chrisvoncsefalvay/vaers-outcomes huggingface dataset:
panic attack; feeling body aches; short of breath; their left gland was inflamed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANIC ATTACK (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "feeling body aches"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "their left gland was inflamed".  Additional information: In the beginning of the call, the agent confirmed twice with the user if they are a trial participant or not. They stated they were. They reported feeling body aches after a Pfizer Vaccine (at this point, it was not yet confirmed if this was Covid or a Clinical Trial), and that their left gland was inflamed. Following that, the agent asked them to confirm if they had their Emergency Contact Card with them, which they confirmed. They confirmed it was a physical card. While looking for the card, the person on the call started getting short of breath. The agent asked them if they were feeling okay and stated that if they were having a panic attack (as it sounded like it on the phone), and/or if their symptoms are worsening, they need to seek Emergency Medical Help. The caller advised that they were having a panic because 'they couldn't find their bag' and that 'the symptoms weren't worsening, they were just very worried'. Upon asking to confirm what was stated on the card, the agent advised them to not confirm any names/phone number (as at this point the agent still unsure if they are NOT a Pfizer Clinical Trial Participant) at the 'Sponsor Protocol Number' field, they said 'PFZ699'. As that did not sound like a study during the call, the agent asked them to confirm the Principal Investigator's name/s and if there would be a phone number on the card. They advised there was no such information present on this card, but rather, when they were distributed with a Covid Vaccine and the type of it. The agent asked the caller how they got our phone and they admitted they just searched it. After confirming that the line was for Pfizer Clinical Trials only, the caller asked what phone they should call.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 21 year old female who on approximately 29-MAY-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine. There was no adverse events reported. On an unspecified date the patient was vaccinated with a second dose of Gardasil vaccine. Subsequently, one day after vaccination the patient experienced flu-like symptoms including fever and nausea. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. 02/12/2010 The patient was vaccinated with a third dose of GARDASIL on an unspecified date. It was reported that the patient did not experience any symptoms after the first and third vaccinations. Additional information is not expected.
Information has been received from a case in litigation from a consumer concerning her son who on 07-MAY-2004 was vaccinated with a dose of MMR II (dose, route and lot number not provided). Concomitant vaccinations received on the same day included VARIVAX and PEDVAXHIB (manufacturer unknown). The patient's mother reported that her son developed idiopathic thrombocytopenia purpura and seizure disorder and unspecified neurological injuries after vaccination. The patient's mother felt that the vaccines caused her son's idiopathic thrombocytopenia purpura, seizure disorder and unspecified neurological injuries. Upon internal review, idiopathic thrombocytopenia purpura and seizure disorder were determined to be other important medical events. Additional information is not expected.
Swollen lymph node under arm beginning approx 12 hours after injection. Stiff neck beginning approx 20 hours after injection. Tailbone pain on left side beginning approx 31 hours after injection.
back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient had the shot on the 09Mar2021 back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger. The outcome of the event was unknown.  Information on batch number has been requested.
vaccination site reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (vaccination site reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (vaccination site reaction). At the time of the report, VACCINATION SITE REACTION (vaccination site reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data provided by reporter. No concomitant medication provided by reporter. No treatment medication provided by reporter.   Reporter did not allow further contact
Itchiness, hives and maculopapular rash developed 4 days after 2nd injection of Japanese encephalitis vaccine.  No respiratory problems, hypotention, loss of consciousness or any other symptom.  Responded favorably to prednisone and Benadryl.
Pt returned to clinic approx. 1.5h after vaccination reporting that her tongue feels heavy and her throat feels like it's closing. Pt appeared in no acute distress- speech clear, VSS (BP 120/75, HR 73, O2 100%). 10ml PO benadryl administered. Pt observed for additional 15 minutes and reported that she felt "much better". Pt advised to see PCP.
CDC reports: 3 mo infant experienced fever to 103 & screaming episode lasting more than 4 hrs following immunization.
Woke up next day (Saturday) feeling achy, ran fever off and on all day (never over 101.5), headache, sick to stomach  Was fine on Sunday
6 days after vaccine given in R arm, patient presented with severe R shoulder/arm pain x 1 day. Patient unable to lift her arm and had constant severe pain. No swelling, bruising or redness to joint or site. No fevers/chills, nausea, vomiting, chest pain, shortness of breath. R arm had no active ROM and minimal passive ROM with pain. She had pain to palpation of the anterior and posterior shoulder as well as lateral area of deltoid. Patient was referred to PCP for further imaging/evaluation and provided education for rest, ice/heat, and ibuprofen/tylenol as needed. She was medicated with 600mg Ibuprofen in the office.
Fluzone high dose QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Fluzone high dose QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA318835(CLUSTER), 2023SA318839(CLUSTER), 2023SA321113(CLUSTER), 2023SA321127(CLUSTER) and 2023SA319055(CLUSTER).  This case involves a 68 years old female patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] and was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of 0.7 ml once of suspect influenza quadrival A-B high dose HV vaccine (lot: U8162BA; strength: high dose; expiry date: Jun-2024) (formulation unknown) via intramuscular route in left deltoid for Immunization.  On 16-Oct-2023 the influenza quadrival A-B high dose HV vaccine was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
anaphylactic shock; 2 months of misery; Initial information was received on 17-Nov-2020 regarding an unsolicited valid serious case from a consumer/non health professional via social media.   This case involves male patient (unknown age) who had anaphylactic shock and 2 months of misery (feeling abnormal), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious anaphylactic shock (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed 2 months of misery (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from Facebook involves a male patient (unknown age) who had anaphylactic shock and was feeling abnormal after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient's medical history, health condition at time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed
Initial case received from a health care professional, who is also the patient, on 10 November 2009. A female patient reported that she received an influenza vaccine (manufacturer, lot number, and date of administration not reported) "two years ago". Three days post-vaccination, she experienced shortness of breath, palpitations, chest pressure, and left arm weakness lasting several weeks. The following year she experienced a similar reaction but reported that it was not as severe. No additional information was reported. Documents held by sender: None.
TDAP given too early. No known adverse event occured. Patient received an extra dose of Tetanus in the form of Tdap at an age younger than recommended.
normal, aches and lethargy for two days after and then all good until 7 days after shot.  Injection arm, got sore, developed a hard mass (walnut sized) where shot went in, and for next day and a half was hot, itchy and quite swollen.  Had aches and chills, no fever.  By Day 3 started to resolve, day 5 no remaining issues.
I experienced flu like symptoms, pain at the injection site, chills, body aches, loss of smell and extreme fatigue on 07/19/2021. I went to Urgent Care and was given a COVID-19 test which came back negative. Doctor prescribed cough medicine and Tylenol along with continued hydration with Albuterol and Mucinex.  I did get the Shingles vaccine a week before my symptoms begin.
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. This case was originally opened on 06-OCT-2014 to evaluate improperly stored vaccines. On 13-OCT-2014, (also reported as since the first call) patient was possibly vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Pt was given vaccine that had exceeded the 45 days in the refrigerator. Pt did not report any symptoms and was notified of the vaccine error
Sore nipples.  No treatment has been sought.  Still painful on day 4.
warm to the touch at the injection site; knot at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE WARMTH (warm to the touch at the injection site) and VACCINATION SITE NODULE (knot at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE WARMTH (warm to the touch at the injection site) and VACCINATION SITE NODULE (knot at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE WARMTH (warm to the touch at the injection site) and VACCINATION SITE NODULE (knot at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient did not use any treatment medication.
No adverse event.  Patient given the adult Pfizer formulation and dose (0.3 mL) when he should have received the Pfizer 5-11 yr formulation and dose.    Patient came to vaccine clinic with two siblings. 5  year old patient was given an adult dose that was meant for 12 year old sibling. Nurse noticed it right away and notified mom, clinical coordinator, and pharmacist. Educated mom on what to monitor for and provided her with a MIIS print out for her vaccine records.
This spontaneous prospective pregnancy report as received from a medical assistant refers to a 24 year old female patient. The patient was allergic to penicillin. The patient's medical history included pregnant. Concomitant therapies included prenatal vitamins. On 12-AUG-2014 the patient was vaccinated with GARDASIL lot # J010668, expiration date: 29-APR-2016, 1 single dose/ as directed, intramuscular by the medical assistant and meant to give a Tetanus shot. The event happened in the medical office. No adverse effect reported. No treatment was given. No labs was performed. It was reported that the patient was pregnant with LMP of 20-FEB-2014 (pregnant gestation was reported as at 26 weeks at the time of reporting) and EDD of 27-NOV-2014. Initial exposure to GARDASIL was at 24 week(s). Additional information has been requested.
1/27/21 developed dime sized redness and soreness in arm. the next day was 2 inches the next day was 4 inches across and swollen and warm. Pt also having difficulty breathing, Went to Doctor and ER due to breathing distress.  Was monitored but not admitted. Still  continues to experience headaches, chills, and an increase in salivary secretions.
Had Hep B #1 at about 9:00am on 09/07/2005. About noon developed weakness in legs, dizziness, felt like couldn't do anything. No rash, no swelling. Went home and laid down, Next day had sinus drainage, sneezing. Think this was reaction to shot.
Small rash spot on her abdomen; Rash on injection arm; Injection arm generating heat; A spontaneous report was received from a Consumer concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection arm generating heat, rash on injection arm, small rash spot on her abdomen.  The patient's medical history was not provided. Concomitant medications reported were Diuretic, Blood Pressure Medication for drug use for unknown indication.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039T20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the events injection arm generating heat. rash on injection arm, small rash spot on her abdomen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, injection arm generating heat, On an unknown date the outcome of events, rash on injection arm, On an unknown date the outcome of events, small rash spot on her abdomen was not reported.
Pt. came to the pharmacy so we could check her arm. Her arm appeared extremely red, swollen and warm. Pt. also stated her arm was itching. I recommended she use some hydrocortisone cream and BENADRYL, then contact her PCP.
Pt describes no pain on day of injection. Following day arm is very painful when moving it. The pain is sharp and she has had no relief using Aleve or ice. She is unable to drive or put on clothes due to the pain. The pain is at the location of the shot, not traveling along the arm. Pt is only caregiver of husband
Patient just called the pharmacy and said he was released from the hospital and had a stroke on 4/12-4/13.  He believes it to be due to the vaccine.  He received his second dose on 4/7/21
Mom calls to report that patient is having a reaction to the immunizations she received yesterday. She has been crying non-stop since she received the immunizations (HIB, Hep A, PCV 13).  Has a fever of 99F and is very warm to touch, and she doesn't want to be touched. She is limping and shaking when trying to ambulate. Mom states that she is potty trained but urinated on herself without saying a word. Mom has given ibuprofen but that did not help. Dr. recomended monitoring for changes and to try Tylenol if Ibuprofen not helping.
This spontaneous report as received from a pharmacist refers to a 38 year old female patient. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with MMR II for immunization as a child. Also reported that the patient was unsure if she had one or two doses of MMR II, live as a child. Reporter stated that on an unknown date and month in 2013 the patient has unspecified titers done, and the titers were negative. Pharmacist also reported that on an unknown date in SEPTEMBER-2013 the patient had one dose (unspecified) of MMR II, live cancer and overdose was not reported. The outcome of the events was unknown. Causality for the event 'titers were negative' was unknown. Additional information has been requested.
Pt. had dizziness, nausea & faint, right away. On 11/8/99, she called to say, she is still having sx's of dizziness, nausea, maybe a temp. & chills, muscular pain in shoulders & neck; arm hurting & hand slightly swollen; cold sx's; by 11/12
No additional adverse events reported; was administered improperly stored during a temperature excursion found; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 30-SEP-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027115 was verified as valid, expiration date: 17-FEB-2022, albumin status: rHa), in dose 0 .5 ml for prophylaxis (dose number, route of administration and anatomical location were not reported). The temperature to which the vaccine was exposed was: 6 degrees of Fahrenheit (F) to 14 F (8.5F) and the time frame was reported as 18 minutes and additionally vaccine was exposed to 6F to 14F (11.9F) for 1 hour. Cumulative Timeframe was 1 hour and 18 minutes. No previous temperature excursion was reported.  It was unknown if digital data logger was involved. No additional adverse events reported.
Fatigue really settled in roughly 24 hours after shot.  However, once I slept (going to be earlier than usual) when I work up fatigue was gone.  There was also injection site soreness for around 3 days after shot.  Note - This was my COVID booster, my first 2 shots were with pfizer on 4/6/21 and 4/29/21.  This booster was with Moderna.
chills, dry heaves, dizzy, headache   continuing for 13 hours so far
Chills, fatigue, muscle and body aches, sleepiness this lasted 36 hrs
Patient reports she had "metallic taste" in her mouth for roughly 3 hours post vaccination.  Patient reported that on 4/8, she woke at 0100 with "toe cramps", she got out of bed, walked around and took some Tylenol, this resolved.  Then on 4/9 around 1400, she had what she described as "the beginning of a migraine" in which she had blurry/wavy vision.  She has had migraines in the past, however they are very infrequent.  She is not treated for migraines due to their infrequency.  In the past, she would take a Tylenol at the first sign of blurry/wavy vision and this would prevent a full blown migraine.  On 4/10 at 0530, patient woke from "charlie horse" in left calf.  She got up, walked around again and took a Tylenol, this resolved.  Later that same day, patient developed the blurry/wavy vision again, took a Tylenol again and this resolved.  On 4/11, patient reported soreness in left calf from previous day's cramp and used heating pad.  Patient has had 2 more episodes of blurry/wavy vision yesterday 4/12 and today, 4/13, which both resolved with Tylenol.  Patient has not yet spoked with PCP.  Due to the nature of the events, and the recent update of J&J vaccines,
numbness in face, some SOB, gen itching-treated self w/pred & atarax;
flu type symptom;general body pain, diarrhea;pt not seen;illness lasted about 8hr;
Patient had a positive COVID test on 1/24/2022 and passed away on 2/15/2022.
11-1-2010 3 day history of rash (dark pink bumps on inner right thigh)blister area.  No fever, vomiting, eating well everything else was normal, vesicular lesions.