chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 22-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 29-SEP-2016, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving the ZOSTAVAX, the patient suffered herpes zoster. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Herpes zoster was considered to be disabling. Additional information has been requested.
Patient did not receive the second dose within the appropriate window of time between two doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose within the appropriate window of time between two doses) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose within the appropriate window of time between two doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose within the appropriate window of time between two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
pt recvd vax 14DEC92 & 15 mins p/vax exp sharp pain in lt arm @ the inject site; stated pain was in entire arm extending to shoulder; pt was seen by MD wh dx neuralgia type pain; also stated that pt had numbness in arm;
Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Reporter's email was added. Anatomical location of vaccination and patients medical history were also updated.
@/14/07:   Given IM injection on 12/6/06 in right deltoid.  States injection site still very sore and complaint of pain in right shoulder and upper arm when doing exercises or at rest.  Has not taken any OTC meds or used moist heat to arm - may have taken Advil immediately after vaccination.
Dosage 1 had heart palpitations; anxiety and jittery feeling; tired. Slept it off. Heart palpitations (benign) lingered for at least a few weeks. Had not experienced them for months before the vaccine.  Dosage 2: Received dosage 2 on 04/07/2021 and developed Shingles on 04/24/2021. Notified healthcare provider that I had shingles, and was prescribed medicine.
Lower lip is swelling very much; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8730, Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation. On an unspecified date, the patient experienced lower lip is swelling very much. The reporter was asking if the event was a side effect of Pfizer vaccine. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Suddenly at 5 PM, that day I felt I was coming down with a cold. That evening I was very congested. The next day I had a fever up to 102 and stayed that evening with a headache. The next day, day 3 I had a fever and was really congestion. That was the worst part. I did not have any aches just shivering from the fever. I called my doctor's office and was prescribed PAXLOVID that Thursday afternoon after having a positive COVID-19 at home test. The medicine was fine, it was just a metallic taste in my mouth. By that next day I had two doses and felt much better. The fever was gone, and the congestion was much less. This is the first time I've had it. I mask at almost all places I go. I am still congested and kind of tired.
Site: Pain at Injection Site-Severe, Systemic: Fever-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Information has been received from a health professional concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck) (MSD). No additional information was provided. Additional information has been requested.
chills, body aches, nausea, exhausted, tired from December 24 until December 27.  Had to drink Pedialyte .  Fear of losing electrolites from not eating for a few days.
The pt experienced paleness, dizziness, nausea, "weird feeling". BP 110/76 and when rechecked 90/68, Pulse - 80, complained of numbness in fingers and hand. Epinephrine was administered as well as Benadryl. The pt was taken to the ER.
I had severe headaches after my second Covid-19 vaccine. It lasted  for three days along with mild fatigue that lasted for four days.
13:35 pm - Pt found as beginning to slump over in chair. Assisted from chair to floor. Pt lying down, responding to stimuli, eyes opened and closed. Answered questions appropriately. Episode lasted approximately 2-3 minutes. Pt cold and clamy. V/S taken BP 144/113, pulse 59, temp 96.7. O2 98%. Pt stated had hx of lightheadedness once as a teenager when having blood drawn. 13:46 V/S BP 151/106, pulse 72. Patient stated feeling comfortable. 13:50 Pt sitting up in chair. 2 pm BP 146/105, pulse 72. Pt states feeling better and cooler. given bottled water. 14:20 pm Pt left on own stated friends to meet him at site.
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Medical history and drug reactions or allergies for the patients involved were not reported. On an unknown date the patients were vaccinated with ROTATEQ, orally, lot number: M016238 (Expiration date: 07-DEC-2017) and M025569 (Expiration date: 18-JAN-2018), for prophylaxis(strength, dose or units were not provided). There was digital data logger involved. The nurse reported that on an unknown date multiple doses of improperly stored ROTATEQ were administered to multiple unspecified patients, with the characteristics were the following: - Temperature: 32°F to 35°F - Time frame: 8 hours. Previous temperature excursion: No. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007951.
Swollen lymph node in armpit of left arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in arm left on 20Feb2021 11:30 (at the age of 59-year-old) at dose 2, single for covid-19 immunisation. Medical history included penicillin allergy. Concomitant medications included losartan (LOSARTAN); simvastatin (SIMVASTATIN); ibuprofen (IBUPROFEN); mometasone furoate (FLONASE [MOMETASONE FUROATE]) (medications the patient received within 2 weeks of vaccination) all drugs taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in arm left on an unspecified date in Jan2021 14:30 at dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Feb2021 09:00 the patient experienced swollen lymph node in armpit of left arm. Patient did not receive treatment for the adverse event. Outcome of the event was resolving.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 17-JUN-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 88 hours with a lowest recorded temperature of 33 Fahrenheit (F) (0.55555556 Celsius(C)) and other one of 80 hours with a lowest recorded temperature of 34 F (1.111111111 C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
The following morning post vax, noticed site of injection was warm, red, swollen to size of silver dollar.
began sl fever 2AM 14JUL92; temp to 106 went to hosp ER 6AM 14JUL92; 1145PM 14JUL92 had generalized sz; t104 taken to ER by ambulance; unresponsive; crying; annorexia, vomiting, chills, eyes rolled back, shaking; drowsy; weakness;
became nauseous w/ episode of vomiting w/in 10 mins of vax administration; BP 102/54-82/44 w/circumoral pallor; cap refill WNL; became drowsy; administered 02 per maks @ 4PM; also given EPi;
This spontaneous report was received from a Registered Nurse referring to a 20 month old patient of unknown gender. No concurrent or historical conditions were reported. On 14-DEC-2016 and again on 08-FEB-2016 the patient was vaccinated with VAQTA (Lot numbers and expiration dates were unspecified), dose, route and frequency were unknown. No concomitant mediations were reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Patient got the Jansen covid 19 vaccine today.  She waited 30 minutes (since she stated she got a rash as a kid from a vaccine and hadn't received a vaccine since then).  She was fine after 30 minutes and handed us the timer and walked away.  She came back and said she thought she is just hungry since she hadn't eaten and felt funny.  She said she was going to get some food.  We had associate walk her over.  They came back.  She sat down and ate her food.  We checked on her but now she stated she had vertigo and needed meclizine and thought she'd be ok if she went home and laid down. I offered her ice for her neck or head and she refused.  I also offered to lay her on the floor and elevate her feet, but she refused.  She said her neck gives her problems so didn't want ice or to lower her neck. She was sitting this whole time and said she felt in slow motion.  She said she wanted to go to the restroom but I didn't want her going alone. She called her son in law that was shopping in the store and we asked him to come over.  He was going to drive her home but she said no one was home.  I asked if they'd like an ambulance and they both said yes.  We called 911 and stayed with the patient until EMS arrived.  She was feeling somewhat better but they took her to get checked out to be safe.
red raised patch on cheek & spread to extremities & trunk;persist as of 10OCT95;
On 1/18/21, 20minutes after receiving the shot,  I started having numbness and tingling in my right arm, all the way down to my finger tips.  it lasted for 10-20 minutes then slowly improved.  This also happened after the first shot  but I didn't think much about it because it only lasted for 3-5 minutes was mild and it was mostly just tingling.
Information has been received from a registered pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). On an unspecified date the patient experienced a large mass at the injection site the size of a "golf ball" which eventually dissipated. Additional information has been requested. This is one of several reports from the same source.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 11:54 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021 at 11:54 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021 at 11:54 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. Reportedly, patient vaccine status was 1/2 COVID received. Vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's daughter) via the Pfizer sponsored program Pfizer First Connect. An 88-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 to 28Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The reporter stated that the patient had tested positive for covid on 11Jan2021. Outcome of the event was unknown.   Information on the Lot/batch number has been requested.
Serious issues with blood pressure stability disease blackouts, serious headache initially, my headache subsided three days later, Extreme stiff neck and joints of hands, some light sensitivity,  and feet  relieved primarily by Benadryl. (Sixth day vomiting and diarrhea, but I am uncertain if that was related to the vaccine or not).  Still having issues with stamina but overall dizziness has subsided.  Some pain and hands and feet still occurring this is not uncommon with an inflammatory response. Most of these are controlled by diet  it under normal circumstances
9MAR rash appeared top of body; 4MAR-6MAR fever 101; 13MAR rash reappeared all over body; mom stated MD felt was a viral illness;
Pt. received her coivd vaccine, menactra, and tdap shot on 08/12/21. At 11:38 Am the Pt passed out for 30 seconds. pt. was very pale, diaphoretic, and stated she felt flushed. After the pt. came to the nurse took her vitals which were Bp92/60, HR97, O2 98%. The nurse had pt. lie down for a few minutes and gave her some food and water. At 11:57 Am the pt. passed out again for 30 seconds and came to. The nurse immediately laid the patient down and took her vitals. BP98/70, HR 53, O2 99%. Pt. was pale, diaphoretic and felt flushed. The nurse offered her more food and water and retook the vitals at 12:07 Pm Bp98/70, HR90, O2 98%. Pt. was able to leave at 12:44 Pm. F/U 8/13/21 no subsequent events, pt. was fine.
Few minutes post vaccination, after moving to observation area via wheelchair, the patient complained of dizziness. She took glucose tabs she had brought with her. Staff wheeled her to Triage # 1.  Her eyes rolled back in her head and she lost consciousness. Staff (paramedics on site) transferred her to gurney and started compressions. AED placed, V- Fib was rhythm, Shock # 1 given, CPR resumed. Shocked again.  Fire truck and additional EMT arrived on site and  took over care. Epinephrine was given 3 times via intra-osseous route, Amiodarone given intra-osseous route.  Additional defibrillation with on site AED for a total of 6-7 times. Patient had good chest rise with ambu-bag, no airway obstruction or peri-oral edema noted.  Code called at 12:40 PM.
itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disorder.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (itchy). At the time of the report, PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications included diabetes, cholesterol and heart medicines.  No treatment information was provided.   This case was linked to MOD-2021-218372 (Patient Link).
No additional adverse events; Patient completed series on schedule and this was a fourth dose; This spontaneous report was received from a nurse practitioner, referring to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 04-MAY-2022, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), orally (lot #, expiration date and dosage were not provided) for prophylaxis. The patient completed whole series on schedule and this was a fourth dose (Extra dose administered). No additional adverse event was reported (No adverse event).
Patient went unconcious shortly after receiving first dose of COVID-19 vaccine, he slowly woke up but reported blurry vision and was very lethargic and not fully alert and very pale. We called 911, gave him water, took his blood pressure and made sure he didnt fall. Ambulance took patient to hospital. He was alert at time of transport.
Patient head tilt back and seized, not responsive and gasped for about 30 seconds, then became responsive.  Talked with patient who know date and time got water.  EMS was called and arrived within 10minutes.
Shortness of breath; Erythematous (generalized); Diaphoresis; Face swollen; Anaphylaxis.
Initial report received on 27 August 2012 from an investigator. A 28-year-old male subject was found to have an elevated Troponin level (Rapid Troponin I level reported as within normal limits (Negative) and an elevated central laboratory Troponin I level result of 0.12 ng/mL) on 22 February 2010 (with reported date of 25 February 2010) after receiving injection of ACAM2000, SP Biologics Co., (lot number, route and site not reported) on an unspecified date. Central laboratory Troponin level results were reported as less than (<) 0.10 ng/mL, "repeat test normal" according to Investigator, on 26 February 2010. ECG was reported as normal on 26 February 2010. Treatment reported as "treatment (other than medication)". The subject had a past medical history of psychiatric illness reported on 09 February 2010 and took concomitant medication, CELEXA for depression since May 2009. Psychiatric illness was reported as "no" and concomitant medication was reported as "no" on visit on 22 February 2010. The subject had no reported surgical history, denied usage of topical steroids, and denied drug allergies. The rest of the subject's past medical history was negative (reported as "never" or "no"). The subject denied use of alcohol (reported as "never") and denied tobacco use. The patient recovered (also reported as "no residual effects") with stop date of adverse event reported as 28 February 2010. According to the investigator the event of elevated Troponin was possibly related to the trial product or the trial procedures. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: Medical records.
patient younger than indicated received dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received DTPa-IPV (Kinrix) (batch number pk27b, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient younger than indicated received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sharp pains all throughout body, extremely powerful headache, fever, pressure in chest, caused my Chron?s to flare and I have bowel spasms, sulfur burps, diarrhea, fatigue. For 48 hours.
heat, high temperature, hyperemia in the right ear and under the right cheek, neck and chest