chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the vaccine and got the shingles/suspected vaccination failure; got the shingles; sick; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the vaccine and got the shingles, the patient was sick a long time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Itchy, hot red rash around injection sight. Spread to about 6? X 8? across upper arm
2 hours post vax, the pt developed rash on side of face. Calamine applied by nurse and mother notified. Rash spread to other parts of the face over the weekend and is still present. Rash is mixed with urticaria and papules.
Within 15 minutes of injection administration, felt flushed and nauseated. Later that evening, was woken up with nausea, sweats, chills, muscle and body aches, arm pain at injection site. Chills and aches continued into the next day, easily fatigued. Cold sweats continued for 1 week.
Information has been received from a nurse concerning a 13 year old female who on 21-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL. On 22-MAY-2008 the patient fainted at school after receiving her first dose the day before. It was reported the patient did not have breakfast or anything to drink before lunch and was sent home from school. The mother of the patient reported the patient continued to have symptoms of weakness, back pain, fever, fatigue, dizziness and vomited during the night. The patient required an office visit. The patient's outcome was reported as not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/13/2008.  The patient never came back to the office therefore the physician has no additional information about the patient. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Cows milk" (unspecified if ongoing); "known allergies: Pennicillian" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 10Mar2022. Past drug history included: Imuran, reaction(s): "known allergies: Imuran"; Ammoxicillian, reaction(s): "known allergies: Ammoxicillian"; Pentasa, reaction(s): "known allergies: Pentasa". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 101.0+; SARS-CoV-2 test: (27Jan2023) Positive, notes: covid test positive 27Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Moderna Bi-Valent at 01:00 PM. Covid symptoms started 25Jan2023 with a sore throat, covid test positive 27Jan2023. Started Paxlovid 27Jan2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt had small area of urticaria @ flexor surface of (R) arm on day of vaccination, but four days later, she developed urticaria over entire upper body & face.
cried, like painful hurting 2-3 hrs p/vax 22FEB93;
Tingling to lips and tongue, throat "tightness". Treated with IV Benadryl, Pepcid and Solumedrol. Pt reported improvement of symptoms about 1 hour later.
Facial flushing, itching.  No swelling of lips or tongue.  No difficulty swallowing or breathing.  Given Solumedral 125mg, Benadryl 50mg and Pepcid.  Discharged with prescription for Medrol dose pack, Benadryl and Pepcid.
Tiredness, fatigue, headache, nausea, chills, fever. Starting about 9:PM on 02/27/21 continuing all the next day 02/28/21. Still had a slight headache on 03/01/21.
Nausea, low blood pressure, fainted, body pain, adverse reaction to cosmetic filler.
sinus congestion/drainage 2 weeks, no treatment positive covid test 9/13/21 no taste/smell, ongoing breathing problems/chest congestion, 3 weeks, Mucinex\ joint pain, ongoing
received the 1 dose / on 08/5/2020 / had not yet received the second dose of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on 5th August 2020 from batch number 4F472, expiry date 6th November 2022).   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 were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination. The reporter consented to follow up.
Within 12 hours of flu shot patient had 4 episodes of vomiting, fever to 103 for 24 hours and sore throat and runny nose.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Nov 12, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient "got the booster shot" and experienced diarrhea, onset Nov 14, 2021, with outcome of unknown. Additional information: Report not related to a study or program. The patient got the booster shot on Friday and today started feeling some side effect. The patient does not know if related, but just today started with diarrhea. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Flu vaccine given at 2pm. Patient reports at 9pm right side of face and throat numb (describes some feeling as with dental anesthesia). Trouble swallowing and swelling. Took antihistamine and symptoms resolved over next 24 hours.
People were complaining about vertigo days after the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (People were complaining about vertigo days after the shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (People were complaining about vertigo days after the shot). At the time of the report, VERTIGO (People were complaining about vertigo days after the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter treatment information n was not provided. This patient was reading a form on the internet where people were complaining about vertigo days after the shot.
I?ve had a weird pressure feeling on the left front of my face, sinus-like pressure that also effects my left eye and dizziness, tiredness to accompany it.  tried to take ibuprofen and Tylenol to help it, it didn?t help
Vaccine given to 17 year old was moderna and not Pfizer (Both doses.) - Patient reached.  Had  no  issues.
Nasal discharge, no fever, crying unconsolable, no relief from Tylenol. No erythema of thigh, screaming uncontrollable 5/16. Rule out for UTI-UA/C&S urine. No growth, UA WNL. Motrin of 6 hours ATC.
This spontaneous report as received from a patient of unknown age and gender refers to herself/himself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, dose, route and strength not reported). The patient reported that she/he had been suffering from shingles on and off for 39 years. Even after the vaccine she/he was still getting shingles on an unknown date. The outcome of event was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Systemic: Vomiting-Medium, Systemic: Other- low blood pressure-Medium
All symptoms occurred at 8am the following day after the administration of the vaccine. Patient developed swelling in the lymph nodes and swelling under the arm. Patient also complained about body aches, high blood pressure (189/100), heart rate of 127, and a fever of 101.7F. Patient went to the ER and was prescribed a beta blocker. Patient feels fine now. Heart rate and blood pressure has normalized.
Two days after vaccine I noticed a rash, it feels warm to the touch and I called the pharmacist and he looked at it and felt it. By Sunday it started itching and the pharmacist said to put ice on it and not anti-itch and if it didn't feel better to contact my PCP. If I don't put ice on it it itches and its under the skin itching and not on the surface of the skin.
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication use were not provided. On 11-JUL-2016 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot # L011533, expiration date 03-JUL-2016). No adverse effect was reported. The outcome of the event was unknown. Additional information has been requested.
Injection site swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Temp 99.1 3 days later pt. has redness, swelling, induration and warmth, pain, itch to (L) deltoid. Calamine lotion applied. Started on Augmentin x 5 days, Motrin
Indication: Covid; Indication: Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "nerve pain" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication: Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Prior Vaccinations (within 4 weeks) was No.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Tachycardic (HR 120). Gave an epi pen injection and brought to ED to be monitored. Patient shortly improved after ED arrival and was discharged.
10/29/2021: Positive pregnancy test. Ultrasound done 1/4/2022: Negative fetal heart tones, consistent with miscarriage. First trimester post vaccine miscarriage.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medication, drug reactions/allergies and concomitant medication were not reported. On 25-MAY-2010, the patient was vaccinated with the first dose of VAQTA (dose and lot# were not reported), intramuscularly. On 08-NOV 2010 the patient was vaccinated with the second dose of VAQTA, intramuscularly (dose and lot# were not reported). The reporter stated that the second dose was too soon after the first dose. No known adverse effects were reported. Additional information has been requested.
Pt recvd 3 booster doses of Engerix-B & was determined to be a non-responder; pt recvd 5th booster dose & still was a non-responder;
Rec'd. routine 4 mo Imm. and WCE in office 07/06/16. S/S present approximately 1 week - frequent, intermittent fussiness; waking approximately 20 min after HS. Afebrile; no S/S illness. OTC TYELENOL "not helping" per Mom. AXID dose increased from 1.6 ml BID - to - 2 ml BID on 7/16/16 with no A. Tx Rec = TYLENOL HS x 1 wk.
Patient reported significant muscle pain that started the morning after having the vaccine. She reports that the pain started in her back. She denies having any other significant symptoms.
pt recv vax & devel local rxn characterized by itching,swelling @ site of inj & hard knots;pt also had a fever;no other details were known as of reporting date
10-17-18; 24 hours after receiving vaccine the patient experienced redness and swelling at injection site. She then felt feverish and experienced swollen, red eyes. She preceded to the ER and was confirmed to have a fever of 103 degree F. The ER doctor recommended taking diphenhydramine, ZYRTEC, and TYLENOL. The patient has been taking diphenhydramine and ZYRTEC for 5 days. The following day the patient reported to her eye doctor with concerns of shingles in her eyes. The eye doctor stated there was no signs of shingles and recommended using OTC eye drops and an eye pack for redness and irritation. Patient has been using eye drops for 4 days. On 10-22-18 the patient reports no swelling and only a light pink shade over the injection site. Her eyes are slightly irritated, but she reports improvement.
Initial report received from a healthcare professional on 17 July 2013. A female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine (Lot number: U4667AA, anatomical site of administration not reported) on an unspecified date. The last menstrual period was reported as 03 December 2012. The patient's estimated date of delivery was reported as 09 September 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. The patient's had experienced adverse events on an unspecified date. Concomitant medications and past medical history were not reported. Treatment for infertility was not reported. List of documents held by sender: none.
Our facility was providing pre exposure rabies vaccine to employees of animal hospital. This was 1st injection. Felt ill night of shot, next AM awoke with left eye swollen, itchy, had red line from left eye through nose and down to chin. Nasal discharge. Muscles sore in left arm, neck and left shoulder. Felt fatigued. Sx. Resolved 72 hrs.
Pfizer 6/24/21, 7/15/21, 2/10/22. Positive on 4/27/22
Positive influenza type B after influenza vaccine on 10/20/2012. TAMIFLU given.
Since then, I?ve had constant light menstrual bleeding. Been on depo since I was 17 ish, so very familiar with what is normal and even the few times it?s been off, but never has it done this - when it did (not on schedule even for my irregular depo impacted cycle) or for the length (constant) or in quantity (super light but constant).
Patient presented with minor rash, red, hives on neck area above left arm.  Provided Benadryl and patient felt better within 30 minutes.
immediately after i gave pt her first dose of moderna, she said her tongue was tingling and her chest was tight. she said she had anxiety and was nervous about getting shot. i had tech call 911 and offered her a dose of benadryl, which she accepted. she said she was feeling better and asked me to cancel ambulance. i had her sit directly in front of me and checked on her every few minutes. she said her chest continued to be tight but that it was just nerves and that she was fine. a few minutes later i saw that she had lowered mask and she said she had chest tightness and burning sensation on chest. i called ambulance. pt was alert and speaking and concious the whole time.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 11 year old male patient. On 09-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot # L043214), (route: intramuscular) in the left arm. On 09-AUG-2016, the patient experienced syncope. The outcome of syncope was reported as recovered. The causality of the event was unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
03/18/10 administered (L) thigh large indurated area 170 mm x 220 mm vaccine site central to lesion with small blisters at my site, warm to touch, blanches hard/firm to touch.
2nd dose did not receive/ do i have to start over, or just get the second one; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (patient thought he/she had his/her first shot a long time ago in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose did not receive/ do i have to start over, or just get the second one). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-OCT-2023 The patient self-reported this case. The patient wanted to know do he/she have to start over the Shingles vaccine series, or just get the second dose. The patient further stated that, he/she received different answers from different professionals. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The consent to follow up requested.
7 days, post vax, and after Amoxicillin started, the pt developed a rash, fever and irritability. She had extensive urticarial rash on forehead to lower extremities with purple areas. This lasted 3 days and was thought to be MMR reaction versus drug reaction to Amoxicillin.
Information has been received from a physician concerning a 4 month old male with no medical history or allergies who on 25-JUN-2008 was vaccinated with 2 ml dose of ROTATEQ. Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, PNEUMOVAX 23 (manufacturer unknown) and PEDVAXHIB (manufacturer unknown). The physician reported that the patient developed diarrhea after receiving his first dose and only dose of ROTATEQ on approximately 25-JUN-2008. The patient experienced 8 to 10 diarrhea episodes daily. The patient was seen by the physician. It was reported "the culture resulted negative." Subsequently, the patient recovered from the diarrhea 17 days later. No further information is available. A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from the physician on 24-OCT-2005. The physician reported that her son developed diarrhea when he was 4 months ild after his second dose of ROTATEQ (previuosly reported as the first dose). The diarrhea lasted 2 weeks (previously reported as 17 days). It was unspecified iif this physician brought her son back to the pediatrician's office related to the diarrhea. This name infant spit out his third dose of ROTATEQ . No other information available at this time. Additional information has been requested.
pruritic rash started at 7pm > mother applied cool compresses which helped for a bit
Narrative: 01/15 COVID swab, result: NOT detected 03/05 COVID swab, result: NOT detected COVID infection following COVID vaccine series 04/27 Janssen, dose #1 08/06 COVID swab, result: detected 08/06 pt cc: cough, headache rhinorrhea, congestion, fatigue, vomiting, myalgias, exposure: COVID+ sister and BIL 08/12 SARS-COV-2 LINEAGE AY .10 08/12 SARS-COV-2 CLADE 21A DELTA