chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I began having itchy throat and eyes, them wheezing, tightness in chest, hives, my body felt like my insides were burning but I did not have a fever. It lasted for a few days and the only thing that helped me was taking Benadryl and Albuterol nebulizer treatments. My eyes were swollen and my uvula was swollen. My heart rate sustained in the 120s. I thought I was having a heart attack. I am 20 weeks pregnant and I am a COVID nurse.
A 44 year old FEMALE who c/o lightheadedness and "general discomfort" while in  the monitoring area after getting Covid 19 vaccine. Denied hx of HTN. Provided PO hydration.  vitals re-checked at short intervals. Patient BP stabilized. Discharged to work area w/o symptoms.
Reports that developed diffuse, very itchy rash overnight.  Rash went away, but persistent and intense itching.
my blood pressure start going up, it is been elevated ever since I had shot; This is a spontaneous report from a contactable consumer (patient). A 63-years-old patient of an unspecified gender received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot Number: EP6955; Expiration Date: Jun2021), dose 2 intramuscular, administered in Arm Left on 06May2021 (at the time of 63-years-old) as second dose, single for covid-19 immunisation. Medical history included dialysis (Verbatim: Dialysis). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot number-EP6955) on 15Apr2021 (at the time of 63-years-old) for Covid-19 immunization. The patient was calling in and reported got the Pfizer vaccination and got last shot (second dose) on 06May2021. On 07May2021 blood pressure start going up, it was been elevated ever since had shot. Consumer stated, patient did not know the expiration date, it was "621" (further not clarified) that the only date saw here, getting hard. Now patient taking medication for blood pressure (treatment for event) because it went up after got the second shot. The consumer stated had been lab work for Kidney, past week. When probed for lab results, consumer stated, "Test name "DCI" (further not clarified). The patient underwent lab tests and procedures which included laboratory test: unknown (I been lab work for my Kidney, past week) on an unspecified date, blood pressure start going up, it was been elevated ever since had shot on 07May2021. Therapeutic measures were taken as a result of my blood pressure start going up, it is been elevated ever since i had shot. The outcome of event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Experienced Arm Numbness; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (Solution for injection, lot number and Expiration date: unknown), via an unspecified route of administration, on 02Feb2021 as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications was not reported. On 02Feb2021 (today), the patient had experienced arm numbness after taking the 1st dose of the vaccine. The outcome of the event was reported as unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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 ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was reported.  It was reported that patient was administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Hidradenitis suppurativa; Ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa), PAIN (Ache) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN (Ache) and FATIGUE (Fatigue). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa) had not resolved and PAIN (Ache) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.  Patient received Humira (1159931).  No treatment medications were reported.  The reporter assessed the event of hidradenitis as not related to Moderna vaccine. The reporter assessed the events of ache and fatigue to be probably related to Moderna vaccine.  The reporter assessed the event of hidradenitis as reasonably possible with Humira. The reporter assessed the events of ache and fatigue as not reasonably possible to Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
He had a fever and was cranky. His fever got up to 104.6. I contacted the doctor, and they told us to alternate TYLENOL and MOTRIN. His fever went down and then spiked again. I took him to the doctor, and they said he had a viral infection, but also diagnosed and ear infection. They prescribed cefdinir. He is feeling much better now.
Rash w/patch centrally red base with varying degree of induration & pre-vesicular changes.
Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female patient with no medical history, drug reactions or allergies reported, who on 10-NOV-2009 was vaccinated with a 0.5 mL first dose of GARDASIL intramuscular route (lot # 663454/0672Y) after a negative urine pregnancy test. Concomitant therapy included birth control pills. The nurse stated that on 24-FEB-2010, the patient returned to the office for her second dose of GARDASIL but a urine pregnancy test was positive and the second dose was not given. The nurse also reported that on 24-FEB-2010, some bleeding was noted. A beta quant blood test was performed with unspecified results. The patient's last menstrual period was approximately on 17-JAN-2010 and the delivery date is 24-OCT-2010. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Follow up information has been received from the physician who reported that the patient was not under her care and she had no information. No further information is available.
One day after I had the Pneumonia vaccine, started coughing all night and had short of breath, when going up the stairs I was feeling tired and it got worse so the 6th day after I had the vaccine (I had it on June 22nd 2016) went to doctor and she prescribed: FLOVENT 110mcg inhalation, PROAIR 8.5GM inhalation, on July 1st prescribed antibiotics: Azithromycin, Benzonatate.
2 hours following administration of HiB vaccine, baby was inconsolable, with fever (101.5), arching back, sensitive to light and touch. Unable to be calmed by breastfeeding, pacifier, or walking/motion. Administered cool compresses and appropriate dose of Tylenol with no improvement. Baby improved at 36 hours post-vaccine but still sensitive to light, touch, and fussy.
Client came to facility for her COVID vaccine on 5/12/21.  Dr. saw her.  She had a vasovagal reaction.  Her B/P was 100/50 and pulse ox was 98%.  She was given water and a candy bar.  She recovered and was sent home.  She did not get any medications.
Local erythema, tender, raised, swelling of leg 5cm x 5cm as described by parents in 24 hrs, gone by 72 hrs. Post vaccine, temp ranging 102-104 deg F, emesis, fussy.
No adverse reaction reported. Patient received a covid booster dose of primary series formulation when he should have received the updated bivalent booster
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "controlled hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; VALSARTAN; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Positive, notes: I tested positive for covid after testing negative; (unspecified date) Positive, notes: Tested positive when feeling tired and Achy again approx 5 days after neg test; (18Nov2022) Negative, notes: Tested negative couple 3 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Elderly (65 plus years). The patient received anti viral covid-19 treatment from 09Nov2022 to 15Nov2022. The patient had received other medication in 2 weeks. The patient have no known allergies.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
After receiving the first shot on Monday,  I developed a headache and double vision on Tuesday night. I consulted an ophthalmologist and I am awaiting the scheduling of an MRI. He could find no physical problem with either eye. The double vision persists. I realize this may be purely coincidental and unrelated to the vaccine, but I felt I should report it.
Back pain; Neck pain; Jaw pain; Day 5 and 6 bicep/shoulder/back/hip/neck/jaw pain on the side of the injection; Shoulder, hip pain; Headache; Muscle aches; Feverish; Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old, non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FC3183) via an unspecified route of administration on 27Aug2021 at 16:30 in the left arm (at an age of 55-year-old) as single dose for COVID-19 immunisation. The medical history of the patient included breast cancer twice. The patient was in chemotherapy during vaccine dose 1 and was out of chemotherapy at the time of vaccine dose 2. This was her booster, all Pfizer. The patient was allergic to hydrocodone (MANUFACTURER UNKNOWN) and experienced itching with the medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and acyclovir (MANUFACTURER UNKNOWN) started on unknown date for an unknown indication. On 28Apr2021 at 05:00, the patient experienced two days of fatigue, muscle aches, feverish and headache. Days 3-4 better, still fatigued. On day 5 and 6, the patient experienced bicep, shoulder, back, hip, neck and jaw pain on the side of the injection, headache and fatigue on an unknown date in Sep2021. Pain was the worst part. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feverish was recovered on 30Aug2021 while that of the events fatigue, muscle aches, headache, bicep, shoulder, back, hip, neck and jaw pain was not recovered at the time of this report.
Information has been received from a physician concerning a 16 year old female with a history of wheezing who on 20-AUG-2007 was vaccinated with her first dose of GARDASIL.  On 22-SEP-2007 the patient experienced tonic clonic seizure and was hospitalized.  On 15-NOV-2007, the patient received the second dose of GARDASIL.  The patient was admitted to the hospital for an unspecified period of time on three separate occasions since the onset of the first seizure.  The patient has a positive familial history of seizures.  The patient's last seizure occurred on an unspecified date in January 2008.  Concomitant therapy included folic acid and MINOCIN.  No other symptoms and no other treatment reported.  Additional information has been requested.  8/11/2008 MR received for multiple DOS 9/22-25/2007, 10/29-11/01/2007, 11/7-12/2007 and ER 1/18/2008 with DX: Epilepsy. Pt presented with 1st seizure 9/22/07. Pt lost consciouness, fell and had generalized convulsion with shaking of upper and lower extremities. Sleepy after. Started on Keppra following EEG. Staring episodes noted with adventitial movements during video. D/C for outpt f/u. Returned again 10/29/07 with 2 episodes of seizure on meds. Recent increase in blinking and decreased attention. Keppra increased. Returned again due to allergic rxn to Keppra.  Med changed to Zonegran. ER visit for seizure in school. Dose increased.
vaccine exposure during pregnancy; wrong vaccine administered; product confusion; patient vomited "uncontrollably"; nausea; This spontaneous report was received from a consumer and refers to a 37-year-old female patient (reporter's wife). No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On an unknown date in November 2022, also reported as the week before Thanksgiving, the patient was supposed to be vaccinated with influenza vaccine (FLU [INFLUENZA VACCINE])(strength, dose, formulation, lot #, expiration date and route of administration were not provided) for prophylaxis, but accidentally received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly (strength, dose, lot # and expiration date were not provided) for prophylaxis (Product confusion, Wrong product administered). The patient was pregnant at the time of vaccination (Exposure during pregnancy).  On an unknown date in November 2022, also reported as for about 10 - 15 minutes after the vaccination, the patient vomited uncontrollably (Vomiting) and since then has been experiencing nausea (Nausea). It has been stated that the reporter is unsure if this is a side effect of pregnancy. The outcome of nausea and vomiting was reported as recovering.   The causal relationship between nausea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The causal relationship between patient vomiting "uncontrollably" and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
SM noted redness, swelling around primary SPV site approx. 6 days after receiving vaccine.  Symptom: Erythema Start: 12/10/2007 Symptom: Swelling Start: 12/10/2007 Symptom: Tenderness Start: 12/10/2007
One week after my first dose, my arm got swollen and itchy at the injection site. It lasted several days.
Redness and swelling from deltoid to elbow, elevated temp, headache, muscle aches, rib pain, wasn't able to rest, started improving 02/10/19. Patient felt symptoms were severe. Used Tylenol, rest, and comfort measures at home.
This spontaneous report was received from a health care worker referring to a 16 year old female patient. No medical history was reported. Approximately on 24-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
My chest is feeling like it's tightened itself; I am having a lot of trouble breathing; Headache; I am feeling little bit off; I don't feel well; This is a spontaneous report from a contactable consumer, the patient. A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 02Sep2021 (age at the time of vaccination 31-years-old), as a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date (age at the time of vaccination 31-years-old), as a single dose for COVID-19 immunization. On 02Sep2021, the patient experienced My chest is feeling like it's tightened itself, I am having a lot of trouble breathing, Headache, I am feeling little bit off, and I don't feel well. The patient took Excedrin for headache while patient did not receive any treatment for other events. The patient did not receive any other vaccine prior to 4 weeks of COVID Vaccine. The patient underwent lab tests and procedures which included blood cholesterol, blood glucose, blood iron and lipids which was great on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
12/06/2021 -  Vaccination  12/09/2021 -  Contacted my doctor about pain / burning in right leg. Took 15 days after vaccination to begin swelling. 12/21/2021 -  When I noticed the swelling.  Hives began, I don't know if I would have been this swollen if I hadn't taken allergy medication. I experienced burning all over. visibly swollen; Urticaria, Angioedema.  *Both doctors on maternity leave. Working with the PA. She is prescribing Pepcid which I have to pick up and over the counter antihistamine.  *Waiting for results and doctor to come back. I can't get to a specialist, immunologist in my network, until March.
This spontaneous report as received from a medical assistant refers to a 18 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 07-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours on 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009325:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 30-JUN-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir, gabapentin, and MEDROL for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a physician concerning a 13-week-old male with reflux and no allergies who on 20-JUL-2006 was vaccinated by mouth with a 20. ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653754/0139F).  Concomitant vaccinations administered on that same day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR).  Other concomitant therapy included famotidine (PECPID).  The physician reported that in July 2006, several days after being vaccinated, the patient developed constipation.  Unspecified medical attention was sought and the patient was treated with diluted prune juice.  No laboratory/diagnostic tests were performed.  Subsequently, the patient's constipation resolved.  Additional has been requested.
Severe fatigue starting 20hrs after vaccination , some dizziness, mild nausea.  36 hours after the shot those symptoms cleared up.
Developed chest pain and it did not go away. Usually these goes away after 10min. Was advised to keep record of BP, and when it kept going up across 4hrs. decided to go to ER. 3/4/2021 Was given a blood test and found elevated levels of lipase pointing toward pancreatitis. With that they did Metabolic Panel, PT/PTT INR, Lipase, D Dimmer Quant., Chest X-ray, CAT scan of abdomen and pelvis. Also did a COVID-19 test and MRSA, 3/5/2021 Inorganic Phosphate, Magnesium, Direct Bilirubin, Hep C antibody, TSH, D, Lipid, Lipase and Comprehensive Metabolic panel.