chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This morning it started all these different side effects and it's progressively getting worse, so I left work; Body aches; Headache; Stomach issues; pain; Diarrhea; Chills; Fever I just checked it's 102.4; Little sore arm at night; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EK9231) at single dose on 06Jan2021 around 2 O'clock for Covid-19 immunisation, administered ad hospital.  Medical history included high cholesterol, hypertension, irregular heart beats, arrhythmia, acid reflux. Concomitant medication included amlodipine (AMLODIPINE) 10 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg, once a day, carvedilol (CARVEDILOL) at 12.5 mg, two times a day hypertension, flecainide (FLECAINIDE) at 50 mg, twice a day for irregular heart beats, arrhythmia, olmesartan (OLMESARTAN) at 40 mg once a day for hypertension, omeprazole (OMEPRAZOLE) at 40 mg when needed for acid reflux, rosuvastatin (ROSUVASTATIN) at 20 mg, once a day for high cholesterol.  The patient experienced little sore arm at night on 06Jan2021. Then, on  07Jan2021 morning he went in to work and it started all these different side effects and it's progressively getting worse, so he left work at abut 10 O' clock AM. He was getting body aches, headache, stomach issues, pain, diarrhea, chills, and fever I just checked it's 102.4 on 07Jan2021. The patient underwent lab tests physical examination with unknown results in Dec2020 3 weeks before this report (he had complete physical lab work with his doctor).  Treatment included taking Tylenol and Advil. The outcome of all events was not recovered. Due date of second shot will be 23Jan2021.
On 02/14/2021 I received my first dose in the morning and I felt fine with just a little arm pain. 2-3 weeks later I developed a rash on my right side resembling shingles. I took a picture and sent it to my aunt who is an MD and she said it resembled shingles and to go to the urgent care. I went to the urgent care and they said that it wasn't shingles and asked about the vaccine shot and they were assured that it was a reaction from the shot. She prescribed me topical ointment to put on the rash 2x a day and it cleared up in 1-2 weeks.
increased cough; severe skin reaction in his groin area; Face and feet were also affected by rash; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (increased cough), SKIN REACTION (severe skin reaction in his groin area) and RASH (Face and feet were also affected by rash) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma (Severe persistent asthma, Uncomplicated) and Bronchiectasis. Concomitant products included OMALIZUMAB (XOLAIR), VITAMIN D [VITAMIN D NOS], ZINC, VITAMIN C [ASCORBIC ACID], AMLODIPINE BESYLATE, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), METOPROLOL SUCCINATE (TOPROL), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), EPINEPHRINE, BENZONATATE (TESSALON PERLE), SALBUTAMOL SULFATE (PROAIR HFA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (increased cough), SKIN REACTION (severe skin reaction in his groin area) and RASH (Face and feet were also affected by rash). At the time of the report, COUGH (increased cough), SKIN REACTION (severe skin reaction in his groin area) and RASH (Face and feet were also affected by rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concurrent condition included chronic cough. Concomitant medication included probiotic ultra flora plus. No treatment medication was reported.
SQUESSING SENSATON IN HEAD AND DIZZY WHEN MOVED HEAD SLIGHTLY' . DIAHREA  STOMACH ACH AND SLEPT HOURS AND HOURS AND WEAK.
Patient woke up with severe arm pain in the shoulder, she was unable to move the shoulder at the time of reporting.
This spontaneous prospective pregnancy report as received from a 2" year old female consumer regarding herself as a patient with pelvic congestion syndrome (PCS). There was no drug reactions or allergies. On 19-OCT-2013, the patient was vaccinated with M-M-R II (lot and dose not reported), dose 1, route reported as injection. Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of 13-OCT-2013 and EDD of 20-JUL-2014. The patient believed that she was pregnant as of 19-OCT-2013. Initial exposure to M-M-R II was at 1 week. The pregnancy outcome was pending. In October 2013, the patient experienced cramping in the pelvic area and nausea. In 2013 (exact date unknown) the patient underwent an appendectomy. On 16-NOV-2013 the patient gave herself a home pregnancy test that resulted positive. She gave herself a second one on 18-NOV-2013 and it was positive. The patient has not yet seen a physician. No treatment given for the events. The outcome of cramping in the pelvic area, nausea and appendectomy were unknown. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 18 months old female patient. Medical history and current conditions were not reported. On 03-MAR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medications was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested. Event, Analysis was updated.
Flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who had flu (influenza), 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 non-serious had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that it was the only time patient had flu when he took the shot.  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.
Pt developed high pitched screaming, cry approx four hours post immunization administration. Infant cried inconsolably for 45 minutes. Mother called ME office was told to return and infant was reexamined.
Day following Hep A vaccine, pt. with diffuse urticaria. No fever. No SOB. No increased WOB. No airway compromise. Giving BENADRYL Q6 hours.
6:00pm lower jaw began to be numb, 6:05pm right arm was numb, gave 50mg of Benadryl orally. 6:20pm symptoms resolved and feeling better pt will follow up with provider.
pain in the injection site/a little bit of pain at the injection site; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) on an unspecified date then the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), on 24Jan2021 - both via an unspecified route of administration, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just received the 2nd dose of the Covid-19 Vaccine yesterday morning (also reported as around noon time), 24Jan2021. The patient stated she was fully aware of the other side effects, but she was not experiencing those other than pain in the injection site on Jan2021. She added she was not experiencing any of the effects that she was told that she should and with other people she knew who have gotten the vaccine that they have. The only thing that she had was a little bit of pain at the injection site which was what she also had on an unspecified date after the first shot on an unspecified date. She stated she had nothing, no fever, no chills, no headache; nothing that they said she should be experiencing. She then asked if that meant it was not working. She wanted to know more information about herself and if she was immune to those. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included mild covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: not reported) dose was not reported, once a total administered, start therapy date not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, fever, and headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210358903.
Approximately 6 hours following injection, I had headache, chills and muscle aches. These lasted for about 36 hours.  48 hours after injection, I started having menstrual cramps and begin bleeding. I bled for about 1 week and then began bleeding again approximately 1-2 weeks later. This second period lasted over a week. So, I had two periods in the span of 1 month. Neither period was expected or coincided with the placebos in my birth control. I do not normally menstruate at all on my birth control pills.
Per patient report by phone: mild fever, erythema and warmth at and around injection site, nausea, and difficulty raising her arm.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
expired dose administered to a patient; This spontaneous report was received from a medical assistant and refers to a 67-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 03-FEB-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) vial, 1 ml, lot # S037821 was confirmed to be valid, expiration date 07-JAN-2021 (route of administration and anatomical location were not reported) for prophylaxis. No additional event details were available
Arm swollen for 7 days with decreasing pain as it got smaller. This happened right away, and within a few hours increased in size and then remained very swollen for several days. Pain was tolerable. Sinuses are aggravated which is a usual immune response for my body.  By 2nd day, experience sleep disruption in morning (jerking awake every hour) and then slept most of the afternoon. I also started getting a pain under my armpit, like a swollen lymph node that hurt., I put up with it for two days and then took an NSAID and the pain was faint by the next day until it faded out two days later. No other side effects were experienced.
tested positive on 06Jan2021/Came positive for COVID; I am concerned because I am positive; tested positive on 06Jan2021/Came positive for COVID; I am concerned because I am positive; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date Mar2021), via an unspecified route of administration on 28Dec2020 at a single dose for covid-19 immunization. Medical history included diabetes. There were no concomitant medications. The patient got the vaccination on 28Dec2020. He have been testing every day. The patient got a tested on Sunday, 03Jan2021 and was negative. He was negative on Monday, 04Jan2021  different Company. He went back on Tuesday, 05Jan2021, different Company and was negative. On Wednesday, 06Jan2021, he was tested positive, then on Thursday, 07Jan2021, he was tested negative. He wanted to know if he can continue to get the second vaccination shot 18Jan2021 or not?. The patient did not received any treatment for the event and he just stayed at home. The patient had a lab work last Sep2020. The outcome of the events was unknown.
Case had first shot on 3/19 and second shot on 4/9, developed a head to toe rash on 4/14, called dermatologist, she took her off turbinafine and put her on triamcinolone cream and claritin.
COVID 19 Moderna vaccine dose given beyond use date.  There were no signs or symptoms of side effects. There was no treatment necessary.
Physician has a patient that didn't have her Menactra at 11 years of age but got it at 12 years of age with no adverse event; Initial information was received on 02-Apr-2021 regarding an unsolicited valid non-serious case from a physician (Inquiry number: 00546483).  It was reported that vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) was administered to a female patient of 12 year old by a physician instead of 11 year old on an unknown date for prophylactic vaccination (inappropriate age at vaccine administration).  It was a case of actual medication error due to product administered to patient of inappropriate age.  The female patient came back in for a visit at 16 years old but was 25 days shy of her 16th birthday, physician states that the school is telling the mother that the child is not adequately vaccinated  At the time of report, no adverse event reported.  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 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.  There will be no information available on batch number for this case.
redness, swelling, soreness, pruritic symptoms subsided,  for treatment patient applied cold compress to injection site and active ROM was initiated to left arm.
AFTER FOOTBALL PRACTICE HEART BEGAN TO BEAT 205-215 BPM. MEDICATION WAS ADMINISTERED THROUGH HIS IV AND HIS HEART RETURNED TO A NOMAL RYTHUM.
This case was reported by a physician via sales rep and described the occurrence of upset stomach in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown. It was unknown if the reporter considered the upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case has been linked with case US2018GSK169677, reported by same reporter.
Patient stated that she always gets injection site redness after a vaccination.  On 2/25/2021, she noticed a "lump" at the injection site so she called her PCP.  She had an office visit and Dr. diagnosed her with Cellulitis and prescribed Doxycycline 100mg PO for 10 days.
patient had recently been diagnosed with CIN II; This spontaneous report was received from a nurse prescriber referring to a female patient of unknown age.  Information about medical history, concurrent conditions and concomitant therapies was unknown.      On unknown dates the patient was vaccinated with 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb, Vaccine (GARDASIL) (route of administration, strength, lot # and expiration date were not reported) for prophylaxis. The patient had received the full quadrivalent human papillomavirus (types 6,11,16,18) recomb, Vaccine (GARDASIL) series at an unspecified time. On an unknown date, papanicolaou (PAP) smear was performed. On an unknown date, the patient diagnosed with cervical intraepithelial neoplasia II (CIN II).  The patient had sought medical attention and treated with cryotherapy.  The outcome of the event was reported as recovered.  Causality assessment was not provided.
Chills, body aches, fevers, headaches, migraine diarrhea Started a bit after the vaccine was administered.   Body aches, chills head aches and migraines. Have been on going since Monday January 11, 2021
Within 4 hrs of receiving vaccine I had tightness of my throat, cough, bloodshot eyes and muscle and joint discomfort. Eyes are less bloodshot today, still tired. The other signs are gone.
He was admitted 1-28-22  to  Hospital  due to GU problems and tested + for covid.  no cough , no dyspnea or sore throat.   Had fever but had indwelling foley that had been placed that day after having outpatient cystoscopy.   He reported having had one covid vaccine only.   He presented to er with urinary pain and apparently had urinary retention.  Also c/o not being able to walk for three weeks due to lower extremity edema and had anasarca and acute on chronic renal failure.  .covid- patient did  not have oxygen requirement at time of admission 1-28-22.
Muscle pain, went to dr and he gave prednisone 5mg dosepak.
pt stated that she felt sick and her right arm got very sore. She developed about a itchy 4" red circle and a 2" lump at the injection site .  She still has this spot on her arm.  The redness is gone but it is still red and itchy.
body ache; tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and FATIGUE (tired) 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 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced MYALGIA (body ache) and FATIGUE (tired). At the time of the report, MYALGIA (body ache) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were reported.
10/7/16 - Pt stated vaccine was adm. too low in her fatty tissue - saw medical provider 11:30 AM red inflamed - instructed to take BENADRYL - at 2:30 - she denied taking BENADRYL - RN advised take BENADRYL per MD - follow MD instructions. If hives or trouble breathing call 911. Call back if condition does not improve or worsens.
Shooting pain near the colon area followed by loose bowel movements at around 10:00 PM. Previous meal was cooked salmon, asparagus, and potatoes at 6:30 PM.
C/o significant arm pain, temp 99.6, shaking, chills, stomach ache and headache on the evening she received vaccination. The following day temp to 100.4, lightheaded - lasted 24 hours. By following day (9/29/10) she felt better and returned to work. Did not seek medical care.
Per parent pt lost consciousness approx 30 seconds; legs/arms went limp; jerky, turned blue; called 911 went to ER via ambulance; 24APR seen by neurologist; nl EEG; 30APR MD spoke w/mom pt doing fine;
Rash from elbow to shoulder, nausea, vomiting, pain, bruising. Diagnosed with cellulitis.
Sore arm on day of shot  First day in bed.  Tired, flu like ,  second and third day tired,  4th day tired with sinus headache and sleepy, 5th, 6th 7th days no enery eighth day felt normal
Fever - 100.7,  Chills, Mild Headache Taking ibuprofen and acetaminophen ,  and rest
client became itchy all over 5 min after vaccination and injection site arm became red with rash on wrist and soreness in back of arm.  EMS on site and gave one benadryl at 10:45 and another at 11:00.  Client waited 45min to 1hr before leaving vaccination site.  F/U call, client still has some soreness and mild itching and continues with benadryl as needed.  States she reacts to a lot of different things and has had similar reactions from other medications and food products.
Information has been received from a registered nurse referring to five patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Pertinent identifiers was given. This case refers to a 16 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of lip swelling in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX. On 19th August 2018, 2 days after receiving SHINGRIX, the patient experienced lip swelling, facial swelling and lip blister. The patient was treated with Acyclovir Ointment and BENADRYL. On an unknown date, the outcome of the lip swelling, facial swelling and lip blister were recovered/resolved. The reporter considered the lip swelling, facial swelling and lip blister to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Two days after vaccination with SHINGRIX vaccine, the patient experienced swollen lips, facial swelling, blisters on lips. This symptoms were lasted for 7 days. The physician thought that, this events were related to SHINGRIX. The patient was given acyclovir ointment and BENADRYL for treatment. The reporter agreed to follow up from GlaxoSmithKline.
Had Fluad vaccine on 9.28.22.  On 9.29.22  started new onset of ambulatory dysfunction.  On 9.30.22 new onset of seizures and sent to Hospital.  Progressed to Respiratory Failure.  Passed away 10.2.22
BLOOD CLOT: SEE RADIOLOGY REPORT TREATMENT: XARELTO FOR 6 MONTHS STARTED ON JUNE 25, 2022