chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received third dose in Gardasil 9 immunization series and reported the vaccination to be "painful going in and coming out compared to other vaccinations."; This spontaneous report was received from a pharmacist and refers to a 38 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 14-FEB-2019, the patient was vaccinated with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular for HPV prevention (dose, lot number and expiration date were not reported). It was reported that, the vaccination was painful going in and coming out compared to other vaccinations (vaccination site pain). The prior doses, dates and lot # in series were unknown. The patient did not receive treatment for the adverse event. The outcome of vaccination site pain was reported as recovered. The causal relationship between the event and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-1906USA006867:
tiredness/tired; weakness/weak; headache; This is a spontaneous report from a contactable consumer.  A male patient (husband) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient is due to receive his second dose of Pfizer-BioNTech Covid19 vaccine this Friday, 05Feb2021. After the first dose on an unspecified date, the patient experienced, tiredness/tired, weakness/weak, and a headache. The reporter wanted to know if they should push back the interval to 4 weeks, to alleviate adverse events after the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever (100F); This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. Follow-up (04Jun2021) was processed together with initial information.  A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 (at age of 71-year-old) as single dose for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient's historical vaccine included Methotrexate as immunosuppressant back in Dec2020 and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 (at age of 70-year-old), as single dose for covid-19 immunization. On 03Mar2021, the patient reported that experienced fever (100F) on the second day, after her 2nd dose of vaccination. Patient did experience a mild fever the second night of her second dose. She had a question about Methotrexate that was covered by Medical Information. she was just calling because she has been on Methotrexate for a year and gave it up in December. She didn't have the vaccine until February and March. Pfizer's research didn't begin with identifying immunosuppressed people. She may not be covered, so she called to find out what's new. Mild fever patient had the second dose of the vaccine on 02Mar2021, and it was 03Mar2021 in the evening that she had a fever. She took 2 Aspirin and went to bed. She was probably getting it as the evening wore on from earlier. It was only for a few hours that she was conscious of it and then she went to bed. She is trying to get out before traffic starts and she can't drive. Caller states that she would like to go now and that Pfizer can follow up with her and call any other time. The patient underwent laboratory tests and procedures which included body temperature showed 100 Fahrenheit (Mild fever), on 03Mar2021. The patient received treatment with Aspirin for fever. The outcome of the reported events was unknown.   Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 6 year old male patient who on an unspecified date was vaccinated with a dose of MMR II. On 01-DEC-2009 the patient experienced mumps outbreak (date of diagnosed was reported as 24-DEC-2009). The patient was afebrile and had parotitis. The outcome of the patient was not reported. Follow-up information was received from a physician concerning the 6 year old patient (also reported as 22 years old) with previous exposure to mumps at school. It was reported that on 04-DEC-2009 (previously reported as 01-DEC-2009) the patient experienced a mumps outbreak. The patient had right parotitis. At the time of reporting the patient's final outcome remained unknown. This is one of several reports from the same source. Additional information has been requested.
Patient stated half of his face swelled and the eye in that same area became bloodshot. He also had some breathing difficulty.
Diffuse rash upper extremities, trunk and abdomen. Mouth sores/ulcers, joint swelling and pain.
Began flailing arms, eyes 1/2 closed and tearing, pallor and not breathing but very shallow breathing, then revived with patting with cold water. Total episode lasted less than 2 minutes.
Normal vaccine side effects included mild fatigue, malaise, with brief but severe chills/shaking.  Brief fever.  These side effects appeared after 12 hours and were gone within 24 hours. 24 hours after the vaccination there was swelling and pain in both arm pits, greater of which in the injection arm.  Between 48 - 72 hours after vaccination, BOTH arms swelled between the shoulder and elbow, primarily in the inner-tricept area, greater of which swelling in the injection arm.  Some mild swelling behind both knees and lower hamstring may also be occurring.  There is some mild skin irritation on the arm, but no injection site swelling or irritation. No other side effects are remaining, and exercise has resumed daily without any fatigue, although the swelling in both arms and mildly behind the knees exists as of 4 days after vaccination.
Patient reported side effects to pharmacy staff on 11/10/2021.  Patient reported a mild fever and fluctuations in blood sugars.  Patient said she increased her blood sugar testing frequency to more closely monitor it but reported no other intervention.
COVID Vaccine Breakthrough Case: Moderna Dose 1 2/12/21 (031M20A). Moderna Dose 2 3/12/21 (036A21A). Moderna Dose 3 11/17/21 (939909). COVID Positive 1/13/22. 1/13/22: The patient presents with patient has not been feeling well since 1/2/22. Tired, fatigue. Struggled along for a bit but this Monday was bad, severe nausea, could not eat but no vomiting, no fevers. Covid and flu negative then, but edema in legs. Worse over last few days, back to PMD today and still not eating, no vomiting but severe nausea. edema in legs remains, no wheezing or SOB or cough. No HX of CHF at all but has HTN and is very high. COVID POSITIVE today in office. No loss of taste or smell, but severe fatigue, no cough or SOB. No chest pains at all this entire time. She was on hormone therapy all of 2021 for breast cancer and was told to stop it for a month while all this was going on. 1/17/22: Patient was admitted for severe hyperosmolar hyponatremia with Covid-19. Patient was treated with remdesivir, azithromycin,  dexamethasone, and hydroxychloroquine. Patient improved steadily and feels wells to go home today. She will receive her last doses of medication prior to discharge.
rash; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: FN6194) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: She only takes the inhaler in the morning if she needs to.; "Insomnia" (unspecified if ongoing), notes: Insomnia; "Inflammatory Bowel" (unspecified if ongoing); "Supraventricular Tachycardia" (unspecified if ongoing); "allergic to Latex" (unspecified if ongoing); "Vitamin D deficient" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "GERD" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol increased; KLONOPIN taken for insomnia; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease; CARDIZEM [DILTIAZEM] taken for supraventricular tachycardia, start date: 2018; AIMOVIG taken for migraine; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL] taken for vitamin d deficiency; ZINC. Past drug history included: Flu vaccine for Immunization, reaction(s): "allergic to the Flu Vaccine". Vaccination history included: Mmr, for Immunization, reaction(s): "had a reaction". The following information was reported: RASH (non-serious) with onset Mar2021, outcome "recovered". Therapeutic measures were taken as a result of rash.Patient did not received any prior Vaccinations (within 4 weeks). She hasn't gotten her shingles shot.
This spontaneous report has been received from a pharmacist, concerning a 23 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were unknown by reporter. On 09-MAY-2018 (reported as today), the patient was vaccinated with the second dose of VARIVAX (frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported. On an unknown date, the reporter stated that the patient previously received one dose of VARIVAX when the patient was child (inappropriate schedule of drug administration). The reporter stated that the patient did not receive the second dose when was a child because the patient's mother would not allow him, because the patient's brother received a mutated VARIVAX (MARRS# 1805USA004364) and got very sick. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1805USA004364:
Each day after second COVID-19 vaccination I had an upset stomach and aches; but was not that severe.  However, last night (3/18) the stomach pain and aches got intense and kept me up.
Found to be in A fib with RVR. On dilt gtt, converted to NSR, then able to go back on metoprolol. Elevated chadsvasc score so started on eliquis. Finally decisions was made to switch to hospice on discharge. Although the patient did show general decline day-to-day consistent with end of life, the did take longer than expected.  Patient was made comfort measures on 12/8, but by 12/13, the patient had only recently become nonresponsive. ED visit, hospital admission and death within 6 weeks of receiving the COVID vaccine.
PER PT, HAD A WELT THE SIZE OF A BASEBALL AND WAS RED FROM LEFT SHOULDER TO LEFT ELBOW
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 27 year old female patient with no pertinent medical history and no drug reactions/allergies who in 2007, at the age of 25 year was vaccinated with a series of GARDASIL without incident. There was no concomitant medication. On approximately 09-JUL-2009, the patient became pregnant. Her LMP was approximately on 25-JUN-2009. Expected due date was April 2010. In August or September 2009, the patient miscarried at two months pregnant. Upon internal review, miscarriage was determined to be an other important medical event. The patient subsequently became pregnant again and experienced blood beta-human chorionic gonadotropin level decreased and progesterone level abnormal (WAES#1004USA02387). Additional information has been requested.
Client states soreness noted in right deltoid in the evening. The following day, swelling was noted. Physician office visit on 11-8-07. Rx sulfamethoxazole b.i.d. By report date patients state soreness is gone and swelling is minimal.
Darkened skin lesion/rash along bilateral flexor surface of forearms, and at base of neck.  I evaluated on 1/19/2022, and son has photos from 05/2021, that document the present skin lesions.
Blistering of roof of mouth; swollen gums; jaw pain; swollen gland on right side of face; Extremely blood shot eye on left side; This is a spontaneous report from a contactable consumer (patient) received. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm, on 13Mar2021 at 12:00 PM (Lot Number: EN6208) (at the age of 60 years old) as dose 2, single for COVID-19 immunisation. The patient has no relevant medical history. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER); cyanocobalamin (B-12); vitamin C (ascorbic acid); colecalciferol (D3); chondroitin sulfate sodium, glucosamine hydrochloride, manganese ascorbate (COSAMIN DS); sumatriptan, all taken for an unspecified indication, start and stop date were not reported. The patient was previously administered the first dose of BNT162B2, dose 1 via an unspecified route of administration, administered in left arm, on 20Feb2021 at 05:00 PM (Lot Number: Unknown) (at the age of 60 years old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, the patient experienced blistering of roof of mouth, swollen gums, jaw pain, and swollen gland on right side of face. As oral effects began to resolve, the patient developed an extremely blood shot eye on left side. The events resulted to physician office visit. The patient received no treatment for the events. The outcome of events blistering of roof of mouth, swollen gums, jaw pain, swollen gland on right side of face, and extremely blood shot eye on left side was recovering.  No follow-up attempts are needed. No further information is expected.
Raised red circular area (hot to touch) which grew larger each day through 4th day following vaccine. Frontal and temple area dull headache. Slight vertigo.
Information has been received from the patient's mother who is an office manager, concerning her 18 year old daughter who on 21-NOV-2008 and on 03-MAR-2009 was vaccinated IM with the first and second dose GARDASIL. On 10-JUL-2009 the patient received IM the third dose of GARDASIL (lot # 662404/0312Y). There was no concomitant medication. On 03-MAR-2009 while the second dose of GARDASIL was being administered the "injection burned" but no other symptoms occurred. In the evening of 10-JUL-2009 after the third dose of GARADSIL was administered, the patient experienced sore joints, nausea, fatigue, sore throat and other flu-like symptoms. On 13-JUL-2009 the patient saw her primary care physician who prescribed her ZITHROMAX but her sore throat worsened and she experienced vomiting. On 15-JUL-2009 the patient went to the Emergency Room because she felt pressure in her chest. She had a chest X-ray but results came back inconclusive so she was sent home without being admitted to the hospital. At the time of reporting the patient had recovered from all symptoms. Follow up information has been received from the Medical Assistant who reported the DOB of the patient 14-MAR-2009. Additional information has been requested.
30-45 minutes after injection lips began to tingle and swell - face tingling - given PO hydroxyzine HCl 25mg PO. Observed in clinic.
Client c/o difficulty swallowing and feeling of heaviness in the tongue.  Client seen and assessed by EMT and all vitals were within normal limits.  15 minutes within observation, client stated that she was able to swallow and client observed drinking water without problem.  Client cleared to go home by EMT.
ARM PAIN; TINY HEADACHE; This spontaneous report received from a patient 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm pain, and tiny headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiny headache and arm pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210717233.
severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (severe reaction) in a female patient of an unknown age 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 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (severe reaction). At the time of the report, VACCINATION SITE REACTION (severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown
A red, sore rash appeared 48 hours after administration of vaccination. The area was the size of two quarters side by side and was itchy. No treatment was used. The symptoms improved 48 hours after it was first noted and were completely resolved six days later.
Arm hurt after second dose; Horrible headache, seems sinus headache; seems like a sinus headache because it is making her teeth hurt; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt after second dose), SINUS HEADACHE (Horrible headache, seems sinus headache), TOOTHACHE (seems like a sinus headache because it is making her teeth hurt) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 002A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL for Blood pressure management, DILTIAZEM and PANTOPRAZOLE SODIUM for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt after second dose), SINUS HEADACHE (Horrible headache, seems sinus headache), TOOTHACHE (seems like a sinus headache because it is making her teeth hurt) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm hurt after second dose), SINUS HEADACHE (Horrible headache, seems sinus headache), TOOTHACHE (seems like a sinus headache because it is making her teeth hurt) and CHILLS (Chills) outcome was unknown.            No treatment information was provided.
Localized redness and swelling on left arm noted 2 days post vax at injection site. Pink, pruritic, non tender area.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed atypical chickenpox with over 100 pustules. The pt was also vomiting 6 times a day and had a fever between 104-105F. A physician diagnosed breakthrough case of chickenpox in its atypical presentation. The pts unvaccinated sister was reported to have had an outbreak on the same day that was thought to be hives.
Significant pain after vaccination; (NO Injury)Short term redness. Long term pain, decreased range of motion. Treated for adhesive capsulitis initially with conservative measures including ibuprofen, Tylenol, ice therapy. Then started PT. Pain worsened. Received steroid injection. Ordered an MRI
pt became weak, dizzy following vax of MMR; BP 80/40; pt put in reclining position w/feet elevated; BP rose to 102/64 in 15 mins; pt recovered sufficiently to leave clinic;
Hypotension. Headache. Itching/rash. Throat swelling.
Headache, Myalgia, NauseaVomiting, chills, h/a muscle aches fatigue, nausea Narrative:  Other Relevant History:
patient states that it has been 5 days since vaccination and she has been having numbness and tingling down both arms. Advised to contact PCP to make PCP aware of situation.
Excruciating headache- different than any other headache I've had.  Body aches and fever.  Waited as long as I could before taking Tylenol at 2am.  Helped, but didn't make it go away.  Took the edge off.   Continued with Tylenol as often as I could the next day because headache was still strong.  Within 24 hours, I felt much better...mainly just tired.   Have had a slight headache off and on since then.  A little tightness in chest when breathing, but all mild.
Local injection redness/swelling started ~ 5 hrs after injection, and progressed without significant improvement over 2 days. Symptoms consisted of L arm swelling, erythema, pain, and slight pruritis. Slightly improved pain with ALEVE. No fevers, chills, or significant swelling/extension of erythema over last 24 hrs. Will treat as local inflammatory reaction secondary to vaccine with vaccine listed as allergy, with careful monitoring for potential development of cellulitis.
This spontaneous report as received from a nurse via a company representative refers to a 15 year old no-pregnant female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On and unknown date, the patient was vaccinate with the dose of PROQUAD (dose, route of administration, lot # and expiration date were not reported). On 230JUN-2016, the patient was vaccinated with the dose of PROQUAD (lot # L031602; dose, route of administration and expiration were not reported) outside the recommended dose. The patient did not seek medical attention and no treatment was given for the adverse event. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182), via an unspecified route of administration in the left arm on 14May2021 at 12:00 (at the age of 55-years-old), 1st dose, single, for COVID-19 immunization. The patient had no medical history. Concomitant medication included quetiapine fumarate (SEROQUEL). The patient previously took zithromax z-pack and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 15May2021 at 07:00, the patient started experiencing severe back pain and on 18May2021 she developed a weltish rash all over her lower back. As of the day of report, the patient was still experiencing back pain. The events were reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient had three visits to chiropractor to relieve back pain. The patient had not been tested for COVID-19 since vaccination. The outcome of the event severe back pain was not recovered and that of another event was unknown.