chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have heart palpitations - I had that have increased over time. Those are worsening. I am having lots of palpitations. I developed fever and joint pains too but that was expected. My blood pressure was sky high and I had blurred vision. I couldn't get in to doctor until Monday - by Monday I was sneezing, runny nose, and had a cough. They gave a heart monitor to wear and I do not have the results back from that yet. For COVID symptoms - they prescribed a Steroid inhaler; for the blood pressure and the palpitations - have had low heart rates, too. No treatment yet for the heart palpitations. They did put me on Losartan for the blood pressure and they started me on Doxycycline - for what seemed like a sinus infection (before they had the test results back). It's a five day course and I am still on it (Doxycycline). It hasn't helped with my symptoms but has aggravated my asthma and so I was put on a steroid inhaler to try to get a head of it. Positive test result yesterday - a send out COVID test - that was done at doctor's office on Monday.
erythema, swelling, pruritus, no pain, no fever; sensation intact, no tx;
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On unspecified dates, since 03-AUG-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L007558 with expiration date 10-NOV-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. The RECOMBIVAX HB was also exposed to 68F for 19 hours. Additional information has been requested.
The vaccine was refrigerated on 03-Jan-2022, its used by date was 02-Feb-2022 but was administered on 09-Feb-2022; Patient received vaccine after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 03-Jan-2022, its used by date was 02-Feb-2022 but was administered on 09-Feb-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 03-Jan-2022, its used by date was 02-Feb-2022 but was administered on 09-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 03-Jan-2022, its used by date was 02-Feb-2022 but was administered on 09-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported.  The vaccine was refrigerated on 03-Jan-2022 and used by date was 02-Feb-2022 but was administered on 09-Feb-2022. The vial did not undergo any temperature excursion.  No information on treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow document received includes no new information.
Covid vaccine monitoring documentation. PT admission    1/18/22 ? 1/23/22.  COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 01/29/2021. No lot available.  COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 02/19/2021. No lot available.  COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 10/28/2021. Lot FF2593
(L) arm with localized redness and swelling that does not extend below the mid forearm improving after 2 days.
a 79 year old female was administered Fluzone High-Dose on 08Nov2019 and again on 15Nov2019 instead of the tetanus shot/No AE; a 79 year old female was administered Fluzone High-Dose on 08Nov2019 and again on 15Nov2019 instead of the tetanus shot/No AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 79 years old female patient who was vaccinated with a 0.5ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Pre-filled syringe on 08-Nov-2019 lot number: UJ300AB and Expiry date: 26-Jun-2019) via intramuscular route in the left deltoid and again received the same shot instead of TETANUS TOXOID shot on 15-Nov-2019.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered and extra dose administered.   Pharmacist states that she injected a 79 year old female with Fluzone High-Dose on 08Nov2019. The patient came back in on 15Nov2019 to get a Tetanus shot and the medical assistant accidentally pulled the Fluzone High Dose shot again instead and injected it instead of the tetanus shot.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
pt exp 8cm erythema, induration-upper lt arm w/central blanching;
She couldn't sleep at night because of aches and pain; She had pain in her head and some chills on next day; Patient reports that she felt dizzy after 3-4 hours of receiving 2nd dose; She had pain in her head and some chills on next day; She couldn't sleep at night because of aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient reports that she felt dizzy after 3-4 hours of receiving 2nd dose), INSOMNIA (She couldn't sleep at night because of aches and pain), PAIN (She couldn't sleep at night because of aches and pain), HEADACHE (She had pain in her head and some chills on next day) and CHILLS (She had pain in her head and some chills on next day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Mar-2021, the patient experienced INSOMNIA (She couldn't sleep at night because of aches and pain). On 16-Mar-2021, the patient experienced CHILLS (She had pain in her head and some chills on next day). On 18-Mar-2021, the patient experienced DIZZINESS (Patient reports that she felt dizzy after 3-4 hours of receiving 2nd dose). On an unknown date, the patient experienced PAIN (She couldn't sleep at night because of aches and pain) and HEADACHE (She had pain in her head and some chills on next day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Patient reports that she felt dizzy after 3-4 hours of receiving 2nd dose), INSOMNIA (She couldn't sleep at night because of aches and pain), PAIN (She couldn't sleep at night because of aches and pain), HEADACHE (She had pain in her head and some chills on next day) and CHILLS (She had pain in her head and some chills on next day) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
have two discoloration in my right thumb one black long line and one red line side by side  around 1 and a half inches long and behind it is a circular black and discoloration; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3247), via an unspecified route of administration on the right arm on 19Jan2021 12:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, supraventricular tachycardia and hearing loss from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) and metoprolol tartrate (METOPROLOL TARTRATE). On 22Jan2021 05:00 AM, the patient stated, "I have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration." No treatment was received for the events. The outcome of the event was not recovered.
sleep a lot 9 sft; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleep a lot 9 sft) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (sleep a lot 9 sft). At the time of the report, HYPERSOMNIA (sleep a lot 9 sft) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use not provided.  Treatment information not provided
PATIENT GOT RED AROUND INJECTION SITE AND LUMPS THAT TRAVELED DOWN THE ARM. RED SPOTS TRAVELED DOWN THE ARM AS WELL AS TRACKS THAT LOOKED LIKE SHE HAD BEEN SCRATCHED OR GOT A MILD CASE OF SHINGLES FROM THE VACCINE.
body ached so badly that felt like a truck ran over; severe headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 20Jan2021 at 09:45 in the left arm at a single dose for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications included trazodone, escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN), and raloxifene hydrochloride (EVISTA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021 at 09:45, the patient's body ached so badly that felt like a truck ran over and had severe headache. The patient had a physician office visit but did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
1. within a few days of second Pfizer Covid-19 injection: shortness of breath, high chest pains; went to emergency room; admitted on 3/31/2021, only finding was evidence of a previously unknown A-Fib, released 4/2. 2.  returned to emergency room on 4/11/2021; found abnormally build-up of fluid in pericardial lining of heart; diagnosis was acute pericardial effusion; emergency surgery required to drain fluid; insertion of discharged 4/16/2021 3. returned to emergency room on 4/30/2021 with same symptoms as earlier; no additional fluid found around heart, but draining led to some pleural effusion; general belief that the heart lining was still inflamed; discharged 5/3/2021
I felt odd as soon as I received the vaccine, about 20 minutes later I LOC and woke up unable to speak and paralyzed from the neck down. I was able to speak within an hour or so, but my speech was very slurred. I was able to move my upper body within 3 hours or so. I was only able to move my toes  and my knees slightly that night. The next day I was able to move my legs a little more. I was hospitalized for a week and now, 20 days later, continue to have residual weakness on both of my lower extremities, which is more pronounced on my right leg. I am walking with a walker and having PT/OT at home in order to be able to return to work. A nightmare is an understatement.
pt recv vax; 5 days p/ vax began inc pain & dec strength in rt shoulder; pt now has dec ROM in rt shoulder;being referred to orthopedist; pt had "frozen shoulder" 30 yr ago same side;
Injection site reaction (itching, rash, and skin warm to the touch) along with fever of 102.
Pt developed itchiness of skin 5-10 mins after the vaccination. Developed rash on arrival to home. Pt has brought back to the clinic. He has intense itchiness all over trunk, extremities. Erythematous rash and scattered urticaria on abdomen and lips. Responded immediately with epinephrine s/c no respiratory symptoms. V-S are work.
Client stated he received the Monkey Pox vaccine on 1/31/2023 to the left arm. and noticed some soreness that night. On 2/1/2023 wednesday night Thursday morning client stated he looked and saw the expanded redness and then marked it with a pen and noticed this morning 2/3/2023 that the redness had expanded past the pen mark and that it tender where the injection site is but not where the redness occurs
Patient reported today that she has  pain in shoulder blade & rib area after 24 hours of receiving vaccine. She takes Oxycodone for hip pain but states no relief with rib & shoulder
In May of 2022 I was at the doctor for an unrelated issue, gout. I also had a colonoscopy. After these two events I then began having trouble with right leg. I had pain in right leg all the way up from my calf to my thigh. I could not put pressure on my leg to walk. At that time I had an ultrasound of my right leg. They found blood clots in my femoral artery in right leg. They put me on medications (ELIQUIS) to help the clots dissipate on their own. My next appointment is August 3rd and I will learn more by ultrasound to see if medicines are working. My mother also had blood clots and so did my daughter, many years ago, but I tested negative for the clotting gene.
sore arm; Fever; Myalgia; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm, fever and myalgia. On an unknown date, the outcome of the pain in arm, fever and myalgia were unknown.   It was unknown if the reporter considered the pain in arm, fever and myalgia to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Medical Assistant reported that she had patients that experienced sore arm, fever, myalgia upon having received a dose of Bexsero.
This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 17 year old female patient. On 05-NOV-2013 the patient was vaccinated with VARIVAX (Merck) by her unspecified general health care provider. No concomitant medications, pertinent medical history or drug allergies. The patient was subsequently determined to be pregnant. The date of last menstrual period was 08-SEP-2013 and estimated date of delivery was 15-JUN-2014. Initial exposure to VARIVAX (Merck) was at 8 week(s). The pregnancy outcome was pending. The patient had her first obstetrical evaluation with the nurse practitioner on 22-JAN-2014. On 22-JAN-2014, the patient had a positive pregnancy urine test, an ultrasound revealed a pregnancy of 19 weeks 3 days gestation. No problems reported. No treatment was provided. The patient sought medical attention by making an office visit. Additional information has been requested.
It was mainly a cough, sneezing, headache, tickly and sore throat. I also had hoarseness. They kind of got worse around day 3 and started to go down hill by day 5 or 6. I don't have much of a cough now but I am still hoarse.
I fell that this shot # 1 &2  made my arm sore and destroy my anchor fall a part and now I have to have surgery again
I woke with a headache and my ears were ringing the day after receiving the vaccine. The ringing in my ears has continued to this day. The headache was worse the day after getting the shot, but has never gone away entirely. I've had severe migraines in the past, but this headache is of a completely different type.
This spontaneous report was received from an office manager concerning an 18 year old female patient with no relevant drug reactions/allergies and with no pertinent medical history. There were no concomitant medications. On 12-JUN-2017 the patient was vaccinated with a dose of GARDASIL 9 lot # N001533, expiration date  for prophylaxis. Other suspect therapies included a tuberculin(TUBERCULIN) test reported as "TB test" and a dose of HAVRIX for prophylaxis (dose, route of administration, lot number and expiration date were not reported), on the same date. And then immediately the patient had an episode of syncope. No laboratory test was performed. The outcome of syncope was reported as recovered, on an unknown date in 2017.
Redness, heat, and  swelling at site of injection from day of injection. 7 days after injection, itching  at site of redness and swelling began. On 8th day, redness, swelling, and heat spread to a wider area. Area still itches and has not subsided.
Moderna COVID-19 Vaccine: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/13/2021, 2/11/2021, and 8/25/2021. Presented to Emergency Department for altered mental status and failure to thrive. Admitted for hepatic encephalopathy and COVID. Status continued to decline going into septic shock and respiratory failure. He was intubated and required 3 maxed pressors. Received antibiotics. Transitioned him to comfort care, DNR/AND. He expired 11:58 pm on 1/12/2022.
Information has been received from a employee concerning her approximately 13 month old daughter with amoxicillin allergy and no other medical history who on 23-DEC-2010 was vaccinated with MMR II and FLUZONE (manufacturer unknown) shot and 2 other vaccines. On 30-DEC-2010 the patient experienced a low grade fever, was lethargic, irritable and had diarrhea and recovered in 2 days. On 06-JAN-2011 the patient experienced a rash and had not recovered from the rash as of 07-JAN-2011. No lab diagnostics studies were performed. The patient did not seek the medical attention. Follow-up information has been received from the physician indicating that on 23-DEC-2010 at 9:15 AM, the patient was vaccinated with a first dose of MMR II (lot # 667246/0907Z) subcutaneously in right arm, a first of VARIVAX (Merck) (MSD) (lot # 668318/1005Z) subcutaneously in left arm, and a first dose of FLUZONE (lot # UT3667BB) intramuscularly in thigh. Additional information has been requested.
Symptoms started two days after recieving the vaccine.  Experienced muscle pain, spasm, and weakness.  Have seen multiple doctors for treatment still no improvement.  Time course is about 3 months.  02/05/2009  MR received from PCP from 12/8/08 to 2/3/09. OV 12/8/08.  Pt preports increased body twitching, dizziness, difficulty walking, and muscle soreness of the arms and legs beginning on 10/19/08. Symptoms initially began in 2005. Nutritional IVs prescibed. Seen 1/6/09 with c/o facial rash since late october 2008. Papular rash noted of face/neck, tender to touch. Assess:  2 different rashes- 1-possible staph. 2-unknown possible derm rxn. Will cx if reoccurs.
Phantom smell/ parosmia; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 18:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in Apr2021, the patient experienced phantom smell, parosmia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event phantom smell, parosmia was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a female patient of unknown age reporting on herself. Concomitant medications included acyclovir. The patient's medical history included shingles before receiving ZOSTAVAX. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage schedule, lot# and expiration date were not provided). On an unknown date, the patient experienced flu like feeling, joint pain, feeling aching, blotchy skin and a cold sore from her lip to her nose. The outcome of patients events was not reported. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected as there is no contact information available.
I got the shot on 4-21 and on may 2 i got a rash. The rash got worse the next day. Then stayed for a couple of days and went away. I take the birth control pill and it also made my period late and lighter and that is still continuing. After second shot i got a rash the day after the shot that lasted for a few days and went away. My period is still delayed and shorter/lighter
This spontaneous report as received from a pharmacist refers to a his father of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was not reported). The pharmacist mentioned his father developed nerve pain approximately one week after receiving ZOSTAVAX. The outcome of his father developed nerve pain was unknown. Additional information has been requested.
Fever or Chills  Cough  Shortness of Breath  Headache  Congestion or running nose  Nausea or vomiting
Shortness of breath, exhaling moredifficult than inhaling,; Chest heaviness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Nov2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Nov2021 the patient experienced shortness of breath, exhaling was more difficult than inhaling and chest heaviness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events shortness of breath, exhaling more difficult than inhaling and chest heaviness was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation.    The lot number for BNT162b2 was not provided and will be requested during follow up.