chrisvoncsefalvay/vaers-outcomes huggingface dataset:
runny nose on one side of her nostril.; sneezed; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable female consumer (patient) reported for herself. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13MAR2021 at single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. Patient got her first dose last March 13. She is scheduled to return today which is April 3 for her second dose. However, at 3 AM today upon waking up, she sneezed and started to have a runny nose on one side of her nostril. She is not sure if this is an allergy and she wanted to know if it was okay to get the shot. Provided PMI's number and hours of operation in case call gets disconnected since the caller has a medical inquiry. Cold Transferred to DSU and Created Manual AE Form. Customer and/or medical inquiry forwarded or referred to MI. Reported as non-serious. Patient stated she just had really, it was just a simple question. She had the first Pfizer shot on March 13th and she had no problem with it and she was scheduled today to get her second one and she woke up like in the middle of the night like she sneezed and like she just had this runny nose and she had no other symptoms. She felt fine and she just want to know if it was okay to get the shot. Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Possibly inadvertently injected patient with empty syringe with J&J vaccine and ml vanish point syringe.
1 week after vaccine administration (12/29/20), I developed diarrhea that has persisted for ~2 weeks at the time of this report and is ongoing.  Currently pregnant with EDD 2/22/21. Uncomplicated pregnancy so far.
Pt got shingles vaccine and about 20 min after injections pt felt dizzy. Their BP was 172/76 and 179/81 10 mins later. Called Dr and was told to have pt come in to be seen.
Rash; Redness; Swelling; Little tenderness in injections site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Little tenderness in injections site), VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little tenderness in injections site). On 26-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). On 20-Jan-2021, VACCINATION SITE PAIN (Little tenderness in injections site) had resolved. At the time of the report, VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Here with for questionable reaction, yesterday at approximately 8 AM he had a Menactra injection. At the time he had no symptoms of illness. At 3 PM he felt tired, at 10 PM felt "odd body" pains, at midnight he had uncontrollable twitching, shivering and was unable to speak. He also states he was hallucinating, he had taken Advil at 10PM. Also takes doxycycline for acne, he took it at approximately 7 AM. He states he has pain all over since last night especially at the injection site. He took Tylenol at noon today, he had a temperature of 100 at noon. He started to communicate his symptoms to mom at approximately noon today. Better, less intense, walking and talking fine. 8/4/06- temp 98.7 (po) BP 124/68 Medications Benzaclin 1-5% take as directed Doxycycline Hylcate 100 mg take one capsule by mouth twice per day. Retin-A 0.025% apply sparingly to dry face twenty minutes after washing. Head without tenderness. TM, nasal, eyes  fundi disc WNL, clear. Neck supple. Chest clear. HT clear. Abdomen soft. Ext without swelling, normal joints, full ROM of all. Neuro normal limit motion. Normal DTR. Skin mild acne. Imp: Reaction to Menactra
Information has been received from a nurse concerning an 82 year old female patient. The patient's concurrent conditions included hypertension, thyroid issue, high cholesterol and diabetes. There were no drug reactions or allergies. No pertinent medical history was reported. Concomitant therapies included unspecified high blood pressure medicine, unspecified diabetes medicine, high cholesterol medicine and unspecified thyroid medicine. On 17-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 for prophylaxis (lot # M026317 with an expiration date of 11-JAN-2018) (dose, route, anatomical location of administration and expiration date were not reported). Other suspect medications were not reported. On 19-OCT-2016, after receiving PNEUMOVAX 23, the patient experienced redness and swelling around the injection site, the swelling was from "her armpit all the way down to the elbow" and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and she was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On an unknown date in 2016, the patient recovered from the cellulitis. The relatedness between the event and therapy with PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is one of several reports received from the same reporter. Follow up information has been received from the nurse on 20-DEC-2016. It was reported that on 17-OCT-2016 at 10:58 AM, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly at right deltoid for prophylaxis. On 19-OCT-2016 at 16:14, the patient had arm hurting from armpit to elbow, it was red and swollen. It was warm to touch. The patient received cephalexin 500 mg tid (three times a day) for 7 days and MEDROL dose pack. The patient was recovered from the event on 27-OCT-2016. Additional information is not expected as all the follow up information has been received. Reporter, Patient, Product, Event and Narrative have been updated.; Sender's Comments: US-009507513-1611USA007073: US-009507513-1611USA007077: US-009507513-1611USA007088: US-009507513-1611USA007131: MERCK 1611USA007096:Mfr number.
Headache, Myalgia, Fever, NauseaVomiting, SORE UPPER EXTREMITIES Narrative:
fever began on Saturday morning. By sunday arm was swollen at site of injection and red. fever went up to 102. per patient. Came in to report tuesday
patient received 2nd dose of GARDASIL 9 and became dizzy, did not pass out, just got dizzy; This spontaneous report was received from a consumer, via a company representative, referring to herself, a female patient of unknown age. Patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown.      On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection once, for prophylaxis and she became dizzy, did not pass out, just got dizzy. Patient received treatment for the adverse experience, was observed in office and she left the office on her own later that day, recovering this same vaccination day, after being monitored.       The causality assessment was not reported.
Woke up with uncontrollable shaking in teeth chattering, lasted a couple of hours until I fell asleep. Terrible headache, body ache & fatigue all day. The next day I had a headache and fatigue.
No additional adverse event; Administration of expired MMR II; This spontaneous report has been received from a consumer referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies was not reported.      On 26-Jan-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (Expired product administered) (lot# T001214 and expiration date: 12-JAN-2022) (exact dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported), as prophylaxis. Reporter inquired viability of administered dose.  No additional adverse event (AE) reported. No PQC reported.
L Deltoid site red, swollen and very painful reddened area went down to forearm.
Fever up to 100.7. Severe chills. Headache. Body aches. Nausea. Gas/bloating.
12/15/2021 heart palpitations, on and off pressure that comes and goes. I had these symptoms but it was an increase in frequency. In January 2022, I saw my cardiologist, no change in treatment and no outcome. The same diagnosis as my previous diagnosis, A-fib. I am still having the irregular heart beats, heart palpitations and pressure.
Pain, swelling & redness between injection sites on arm (Flu & Pneumo). Day 1 - no reaction. Day 2 - Rxn - treated with APAP & cold compress. Day 3 - Rxn continued - referred to PCP.
This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Er8737) via an unspecified route of administration in the arm left on 04Apr2021 at 12:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, 6 days after vaccination, the patient experienced ear ache and jaw ache. On 11Apr2021, the patient experienced high fever with chills. On 15Apr2021, the patient experienced rash on arm. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events ear ache, jaw ache, chills, high fever, and rash on arm was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Pt experienced dizziness post vaccination. States anxiety present "because of needles." No s/sx of respiratory distress. Given juice/water, laid down on stretcher. Pt states this happens any time he is in a medical facility. Sx resolved after 10 minutes. Monitored for 10 minutes, pt left on own
Post vaccination approximately 15 minutes, patient and caretaker described patient's condition as being uncomfortable or not feeling well when asked. Patient appeared nervous, clammy, and cold. Patient was able to breathe and respond when spoken to. Patient did not lose consciousness. Patient condition remained the same and there was no mention of condition worsening. EMT was called immediately. Upon arrival patient walked away with EMT workers.
Lips and tongue went numb within 10 minutes. Followed by dizziness and thoat tightening.
Pain and redness in RT upper arm. Upper Extremity Ultrasound on  9/14/2021 shows a "Venous Thrombosis involving the Cephalic Vein Rt Upper Extremity."
This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (syringe issue and liquid leaked from the barrel down her arm/ did not get the full dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 017C21A) for COVID-19 vaccination.  No Medical History information was reported. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-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 experienced UNDERDOSE (syringe issue and liquid leaked from the barrel down her arm/ did not get the full dose). At the time of the report, UNDERDOSE (syringe issue and liquid leaked from the barrel down her arm/ did not get the full dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that patient had concern that did not get full dose due to syringe liquid leakage issue from barrel down to arm. Pharmacist stated that product was supplied from state which is Easy Touch Fluringe FlipLock Safety Syringe of 25 gauge 3 cc inch having an expiry date 11Mar2026, manufacturing date 12Mar2021, lot number 53419, Item number 825231. No Concomitant medication was reported. No Treatment medication was reported.
Spotting in between menses, diarrhea, nausea, body aches.
Information has been received from a 23 year old female emergency medical attention with a penicillin allergy who on 29-JAN-2007 was vaccinated IM with a second 0.5 ml dose of Gardasil (yeast). On 29-JAN-2007 the patient reported feeling "weird or slow in the head" and "can not concentrate or think clearly". The patient received a first IM 0.5 dose of Gardasil (yeast) on 12-DEC-2006. Additional information has been requested.
Information has been received from a physician concerning a 17 year old female student with no illness at time of vaccination who was vaccinated with the second dose of unspecified vaccine. On 19-DEC-2008 the patient experienced rash at injection site and flu like symptoms. The patient was last seen on 20-APR-2009 and the patient was still had a rash at injection site. Subsequently, the patient recovered from rash at injection site and flu like symptoms. Follow up information has been received from a physician concerning the patient who was vaccinated with the first and the second dose of GARDASIL (lot #s were 0947X) on 22-OCT-2008 at 14:29AM and on 19-DEC-2008 at 16:06 AM respectively, both doses were vaccinated IM in right deltoid. No further information is available.
The first dose on 4/15/21, outcomes were the same night, chills, tiredness, headache. Second dose 5/6/21, sore arm, lasting tiredness, tender arm where shot was, cold sore outbreak 1 week after second shot. Cold sores are continuous, one after another with medication not helping. So far lasting 4 weeks with going on the 5th cold sore. Burning sensation in the lungs while running, shortness of breath while  running and being physical. Almost feels like I cannot breath.
Headache, Myalgia,  "FREIGHT TRAIN," Narrative: CDC CONTACTED HER FORM V-SAFE
Anaphylactic reaction: tongue/throat numbness, throat closure, rapid heart rate, dizziness, body tremors.
Per vaccinator client complained of nerve pain and stiffness 3 weeks after shot. Client was concerned about placement of vaccine. Client is continuing to rest and ice arm/shoulder.
Patient received FLUZONE High-Dose around noon today (9/5/2014). Her daughter called stating that she has fever (102 degrees F), chills, headache, and is nauseated. Her face is swollen. BP = 131/59. Daughter was advised to bring patient to the E.R.
Patients family was concerned with her extreme weakness and fatigue. Upon ER arrival she was dx'd with COVID19.
Information has been received from a pharmacist referring to a 75 years old female patient. The patient pertinent medical history was unknown. The patient did not have drug reactions/allergies. Concomitant medications included pravastatin and blood pressure medications. On 13-DEC-2016, the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route not reported) for prophylaxis. On 14-DEC-2016, the patient developed a rash and redness below the injection site. The patient did not seek medical attention. The reporter recommended treatment with BENADRYL and ibuprofen. The outcome of the event was unknown. The causality between PNEUMOVAX 23 and the event was not provided. Additional information has been requested.
Dose was administered from vial that was initially punctured 2 days prior, therefor expired.  Patient did not experience any reaction aside from expected side effects of vaccine.  Patient did report sore arm the night of injection, and body aches the day following.
The patient received his covid vaccine and minutes later, he had a syncopal episode. He recovered shortly after, but his heart rate was low at 44 bpm. EMT was called to the pharmacy for emergency assistance.
A 26 yo male experienced a syncopal episode for approx. 12 seconds X2 at 10 min after receiving J&J vaccine (L) deltoid. No post-itch symptoms and no loss of bowel or bladder.  He became nauseous with emesis X1.  Declined transport to hospital.  His uncle provided transport home.
Numbness of right side from stomach all the way down to right foot; nerve squeezing/nerve pain; itching at stomach; Gait and Mobility loss on right side; Gait and Mobility loss on right side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 (Lot number: EL9664) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Contact Dermatitis ylang-ylang" (unspecified if ongoing), notes: Known allergies: Contact Dermatitis ylang-ylang; "Contact Dermatitis" (unspecified if ongoing); "Known allergies: decyl glucoside, thiuram mix, thioreas" (unspecified if ongoing), notes: Known allergies: decyl glucoside, thiuram mix, thioreas; "Breast cancer survivor (2 year survivor at time of Vaccine)" (unspecified if ongoing), notes: Other medical history: Breast cancer survivor (2 year survivor at time of Vaccine); "have BRCA2" (unspecified if ongoing), notes: Other medical history: have BRCA2. Concomitant medication(s) included: CLARITINE; LETROZOLE; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; ZOLADEX. Past drug history included: Thimerosal, reaction(s): "allergies", notes: Known allergies: thimerosal. no other vaccine in four weeks. No Covid prior vaccination. Vaccination history included: Bnt162b2 (lot number: EL3302, administration date: 21Jan2021, dose number: 1, Vaccine location: Right arm), administration date: 21Jan2021, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (disability) with onset 26Mar2021, outcome "not recovered", described as "Numbness of right side from stomach all the way down to right foot"; NEURALGIA (disability) with onset 26Mar2021, outcome "not recovered", described as "nerve squeezing/nerve pain"; PRURITUS (disability) with onset 26Mar2021, outcome "not recovered", described as "itching at stomach"; GAIT DISTURBANCE (disability), MOBILITY DECREASED (disability) all with onset 26Mar2021, outcome "not recovered" and all described as "Gait and Mobility loss on right side". The events "numbness of right side from stomach all the way down to right foot", "nerve squeezing/nerve pain", "itching at stomach", "gait and mobility loss on right side" and "gait and mobility loss on right side" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; magnetic resonance imaging: (2021) unknown results; sars-cov-2 test: (2021) negative. Therapeutic measures were taken as a result of hypoaesthesia, neuralgia, pruritus, gait disturbance, mobility decreased.
Everything tastes metallic after the 2nd dose; Tongue feels like weird; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Everything tastes metallic after the 2nd dose) and TONGUE DISCOMFORT (Tongue feels like weird) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Everything tastes metallic after the 2nd dose) and TONGUE DISCOMFORT (Tongue feels like weird). At the time of the report, DYSGEUSIA (Everything tastes metallic after the 2nd dose) and TONGUE DISCOMFORT (Tongue feels like weird) outcome was unknown.            No Concomitant Medication was provided. No treatment  was provided. The action taken with mRNA-1273 in response to the event was not applicable.
UrticariaPruritus & NauseaVomiting Narrative: Experienced intense pruritus just around injections site, developed 2-3 days after the injection and persisted for about 2 days. No therapies tried or applied. Also states having episodic nausea without vomiting 1-2 days after vaccination that lasted for about 1- days. NO other adverse effects noted.
This spontaneous report as received from a certified medical assistant refers to a 18 month old patient of unknown gender. No information regarding to the patient's medical history, concurrent conditions and concomitant medications was provided. On 10-MAR-2016, unspecified nurse in the practice inadvertently administered to a patient a dose of GARDASIL 9 injection, Lot L014415, expiration date 25-JUL-2017 (dose and route of administration were not reported) instead of the intended dose of VAQTA (not administered at the time of the call) due to product confusion. The reporter stated the nurse that administered the dose didn't check the vial before administering the vaccine. No adverse effect were reported. Additional information has been requested.
Patient was seen on 10/17/2005.  Rash in groin area, legs, complained of being itchy started on Thursday.
had both shots / since have gotten shingles 3 times / got both Shingrix doses / has had shingles 3 times/suspected vaccination failure; since have gotten shingles 3 times / has had shingles 3 times; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had both the doses of Shingrix within the required time frame (within 6 months) and had shingles 3 times since. The reporter asked are there any other ways to protect against shingles. This case was considered as suspected vaccination failure as details time to onset and laboratory confirmation were unknown at the time of reporting.