chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uncontrollable diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Uncontrollable diarrhea) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F234) for COVID-19 prophylaxis.     Concurrent medical conditions included ALS.    In September 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced DIARRHOEA (Uncontrollable diarrhea). At the time of the report, DIARRHOEA (Uncontrollable diarrhea) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  On 23 March 2021, Patient took Moderna COVID-19 vaccine with batch lot number 044A21A, On 23 April 2021 took with lot number 036B21A and on 06 December 2021 took with lot number 017F21A respectively.   She was her husband's caregiver who had ALS and had bad reactions to Spikevax, uncontrollable diarrhea. Had the vaccine 6 pm on Friday and started that evening between 1-3 am and was happening every 2 hours. It slowed down, but just happened on 25 September 2023.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.
Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benadryl 50 mg at night since 1/6. Facial swelling continues. Hives reduced, but redness continues.
Red blotches on bilateral arms from elbows to wrists which started 5 hours after hepatitis B vaccination and IPPD placement.
vomiting; chills; severe headache; stomach pain x72 hrs; severe nausea; dizziness; low blood pressure; This is a spontaneous report from a contactable healthcare professional. A 48-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 05Jan2021 10:00 to 05Jan2021 10:00 at a single dose for COVID-19. Medical history included asthma, sibo, allergies to wheat, gluten, corn, tomato and peanuts. The patient's concomitant medications were not reported. It was reported that the patient's initial response to shot was severe nausea and dizziness, low blood pressure lasted 24hrs on 09Jan2021. 5 days later, the patient had nausea, vomiting, chills after meal, severe headache and stomach pain 72 hrs. The patient received IV fluids as treatment for all events. The patient underwent lab tests and procedures which included Covid Nasal Swab Test on 04Jan2021 which tested negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
itching all over my body/itchy; fever of 98.5F; I can't even work; sore arm; feeling crappy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955) via unknown route of administration on 27Mar2021 at left arm as a single dose for COVID-19 immunization. The patient medical history included ongoing Crohn's disease. Concomitant medications included certolizumab pegol (CIMZIA) as a SINGLE DOSE (2 shot Once a month) for Crohn's disease and other unknown products. Patient states that she received her 2nd dose of the vaccine on March 26. On Sunday she started itching. Patient took 2 Benadryl and it didn't help. Patient has taken cortisone and used topical Benadryl as well. Patient was itching all over her body on an unknown date in 2021, it started on the arm where I got the shot, but it's spreading." Had a fever of 98.5F on an unknown date in 2021. Patient know someone else with Crohn's who had a bad reaction to the Moderna COVID vaccine. Patient stated, "I had some of the expected Pfizer side effect but I was not expecting this thing to be this itchy. Patient was literally wanting to crawl out of my skin. Patient have been on Benadryl since Sunday when it started and it started Wednesday and patient can't even work on an unknown date in 2021 because she have to take so much Benadryl just to stop the itching and it knocks me out. Patient was taking over the counter Benadryl and topical Benadryl and Cortisone, I mean it's bad. When confirmed that consumer took the COVID shot, consumer stated, "Yes I took my second shot, I took it on Saturday. On an unknown date in 2021, patient got sore arm which was expected, she was feeling crappy but I was not expecting to have this severe itchiness." Patient have been itchy for 4 days now since Sunday. Patient sated, "Just document that I am getting itchiness, because the itchiness is bad and they really need to disclose that on their side effects." Confirmed that consumer took the vaccine for the prevention from COVID 19 vaccine. The therapeutic measures received for the event itching included Benadryl and Cortisone. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
After 2 weeks from injection still have red spot on my upper arm and when I "massage" red spot it begins to throb. Hopefully the vaccination went into my body and not stayed at point of entry.
After receiving the shot, my period lasted over a month.  I went to my gynecologist who prescribed the depo shot to shot the bleeding. Prior to I didn?t have any cysts or fibroids. I went to the doctor again in December 2021 for the same issue of continuous bleeding. The doctor ordered an ultrasound and it was discovered that I had a small fibroid but the doctor could not conclude if this was the source of the bleeding. I was given a second depo shot to see if it would help. I have continued to have irregular bleeding this year as well.  Prior to the vaccine, my period was regular and only lasted a week.
ADMINISTRATION OF PUNCTURED VIAL VACCINE STORED AT UNKNOWN AMOUNT OF TIME AT REFRIGERATED TEMPERATURE, NOT IN ORIGINAL PACKAGING; DOSE PREVIOUSLY LEFT IN THE REFRIGERATOR WITH NO INDICATION ON THE VIAL HOW LONG IT HAD BEEN STORED THAT WAY; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were 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: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced administration of punctured vial vaccine stored at unknown amount of time at refrigerated temperature, not in original packaging. On 05-JUN-2021, the subject experienced dose previously left in the refrigerator with no indication on the vial how long it had been stored that way. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of punctured vial vaccine stored at unknown amount of time at refrigerated temperature, not in original packaging and dose previously left in the refrigerator with no indication on the vial how long it had been stored that way was not reported. This report was non-serious.
Pneumonia; Stage four stomach cancer; Parent died after receiving both doses; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stage four stomach cancer/gastric cancer stage IV, pneumonia and parent died after receiving both doses.  The patient's medical history, as provided by the reporter, included stomach cancer. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route of administration for prophylaxis of COVID-19 infection. On an unspecified date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route of administration for prophylaxis of COVID-19 infection.   On an unspecified date, patient was diagnosed of stage four stomach cancer and developed pneumonia after both doses of vaccine with seriousness criteria as medically significant. The patient died on 21 Mar 2021. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events were not applicable.  The outcome of the events, stage four stomach cancer and pneumonia were fatal.  The patient died on 21 Mar 2021. The cause of death was reported as stage four stomach cancer and pneumonia. Plans for an autopsy were unknown.; Reporter's Comments: This patient's stage IVgastric cancer is unlikely due to the Moderna's mRNA-1273 vaccine due to the latency of gastric cancer. Very limited information regarding these events have been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
(R) Ipsilateral wrist drop consistent with radial nerve palsy 1 week after vaccination in deltoid. Seen by neurologist 11/20/10 who thought Tdap was likely cause of problem.
On the same date flushed,  headache, shaky   Next day sore arm  2 days after flu like symptoms
Right after the vaccine, I had shortness of breath, and dizziness. I had chills within 1 hour, and about 4 hours later, I had a heartbeat of 132, shortness of breath, and dizziness, and lightheaded.
patient developed pericarditis and myocarditis with pericardial effusion and chest pain and elevated tropinin levels
wrong vaccine administered; wrong vaccine administered; soreness where the injection of SHINGRIX; This case was reported by a consumer and described the occurrence of injection site pain in a 43-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 9th November 2019, the patient received Shingrix .5 ml. On 9th November 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. In November 2019, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: Shingrix was administered in left arm and Boostrix was administered in right arm. The patient was accidentally administered by Shingrix instead of Boostrix at the age of 43 years, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient went to the reporter's pharmacy to get a Boostrix injection and the pharmacist inadvertently administered Shingrix instead. As expected, I am experiencing only (so far) soreness where the injection of Shingrix was administered.
Itching around injection site, rash around injection site, fever, chills, injection site soreness,
This spontaneous report was received from a registered pharmacist via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Other suspect therapies included PNEUMOVAX23 (lot#, expiration date and route not reported) and influenza virus vaccine (manufacturer unknown). On an unknown date the patient experienced 104 degrees fever and complained of "not feeling good". Treatment was not rendered for the events. Medical attention was sought for the events by contacting the pharmacist. The events resolved on an unknown date. Causality was not reported. Additional information has been requested.
No adverse effects were reported in the patient; A 13 year old male patient received a dose of GARDASIL 9 on 11/4/2019, after it expired; This spontaneous report was received from a medical assistant referring to a 13-year-old male patient.   The patients' medical history, concurrent conditions and concomitant medications were not reported.  On 04-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (lot # R024264 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and establish as 29-OCT-2019) (strength, dose, route of administration and frequency were not provided).   No adverse effect was reported.
muscle weakness; melted on the carpet/went to the floor; no muscular control; nearly killed her; haven't been right since; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. An 85-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), dose 2 via an unspecified route of administration on 19Mar2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she was having hard time to advise her friends to take the Pfizer vaccine after what happened to her. Patient took the second Pfizer shot and nearly killed her on an unknown date in Mar2021.  Patient got it Friday (19Mar2021) and haven't been right since (Mar2021). A day after the shot (20Mar2021), she stated she got up from her bed put her feet and melted on the carpet, had muscle weakness and no control what soever. Patient asked if Pfizer was aware about the side effects of the 2nd dose. Patient further reported the events as follows: The next day, she went to get out of bed and stated she had no muscular control and went to the floor, and stated she never had a problem with flu shots or her first dose of the covid-19 vaccine. She stated she was on hold all day yesterday and never was able to talk to someone. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Dose 2 in 8-30-21, lot FD8448. On 9-13-21 experienced first tachycardia plus palpitations, irregular heart beat with skipped beats, pounding and short of breath. Subsequently diagnosed by cardiologist with AFib and given medications. Ongoing issue now.
Shortly after receiving MMR next day a small pool of blood in crib next morning. Stopped talking and eating. Was saying "mommy & daddy". According to vaccination records, child has now has autism.
Patient recieved 1st dose of Moderna- EUA covid-19 vaccine. Directly following her vaccine, she started vomitting, was pale, diaphoretic ,and reported having a headache. Vitals assessed: 11:38 am- 55/32, HR 47, Resp 14, o2 96% 11:42 am - 63/38, HR 52, Resp 18, o2 97% 11:45 am - 124/66, HR 71, Resp 18, o2 97 % 11: 48 am - 118/71 , HR 69, Resp 18, o2 96 % 11:52 am - 120/73, HR 64, Resp 18, o2 96 % 11:56 am - 144/82, HR 76, Resp 18, o2 97%  12:01 pm - 117/76, HR 76, o2 97 %  12:06 pm - 60/28, HR 76, o2 97 %.  EMS called at 11:42 am ; arrived on site at 11:54 am. Patient transported via ambulance to hospital at approximately 12:07 pm.
Starting on the day of the vaccine (2nd dose), I noticed typical sore arm.  At 7pm, had a fever, nausea, ful body pain, and flu-like symptoms. I did take ibuprofen and Benadryl a few hours later around bedtime.  I woke up with  fatigue, lethargy and Covid fog (decrease mental acuity and lethargic).   I had symptoms for 4 days and symptoms started to improve.  I noticed my heart rate increased at 120 and would only decrease if I lay down.  I went to see a doctor who diagnosed me with POTS (posterial orthostatic tachycardia syndrome).   I was prescribed metroprolol 25mg once a day.
I had a mild fever for about 24 hours. I took 3 doses of Motrin to clear the fever symptom. After the third dose of Motrin, the fever did not return.
Pt developed HA 2 days after Tdap given. In 4 days she developed right facial paralysis.
Report received from a consumer on 09-Dec-2009.  A female patient, who is a CSL company employee received Panvax H1N1 (lot 00349611A) intramuscularly on the morning of 03-Dec-2009.  On 03-Dec-2009 later that same day as vaccine administration, the patient developed a severe headache.  The headache continued through Friday and Saturday (she slept all day due to the headache).  The headache eventually resolved on Tuesday, 08-Dec-2009.  Awaiting further information.  The company considered events possibly related to vaccine administration.  Information derived from this AE report does not change the current safety profile of the product.  Follow-up was received from the initial reporter on 29-DEC-2009.  The 44 year old female received the H1N1 vaccination on 03-DEC-2009 at 13:00.  She was not pregnant at the time of vaccination.  On 04-DEC-2009 at 10:00 hours, the female experienced an unbelievable, migraine-like headache.  She had "throbbing pain on the right side of her head, including the eye, sensitivity to light.  Out of order!"  The female was not a migraine sufferer and knew something unusual might be going on.  She recovered on 07-DEC-2009.  No further information is expected.  Batch review request received for 00349611A on 29-DEC-2009.  On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues related to this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
4/20/21: patient arrived to ER per EMS status post PEA arrest. Per ER records, patient became unresponsive while sitting in bed witnessed by husband at home. According to husband, they had come home, she sat on the bed and complained she was not feeling good. She then fell back on the bed and began to seize. Subsequently she had intermittent episodes of alertness and was able to speak to the husband followed by unresponsiveness. At time of EMS arrival pt. was unresponsive. EMS noted BS 120s, SBP 50s. En route to hospital, pt. had a CP arrest for which epinephrine was given, CPR initiated with ROSC. Pt. arrived to the ER on a NRB mask attempting to speak. Subsequently, pt. had several CP arrests with asystole, and
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 3:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:16 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 45.81 at vaccination on 28-Feb-2021 and 45.88 at 28-Mar-2021.  Concomitant product was not provided.  On 28-Feb-2021, excursion time were 09 AM and 01 PM, temperature was 27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 30 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 28-Mar-2021, excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration at 9 AM: 27, 10 AM: 40, 11 AM: 44,  12 AM: 46, 1 PM: 26, 2 PM : 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medication was not reported.
This child presented in the office with 5-6 vesicles on her trunk day # 1 today 08/22/01. Typical chicken pox lesions. Had vaccine 02/07/99.
SEVERE REACTIONS; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were 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, and batch number were not reported) 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 severe reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20220201531.
Medical Assistant gave HAVRIX when INFANRIX was ordered by provider. Parent was notified, and no adverse signs or symptoms have occurred.
48 hours after vaccine, she developed diffuse pruritus but no rash. Pruritus gradually worsened so PCP treated her with prednisone this was started about 4 days after vaccine administration. About 24-48 hours after starting prednisone, the pruritus resolved. She never did have any kind of skin eruption.
To hosp with c/o SOB 4 days after being diagnosed positive for COVID; fevers; O2 sats at 72% on RA; started on O2, remdesivir, dexamethasone, antibiotics; O2 requirements increased requiring Vapotherm and eventually BiPAP; condition worsened requiring intubation; kidney function worsened; poor prognosis; placed on comfort measures, extubated and pt died shortly afterward in the hosp
I had  a 3:00 pm  dose  first dose  of the Moderna vaccine yesterday 2/11/21.   8 hours later I had a 90 minute episode of tachycardia (up to about 125 bpm - fast for me with a usual rate of 50) and I can't say if the rhythms were off - it was just a very uncomfortable pounding in the chest. I certainly intend to get the next shot on March 11 but is there anything I should do if/when this happens again?  Thanks.