chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stable Narrow Complex SVT Narrative:  Pt with hx of DM2, HTN, HLD, OSA and recent Holter monitor with SVT who presents for dizziness and tachycardia after receiving the COVID19 vaccine. He reports becoming dizzy upon standing after receiving vaccine. His HR was found to be 190 and BP was 119/66 and he was sent to the ED. Upon arrival to the ED HR remained in 180s, BP stable but patient was no longer symptomatic. Denied dizziness, HA, CP, SOB, nausea. Denies any recent drug use or toxic ingestions. Reports he has noticed his hear racing intermittently over the last few months,but has never had dizziness with it. Holter monitor done 12/2020 showed SVT typically preceeded by PACs, concerning for AVRT. resolved with 10 mg IV diltiazem push. Remained hemodynamically stable throughout the episode and symptoms of dizziness resolved. Patient was to be admitted for monitoring and cardiology evaluation but elected to leave against medical advice. The risks including death were explained to the patient. He was A&Ox4 and verbalized understanding of this. HR in the 60s and BP 124/62 prior to leaving.
54 yo f pt presents to clinic for pfizer booster. Pt states within the 15 minutes of observation her tongue/mouth started tingling. Pt denies redness,swelling, difficulting breathing. No previous hx of allergies to medication, reactions to other vaccines, or previous pfizer doses. Pt refused ER transport, but remained in observation for 45 minutes. Pt stated she was not getting better and did not think she would get worse, but continued to refuse the ER. VS @ 1332 BP 146/94, HR 88, O2 100, PAIN 0, RR 18; @1346 BP137/84, HR 74, O2 100, PAIN 0,RR 18.
Erythema Multiforme. Recommended symptomatic treatment with Acetaminophen or Diphenhydramine as needed.
After receiving my fourth dose in April of 2022, I was contacted by my pharmacist to inform me that the vaccine was expired and had been stored at the improper temperature and may be less effective than it should have been. On 09/28/2022, I felt poorly. I drove to a neighboring town and was tested for COVID-19 and was positive. I had a temperature of just over 100 degrees. My symptoms were fairly conventional. I did not lose my sense of taste or smell but felt really quite sick for a few days. I measured my oxygen level, and it was down to around 90. I called my doctor who informed me to go to the emergency room if it went below 90. The next four or five days it ranged from 90-96. I was prescribed PAXLOVID, and I would say it was around 6 days before I was able to get up and around.
Patient described waking up the day after receiving the second dose in her covid pfizer series with her R eye swollen shut on 04/09/21.  The same thing happened after her 3rd dose of the pfizer series on 10/16/21.  The R eye swelling lasted 5 days in both 2nd and 3rd doses.
Flu like symptoms; body temperature increased (over 100 degree temp); Initial information received on 30-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media. This case involves a patient of unknown demographics who had symptoms (Flu like symptoms) which had the patient on the couch for week over 100 degree temp the next day (Body temperature increased), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided.  Concomitant medication was 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 on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported that it looked like symptoms (Flu like symptoms) which had the patient be on the couch for week with over 100 degree temperature the next day (Body temperature increased), (non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE. It was also reported by the patient that no such symptoms of flu were seen since that.   Other relevant tests were not reported.  It was not reported if the patient received a corrective treatment for the events.  Event outcome was reported as unknown for both the events, at the time of reporting.  There will be no information available on the batch number for this case.  No further information was reported.
Vomiting, chills, muscles pain from 6am till 3pm. Never felt so sick in my life
Case number PHEH2013US007327 is an initial spontaneous report received from a medical assistant on 27 Mar 2013, with a follow-up received on 27 Mar 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12004, expiry date: Sep 2014) intramuscularly on 26 Mar 2013. On the same day immediately after vaccination, he experienced dizziness, decreased blood pressure and dark circles under his eyes. The reporter stated that the patient was kept in the office for 30 minutes after vaccination and his symptoms resolved, and then he was discharged from the office. The seriousness and causality were not reported. No other information was available. Follow-up was received on 27 March 2013: Expiry date of MENVEO was updated.
His wife has pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "His wife has pain at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blotchy, flat rash noted by parent on trunk of body upon on waking. No fever, any other adverse symptoms reported.
Redness, swelling, pain and tenderness on the left upper arm. Cephalexin 500 MG Cap  1 by mouth three times a day for 10 days ordered on 4/1/2018. MD decreased this to 5 days on 4/2/2018 - area improving.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 173 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
Patient called on 11/16/19 in the morning, saying that she received flu vaccine on Monday, 11/11/19.  The injection site had been sore all week but this morning she woke up and pain was from shoulder to elbow, felt pinched and she felt left arm was weaker (lifted gal of milk and it felt heavier in left arm than right arm).  She was going to take ibuprofen to see if that helped.  I called back about 3:15pm to follow up and her husband reported that she had gone to work.  He said she had taken 600mg of ibuprofen and felt 70-80% better.  I told him that I would be reporting this as an adverse event.
only half of the dose was able to be given; syringe malfunctioned; This is a spontaneous report received from contactable reporter(s) (Physician) and a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED BY DEVICE (non-serious), described as "only half of the dose was able to be given"; DEVICE MALFUNCTION (non-serious), described as "syringe malfunctioned".  The reporter considered "only half of the dose was able to be given" and "syringe malfunctioned" associated to pneumococcal 13-val conj vac (dipht CRM197 protein).  Additional information: Conclusion: The complaint for ''the syringe malfunctioned y'' of Prevenar 13V Injectable was investigated. The investigation included reviewing an analysis of the complaint history for the product type. The final scope was determined to be the reported product and product type, as no lot was available. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Agency concludes that the reported defect is not representative of the Pfizer withheld process quality and remains acceptable. The agency process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Follow-up attempts are completed. No further information is expected.  Follow-up (18Aug2022): This is a spontaneous follow-up report received from a contactable Physician via Pfizer . Updated information included reporter details, reaction data and clinical course details.  Follow-up attempts are completed. No further information is expected.  Follow-up (14Sep2022): This is a follow-up report from product quality group providing investigation results: Updated information included Product Complaint No. was added.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 21 year old female patient with penicillin allergy who was vaccinated intramuscularly with three doses of GARDASIL (lot#s not reported) respectively on 27-MAY-2008, 28-JUL-2008 and 17-JUN-2010. Concomitant therapy included YAZ and ADVIL. The third dose fell out of the recommended interval, but in addition to the misuse, on 17-JUN-2010 the patient experienced pain at the injection site. No medical attention was sought. There were no laboratory diagnostics studies performed. The patient was gone within 2 days, 19-JUN-2010. Additional information has been requested.
Developed shooting pain, tenderness, redness at injection site. Pain worsened with movement. Continued to have pain & erythema/induration increased greatly by 10/28/2010.
On the second day after the first shot, a muscle ache started in the arm with the injection (left). Then, 3 days later the ache subsided to allow for arm weights training to resume. At that time a 5-inch rash that felt hot to the touch started at the injection point and it continued there for around 2 weeks before fading away. After the second shot on 5/19/2021, there was a muscle ache for 2 days, and a much smaller 1" barely unnoticeable rash at the right-arm injection point.  I also felt feverish, but did not check the precise temperature on the night after I got the second shot. I might have had some heart palpitations together with this fever, but it was at night, so I can't be sure. And I felt exhausted on the following day, but it didn't stop me from working on my research (entirely). I did not treat these symptoms because they were reported as "Covid-arm"/normal side effects on sites I checked. I just wanted to report these side effects for your statistics. I now feel okay and I think the side effects are all over 7 days after the second shot. I mentioned these to the pharmacy, and when they told me there was a form, I told them I would fill it out on your website.
I had 3-4  episodes of tachycardia that lasted 10-15 minutes each time during 3 and 4 post vaccine. I also experienced ringing in my ears that lasted 7 days.
This non serious case was received on 06 April 2009 from a health care professional. A 28 year old female patient received ADACEL (lot number C3065, US lot number U2078CA), MENACTRA (lot number U2844AA) and RECOMBIVAX HB (manufacturer Merck, lot number 1648X) on 30 March 2009 at 4:00 PM. On 06 April 2009 at 3:15 PM the patient developed a 5.5 x 4.5 cm red, warm area with 2 cm indurated area to the right deltoid 10 cm below shoulder which was tender to touch. The patient was instructed to return to the office to visit with nurse practitioner, however the patient did not return. The recovery status was not known. List of Documents held by Sender: none.
every time she gets it she gets the flu; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age female patient and reporter stated every time she gets it she gets the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on batch number was requested  On an unknown date the patient had an event of every time she gets it she gets the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.
you read that correctly, the 2nd dose was THE WORST! I am going to attempt to type this again, yall timed me out while typing. If the CDC hadnt asked then I wouldnt have bothered with your reporting system timing me out.  Symptoms started the day of the shot, started with soreness and some sinus issues, however things escalated quickly! I received a high fever at one point (think 104 if I remember correctly) and everything went to DOWNHILL, stupid hot cold swings of massive extremes. One moment I would feel so hot it was like standing on the surface of the sun, then suddenly so cold it was like I was frozen on Pluto. I would get cold grab a blanket and be hot, then take it off and freeze, literally no in between, I was either severely cold or extremely hot. Experienced all the sinus issues, running, drainage and dryness back and forth, arm was basically useless, fatigue and lethargic symptoms were stupid extreme, I remember leaning up in the bed and trying to open a water bottle only to find out I physically was not capable of squeezing the cap enough to turn it, I had to attempt with every fiber of my being and last ounce of strength to turn that dang lid and eventually got it, but if it hadn't turned i likely would've died, just didn't have the strength to move. After 3 days of AGONY around noonish or 1ish I started to feel a bit better, like a switch flipped and the hot cold spells stopped. Things got better after that, but oddly some weird symptoms seemed to persist and currently still persist. Had very, very vivid and strange dreams for a while after (these seem to have subsided) and odd tightening of muscles that persist. Currently my jaw is tight on the right side and when opening it leans to right and sometimes pops. something in my arms, legs and wrists (I think its a ligament) tightens up and becomes sore. Not sure what that's all about, but I was asked to report this stuff so here it is!
No additional AE/PQC reported.; vaccine stored out of recommended storage range was administered to patient; This spontaneous report as received from another health professional (Nurse prescriber) referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug allergies and reactions were not reported.      On 14-DEC-2020, the patient was vaccinated was vaccinated with the temperate excursion vaccine (also reported as vaccine stored out of recommended storage range) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, and route of administration were not provided) (Lot # was T027937 and expiration date was 08-AUG-2022) for prophylaxis. The patient did not experience any adverse event.
Swelling and pain of the upper arm in which injection was received.  Had headache and fever. Symptoms lasted 5 days.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 53-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). Previously administered products included ZOSTAVAX (received before and the injection site was hard and red). Concurrent medical conditions included sulfonamide allergy. On 21st February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shivering, muscle pain, fever and burning sensation. On an unknown date, the outcome of the shivering and fever were recovered/resolved and the outcome of the muscle pain was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved. The reporter considered the shivering, muscle pain and fever to be probably related to SHINGRIX. It was unknown if the reporter considered the burning sensation to be related to SHINGRIX. Additional details were reported as follows: The patient received lots of other concomitant medications. The patient received SHINGRIX on left deltoid. The patient stated that her arm still hurts 8 days after the vaccination. The area was burning and she could not sleep on the arm due to the pain. The batch number reported for SHINGRIX (525LX) did not exist and was updated to 5Z5LX as per sales database.
maybe some soreness for 24 hours; slight dizziness after about 4 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:30 (Lot number: ER 8734) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TETANUS VACCINE, start date: 08Mar2021, stop date: 08Mar2021; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: ER2613, Lot unknown: False, Administration date: 26Mar2021, Administration time: 11:30 AM, Dose Number: 1, Vaccine location: Right arm), administration date: 26Mar2021, when the patient was 51 years old, for Covid-19 immunisation, reaction(s): "aches for 24 hours, mostly in torso", "sore arm for a couple days". The following information was reported: DIZZINESS (non-serious) with onset 12Apr2021 14:30, outcome "recovering", described as "slight dizziness after about 4 hours"; PAIN (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "maybe some soreness for 24 hours". Therapeutic measures were not taken as a result of dizziness, pain.  No follow-up attempts are possible. No further information is expected.
Heart palpation, heart flutters, pain general discomfort in chest/heart, warm sensation in chest
body aches; diarrhea; accidently received 2 doses of AREXVY on Wednesday 6-SEP-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-SEP-2023, the patient received the 2nd dose of Arexvy and the 1st dose of Arexvy. On 06-SEP-2023, an unknown time after receiving Arexvy and not applicable after receiving Arexvy, the patient experienced accidental overdose (Verbatim: accidently received 2 doses of AREXVY on Wednesday 6-SEP-2023). On 07-SEP-2023, the patient experienced general body pain (Verbatim: body aches) and diarrhea (Verbatim: diarrhea).  The patient was treated with paracetamol (Tylenol). On 07-SEP-2023, the outcome of the diarrhea was resolved.  On 08-SEP-2023, the outcome of the general body pain was resolved (duration 1 day). The outcome of the accidental overdose was unknown.   It was unknown if the reporter considered the general body pain and diarrhea to be related to Arexvy and Arexvy.     It was unknown if the company considered the general body pain and diarrhea to be related to Arexvy and Arexvy.   Additional Information: GSK receipt date: 08-SEP-2023 Reporter was the patient, who accidently received 2 doses of Arexvy on Wednesday.  The patient experienced diarrhea on Thursday morning which resolved midday. She experienced body aches late Thursday for which she took Tylenol and resolved when she woke up today (on the day of reporting). The patient received accidentally received 2 dose Arexvy on same day, which led accidental overdose. The reporter consented to follow up.Call Notes:
1/20 1830: dose given. Local injection site pain.  1/21 0830: woke with mild HA, mylagias 1030: worsening HA, myalgias, chills, nausea, diarrhea (not typical for UC)
Flushing/rash on torso arms and neck. Slight tightness in chest.
soreness at injection site.  severe chills throughout the night.  fatigue for three days.  all fine after.  same symptoms after second shot but , not as bad.
No Adverse Event; HBP reporting that VARIVAX was administered after it experienced a supported temperature excursion. No side effects reported from HBP.         ?    Names of vaccines involved (including lot/exp): VARIVAX, Lot: W025277, Expiration: 8/10/2024; This spontaneous report was received from an administrator refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with the first dose of improper storage varicella virus vaccine live (oka/merck)(VARIVAX) lot #W025277, expiration date: 10-AUG-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis, dissolvent with sterile diluent.   Administered dose of vaccine was exposed to the temperature excursion of -8.6 degree Celsius for 51 minutes. The previous temperature excursion of -11.5 degree Celsius for 1 hour and 16 minutes (product storage error). There were no additional adverse events reported (no adverse event).