chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad headache due to high blood pressure, it went up to 174/114; was in bed for three days feeling very bad; bad headache due to high blood pressure, it went up to 174/114; This is a spontaneous report from a contactable consumer (the patient). This non-pregnant 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 at 09:00 (Lot number was not reported - misplaced/discarded)  at the age of 55 years, as DOSE 1, SINGLE for COVID-19 immunization.  Medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination On 22Mar2021 at 09:30 the patient experienced bad headache due to high blood pressure, it went up to 174/114. She was in bed for three days feeling very bad. The verbatim clinical course was reported as follows: When the patient was waiting to see if she had any reactions her blood pressure went to the roof, had the paramedics testing her, it never went away, she was in bed for three days feeling very bad. Went to emergency room on her own since that same afternoon it just wouldn't go away, bad headache due to high blood pressure, it went up to 174/114. The patient did not receive any treatment for the bad headache due to high blood pressure, it went up to 174/114. The clinical outcome of bad headache due to high blood pressure, it went up to 174/114, and was in bed for three days feeling very bad was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Onset of dyspnea approx 3 hours after injection. Pt had managed was not breathing and nasal congestion as well. O2 Sat 97% RA. She was tx with KENALOG 40 mg IM with rapid improvement of symptoms. Discharge home with albuterol\HFA and BENADRYL instructing.
Developed swelling and discoloration of flu site. Next day low grade temp (99.5) and fatigue.
pt devel inject site rxn w\ redness, itching & a knot.  This is 1 of 4 patients from this site and lot# to report adverse rxn.
This spontaneous report as received from a pharmacy intern refers to a patient of unknown age and gender. The pharmacist reported that, on an unspecified date in November 2012 according to the pharmacy's record (or an unspecified date in February 2013 according to the patient) the patient was vaccinated at an unspecified provider's office with the first dose of GARDASIL injection (lot number, dose and site administration were not reported). On 30-AUG-2013, the patient was vaccinated with the second dose of GARDASIL injection (lot number, dose, route and site administration were not reported). No adverse effects were reported. Additional information has been requested.
bilateral lower extremity muscle "soreness/weakness"; fatigue; mild headache for most of the day (coughing made it worse); bilateral lower extremity muscle "soreness/weakness"; coughing; left arm pain/bilateral arm pain (worse of the left); This is a spontaneous report from a non-contactable physician. A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration administered on arm left on 04Mar2021 at single dose for covid-19 immunisation (At the age of 30-year-old).  Medical history included chronic hives from an unknown date and unknown if ongoing. The patient had known allergies: shellfish from an unknown date and unknown if ongoing. Concomitant medications in two weeks included cetirizine taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Covid prior to vaccination was unknown and the patient was not covid tested post vaccination. On 04Mar2021, the patient experienced left arm pain (the day of the vaccine)and that day after vaccine the patient had bilateral arm pain (worse of the left), bilateral lower extremity muscle "soreness/weakness", fatigue, mild headache for most of the day (coughing made it worse). No treatment was given for any of event. The outcome for all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old (also reported as age 5, units not provided) female patient (child). On 28-APR-2014 at 4:49 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the left thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Headache, Fever, chills, flu-like symptoms with body aches Narrative:  THIS EMPLOYEE HAD HA, FEVER,CHILLS, FLU-LIKE SX POST COVID VACCINE INJECTION YESTERDAY AND CALLED AND LEFT A MESSAGE TO CALL ME BACK PT CALLED ME BACK AND NOTED TEMP OF 100 AND HAD SOME BODY ACHES AS WELL AND TOOK MOTRIN AND NOTES SYMPTOMS CLEARING AND SHE IS OK AND CAME TO WORK TODAY-NO RECURRENT FEVERS
1st dose on 9/27/19,  not received 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked should repeat the first dose.
J96.00 ACUTE RESPIRATORY FAILURE 4/14/2023 CKD STAGE 3B (GFR 30-44)
sore arm for four days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for four days) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for four days). On 27-Mar-2021, PAIN IN EXTREMITY (sore arm for four days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.   This case was linked to MOD-2021-089169 (Patient Link).
one dose of GARDASIL 9 was improperly stored on 11/18/2021 and was administered to a patient on the same day; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 18-NOV-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028582, expiration date: 04-MAR-2023 (dose, route of administration and anatomical location were not reported). Temperature excursion was on 18-NOV-2021 in the temperature of 48 degrees Fahrenheit for 1 hour and 26 minutes.
I am not complaining, but maybe my report might help someone else who gets a high fever. That is, if you can figure out what to offer people who get fevers. I could find no information on what to do. Only that the effects of Ibuprofen, Tylenol, etc. on the covid vaccine in preventing a fever were unknown. That implies that the effects on treating an actual fever are also unknown by you. I did not want to dampen the effect of the covid vaccine, so I let myself have a fever.  It was 103.1 at 10 am. I did not feel too bad so I drove my son back from (privacy). At that time my fever was 104.1.  I tried to get out of the car and stretch before driving back home, but I found to my surprise, I could not walk. I did not have the coordination to put one foot in front of the other. I managed, maybe, 20 steps out, but I am sure people thought I was inebriated. I went back to my car and rested awhile. My temperature came back down to the 103's, and I drove back home. By the next morning I had no fever and felt pretty well. (Maybe if other people have fallen and died after a covid vaccine, you should check. Maybe it was because they had a high fever and couldn't walk, not just a plain fall ?). I will still be happy to get the booster vaccine if I need it.
Patient broke out in a rash a couple hours later, had trouble breathing, eyes were partially shut. Patient felt better after using Benadryl. Patient is very sensitive to medications and the last time she got vaccinated (about 15 years ago), she also had an allergic reaction.
10 minute after receiving intranasal H1N1 Pt developed chest tightness, nasal irritation, congestion, sore throat & bronchiospastic cough alone with anxiety. 11/23/09 Medical records received for date 11/20/09. DX: allergic rhinitis, asthma, acute bronchospasms. Pt. presented w/ request for H1N1 vax per parent. Vax given intranasal. Pt parent called back within 10 minutes to state pt. is having difficulty breathing. Pt not previously seen at this office. Pt parent admits pt has currently had runny nose, sore throat and cough.  Assessment: observed to have bronchospastic cough.
This spontaneous report has been received from the MR moderator referring to 2 patients of unknown age and gender both of them sons of a 50 year old male that was enrolled in a market research. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL 9 (dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. Also, he said that he got his vaccinated off schedule (reported as "did not follow the prescribed 3 dose schedule"). On an unknown date, the patients experienced pain while the vaccine was being administered. Additionally, it was reported that the patients' father got the patients vaccinated off-schedule (reported as "did not follow the prescribed 3 dose schedule"). At the time of reporting, the outcome of vaccination site pain was unknown. The relationship between pain at vaccination site and the administered dose of GARDASIL 9 was not reported. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous route (dose, frequency, and anatomical location were unknown) with lot # N020015 and expiration date 17-JUL-2019 for prophylaxis, reconstituted with properly stored Merck sterile diluent with lot # N026286 and expiration date 06-FEB-2020. The administered dose of vaccine experienced the temperature excursion of -9 degrees C to 8 degrees C (7C) Celsius for 41 hours, and -14 degrees C to -10 degrees C (-9.6C) Celsius  for 5 hours 44 minutes. There was a digital data logger involved, but there was no previous temperature excursion, and no adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA003156.
SOB, numbness and tingling  in lower extremities. Confused, did not know where she was . BP 170/100 HR 135  EKG- PVCs. transported to Hospital
Less than two days after the vaccine was administered, I developed difficulty urinating and a burning sensation while urinating.  This occurred again after the second vaccine and required hospitalization.
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # M004116, expiration date 12-OCT-2017) dose, route and anatomical location were unknown. There was no concomitant medication reported. The vaccines experienced the following temperature excursions on unknown dates: 29 F for 21 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were not identified due to a data logger. It was reported that GARDASIL 9 was not supported, the product was not suitable for use. This is one of several cases received from the same source. Additional information has been requested.
After a shot of GARDASIL 9 to the left arm, cannot move arm, have excruciating pain and cannot sleep.
My wife has gotten sick every time; Initial information regarding an unsolicited valid non-serious case received from a non-healthcare professional (patient's husband) via social media on 22-Nov-2020.  This case is linked to case 2020SA335838 (same reporter).  This case involves a female patient who had gotten sick every time (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had gotten sick every time (illness), (unknown latency) following the shot of INFLUENZA VACCINE. Further reported that a former co-worker almost died and was off work shortly after getting a flu shot. No laboratory data reported.  It was not reported if the patient received a 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.
This spontaneous report has been received from a newspaper article concerning a 10 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with a human papillomavirus vaccine (manufacturer unknown) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was reported that on an unknown date the human papillomavirus vaccine (manufacturer unknown) might have caused the death of the patient. It was unknown if an autopsy was done. The causal relationship between human papillomavirus vaccine (manufacturer unknown) and the event was considered as related. Upon internal review, death was determined to be medically significant.
Patient presented on 12/6/21 with fever, HA, nonproductive cough, sore throat, myalgias and SOB for 3 days. Patient is fully vaccinated. Chest x ray showed no acute abnormality. Patient was given x1 IV vanco/cefepime in the ED.  Patient was discharged on 12/7/21 with an outpatient monoclonal antibody therapy on 12/8.
Noted in retrospective chart review that patient is only 15 years of age.  Patient's mother notified that patient is not eligible to receive the second vaccine at this time.
Interchange of vaccine products; Treatment of COVID-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER8727), in left arm and on 08Apr2021 as dose 2, single (Lot number: EW0151) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm, on 11Jun2022 as dose 4 (booster), single (Lot number: 060A22A), in left arm and on 29Sep2022 as dose 5 (booster), single (Lot number: 027E22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Nov2022, outcome "recovering", described as "Treatment of COVID-19"; COVID-19 (medically significant) with onset Nov2022, outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure  for which included PF-07321332, ritonavir (PAXLOVID) from 21Nov2022 to 26Nov2022.
Waited a half hour in waiting area, no one came to check on me (after I had indicated my allergy concerns and history), left pharmacy and went directly home (less than 5 minutes from pharmacy), upon arrival at home, felt weird, looked in mirror and face was swollen, red patch across cheeks/nose area, chin and red patchy look to forehead, tiny hives appearing just below cheeks and on upper chest, just below neck.  Took some Tylenol, sat in a chair with fan blowing on me and slowly drank 2 large glasses of iced water.  After about 2 hours (this includes the 1/2 hour in the waiting room) of monitoring myself, swelling started to go down and redness had turned pinkish.  Went to bed and took a nap for 3 hours, woke up and felt fine.  On Sunday, right arm where shot had been given felt like a wide elastic band was wrapped around my arm.  Feeling slowly diminished over the next two days.  No other symptoms since. Very concerned about having the next shot because of inflammation concerns.  I had breast cancer in my left breast and have inflammation issues due to lymphedema on that side.  Know that radiation can cause inflammation issues with lung and heart.  Know concerned about inflammation issues with heart from vaccine.  Very nervous to get second shot, contacted PCP and breast surgeon, both said to contact pharmacy with my concerns and one said to contact CDC to find out where I could go to have the vaccine administered at a facility that had a Physician or Nurse present to monitor me. Can anyone give me feedback on my concerns and inform me where I can get a supervised shot, if I should get the shot at all?
I had a breakthrough case of Covid with cough, nasal congestion, body aches, diarrhea, headache.
Pt was noted to be pale, pt fainted. Brought in room in lay. BP checked, Pulse checked. MD notified and checked Pt after resting BP elevated to normal. Pt released with mother to drive.
On 10/5 at approx 12 pm he received flu, pneumovax and shinrix vaccine. About 2 hours after leaving the office, was driving and started to feel off. This increased while driving to point he felt unsafe driving. Later that night fever and chills so severe that stomach hurt because he was so chilled and balled up with the pain in muscles and joints. Did not take his temp. Felt bad enough he was scared and thought he might be having a stroke. Since that time symptoms have come and gone. First night did not take anything. Today took tylenol but not sure it helped as feels so bad. No cough, SOB, chest pain, stomach symptoms, ST a bit, maybe scratchy. Has had bad HA on and off with all of this too.  Arm is red where he got the 2 shots and is tender to the touch. Also reports rash on back.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 case reported by the same reporter for the same vaccine.
Woke up from nap covered in hives. Mom brought pt back into office to be seen. We dosed him with Benadryl 3.75 ml po @ 3:15pm.
After receiving vaccine pt c/o pain in shoulder, lump in axilla, and decreased range of motion of shoulder. Pt was evaluated on 1/22/11 - on which date symptoms were improving.
This spontaneous report was received from medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored PEDVAXHIB (dose, lot # and route of administration were not reported). Patients were also vaccinated with improperly stored Tetanus-Diphtheria vaccine (TD). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache; Pain at the injection location; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 at 19:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient has no known allergies. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and empagliflozin (JARDIANCE) all taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 20:00, the patient experienced headache for about 5 hours and slight headache 15 hours later, improving and pain at the injection location. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and pain at injection location was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Injection arm swelled up above elbow and turned red, very inflamed and itching. Severe itching and inflammation for about 7 days then inflammation subsided. Itching much improved.