chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart was beating really fast; feeling hot; Her nose swelled/swollen nose; Her eyes hurt; she is sure it was her sinuses; She didn't feel good; She adds to it when she gets scared; it was hard to breathe through the nose; face swollen and red; face swollen and red/redness in face; throat tight; inside nose was swollen; headache in the eyes; difficulty swallowing; This is a spontaneous report received from a contactable consumer (Patient herself) PFIZER-BIONTECH COVID-19 VACCINE. A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: er87132 and ER8732) via an unspecified route of administration, in arm left on 23Mar2021 13:30 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. Medical history included Penicillin allergy, Latex allergy and High blood pressure. Concomitant medications included propranolol (PROPANOLOL) taken for High blood pressure. The patient experienced redness in face and difficulty swallowing when she took the first dose of the Pfizer COVID19 vaccine on 23Mar2021. She did not get the second dose. It was asked that if she can take a different brand of the COVID19 vaccine after these symptoms. The patient stated that her heart was beating really fast and it was within an hour after she got it. She started feeling hot and her face was getting red. She washed her face with a rag. Her nose swelled and her face was swelling. It felt like she was at the dentist. Her eyes hurt because her nose was swollen and she was sure it was her sinuses. She didn't feel good. It was hard to breathe through the nose. It was difficult to swallow. At that point it was probably nerves too. She added to it when she gets scared. She tried to calm down and relax. Her nose was swollen for 2 days. She put ice on her face and stuff. The patient stated that the difficulty swallowing redness of face and throat tight started within 45 minutes of getting the shot. The patient also stated that she had never had a flu shot. She did had Tetanus shot. She didn't react bad but was sick from it. She had two Tetanus shots and they affect her, but she doesn't die. Caller did not have NDC, lot, and expiry to provide for Tetanus shots that she also received. She was almost 70 years old next year. She did not want to infect anyone else. The patient stated she had never had measles, mumps, or rubella or no child illness. The outcome of nose was swollen, headache in the eyes, redness in face, throat tight was recovered on an unspecified date in 2021 and was unknown for other events.  Follow-up attempts are completed. No further information is expected.
Patient reported day of (2 hours after) immunization that he had pain radiating down the vaccinated arm. He called again 1-19-15 complaining of continued pain.
Information has been received from a consumer concerning her 14 year old daughter with "braces on teeth" and no drug reactions or allergies who in 2010 was began to vaccinate with GARDASIL (lot # not reported). The third dose of GARDASIL was given on 17-FEB-2011 at 15:30 pm in the right upper arm. There was no concomitant medication. By 17:30 pm on 17-FEB-2011, the patient experienced swelling on the right side of her face between her jaw and ear and it was painful to the touch. The mother contacted the physician, MOTRIN was given to treat the symptoms it did provided some relief. On 18-FEB-2011 morning, symptoms were still present but they did not get any worse. There were no laboratories diagnostic studies performed. The mother stated that child did not experience this with the 2 prior dose of GARDASIL. Additional information has been requested.
HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-MAY-2023 during 50 minutes. Maximum temperature reached was 10.5°F.; No adverse event; total of 13 doses were administered after the excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-MAY-2023 during 50 minutes. Maximum temperature reached was 10.5°F.), POOR QUALITY PRODUCT ADMINISTERED (total of 13 doses were administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     It was unknown if patient had relevant medical history, allergy, concomitant diseases and risk factor. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (total of 13 doses were administered after the excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-MAY-2023 during 50 minutes. Maximum temperature reached was 10.5°F.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-MAY-2023 during 50 minutes. Maximum temperature reached was 10.5°F.), POOR QUALITY PRODUCT ADMINISTERED (total of 13 doses were administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-MAY-2023 during 50 minutes. Maximum temperature reached was 10.5°F.) and POOR QUALITY PRODUCT ADMINISTERED (total of 13 doses were administered after the excursion happened).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F. No other adverse events were reported. No treatment information was provided.   Reporter did not allow further contact
No adverse event; Caller is stating that they found a 69-year-old patient who received expired Bivalent booster; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Caller is stating that they found a 69-year-old patient who received expired Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2023 at 8:30 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-May-2023 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Caller is stating that they found a 69-year-old patient who received expired Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Caller is stating that they found a 69-year-old patient who received expired Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Caller is stating that they found a 69-year-old patient who received expired Bivalent booster).    Concomitant medication was not reported.  Patient received expired Bivalent additional booster beyond 12 hours after first puncture. Patient received dose form 2.5 ml Blue Cap Date the vial was initially stored in the refrigerator on 01-May-2023. Vial was first punctured on 04-May-2023 12:45 PM. Vial did not undergone any temperature excursion. Vial exposed to room temperature for less than 24hrs. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2023: Live significant follow-up received. Patient details, dose details and events and narrative was updated.
Pt left office @ 1130 after receiving  vaccine, Mother Called  office back d/t to pt having hives on her legs @ 1230 pm,. Pt in office has significant hives on legs. Only reaction , 25mg of Benadryl given to pt.
Mother says patient was a bit tired for 2 days after the vaccine and then about 48 hours after developed visible swelling of right side of neck and he complained of pain. He had episode of emesis later that night. No difficulty breathing or drooling. Seen in office the next day 4/4 with reported swelling resolved and no pain and at baseline.
pt recv vax 18oct96; 06feb97 the pt devel 300 lesions on his body & a fever;
Atrial Fibrillation, unsuccessful defibrillation X3. Cardiac Ablation
During the night after my second shot a small ball appeared in my neck (clavicular lymphadenopathy) on the left side
Roughly an hour and thirty minutes after getting the booster, I expierenced swelling in my left and right cheeks (close to jawline), with the right cheek swelling more than the left. The swelling came on somewhat gradually but was sudden- it is not severe (it is currently 10:44 P.M. as I write this) and is pretty puffy. There is mild throbbing and soreness along with the swelling. The swelling is the only symptom I have other than the typical sore arm at the injection site.  IMPORTANT NOTE: I had wisdom teeth removal (it was the four common wisdom teeth that were removed) exactly two weeks ago from today. I had the typical post-wisdom teeth removal symptoms: swelling, throbbing, etc. (cont. on Continuation Page (cont. of advese event description section). Those symptoms from the surgery dissolved fully after roughly a week and a few days. The swelling I am experiencing right now after having the Pfizer booster shot today is fairly similar to the swelling I had around 2 days post-surgery. I believe my immune system may be attacking the surgery site due to being "triggered" by the vaccine as I have no other symptoms besides swelling. No signs of infection (other than swelling) or dry socket.
redness at the injection; swelling at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection) and VACCINATION SITE SWELLING (swelling at the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    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 VACCINATION SITE ERYTHEMA (redness at the injection) and VACCINATION SITE SWELLING (swelling at the injection). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection) and VACCINATION SITE SWELLING (swelling at the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
large inflamed rash @ inj site p/5 days;some asthmatic breathing;rash started 3hr post vax;immed itching;pt cont w/problems p/vax;8 days p/vax rxn area hurt, lethargic, drooling, cont to be hard to breath;rash, barking cough
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jul2023 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 03Oct2023 to 07Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt returned after 1 1/2 hrs from injection stating difficulty swallowing. No other visible sx. Advised to take BENADRYL and go to ER. Patient took BENADRYL did not go to ER, seemed recovered next day.
This spontaneous report was received from a pharmacist refers to a 77 years old female patient with unknown medical history. The patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported) (lot#0366AE, exp. date 23-MAR-2013) on 02-AUG-2012. Concomitant medications were unknown. On 04-AUG-2012 the patient noticed redness and swelling of about 4 inches in diameter around the injection site. There was no laboratory data. The pharmacist recommended that the patient seek medical attention and as of 04-AUG-2012 the patient continued to experience redness and swelling. It was unknown if the patient would continue on the ZOSTAVAX. Additional information is not expected.
The child, within just a few minutes broke hives. The rash was all over her entire body. The doctor gave her an Epinephrine shot to counteract the reaction. Later, during the night, it was necessary to give her Atarax for the hives.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients with unknown demographics. Information about the patients' medical history, concurrent conditions and drug reactions/allergies was not reported. On 08-FEB-2016, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), (dose, and route of administration were not provided), lot # L034372 with expiration date 08-SEP-2017, lot # L032395 with expiration date 26-AUG-2017, lot # reported as L039092 with expiration date 06-OCT-2017 and lot # reported as L037561 with expiration date 29-SEP-2017. Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Patient almost passed out 3 times after receiving the Janssen Covid vaccine. 6 hours prior to administration patient warned pharmacist that he has a severe panic attack and anxiety attack after needle injection. He still went ahead and wanted the vaccine. He wanted to keep his job. 911 was called. By the time EMTs arrived he was back to normal. EMT checked his vital signs, all normal. And he walked out with family after 1/2 hour.
gout flare L wrist (known gout, no flares for ~1 year prior).   Was just a minor flare,  successfully aborted by colchicine.
This spontaneous report as received from a registered nurse, via a sales representative, refers to a male patient in his 80's. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, one injection (total dose, route, lot number and expiration date were not reported) for prevention of shingles. Co-suspect therapy and concomitant medications were not provided. The reporter stated that on an unknown date the patient had developed a herpes zoster outbreak on the neck which was fairly painful; after receiving ZOSTAVAX vaccine. it was not provided if any treatment was given for the adverse experience and if the patient sought medical attention. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were not provided. Additional information has been requested.
after about and hour and a half of reveiving pnuemovax 23, patinet called pharmacy to report swelling in in right arm from injection site to past elbow; otherwise reported no anaphylactic reactions, no increased HR and BLood pressure elevated prior to coming in since she was here to pick up blood pressure medicine; I had coubnseld of swelling at arm injection site to be normal and advised to keep an eye on swelling (spreading), any trouble breathing or increased hr/BP should then call 911, but meanwhile to apply cold compress, take Benadryl and Tylenol(she is diabetic) and keep eye on swelling for next 30 minuites, to please call us if needed for further guidance; called her back and she said selling is gong down, did not end up taking Benadryl nor Tylenol
Had shots on 3/30. Started having redness and swelling on 4/1 to right arm. Visit to Dr. on 4-2-2010.
Pt vaccinated by RN, Pt observed by LVN. Pt observed at 0943 s/s nausea, paleness, dizziness. Vital signs : BP 91/62, pulse 50, R 24, T 96.5 O2 Sat 99%. Reassessed vital signs at 10:00: BP 102/66 , P 79, O2 sat 99 .
Information has been received from a physician concerning a 4 month old female who on 14-MAY-2007 was vaccinated with 2 ml of oral Rotateq (Lot 1231S, invalid). Concomitant therapy included PEDIARIX, PEDVAXHIB and PREVNAR. On 18-MAY-2007, the patient experienced vomiting and diarrhea. The patient's vomiting and diarrhea persisted. Unspecified blood work was performed. The patient's symptoms persisted and on 21-MAY-2007, the physician recommended that the patient go to the emergency room. It was not known if the patient was admitted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a physician concerning a 19-week-old white female who on 14-MAY-2007 was vaccinated PO with the first 2.0 mL of ROTATEQ (Lot # 656201/1231F).  Concomitant vaccinations administered on that same day included the second dose in the left thigh of PEDIARIX (Lot #AC21B113AA), the second dose in the right thigh of PEDVAXHIB (Lot #655396/1437F) and the second dose in the right thigh of PREVNAR (Lot #870143K).  On 18-MAY-2007, the patient developed vomiting, diarrhea and mild dehydration.  The patient was seen in the physician's office.  An electrolyte panel was within normal limits.  On 20-MAY-2007, the patient recovered.  Additional information is not expected.
Rash in body hands, below armpits, ankles, behind knees for about 2 weeks I?ve had. Got worst 2nd week
Developed significant shingles outbreak in dermatome on right side. Had to go to Emergency Room. The case was the worst my dermatologist had ever seen. I've developed post-herpetic neuralgia since; it still bothers me nine months later. (I had not received a shingles vaccine.)
In late July, had a tingling sensation in my right palm. Over two weeks the sensation spread to other areas on the right side of my body and I saw a few doctors which led to an MRI. The MRI showed three strokes, for which I was hospitalized to obtain a full testing work-up as I am an otherwise healthy 32 year old, so the strokes were unusual. I spent three days in the hospital and no underlying condition was identified. Additionally, after the hospitalization, I got tested for COVID antibodies, which I did not have.
achiness in thigh, elbows & wrists since recvd vax; thighs p/5JAN then subsided;
Hives Throat closing up Sores on hands and feet Joint pain  Had to go to clinic and doctor Was prescribed to steroids and antihistamines   It?s been over a month and I still have hives
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: morphine", notes: known allergies: morphine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (06Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 27Jan2023 to 01Feb2023).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a nurse practitioner via a field representative concerning a 24 year old female patient. The patient did not have any allergies or medical history. On 24-SEP-2015, the patient was vaccinated with a first dose of GARDASIL 9, lot # L019286, expiration date 14-SEP-2017 (dose unspecified), intramuscularly. The patient did not take any concomitant medications. On an unspecified date in 2015, after receiving her first dose of vaccine, the patient experienced light vaginal bleeding which lasted 7 days and after those 7 days, she had her regular menstrual cycle. The patient reported that her last regular menstrual cycle was on 14-OCT-2015. On 02-NOV-2015, the patient received the second dose of GARDASIL 9 (lot # L019286, expiration date 14-SEP-2017, intramuscular, dose unspecified). After the patient received her second dose of the vaccine, she started to experience light vaginal bleeding on 04-NOV-2015, which lasted until 08-NOV-2015. The patient visited doctor office to seek medical attention. No treatment was given for vaginal bleeding. No lab diagnostics were performed. Therapy with GARDASIL 9 was also reported not discontinued. The causality of vaginal bleeding and GARDASIL 9 was not provided. Additional information has been requested.
General hip, shoulder joint pain 2 days after injection. Pain in (R) hand (soreness) that started about same time but increased in symptoms (pain when drying hands, shaking of another's hand, using hand to dry off body). Occasionally tingling, throbbing in (R) hand, wrist, elbow, shoulder.