chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NECK ACHES; DIZZINESS; JOINT PAIN; HEADACHE; CHRONIC FATIGUE; NAUSEA; ACHINESS; FEVER; TIREDNESS/CHRONIC FATIGUE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with cetirizine hydrochloride for drug used for unknown indication, and fluticasone propionate for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative, Diagnostic ultrasound (NR: not provided) Negative, Lung function tests (NR: not provided) Negative, and Mononucleosis heterophile test (NR: not provided) Negative. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness/chronic fatigue. On 15-APR-2021, the subject experienced neck aches. On 15-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced joint pain. On 15-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced chronic fatigue. On 15-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, tiredness/chronic fatigue, achiness, headache, neck aches, dizziness, joint pain, chronic fatigue and nausea was not reported. This report was non-serious.
1/9 Was walking thru a new house and started feeling weak and short of breath. And got quickly worse with shifting and later felt like I was on a boat(Vertigo) When I kept my head still it was fine but if I moved my head in the slightest it started again swaying. I asked to go to urgent care and I never ask to go see a doctor always saying it will pass. When I got there I got Xray, physical, blood and urine and when I was checked by moving my head I got REALLY DIZZY and the room itself seemed to be spinning fast. Was given meclizine for treatment and was advised ENT. I was taking the meclizine on  and off since but it seems to be tapering off. Went to see my PCP but he was out of office and was seen by the PA. Only had a physical and agreed that I needed to see an ENT. This will happen on 1/26, and still dealing with vertigo.
STROKE IN PONS AREA OF BRAIN MEASURING 8.5MM; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er2613), via an unspecified route of administration, administered in the left arm, on 17Mar2021 12:00, as 1st dose, single, for COVID-19 immunisation, at a public health department. Medical history included bipolar 2, control hypertension, and control diabetes type 2. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since vaccination. Concomitant medications included lamotrigine; trazodone; verapamil, all taken for unspecified indications, start and stop dates were not reported. The patient previously took metformin and simvastatin and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 19Mar2021 00:00, the patient experienced stroke in pons area of brain measuring 8.5 mm. This event resulted to emergency room visit and hospitalization for 2 days (from 19Mar2021 to 21Mar2021). Unspecified treatment was given by the neurologist, physical and occupational therapy. The event was assessed as serious (life-threatening, disability and hospitalization). The outcome of the event was not resolved.  Follow up needed, further information has been requested.
About 15 min s/p vaccine (IM H1N1) pt developed tingling on epsilateral side of face and periorally. Had blotchy redness on face w/o swelling. Assoc. nausea. Sx resolved w/BENADRYL 25 mg after about 1.5 hr.
Information has been received from a physician concerning a female relative who "3 years ago" (in March 2007), was vaccinated with a dose of GARDASIL. Subsequently the patient experienced a musculoskeletal issue after getting GARDASIL (in March 2007). At the time of the report the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not any known allergies. Patient received Paxlovid from 29Jun2022 to 04Jul2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
dizziness/light headedness; increased blood pressure; anxiety; a rash that developed down to the elbow; cramping; bladder pressure; received the menstrual period earlier than expected; This is a spontaneous report from a contactable other healthcare professional (patient) via Pfizer sales representative.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history included kidney stones. Concomitant medications were not reported. Patient experience dizziness, light headedness after receiving the vaccine. Additionally, the patient had increased blood pressure and anxiety, as well as a rash that developed down to the elbow. The rash resolved the following day. The day after receiving the vaccine, the patient reported cramping, bladder pressure and received the menstrual period earlier than expected. Events took place after use of product. The outcome of events cramping and bladder pressure is not recovered. The outcome of event rash was recovered. The outcome of other events was unknown.  Information on the lot number has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # L049533, expiry date 08-DEC-2017 and lot# M004663, expiry date 27-JAN-2018; dose and route of administration were not reported). The doses of the vaccine were exposed to a temperature excursion of 26 degrees Fahrenheit for a time frame of 5 hours (date unspecified). A digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
The patient is a 67-year-old male with diabetes, hypertension, prostate CA, who presented to the hospital with vomiting, diarrhea, weakness, recent Covid diagnosis. The patient completed his COVID-19 vaccination in April 2021.  15 days ago or so, his son started to have symptoms with fever, respiratory symptoms.  He ended up positive for Covid.  Patient himself has about 1-1/2-week history now of symptoms.  He tested positive at a CVA 10 days ago.  Started with a fever, then developed scratchy throat and cough.  For the past few days he has been nauseated, with multiple episodes of nonbloody emesis. the patient's hospital course was uneventful. He has not required supplemental O2 therefore there was no clinical need for steroid injections. He was treated supportively with IV fluids. He was quite dehydrated as he was hemoconcentrated with his hemoglobin initially at 15 and now it is 12. He has not had recurrent diarrhea. His generalized weakness overall is improved, overall feeling better.
The night of the vaccination, I experienced icy cold hands and feet throughout the night.  I had to get up twice to put additional blankets on the bed, even though the house was heated as usual. I also experienced frequent muscle spasms and cramps in both legs throughout the night.  The following day, Feb 18, 2021 and today, Feb 19, 2021 I have been very low on energy, simply sat all day. Experienced lower than usual blood pressure (98/84 w/ 127 heart rate, 89/71 w/ 77 heart rate. Currently feeling normal at 4:25 pm.
?Janssen COVID-19 Vaccine EUA?    chills, elevated temperature (101 degrees), body aches, nauseous,  extremely weak,  headache, ear ache, majority of symptoms resolved 2 days later  (still have slight headache, and a bit weak), but getting better
This spontaneous report was received from a license practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent(MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD one single injection, lot # N008824 with expiration date: 28-OCT-2019 (strength, route and anatomical location were not reported), for prophylaxis. The reporter denied any adverse effects reported by the patients. The temperature excursion occurred between 6° F to 14° F (9° F) with a time frame of 48 hours. No previous temperature excursions occurred. This is one of two reports received from the same reporter.
Pt vaccinated with Rubella develooped german measles type rash preceded by myalgias, fatigue & coryza.
Patients administered vaccines that have undergone temperature excursion; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022.  On 28-Jan-2022 maximum or minimum temperatures reached range was positive 34.7F to positive 41.2F, on 30-Jan-2022 temperature range was positive 34.7F to positive 41.2F which occurred approximately for 48 hours, on 31-Jan-2022 temperature range was positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temperature range was positive 35.2F to positive 41.7F for 12 hours.  It was reported that the patient did not experience any adverse event. No treatment medications were reported.
Fevers & chills started at 2300. Took (1) one 200 mg Ibuprofen at 0200 and 0600.
Narrative:  Patient reported to clinical pharmacy specialist that he received his first dose of COVID-19 vaccine and had 2 occasions of epitaxies that lasted about 15 mins. He also had what he discussed as "blood blisters" which resolved in >1 week per record documentation on 4/20/21. Patient also on warfarin for a fib and was at therapeutic range (2-3) of 2.7 around the time of vaccine.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 20-JUL-2015 the patient received a dose of expired VARIVAX (lot# reported as J008981, expiration date: 19-JUL-2015, subcutaneous, dose was unknown). There were no known adverse effects. Additional information has been requested.
Local reaction on right thigh area approx 2" diameter with erythema, mild induration, and warmth. Increased swelling. Older sibling died 1 day post vaccine at 2.5 mo of age. Pt monitored for 1 hr in ER, local reaction, sent home.
Woke  up day after shot with uncontrollable full body itching which last for two weeks & scratched so hard all the time that I broke a blood vessel in my eye.  Nothing helped (Benadryl, etc.) The next day I started to have constant ringing & humming in both ears. It  has not subsided at all & I am struggling to hear people talk to me now, at least 15-20% hearing loss. One of the worst experiences of my life & am so sorry I got the shot.  I have NEVER gotten a flu shot that is recommended every year, & I NEVER GET THE FLU.  MY DOCTOR TOLD ME I HAVE A HIGH TOLERANCE FOR WHATEVER STRAIN IS GOING AROUND.  I wish I could turn back time - I would never agreed to get the Moderna - now I am doomed for life with a hearing disability & Tinnituus.  I now read all the reports & learn that Moderna vaccine was not tested (even it had been - it wouldn't have passed.)  For sure I will not get 2nd Booster shot - or any other vaccine that comes along.    Someone told me that they had such sever itching that they had to go to Urgent Care for medical treatment on legs because they stratched so much they could stop the bleeding! NEVER AGAIN!
10 days after the injection, I woke up with an itchy, red, warm, sore to touch rash on my arm at the sight of injection.  It lasted about 36-48 hours.  I did not treat it in any way.  Symptoms were mostly mild.  Oakland County nurse on call suggested Benadryl and Motrin as needed and not to get the 2nd shot.  11 days later, I am so extremely tired.  No idea if it is related.  Plan to follow up with my doctor.
COVID VACCINE REACTION  Patient presented for second Pfizer/Covid vaccination;  about 10 minutes post-injection she started to cough.  She complained of throat tingling.   VS:  Pulse 81, BP 130/75, P02 98%.    She was given water to drink and expressed that she wanted to lay down on a stretcher.  She was attended by the charge nurse and a vaccinator.  The cough persisted and she developed pruritus in the throat but without dyspnea, as well as nausea and headache, and was administered diphenhydramine 25 mg by IM (per policy, 65 year old).    VS: 10 minutes after diphenhydramine: Pulse 74, BP 120/17, P02 97%   Patient stated she was feeling better.  Was offered transport by ambulance to hospital but refused.  The patient is ESRD on dialysis.  She has a history of anaphylaxis to ACE inhibitors.   her rheumatologist, recommended she take the Covid vaccination while still on prednisone.  Advised her to follow up with rheumatologist prior to next dose of Covid vaccine regarding any pre-medication.   The patient decided to leave on her own in satisfactory condition, approximately 1 hour after onset of symptoms.   VS: Blood pressure 120/75, pulse 79 P02 99%.    ADDENDUM:  At 11:00 am patient decided to be transported to hospital due to recurring throat symptoms.  EMS called.  She was administered second dose of diphenhydramine 25 mg prior to transport at 11:13 am.
Patient developed left hip pain 2 days after injection. Presented to the emergency room because of limp/couldn't walk. X-ray of left hip was normal. But ultrasound of left leg showed fluid collection at left proximal femur. Unclear etiology. No fevers. No known injuries. Did not appear to be in the joint itself.
Myalgia, Fever, Tachycardia, employee sated she also experienced chills and malaise Narrative:
Initial and follow-up information has been received from a pharmacist concerning a 67 year old female who on 06-NOV-2007 was vaccinated in the right upper arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658398/1087U). ON 29-FEB-2008 (also reported as 03-MAR-2008 or 04-MAR-2008) the patient developed a shingles rash from her neck to the top of head on the left side only. It was reported that a rash did not occur at the injection site or elsewhere within 42 days of vaccination. Unspecified medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Patient with 2 doses of Moderna COVID vaccine who admitted with respiratory distress and positive COVID test.  Provider d/c note below:  "Patient with Chronic respiratory failure with hypoxia (Home oxygen @ 2 L/m: home ventilator) due to severe COPD with chronic bronchitis presented with Acute on chronic respiratory failure which appears to be due to a COVID-19 infection though computed tomography angiogram chest did not find an pulmonary emboli or evidence of pneumonia.  She was treated with PREDNISONE (five days in the hospital and five further days after discharge) and REMDESIVIR (completed five days in the hospital) Patient improved and was comfortable on 3 L/m.  Patient already has home oxygen and a home ventilator so she felt comfortable being discharged home.  "
Caller states his father is fully vaccinated; Caller states his father is fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller states his father is fully vaccinated". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller states his father finished taking his Paxlovid but continues to feel weak, although he has gotten better. Caller states he wants to know if his father should have an Monoclonal infusion treatment and/or do a continuation of Paxlovid?  Caller states his father is fully vaccinated. Caller goes on to say his father 78-year-old fiance was prescribed Paxlovid but was unable to take more than two and a half days of it due to diarrhea,(going to the bathroom 20 times per day) chills, shaking and her just not feeling well. Caller states, so she got off it and she ended up having a Monoclonal infusion, although it was not recommended by her doctor, but she wanted to provide some sort of protection to herself. Caller says he has spoken with his fathers health care provider but he did not recommended the monoclonal infusion but caller believes this is only due to not wanting to be held liable since there is limited information in regards to Paxlovid and Monoclonal infusions. Caller says there are walk-in clinics in (withheld) in which you can get Paxlovid and Monoclonal infusions and they will also give Monoclonal infusions to those who have had Paxlovid prior, so some doctors must be Okay with it. Caller states he understand the CEO of Pfizer to have said that if you take Paxlovid and you don't feel better you should take more, but the FDA disagreed with that statement.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient become very pale , fainted twice, bumped her head on the wall as she fell. Only out for a couple of seconds. Was alert and oriented to person, place, and time as soon as she sat up. After the second time she fainted, she said her head hurt severely. Did not require an Epi-pen. Offered to call an ambulance but mom declined and contacted pediatrician. Spoke to mom a few hours later, stated a hospital visit was not needed after a phone consultation with the doctor.
BAD REACTION TO VACCINE; This spontaneous report received from a parent concerned an adult male. The patient's weight was 100 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were 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 patient experienced bad reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction to vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211058812.
Started with body aches and fatigue hours after the shot. 24 hours after the shot stomach pains started.  30 hours after the shot symptoms including chills, fever, diarrhea, and vomiting began. Multiple vomiting incidents within the first 5 hours, around 15 hours experiencing diarrhea. Lowest oxygen level was 92%. 46 hours after the shot diarrhea and vomiting had subsided but temperature was rising. At 100.4 he was given Acetaminophen after eating apple sauce and toast. 72 hours after the shot the patient is feeling some fatigue and body aches, no severe symptoms.
Client waved nurse over to observation area and stated, " I feel a little strange".  I asked her to describe how she was feeling and she was thirsty and feeling a bit anxious.  She stated she lived alone and her daughter was out of town.  I asked her if I could take a few vitals.  She agreed to having them taken behind the curtain area.  VS:  BP 134/72, P 66, R 16,Temp:  97.1.   SPO2 99%Client stated that  she normally has pretty low BP so this was elevated for her.    I offered her a bottle of water and she accepted.  We talked about her daughter and people we know in common.  This helped calm her and her next vitals were 126/56, P 73, R 16 SPO2 98%   .   Client stated that she was feeling better.  By 10:55 am she was moved back to group waiting area and waited a few more minutes.  She did not accept the offer of a phone call for someone to come pick her up.  Cleint stated that she felt like she could drive herself home as she did not live far away.  Client last Vitals  10:57 am :  BP 115/67 P; 67, R 14, SPO2 99%.  Client walked out of facility at 11:01 am .