chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of swelling in his right shoulder. The next morning he was complaining that his arm hurt. That afternoon he stated he couldn't raise his arm and it was red. His arm felt like a rock and was red with about a 4 inch diameter. Called the doctor for instructions on dose of Benadryl. Treated with 50 mg Benadryl that evening at about 5:30pm and his albuterol inhaler and ice packs. The next day he received Benadryl 25mg q4h w.a. and an ice pack to his arm. Today, his arm is still swollen and red, but he can move it better and it is not hard.
Tues: Injection Thurs: Called to let us know arm is hot to the touch, some redness and swelling, also blisters in the area. Fri: Arm getting better, still swollen & sore. Used Benadryl topical & Zyrtec. Doing better.
Patient reported dizziness and felt heaviness in her body. Patient reported no difficulty breathing and swallowing. Patient denied pain, itchiness, rashes, and hives. Patient assisted to anti-gravity and given water. EMT assessed patient's vitals: blood pressure 144/90 mmHg, heart rate 107 beats/minute, and SpO2 98%. Patient advised to wait for further observation. Patient reassessed at 1209. Patient denied earlier symptoms. Patient's vitals were blood pressure 136/82, heart rate 94 beats/minute, and SpO2 98%. EMT educated patient on communicating with vaccinator for second dose how she reacted to her first dose. At 1213, patient left facility to family with unlabored respirations and steady gait.
Left axillary lymphadenopathy; This is a spontaneous report from a non-contactable physician. A 33-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 21Dec2020 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Dec2020, the patient experienced left axillary lymphadenopathy. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. The case was assessed as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible. Information about batch number cannot be obtained.
Client received TDAP on 8-29-14, called clinic on 9-1-14 wanted to know if she should see her doctor as she just hadn't felt well after shot. Slept all weekend, had a knot under her arm, knot where she got shot and very sore. On 9-2-14 had redness, tenderness at injection site. No treatment given. Discussed normal side effects.
Patient had grand mal seizure following vaccination X 2.  Event occurred approximately 10 minutes following vaccination.  Patient does report history of "vasovagal episodes".  Pulse maintained throughout episode, no medications given.  Patient spontaneously returned to orientation.  BP 70/50 and HR 59 upon initial assessment.  Patient sent to urgent care clinic for further evaluation by provider.
Fever, Chills, Cough, Nasal Congestion, Nausea, Headache, disorientation 24 hours after injection. Worsened over next  3 days. Improved thereafter. Currently, 6 days after injections and symptoms are mostly subsided.
Hospitilization; Missed second dose appointment and he is beyond day 36; A spontaneous report was received from a Consumer  concerning a male patient of an unknown age who missed  Moderna's COVID-19 vaccine (mRNA-1273) second dose due to hospitalization.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 5-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  Patient was scheduled to take second dose on 15-MAR-2021 but he was missed it due to hospitalization. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event missing second dose due to hospitalization was considered resolved.; Reporter's Comments: This report refers to a male patient of unspecified age who experienced non-serious unexpected event of missed second dose (missed dose) for mRNA-1273 due to hospitalization. There were no reported AEs associated with this case of missed dose. Very limited information regarding the event of hospitalization NOS has been provided at this time.  Further information has been requested.
Fever to 104.5, widespread rash on trunk, 3 months of bloody diarrhea
Initial report received on 10 April 2008 from a pharmacist.  A 19-year-old female patient, with no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a first, intramuscular, left arm dose of ADACEL (Lot # C2842AA), and a second, subcutaneous, left arm dose of "MMRII" (manufacturer Merck, Lot # 0748U) on 19 November 2007.  Thirty-five days after receiving the vaccinations, the patient developed chest pain and her hands turned blue.  She was taken to the emergency room where cardiac and neurology consults were completed.  An Echocardiogram and diagnostic laboratory data were within normal limits.  The patient was discharged from the emergency room with a heart monitor that she wore for one month.  The results of the heart monitor readings were not provided.  One-hundred-five days later, the patient again developed chest pain, and her hands turned blue.  It was not reported whether the patient was medically evaluated that time, or if treatments were received, or diagnostic tests performed.  The recovery status of the patient was not reported.
Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored ROTATEQ lot # M019690/Expiration Date- 02-NOV-2017, lot # L035276/Expiration Date- 09-JUN-2017, lot # M025563/Expiration Date-06-NOV-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Received MMR 8/17/06. 3 days after injection had fever x 1D. Then since 8/22/06 has c/o arthralgia, chest and face rash, adenopathy walked into office 8/28/06 with above complaints. Referred to Dr (Infectious diseases).
Information has been received from a physician concerning a patient who was vaccinated with zoster vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction and erythema at the injection site. Additional information has been requested.
INCORRECT PRODUCT STORAGE; ADMINISTERED VACCINE STORED AT A  MINIMUM TEMPERATURE OF (PLUS) 40.6 DEGREES FAHRENHEIT TO A MAXIMUM TEMPERATURE OF (PLUS) 48.7 DEGREES FAHRENHEIT FOR 32  MINUTES; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 03-NOV-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On 03-NOV-2022, the patient experienced administered vaccine stored at a minimum temperature of (plus) 40.6 degrees fahrenheit to a maximum temperature of (plus) 48.7 degrees fahrenheit for 32 minutes. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored at a minimum temperature of (plus) 40.6 degrees fahrenheit to a maximum temperature of (plus) 48.7 degrees fahrenheit for 32 minutes and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20221116238.
Recieved flu shot Friday October 28th at 10am and by monday morning until wednesday morning had a temperature that hovered between 102 to 104 degrees.
I experienced 4 syncopes in a span of 5 minutes. I was taken to the E.R. and given fluids before they sent me home.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 13th November 2018, 1 days after receiving SHINGRIX, the patient experienced headache, stomach pain, fatigue, loss of energy and feeling unwell. On an unknown date, the outcome of the headache, fatigue, loss of energy and feeling unwell were not recovered/not resolved and the outcome of the stomach pain was recovering/resolving. It was unknown if the reporter considered the headache, stomach pain, fatigue, loss of energy and feeling unwell to be related to SHINGRIX. Additional details were reported as follows: Late on 13th November 2018, the patient started experiencing headache, stomach pain, fatigue and no energy. The stomach pain was bad initially, but it had abated. It was tolerable, but she was still felt ill at the reporting time. The reporter did not consent to follow up.
Severe headache started at about 12:45am. Vomited. Took 400mg Ibuprofin. Chills started. Fell asleep, but had chills and muscle aches the remained of the might. The following day I was on the couch all day with chills, muscle aches and fatigue. Took a lot of naps. Around 4pm on April 7 I took about 200 mg ibuprofen for another headache  (I don't usually get headaches). The muscle aches and fatigue started to ease up by 8-9pm on April 7. Went to bed and woke up feeling myself again on April 8.
25 minutes after receiving shot while driving home left side of head hairline felt like electrical line, left eye began twitching, hard to drive, head did not feel normal-felt like heavy, heavy brain fog.  40 minutes after shot, trouble walking, had to use cane and hang onto wall/furniture, very painful walking.  Brain fog lasted 24 hours.  Trouble walking for 3 days.  Nose bleed on 1st night after getting shot while sleeping.  For first 2 nights after getting shot had tingly, like many fine needles from knees up to waist.  First 2 days had hot/cold feeling, nausea...all in all incredibly unpleasant.
Painful swelling and erythema on inner left arm from elbow to armpit, not on deltoid/ lateral left arm where vaccination was given.  Per urgent care notes, there was a "sac" by the inner elbow when provider saw her on 2/2/20 at 11:19am.  Dx cellulitis.  Rx'd cephalexin 500mg TID x 7 days
no additional AE; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 04-JUN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023, administered intramuscularly for prophylaxis (strength was not provided) after a temperature excursion at 34.2 F for 12 hours (product storage error). There was no previous temperature excursion. No other information or additional adverse event (AE) was provided.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A 43-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 42, on Oct 7, 2021, single dose, for COVID-19 immunisation. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot#unknown); both single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medication included: levothyroxine and Paxil (piroxicam). Past drug history included: Keflex, notes: known allergies Keflex. The patient experienced ineffective drug (medically significant) and COVID-19 (medically significant), with outcome of unknown. Therapeutic measures were taken as a result of ineffective drug and COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Headache, Myalgia, Fever,  chills, arm pain, nausea, cough, fatigue, night sweats
This case was reported by a healthcare professional and described the occurrence of rash in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a male subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A - A0759349A, A0759351A. Follow-up information received on 06 January 2009 provided no additional information concerning the reported event.
Information has been received from a physician concerning a 41 year old male who "20 years ago" (in 1990) was vaccinated with 2 three dose series of RECOMBIVAX HB (lot number not reported). The patient "now" (in 2010) had negative surface antigen, negative DNA levels but had positive core antibodies. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
chills; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache). At the time of the report, CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After giving the vaccine, the dose seeped out of the vaccination site, appeared to be a large majority of the doseNA
Varivax booster give 4/25/07 - Dad of patient called in 4-27-07 - reported patient's arm red, swollen where injection was given approximately 3 inch x 1 inch redness, sore. Ibuprofen given for pain - warm pack to area.
Extreme redness and swelling below site of vax. REd whelts 5x4.5" form reddened swollen and tender diffuse pattern. Probably Pneumococcal allergic reaction.
She had a stroke caused by blood clot in brain.  Suffered a second stroke 4 weeks later.  Has weakness left leg.  Is now in Rehab Center
swelling migrated from right lower jaw region over lips and stopped at the left side of lips; slurred voice; rash with whelps across his back and down both legs with itching irritation; rash with whelps across his back and down both legs with itching irritation; swelling migrated from right lower jaw region over lips and stopped at the left side of lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 06Feb2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, and gastrooesophageal reflux disease (GERD). Concomitant medications included metformin, gabapentin, atorvastatin, and alprenolol hydrochloride (ATENENOL). The patient previously took Demerol and aspirin experienced allergies (known allergies). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Feb2021 06:30, the patient experienced swelling migrated from right lower jaw region over lips and stopped at the left side of lips, some swelling has continued, and slurred voice (more pronounced when standing). On the same day at 06:30, the patient experienced rash with whelps across his back and down both legs with itching irritation. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with Zyrtec and Kenalog. The patient has not been tested for COVID-19 since the vaccination. The patient has not recovered from the events.
Fussy for 2 wks; cry was not usual cry; private MD to infant advised giving DT due to above behaviors; no indepth evaluation done by MD.
14 hours after vaccination I had a sore arm, fever, full body aches, sweating.  It was better in the morning of the 2nd.  Around 1 pm on the 2nd I started feeling nauseous.   It got progressively worse and at 7pm I had severe nausea and intense abdominal pain.  At 10 pm I went to the emergency room
swollen / puffiness on left collarbone neck area.  still swollen / puffy
Low grade fever, chills, fatigue, arm soreness, visibly swollen armpit under left arm. Armpit pain began approx 36 hours after receiving injection. Other symptoms began approx 20 hours after receiving injection. Armpit pain was present after first injection but at the time did not realize it was related to vaccine until symptoms appeared more severely after second dose.
A report has been received from a Health Professional concerning a 61 year old, Female subject, who had been received Nasal FLUMIST (intranasal), 0.2 Millilitres, unknown for INFLUENZA. The patient who was 49 years of age was administered FLUMIST on 28-Sep-2015. FLUMIST (intranasal) was discontinued on 28-Sep-2015. The outcome of the event of OVER 49 YEARS OF AGE and FLUMIST WAS ADMINISTERED OVER THE AGE OF 49 YEARS is unknown. The report was considered to be non-serious.
Patient did not experience Adverse reaction but He received MODERNA shot after receiving JANSSEN vaccine in March 2021 without the Pharmacy's knowledge.  Patient admitted to  intentionally lying on the consent form and also when asked verbally by me (pharmacist) if he received other COVID vaccine prior to today. According to patient "I did not feel safe with just the JNJ especially with the news of the new strains. I wanted the Moderna and now after getting the first shot I feel safer."
Extreme redness, warm, tenderness and allodynia type response starting at the puncture site and spreading 4 to 7 mm out across.; Extreme redness, warm, tenderness and allodynia type response starting at the puncture site and spreading 4 to 7 mm out across.; Extreme redness, warm, tenderness and allodynia type response starting at the puncture site and spreading 4 to 7 mm out across.; Extreme redness, warm, tenderness and allodynia type response starting at the puncture site and spreading 4 to 7 mm out across.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 21Apr2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), medroxyprogesterone (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), ergocalciferol (VIT D) and azithromycin (Z-PAK); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 18:30, the patient experienced COVID arm extreme redness, warm, tenderness and allodynia type response starting at the puncture site and spreading 4 to 7 mm out across. The events did not result in doctor or other healthcare professional office/clinic visit, 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 events extreme redness, warm, tenderness and allodynia type response were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt reported dizziness and chest tightness for 2 minutes post injection. BP 60/20-Epi x 2 NS 1000 CC given, Benadryl 50mg given PO. Pt sx resolved and discharged to home 1:25pm dc'd to home-no further problems.
Baby was in car seat in waiting room became very pale head turned to the side eyes rolled back and she required stimulation to respond. This happened 2-3 times once removed her from car seat she returned to hugging. We did send to ER via ambulance for further evaluation baby was fine and back to herself in the ER. Heart rate & resp. remained normal the entire episode.