chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of arm pain in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Headache, Fever, fatigue Narrative:  missed work following the second dose due to the above symptoms
Lost feeling and numbness and tingle to both arms and legs, trouble walking, slurred speech, twitching, nausea, dizziness, weakness and fatigue, chest pain.
High blood pressure (159/100) starting a week after vaccination and not reducing despite medication; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 21Apr2021 at 16:30 (Batch/Lot number was not reported) at the age of 48 years, as DOSE 2, SINGLE for covid-19 immunization.  Medical history included High Blood pressure (but controlled by medication). The patient had no known allergies to medication, food, etc. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included benazepril. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 for COVID-19 immunization. It was reported that the patient experienced high blood pressure (159/100) starting a week after vaccination and not reducing despite medication on 01May2021.  The patient had lab tests which included blood pressure measurement: 159/100 on 01May2021, sars-cov-2 test: negative on 07Apr2021.  The patient did not receive any treatment for the event. The clinical outcome of the event high blood pressure was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd 1st dose of Engerix-B 20APR91 & exp nausea, fever, chills, vomiting 4 days p/1st dose;
Reddish skin, a lot of yawning, fever, red eyes, chills and uncontrolled shaking.
This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 66-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 15th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), pain, rash, skin red, skin warm, skin induration and skin tenderness. On an unknown date, the outcome of the cellulitis, rash, skin red, skin warm, skin induration and skin tenderness were not recovered/not resolved and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, rash, skin red, skin warm, skin induration and skin tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient started feeling a little bit achy for a few days after the SHINGRIX injection. The injection site looked good but about 4 centimeters below the injection site, the patient had a red cellulitis type of thing that was 6 by 9 cm.  The patient was told by her pharmacist that it looked like a rash, but she said that it was more like a cellulitis that was red, hot, firm and tender. At the time of reporting, the patient was still having these symptoms, but they looked worse. The patient did not consent to follow-up.
itching immediately after injection, rash at injection site, large reddened area 3 days following, slight temp, sore throat, malaise, bruise after three days at injection site
pt recvd vax & fainted hitting frontal part of throat w/ back of chair; neck appeared slightly pink;
Information has been received from a physician concerning a female who was vaccinated intramuscularly with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced severe muscle pain that last about 15-20 days after vaccination. Subsequently, the patient recovered. On an unspecified date, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced severe muscle pain that last about 15-20 days after vaccination. Subsequently, the patient recovered. Additional information has been requested.
Redness at injection site and rash occurring 10 minutes after injection. Migraine for 1 month following injection. Ulcerative colitis symptoms.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 30-month-old male patient who received FLUARIX QUADRIVALENT (batch number DJ395, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
c/o fever, swelling reddness @ site of inject, muscle joint pain; fever next morning p/inject 30OCT91;
Bumpy, itchy rash under right armpit and up onto right breast, started around Nov 15-16 2021.  Appointment with PCP Dr. Avram 3p on Nov 18 2021.  Diagnosed with shingles and started on Valacyclovir HCL 1 gram every 8 hrs x 7 days.  First dose 5pm on November 18 2021.  I took all of the tablets as directed.  I noticed improvement starting after the 3 dose.  I fully recovered in 7 days.  I have had shingles in the past and I have also had both doses of the shingrix vaccine. Dose 2 of shingrix was over 2 years ago.
This spontaneous report as received from an administrator refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route, lot # and expiry date were not reported). The reporter stated that maximum time out of range for the vaccines was minutes only when door was being opened and closed. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case reported by an other healthcare professional, describes the occurrence of  hypersensitivity (allergic reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypersensitivity (allergic reaction). At the time of the report, hypersensitivity (allergic reaction) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, due to allergic reaction with first dose, patient did not complete the series. On May 9, 2021, patient administered second dose of Janssen COVID-19 vaccine (off-label use purpose). On Nov 12, 2021, patient administered the third dose of Janssen COVID-19 vaccine. The time gap between second and third dose was 6 months 3 days hence patient administered an inappropriate schedule of vaccine. The outcome for both off-label use and inappropriate schedule of vaccine: unknown at the time of report. It was unknown whether patient had any adverse events following third vaccination.
lateral aspect lt upper arm w/large area of dermal erythema, distal to inj site;skin mildly warm;
Approximately 32 hours of extreme fatigue, low grade fever, chills and she lost function in her hands which occurs when she gets sick due to her multiple sclerosis
This case was reported by a healthcare professional (nurse) and a consumer (mother of another subject at the nurse's office) and described the occurrence of injection site reaction in a child subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of KINRIX (details unknown). At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction. The mother of another subject at the nurse's office reported that her daughter (see case A0987998A) and other children had the "same reaction". The nurse in the physician's office informed that they have different information from what was provided by the consumer reporter. The nurse stated that she conferred with the physician. According to the nurse, there were a total of 3 children (including the subject whose mother had called) with local reactions, but not confirmed to be systemic and the other two were different lot numbers. The nurse did not have the lot numbers of the two subjects or their information. This is case two of the two subjects. See case A0989130A for the first subject and A0987998A for the daughter of the consumer reporter. At the time of reporting the outcome of the event was unspecified.
Symptoms began with generalized fatigue around 5pm.  By 8pm pt was fatigued and went to bed.  States by 8:45pm he was experiencing "severe" abdominal cramps and had an episode of diarrhea.  While sitting on the toilet he experienced a syncopal episode, fell off the toilet, hitting his head on the shower curb and bathroom wall.  States sustained an avulsion above the left eyebrow and several abrasions to forehead and left parietal area.  States left eye is bruised and left eye is bloodshot.  EMS was called and FD responded along with county ambulance.  He was transported to clinic and treated by Dr.
Shooting pain down arm & into chest, pain, swollen, red at injection site for approx 6 days. Also fatigue & loss of appetite. Injection site upper shoulder area, noted liquid spray & air sound during injection.
developing an allergic reaction to shellfish; she was eating mollusk, and her top lip swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Mar2021 (Lot number: EN6199, Expiration Date: Jun2021) at the age of 77 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, 0.3mL, SINGLE, Lot: EM9809, Expiry: Jun2021, Patient Route of Administration: Intramascular), administration date: 03Feb2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: FOOD ALLERGY (non-serious) with onset 2021, outcome "unknown", described as "developing an allergic reaction to shellfish"; LIP SWELLING (non-serious) with onset 2021, outcome "unknown", described as "she was eating mollusk, and her top lip swelled up". Therapeutic measures were not taken as a result of food allergy, lip swelling.  Additional information: caller wife is 78 years old. He states that she was eating mollusk, and her top lip swelled up. States that her lip swelled up after eating the baby octopus and it lasted a little over a week. She was never allergic to it before. States that she just used a cold washcloth on it and toughed it out. No other treatment was provided. Caller clarifies that they ate the baby octopus and had a reaction to it between the 2nd and 3rd dose of the Covid 19 Vaccine. Caller received Booster received on 02Dec2021, Lot: FF8841, Expiry: Mar2022, 0.3mL IM; she thinks she got it in her left arm. Got the flu shot on 22Dec2021. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as none.  No follow-up attempts are possible. No further information is expected.
Continuous headache ranging from moderate to severe migraine every day since injection, now on day 4. Splotchy, red swollen left eye on day 4. Fatigue, malaise.
Shot was Moderna on 2/25/21 Severe rash/hives on butt, legs and arms with burning,   Went to urgent care on 3/12/21 they prescribed Clotrimazole and Betamethasone cream.  Does not to be working, and the rash is spreading.
Patient received above vaccines on 7/2/18. Parent noted redness and swelling 7/4/18 on (R) upper arm. Seen in office. ? vaccine reaction vs cellulitis started on cephalexin.
never completed the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose in 1999).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B and never completed the series which led to incomplete course of vaccination. No other information known as it was 22 years ago. Reporter denied to follow-up.
2PM h/a, 4PM chills-99 temp; no localized swelling; hurt up the neck to the ear-almost like an earache; 130AM went to Er because wheezing & difficulty  breathing, then t103F; Given Epi & DPH to take every 6 hrs;
shingles blister left upper chest; shingles blister left upper chest; itchiness on left side upper chest; rash on back and chest on right side; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (In February 2021), post herpetic neuralgia (In February 2021) and rash (had a rash on back and chest on right side).   On 8th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th July 2021, 1 days after receiving Shingrix, the patient experienced shingles, blister, localized itching and rash. On an unknown date, the outcome of the shingles, blister, localized itching and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, localized itching and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported bypatient herself.  The patient received the Shingrix vaccine in left arm. The patient stated the next day she had one shingles blister on upper chest left side and had a rash on back and chest on right side.  The patient asked if Shingrix can cause a shingles outbreak? The patient referred to health care professional, Spoke per content.  The reporter consented to follow up.
Reason for TD was a dog bite on 8/5/01 at 20:00. On 8/6/01 PM, "head felt funny". On 8/7/01, "ached all over". On 8/8/01, left arm got hot and red around injection site. On 8/9/01, redness and swelling increased and went to ER and was treated for cellulitis.
c/o tingling to her tongue and itching to left side of face approx. 30 minutes after vaccination. No SOB, dizziness, CP. Given PO Benadryl 50mg. Declined transport to ER.
vulvar aphthous ulcer in adolescent; swollen lymph nodes in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 16:00 as dose 4 (booster), single (Lot number: GJ6738) at the age of 13 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SLOW FE; ALLEGRA 24 HOUR. Vaccination history included: BNT162b2 (dose 3 (booster), administered intramuscularly in the left arm at 18:15, Batch/Lot no: unknown), administration date: 06Jan2022, when the patient was 12-year-old, for COVID-19 immunization; Covid-19 vaccine (primary immunization series complete, manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Dec2022 at 18:00, outcome "recovering", described as "swollen lymph nodes in left armpit"; VULVAL ULCERATION (non-serious) with onset 05Dec2022 at 18:00, outcome "recovering", described as "vulvar aphthous ulcer in adolescent". The events "vulvar aphthous ulcer in adolescent" and "swollen lymph nodes in left armpit" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vulval ulceration, lymphadenopathy.  Additional information: Patient had no other vaccine in four weeks. Doctor confirmed the events on 07Dec2022. Bloodwork was ordered and it was confirmed that no other virus present such as mono, flu, or pneumonia. Therapeutic measures were taken as a result of vulval ulceration, lymphadenopathy which included topical cortisone, topical lidocaine, and ibuprofen.
My arm swelled up, has aches and kind of lumps; My arm swelled up, has aches and kind of lumps; High temperature; Nauseous; I had like a sun burn and very upsetting; I had the bad reaction; This is a spontaneous report from a contactable other health care professional (retired nurse).  A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration on 12May2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history included diagnosed with the Covid virus in end of Dec2020 and then patient tested negative in Jan2021, but patient continued to have antibodies (not clarified) and patient's doctor insisted that he/she should still get the vaccination. The patient's concomitant medications were not reported. Patient thought that Pfizer would have less side effects but when patient got first dose vaccination. On an unspecified date in 2021, Patient's arm was really swollen up and had aches, kind of lumps, so patient was afraid to get the second vaccination. Patient felt good at the first day then next night when patient went to bed, patient woke up with high temperature his/her arm was all swollen. Patient felt nauseous and then patient had like a sun burn kind of and it lasted for a couple of days but was very upsetting. Patient just wanted to make sure, Patient was scared and afraid to get the second dose and scheduled on 02Jun2021. Patient was trying to figure out, was it normal and what they do from now. Patient's doctor wanted him/her to get the second one, but patient was nervous. Patient hoped they had some advice. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Nausea, chills, headache, body aches, diarrhea, burning feeling running up and down right arm
Patient presented today to emergency department approx 12 hours after her Day 3 RabAvert dose complaining mostly of feeling anxious, having subjective sensation of swelling in her lower lips, and feeling "pins and needles" in her lower extremities. She states having a similar reaction to her Day 0 treatment which did include 1200units of hyperRab, but these resolved within 24hrs, and certainly prior to the second RabAvert. I appreciate no rash, no erythema and no swelling. By the time I evaluated her she had had resolution of her symptoms which started about 4 hours after injection and continued during the day and into the evening, lasting until about 10 hours after injection today. I advised the patient to continue her injections, but she wished to know how protected she would be if she stopped the series. 1) Is this likely related to the vaccine? 2)Would she be covered for her current exposure (no bite but unknown contact from sleeping in cabin and finding bat in am)?
The patient MAY have received a dose of Janssen vaccine that was administered after the Beyond Use Date.  The provider may have given the dose outside of the 6 hour window after the vial was opened.  No symptoms or signs.  Pt will be contacted and offered to be re-vaccinated to offer full protection.
Diarrhea side effect for covid19 vaccine; Fever; general body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea side effect for covid19 vaccine), PYREXIA (Fever) and MYALGIA (general body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (general body aches). On an unknown date, the patient experienced DIARRHOEA (Diarrhea side effect for covid19 vaccine). At the time of the report, DIARRHOEA (Diarrhea side effect for covid19 vaccine), PYREXIA (Fever) and MYALGIA (general body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, COVID-19: positive (Positive) covid-19 virus infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 24 Jul 2021 Patient's demographics was updated On 06-Aug-2021: Follow-up information received on 06 Aug 2021 contain significant follow up (New event added-diarrhea).Further follow-up declined.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.