated with Flucelvax QIV. Reportedly, the patient pulled the arm away while being vaccinated and only got around 1/3 of the vaccine, 1/3 leaked to the arm and 1/3 was still inside of the syringe. It was not reported whether the patient experience any adverse event. Incorrect dose administered and Accidental exposure to product are assessed as not related, per company's conventions.; Sender's Comments: The child was vaccinated with Flucelvax QIV. Reportedly, the patient pulled the arm away while being vaccinated and only got around 1/3 of the vaccine, 1/3 leaked to the arm and 1/3 was still inside of the syringe. It was not reported whether the patient experience any adverse event. Incorrect dose administered and Accidental exposure to product are assessed as not related, per company's conventions.
Anxiety, arthritis, balance problems, high cholesterol, difficulty loss and trouble concentrating, depression, digestive problems, energy loss, hearing (ringing and low tolerance to noise), impotence, insomnia, memory difficult/loss, depression irritable, low back pain, pain throughout the body, joint, muscle, neck, back.  Sleep problems, unable to sleep flat, tinnitus, vision problems.
COVID symptoms/ got COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID symptoms/ got COVID) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced COVID-19 (COVID symptoms/ got COVID). At the time of the report, COVID-19 (COVID symptoms/ got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.  COMPANY COMMENT : This is a spontaneous case concerning of unknown age of male patient with no medical history reported. who experienced the unexpected non serious AESI event of Covid-19. The events occurred after the unknown days of second dose of mRNA-1273 vaccine. The outcome of the event COVID-19 is unknown. SARS -COV-2 test was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning of unknown age of male patient with no medical history reported. who experienced the unexpected non serious AESI event of Covid-19. The events occurred after the unknown days of second dose of mRNA-1273 vaccine. The outcome of the event COVID-19 is unknown. SARS -COV-2 test was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
sore arms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient just had 46 sore arms and that was it. The outcome of the event was unknown.  Information on lot/batch number has been requested.
This case was reported by a healthcare professional and described the occurrence of hive in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject's medical history included hive. Concurrent medical conditions included skin allergy. Previous and/or concurrent vaccination included GARDASIL (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date. There were no concurrent medications. On 16 February 2011 the subject received 1st dose of CERVARIX (.5 cc, unknown, unknown thigh) and experienced administered at inappropriate site. On 18 February 2011, 2 days after vaccination with CERVARIX, the subject experienced hive, itching. On 23 February 2011, 7 days after vaccination with CERVARIX, the subject experienced fever and cold sweat; the hives and itching fever continued. The 15-year old subject previously received three doses of GARDASIL two to three years ago. The reporter stated "that it was believed that a booster for HPV would be beneficial and given the CERVARIX data, that is the one they used". The subject received CERVARIX on 16 February 2011 and developed hives and itching on 18 February 2011. The subject was treated with antihistamines and cream. The hives and itching were getting better and on 23 February 2011, she developed a "major case of hives, itching, fever and cold sweats". The nurse, who is the mother of the subject, administered CERVARIX in the thigh at home (administered at inappropriate site). The subject has not previously had any reaction to vaccinations. It was noted that the subject "had hives before but nothing like this". The subject also "has a lot of skin allergies but specifics were no known" at the time of the report. The subject's parents reviewed the two products GARDASIL and CERVARIX looking for ingredient differences that may have caused the reaction". The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the hive, itching, fever and cold sweat were improved and "no serious issues reported in a while". The healthcare professional considered the events were possibly related to vaccination with CERVARIX.