chrisvoncsefalvay/vaers-outcomes huggingface dataset:
miscarriage; Exposure during pregnancy; This retrospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of miscarriage in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Influenza vaccine Quadrivalent unspecified season at an unknown time during the pregnancy. On an unknown date, several days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced miscarriage (serious criteria GSK medically significant) and vaccine exposure during pregnancy. On an unknown date, the outcome of the miscarriage and vaccine exposure during pregnancy were unknown. The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present.   It was unknown if the reporter considered the miscarriage to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The patient had a miscarriage very few days after receiving flu vaccine. The patient stated that, people make fun of her and tell her that it was only a coincidence. The patient would never take one again.
Redness, swelling, warmth to the touch, beginning to blister some near injection site, recommended ibuprofen or tylenol, taking an antihistamine, and ice to reduce swelling.
Fever; Arm soreness; vomiting; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in May 2020. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), Symbistatin and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), VACCINATION SITE PAIN (Arm soreness), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine.   This case was linked to US-MODERNATX, INC.-MOD-2021-068391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068391:Patient's wife (First dose case)
SOB, cough, fever, chills in pt w/previous covid infection (06/2020) and 2 doses of mRNA vaccine; pt w/covid + family at home
The Saturday before I had a headache and the next day, I just felt tired. That Thursday the headache got worse, and I started coughing, a mild fever, chills, muscle aches and congestion.  I was just taking acetaminophen at that point, and it didn't help. Then I felt I was getting worse, so I set up a virtual visit and I was given Dolutegravir.  I took that medication and it all cleared up within 7 days and I was also isolating with my husband until he was hospitalized. I did start to feel sick again not too long after but never did retest.
pt stated that after about 1 month after 2nd vaccine - she noticed the spot where the vaccine was given is now concave.  she has a concave spot on her arm - no pain, or decrease in range of motion, or change - just concave
blood clot in her finger; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Batch/Lot number and expiration date were not reported) as dose 1, single for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. Family history included brain aneurysm. Her mom died at the age of 50 due to a brain aneurysm and both her grandmothers died of a brain aneurysm. The patient reported that in May2021, she had the first dose of the COVID vaccine. About a week later, on an unspecified date, she suddenly, randomly developed a blood clot in her finger. She stated that her mom died at the age of 50 due to a brain aneurysm and both her grandmothers died of a brain aneurysm. Due to this, she was afraid and missed her second dose. She stated that she also got scared thinking about it because she knows that COVID can increase the risk of blood clots. She was wondering if she should get the second dose, but did not know since it's been such a long time since her first dose. She stated that she called her pharmacy and the first lady she spoke to told her it had been too long and that she needed to start over again with her first one and second one. She then asked the person since she had a blood clot, would it be safe to have three doses in a relatively short amount of time. She confirmed that she has never had blood clots before. She verified that she had a blood clot in her finger about a week after receiving her first dose. She did not have her vaccine record card, she believes she lost it. She has not seen it in a long time. She can confirm that she got the first dose sometime in May2021 but does not know the exact date since she no longer had the card. The outcome of the event was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Patient reported that he was at the MD office for other reason and showed his arm to the MD and MD said it looked like a reaction. Arm presented with red rash about 4 inches in diameter.
FEELING INTENSE DEBILITATING PAIN AROUND LOWER STOMACH AND GROIN AREA ON RIGHT SIDE; NEW TREMOR IN HANDS; THOUGHTS JUMBLING; INTERRUPT SLEEP; UNABLE TO EXERCISE; TERRIBLE HEADACHE; TERRIBLE VOMITING; COULD TAKE NO FOOD OR MEDICATION AT ALL; INTENSE VOMITING IT CAUSED TO LOSE CONTROL OF BLADDER; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included dental implants, and concurrent conditions included malignant neoplasm of right kidney except renal pelvis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included axitinib, and ondansetron. On MAR-2021, the subject experienced intense vomiting it caused to lose control of bladder. On 10-MAR-2021, the subject experienced terrible vomiting. On 10-MAR-2021, the subject experienced could take no food or medication at all. On an unspecified date, the subject experienced feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, thoughts jumbling, interrupt sleep, unable to exercise, and terrible headache. Treatment medications (dates unspecified) included: naproxen, and codeine phosphate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible vomiting, could take no food or medication at all, and intense vomiting it caused to lose control of bladder on 2021, and the outcome of feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, terrible headache, thoughts jumbling, interrupt sleep and unable to exercise was not reported. This report was non-serious.
Approximately 5 minutes after the vaccine, while sitting down waiting his 15 minutes, the patient slumped over in his chair and fainted.  Pt took a few minutes to wake up, smelling salts were used.  Pt was taken to a room and laid down for 30 minutes.  He was given gatorade and crackers (pt states had had nothing to eat since Breakfast).  Pt also stated a history of this happening after bloodwork done.  Pt complained of dizziness that lasted approximately 20 minutes.  Things then resolved and pt stated he was feeling good again.  Pt refused to call someone for a ride and stated he would self-monitor.
Temperature 99.5 Dizziness Sleeping for more than 8 hours Elevated heart rate  over 100 Extremely tired Body ache Headache Blurred vision Extreme thirst Dry mouth
the patient received an expired dose of Menactra/no AE; Initial information regarding an unsolicited valid non-serious case was received on 04-Mar-2021, from Physician and Other Health Care Professional via Global Medical Information (GMI) (Reference number- 00503940) and transmitted to Sanofi on 04-Mar-2021.  This case involves a 38 year-old female patient who was inadvertently vaccinated with 0.5 mL expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number U6521AA and expiry date 26-Jan-2021) via an intramuscular route at the right deltoid for prophylactic vaccination (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) at left deltoid for prophylactic vaccination.  Reporter asked if it would still be effective or if the patient needed to be revaccinated.  It was reported that practice would plan to re-schedule the patient to administer an unexpired dose of Menactra.  Product used : Used Still using product : No  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Patient rec'd TDaP in the office with no problems reported.  24hours later he experienced extreme fatigue, low grade fever, dizziness, and mild arm pain that lasted 48 hours.
Starting with fever and headache several hours after vaccine. Fever to 101 degrees F, relieved with TYLENOL. Fever returned next day about 10 hours post TYLENOL. Instructed to take ibuprofen. This did relief fever and headache. F/u on 06/24/16 no further fever or headache, sight has mild swelling at injection site now. Will apply ice to site.
Developed warmth, redness, swelling, tenderness of (?) tissues in 12 x 14cm area adjacent to MMR and DTaP site. Resolution in 5 days.
After patient received vaccine, he came to counter about 5 to 10 minutes later telling tech he was not feeling well. Tech called me after patient slumped over on counter. I ran and helped hold him up and had tech call 911. I had someone bring patient a bottle of water. Shortly, his body began to slump and I and a woman helped him slowly to ground. He was still conscience and talking. He was given a bottle of water and he was drinking. As a few minutes passed, he said he began to feel better. He complained his heart still felt like it was still racing and he was sweating a little.  He never lost consciousness and was talking to us the entire time. The paramedics arrived shortly and took him away on stretcher. He was awake and talking.
5x5 cms (L) arm cellulitis 2 vaccine (1) Influenza and SQ chickenpox varicella. Placed on warm compress & PO AUGMENTIN will do a follow up in 5 days.
Pt received 2nd dose of Moderna at 2pm on 6/29/2021, by 6pm same day started having symptoms of nausea/vomiting/diarrhea. At time of report on 6/30/2021, patient still having these symptoms. Pt states she has to go to work today. PCP was notified and the nurse spoke with pt and OTC meds were recommended. Pt to call back if symptoms persist.
No second dose after 2 Months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose after 2 Months) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose after 2 Months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose after 2 Months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
4/27 68 yo female with a history of RA, osteoarthritis, presents to the ED with left hip pain and erythema x 2 days. Saw Dr. in office today and was sent to ED for concern for septic arthritis.
[03/18/21 ED Report] This is a 74-year-old female who has a history of multiple allergies and angioedema who states she received her second COVID-19 vaccination at 3 PM today.  Patient states that she experienced some mild throat discomfort around an hour later then after dinner she felt like there may be some swelling in the back of her throat so she decided to come in for evaluation of an abundance of caution given her history.  Patient did not take any Benadryl or administer her EpiPen as she is done in the past for allergic reactions with oral swelling.  Of note, the patient was seen here on March 11, 2021 by doctor secondary to right-sided tongue swelling after eating prawns.  At that time, she took Benadryl and administered her EpiPen prior to arrival.  She was treated with Solu-Medrol, Benadryl and Pepcid IV symptoms resolved.
This spontaneous report was received from a registered nurse via a Company representative, referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date in June 2017 (reported as last week), the patient was vaccinated with VAQTA (lot#, dose, and frequency were unspecified), intramuscularly, for prophylaxis. This vaccine was indicated for persons 12 months of age and older. No adverse event was reported. Additional information has been requested.
Patient received a pneumo-ps injection to his left Deltoid on 4-8-08, He had called and said that it started swelling and got red 1 day after injection, and worsened on 4-10-08.
A 60-year-old patient received fluzone high-dose with no adverse event; A 60-year-old patient received fluzone high-dose with no adverse event; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non health care professional via  Media Information (under reference 00824838) in a specific country.  This case is linked to cases 2021SA356620 and 2021SA356392 (same reporter).  This case involves a 60 years old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.  On 22-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Total, lot UJ769AA and expiration date: 30-6-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration and overdose (same day latency).  It was reported "Pharmacist states that today, during a flu-shot clinic, 3 of the patients who received FLUZONE QUADRIVALENT HIGH-DOSE, after attesting to be less than 65 years of age, were found to be younger. Two of the women were 60 and one was 45 years old. Caller asking what should be done."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
No additional AE reported; patient was accidently administered a dose of V ARlV AX and PROQUAD on 17-MAR-2022; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not reported.  On 17-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), once, (lot number T022315, expiration date 30-JUN-2022) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant human albumin) (PROQUAD), once, (lot number U002535, expiration date 24-JUL-2022) for prophylaxis (accidental overdose). For both vaccines dose, formulation, route of administration and injection site were not provided. No additional adverse events were reported.
1.3.5 inches X 3 inches round, red, warm to touch region left deltoid.  Were HEP A given.  Slight red rash around injection site and back.  18 hours post injection given.  Dx: allergic reaction localized.  Tx BENADRYL apply cold compress, monitor if is worsen take to E.R.
lstated "left arm feels funny" happened instantly and felt tight .Had the same issue after the 1st injection  stated " feels like BP is high"  BP 93/53 HR 65
Itching started on right foot on Monday evening, January 4th 2021. By Tuesday evening both feet were itching and toes were red and inflamed along with the itching. I used hydrocortisone cream on them starting Wednesday evening. I contacted Dr. (tele health doctor) on Saturday evening and showed pictures of my feet. I was told it appeared to be "covid toes" and I may have COVID or an adverse reaction to the COVID vaccine. I was swabbed for COVID Saturday night. COVID results were negative. I was told to report my symptoms and reaction to CDC due to it being a reaction to the COVID vaccine. Currently it is January 11, 2021 and my feet are not itchy, just a little redness on my toes. I am continuing to monitor.
PT WAS GIVEN VACCINE, WITHIN MINUTES PT PASSED OUT AND GOT VERY FLUSHED. I WAS CALLED OUT, HE OPENED HIS EYES AND STARTED TO SHIVER, BUT DID NOT WANT TO SPEAK. I RAN TO CALL 911, GET GLOVES, AND GET AN EPI PEN. WHEN I GOT BACK TO THE PT HE LOOKED BETTER BUT WAS VERY SWEATY. NO SIGNS OF ALLERGIC REACTION. A COUPLE MINUTES LATER, EMS ARRIVED. ALL PARAMETERS WERE WITHIN LIMITS. 20 MINUTES LATER PT FELT FINE.
Body aches, low grade fever, nausea, vomiting, diarrhea, HA, arm soreness
Pfizer Covid19 Bivalent booster was administer after being opened for over 12 hours.
Rash near injection site - came on almost two weeks after shot. Still there. Not being treated as I wait for it to go away.
Information has been received from a medical assistant concerning a male patient of unknown age. On 05-JUN-2017, the patient received an improperly stored dose of VARIVAX, lot # M046004, expiration date 18-NOV-2018, (route of administration not provided). The sterile diluent used to reconstitute the VARIVAX was properly stored. No information was received regarding the patient's past medical history, concurrent conditions, or other concomitant medication. No adverse effect reported. Temperature was reported as: 6°F to 14°F (10.8°F), Time frame: 1 hour, 18 minutes, Previous temperature excursion: No, Data logger involved: Yes. No further information was provided. Additional information has been requested.
My right eye twitched continually for two weeks after the second injection.  Although it was not painful or itchy, the twitch was disruptive to me at work and during various other activities requiring sight.
Right Ear fullness, constant ringing or noise.  Hearing impaired in right ear, sounds muffled or some noise is painful.  This has been nonstop since 2-3 days after 1st vaccine.  Have taken Claritin, pseudoephedrine as well as Benadryl to relieve the ear fullness, no relief.
The Medical Assistant Reported me  that Patient came to the clinic with an older brother who was 16 years old as well as his father on 08/02/202. Both children needed Well child checks and immunizations. Older male received MenQuadfi  (secondo doses) and the affected patient only truly needed HPV but was also given MenQuadfi (second doses) Too. Menquadfi was given  in the right deltoid. No redness or issues with administration of vaccine Once I notice that I have given the vaccine at the wrong age, the patient had already left the clinic. The MA   went to speak with me ( vaccine coordinator). I explained I overlooked the date and knew the second dose is given at or after 16th birthday.  I told her I will  look into it and get back to her.then She went and spoke with Provider and explained the situation. She  was told he would likely have to still get MenQuadfi on his 16th birthday to complete the series. Mother of the patient was notified on 08/09/2022 and was told to just keep an eye on her son. She denied any side effects or reaction. Mother was very understanding of the  situation and understood that her son will still need the vaccine at age 16 to complete the series. Moving forward MA will have her co workers double check and review to be sure she has the correct immunization as well as the provider. The medical assistant is  working before she administers the vaccines. She also  will be doing  additional training on immunizations to be more familiar  with vaccines and the vaccines schedule. I called Sanofi Medical Information to report that incident :   MenQuadfi is a vaccine indicated for active immunization that is approved for use in individuals 2 years of age and older. But as a booster The medical recommendation  is to repeat the vaccine  MenQoufut on Patient 16th  birthday. no
Pt. has redness on her arm. She took Benadryl, It helped her to get down little
On 5/3/99, the pt experienced a febrile seizure and generalized morbilliform rash. The pt presented to an ER with symptoms. The child was placed on therapy with Tylenol and ibuprofen for the treatment of the fever. Subsequently, the pt recovered from the febrile seizure and rash.
Patient got Spikevax on 9/26/23, and on 9/27/23, he started having low grade fever that lasted 1 day and redness at injection site. No other symptoms (no swelling, not warm to touch, not itchy)
Patient received an influenza-Fluzone High Dose on 09/23/2020 in the Left Arm-Lot # UJ461AA, and was given another Fluzone High Dose today, 10/01/2020, as described above. Patient was notified of the error. Physician was also notified. Patient is not experiencing any adverse events at the time of the administration of the vaccine.
Severe vomiting, chest pain, little swelling of the lips Went to ER , treated with anti emetic, Benedryl, discharged to home , doing well
Swollen Lymph Node on right side of neck. Rash at injection site. All at 7 days later.
Left arm feels jumpy. Started about 12 days after vaccine in left arm. Occurs occasionaly, during the day and several times throughout the night. I do not loose feeling in fingers.