chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased resting heart rate.  Noticed that my heart started to pump harder, first during an afternoon while sitting, no stress or agitation. The next morning, I woke up in the middle of the night due to some discomfort. I was at 100 BPm (normally at 60).
is not sleeping well due to the pain; injection site was very painful; first dose given in 21Jul2017 and third dose given in 27Jul2019; This spontaneous report was received from a consumer (patient's father) referring to a 17 year old male patient. The patient's pertinent medical history, concurrent condition, drugs reactions/allergies and concomitant medication were unknown. On 21-JUL-2017, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose and lot number with expiration date was not reported) to prevent HPV (human papilloma virus) as a part of normal immunization regimen (prophylaxis). On an unknown date, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose and lot number with expiration date was not reported) and on 27-JUL-2019, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly on high on shoulders (dose and lot number with expiration date were not reported) (inappropriate schedule of vaccine administered). On 27-JUL-2019, after vaccination, the patient experienced injection site pain as he stated that the injection site was very painful. In August 2019 (stated as 2 weeks later), the patient was in severe pain at the injection site and was not sleeping well due to pain (poor quality sleep). The reporter reported that the shot was given high on the shoulders and the patient said it felt as though it went through his rotator cuff. The patient sought medical attention and went back to the physician for treatment and was told that the injection was given normally who didn't think that it went through the rotator cuff. The physician asked the patient to come back in one more week if the pain did not subside by then. The patient was recommended to take ibuprofen for the pain which the patient took and it relieved some of the pain for one evening but the pain came back afterwards. The patient was not currently taking ibuprofen. The reporter did not give permission to contact the physician. No product quality complaint was reported. The patient did not recover from the events of injection site pain and poor quality sleep. Causality assessment for the events was not provided by the reporter.   The reporter considered the events of injection site pain and poor quality sleep as serious (disability).
Patient had Hep A shot in right arm with no reactions. She was given the HPV shot in left arm. Almost immediately she fell backwards on the patient table, appeared to be seizing and then passed out. She quickly came out of it within about 20-30 seconds. She started complaining of a severe headache later that day. The headache lasted for 3 days.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis. On 16th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and myalgia upper extremities. On an unknown date, the outcome of the pain in arm and myalgia upper extremities were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on the left arm. The patient experienced a sore arm with muscle pain after the injection. The pharmacist consented to follow up.
6 hours after having shot it triggered PTSD because she couldn't lift her feet (like heavy rocks) staggering to lay down, diarrhea, nausea, poor appetite, headache, fatigue throughout body, aching bones/joints
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 14-APR-2016, the patient was vaccinated with a 0.5 ml dose of improperly stored (Oka/Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Oka/Merck) VARIVAX (which had a lot # L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
p/ pt recv vax approx 4 days later pt exp a vesicular rash on nose, hand & feet. pt sought unspecified med attention
This case was reported by the son of a consumer and described the occurrence of reduced range of motion in a 74-year-old female subject who was vaccinated with flu vaccine unspecified, manufacturer known to be GlaxoSmithKline. A physician or other health care professional has not verified this report. On 27 October 2007 at 10:30 the subject received unspecified dose of flu vaccine in the right arm. The injection was reportedly given high on the arm at the point where the humorous meets the joint. On 30 October 2007, in the morning, 3 days after vaccination with flu vaccine, the subject experienced injection site pain and pain and swelling in her right arm. As a result, she developed a reduced range of motion in her right arm. At the time of reporting the events were unresolved.
Slight headache after shot into evening.; Slight nausea second night; Slight arm soreness on and off second and third day.; This is a spontaneous report from a contactable consumer. An unspecified age elderly (65+ Years) female patient (patient was not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266 and expiration date was not reported), via an unspecified route of administration in left arm on 26Feb2021 at 03:00 PM, at single dose for COVID-19 immunisation. The patient had medical history of High blood pressure and tachycardia. The concomitant medication included metoprolol, lovastatin, losartan and amlodipine besylate. It reported that, patient experienced slight headache after shot into evening, slight nausea second night and slight arm soreness on and off second and third day. Vaccine facility: Hospital. There was no other vaccine in four weeks and there is no treatment required to the adverse event. No COVID prior vaccination and not tested COVID post vaccination. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
the patient woke up in the morning with right big toe- swelling, red and inflamed; the patient woke up in the morning with right big toe- swelling, red and inflamed; the patient woke up in the morning with right big toe- swelling, red and inflamed; This is as spontaneous report received from a contactable consumer (Patient). A 84-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263/Expiration date: unknown) via unspecified route on 27Jan2021, in the left shoulder as a single dose for COVID-19 immunization. Patient's medical history included regular flu shot about 2 months ago and reported that he doesn't hear very well was that he has been going on for years and prior to the vaccine. Concomitant medications were none. Family history were none. On 01Feb2021, the patient woke up in the morning with right big toe- swelling, red and inflamed which lasted for 12-15 hours. After multiple attempts to get caller to phone, on 01Feb2021 a call back was made to the patient however, allowed phone to ring for 1 minute and not answered. On 02Feb2021, the call was successful and further information was received. As of 02Feb2021 the events were healed. Clinical course of the event was as follows caller clarifies that the shot was administered on 27Jan2021 and he actually woke up at 1am on 01Feb2021 to his toe being inflamed and hurting. It doesn't hurt right now but he is not wearing any shoes and is just sitting there in socks. Caller doesn't know that he has ever gotten a Pfizer vaccine. The patient had no information on the facility the clinic who was providing the clinic. The events were not treated. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date were none. As of last observation events were not resolved. The outcome of the events was recovered.
This spontaneous report was received from a Medical Assistant (MA) referring to an unspecified amount of patients (demographics not reported).  Medical history and concomitant medications were not provided.  The MA reported that an unspecified number of doses of improperly stored vaccines were administered to unspecified patients.   The vaccines involved were: ROTATEQ, (lot M012495; expiration 08-OCT-2017 and lot M011832; expiration 25-JAN-2018), GARDASIL 9 (lot M024261; expiration 30-JUL-2018 and lot M009378; expiration 23-APR-2018), PROQUAD (lot M037011; expiration 21-FEB-2018, lot M031943; expiration 27-DEC-2017 and lot M035145; expiration 30-JAN-2018), and VARIVAX (lot M027345; expiration 01-JUN-2018, lot M020900; expiration 27-APR-2018; lot M033212; expiration 13-JUL-2018, lot M034586; expiration 27-JUL-2018 and lot M027885; expiration 03-JUN-2018). Temperature: ROTATEQ and GARDASIL 9 were stored at 28 degrees Fahrenheit (F).  PROQUAD and VARIVAX were stored between 5 degrees F and 14 degrees F. Time frame: ROTATEQ and GARDASIL 9 were improperly stored for seven days.  PROQUAD and VARIVAX were improperly stored for 48 hours. No adverse effects were reported. Additional information has been requested.
Case number# PHEH2016US007409, is a report initially received from a consumer through phone via a Patient Oriented Program: POP20150640 on 22 Mar 2016. This report refers to a 97 year old female patient. Medical history and concomitant medication were not reported. The patient received ENTRESTO 49/51 mg for the treatment of heart failure from an unknown start date at a dose of 100 mg BID (oral). The patient also received Influenza Vaccine (flu shot) last Friday on 04 NOV 2016 and on 06 Nov 2016, the patient experienced symptoms of sore throat (oropharyngeal pain). On an unknown date, the patient also experienced tightness in her throat right below her chin area (throat tightness) and cold (nasopharyngitis). The outcome of the events oropharyngeal pain, throat tightness and nasopharyngitis was unknown. The seriousness and casualty of the events oropharyngeal pain and nasopharyngitis were not reported. Follow up case initially received from a consumer through phone via a Patient Oriented Program: POP20150640 on 07 Nov 2016: Added patient details, added concentration and frequency of the suspect drug and added two new events (sore throat and throat tightness) and amended narrative. Following an internal review done on 14 Nov 2016, for the date received on 07 Nov 2016, a significant case correction was performed: Coded Influenza virus vaccine as co suspect and updated narrative accordingly.
Mom stated that patient woke up 3 days after Flumist was given and stated that she could not hear. Mom looked up online and found that the Flumist can cause hearing loss. She then waited it out but no patient showed no improvement. Mom then contacted our office to have patient seen for follow up and a full work up was done on patient. No drainage, no swelling and no associated symptoms were found during check up. A hearing test was performed on patient and she failed the right ear. Mom has scheduled a test with audiology and has been referred to hospital. At this time we are unable to predict if this will be a permanent disability.
Patient recieved a SHINGRIX vaccination on 5/22/2018 and called 5/28/2018 to notify us that she had an adverse rnx. She said that she had swelling on bridge of nose and underneath her left eye.  The swelling on nose did ended up turning to open sore and scabbed over. These are the same spots that she has had shingles in the past (aprox. 13 years ago).
Information has been received from a physician concerning a male who was vaccinated with one dose of Hep B vaccine IM. Subsequently the pt experienced dizziness and nausea, queasiness, and fatigue and a vertigo like reaction for "weeks after vaccination."  Additional information has been requested.
Moderna 2/25 and 4/1. Positive on 9/14.
Patient felt depression for the last 3 days; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Patient felt depression for the last 3 days) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced DEPRESSION (Patient felt depression for the last 3 days). At the time of the report, DEPRESSION (Patient felt depression for the last 3 days) outcome was unknown.            The last 3 days (Thursday, Friday , and Saturday) the patient felt depression.  Concomitant products were not provided. Treatment medication were not reported.
Headache; muscle aches; joint pain; fever over 101; chills; fatigue; swelling of injection site; injection site pain; slight nausea; stomach cramping; This is a spontaneous report from a non-contactable other HCP.   A 39-year-old non pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, (Lot Number: EL1484 expiry date unknown), via unspecified route of administration in left arm on 05Feb2021, 03:15 PM (at the age of 39-year-old) as a single dose for covid-19 immunization. The patient medical history included sulfa antibiotics allergy. The patient's concomitant medications were not reported. The patient did not have any other vaccination prior to 4 weeks of COVID vaccine. Patient did not diagnose with COVID prior to vaccine and not tested for COVID-19 after vaccination. On 05-Feb-2021: 18:30 the patient experienced headache, muscle aches, joint pain, fever over 101, chills, fatigue, swelling of injection site, injection site pain, slight nausea, stomach cramping. No treatment received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Headache since shot with fluctuating intensity Extreme fatigue since 4/1/21 Cough since 4/5/21 (asthma) Dizziness since 4/11
This spontaneous report as received from a nurse refers to a 5 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Gradual increase in my skin burning/paraesthesia now the majority of skin is extremely sensitive to light touch in examples my clothing. It waxes and wanes much worse evenings and night time.  My insomnia is much different, I wake up after 3-4 hours wide awake for hours about 2-3 week.
This case was reported by a pharmacist via call center representative and described the occurrence of yellow skin in a 79-year-old female patient who received BOOSTRIX (batch number X9YP3, expiry date 2nd October 2020) for prophylaxis. On 17th July 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 17th July 2018, less than a day after receiving BOOSTRIX, the patient experienced yellow skin and sweating. On 18th July 2018, the outcome of the yellow skin and sweating were recovered/resolved. It was unknown if the reporter considered the yellow skin and sweating to be related to BOOSTRIX. Additional details were provided as follows: The patient told the pharmacist that the day she received the BOOSTRIX vaccine she got sweaty and the skin on her face turned yellow. This lasted for about 1 day before resolving.
Siezure in the middle of the night he has not had one in two years and then this it was not cool at all I will be talking to someone.
Arm sore for couple of days; Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Arm sore for couple of days), EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021. Concurrent medical conditions included Crohn's disease. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.    On 29-Oct-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm sore for couple of days). On 29-Oct-2021 at 1:00 PM, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm sore for couple of days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.   This case was linked to MOD-2021-370301 (Patient Link).
Received first injection 3 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received almost 3 years before the date of reporting).   On 21st March 2022, the patient received the 2nd dose of Shingrix. On 21st March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 24-March-2022 Additional Supportive Information: The patient self-reported this case via Shingrix GSK Chatbot. The patient received 2nd dose of Shingrix dose this past Monday, which led to lengthening of vaccination schedule. The patient asked if this could be considered his/her 2nd dose or had too much time elapsed. The follow-up would not possible as no contact details were available.
Information has been received from a physician, via a company representative, concerning a 17 year old female patient who was vaccinated IM (date unspecified), with the first dose of Gardasil. The physician reported that the patient "fainted in the office waiting room shortly after being vaccinated." The physician stated the patient was presumed to be doing fine, though she had not heard from the patient. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received froma physician, concerning a 17 year old female patient, with no known drug allergies, who on 04-JAN-2007, was vaccinated IM in the lteft arm, with the first dose of GARDASIL (Lot #655165/1425F). Follow up information added that the patient had developed an area of induration at the site of injection (date of onset not specified). The physician indicated that the patient did not require an office visit or other treatment. At the time of this report, the outcome of both events was unknown. Additional information has neem requested.
2 WEEKS AFTER VACCINATION PT HAD SEVERE VERTIGO SAW PMD AND GIVEN RX FOR ANTIVERT.  AS OF 11/14/06 PT STILL WITH DIZZINESS.
this is one of three consecutive pt to devel a fever of 103 deg F, and a rash after reciept of tetramune vax.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/19/2022 ACUTE EXACERBATION OF COPD ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/14/2021 ACUTE EXACERBATION OF COPD
After both the first and second shot it felt like someone was pushing on my diaphragm. The first shot it lasted about six hours but was intense. After the second shot it lasted about 24 hours, but wasn?t as intense. It felt like someone was trying to administer the Heimlich on me. Also, Friday night around 9:30, my jaw was hurting on the right side. Not bad enough to have to take anything for it, but uncomfortable. On Saturday I had to skip lunch and dinner because I could not chew because my jaw was hurting so bad. By Sunday morning it was mostly resolved and completely fine by Monday morning.
Covid diagnosed on 8/1 had Remdesiver in R arm at that time. C/O out pt diagnosis of significant RUExt DVT - sent by PCP to be started on heparin drip - and later convert to po anticoag. Admitted on 8/11/21 for heparin drip. Started azithromycin as well. Patient reports he first began experiencing symptoms on 7/28/21, tested positive on 8/1/2021. Patient received 1 dose of remdesivir as an outpatient.  Patient reports he was been fully vaccinated against COVID-19. Patient continues to have chronic productive cough. Discharged on 8/14/21 with augmentin x 5 days and azithromycin x 4 days and apixaban