chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Achy arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 036B21A, 051F21A and 066K21) for COVID-19 prophylaxis.     The patient's past medical history included Anemia, Vaccination adverse reaction and COVID-19. Previously administered products included for Product used for unknown indication: VACCINE, HERPES SIMPLEX 1, IRON, AZITHROMYCIN, ZINC and PREDNISONE. Past adverse reactions to the above products included No adverse event with AZITHROMYCIN, IRON, PREDNISONE, VACCINE, HERPES SIMPLEX 1 and ZINC.      No concomitant medication information provided. It was reported that patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information provided.
Syncope episode with some seizure like activity. Lasted 4-5 sec. Monitored, checked BP, glucose.
Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision.  Took Tylenol and Ibuprofen.
Onset of unscheduled menstrual cycle, lasted 2 weeks and 5 days, 12 days longer than normal
Pt received Flu shot and Pneumonia vaccine. The arm that got the Pneumonia was red and swollen later @ night no problems breathing or SOB.
Information has been received from a physician concerning a 21 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (Lot#658556/10600) 0.5ml, intramusclar administration. The patient developed hives and joint pain 8-10 hours post vaccination with GARDASIL. The patient sought medical attention and was treated with diphenhydramine hydrochloride (Benadryl) and Corticosteroids.
Hard swollen area around the injection site with white spot where the needle was inserted. Warm to the touch. Soreness to the touch and when moving arm. Headache, malaise. Headache, and malaise gone 24 hours after the injection. redness and lump have subsided much, but not completely gone 48 hours after the injection.
24 hour delay - delayed reactor.  vomiting, tired, nausea, cough, Difficulty breathing - asthma - used inhaler, dizziness & weakness. ,
patient got pediatric dose when they should have gotten an adult dose. Family decided to not revaccinate at this time
Pain in arm, neck, shoulder, back.; Arm pain restricted movement; Headache; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 09:30 (Lot number: FF2589) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; TOUJEO; XIGDUO; GLIMEPIRIDE; BUPROPION. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Misplaced/ discarded, Prev dose administration date=07Apr2021,, Prev dose administration time=10:30 AM,, Prev dose dose number=2,, Prev dose vaccine location=Left arm), administration date: 07Apr2021, when the patient was 63 years old, for covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Misplaced/ discarded,, Prev dose administration date=17Mar2021,, Prev dose administration time=10:30 AM, Prev dose dose number=1,, Prev dose vaccine location=Left arm), administration date: 17Mar2021, when the patient was 63 years old, for covid-19 immunization.  The following information was reported: PAIN (non-serious) with onset 14Oct2021 12:00, outcome "recovering", described as "Pain in arm, neck, shoulder, back."; HYPOKINESIA (non-serious) with onset 14Oct2021 12:00, outcome "recovering", described as "Arm pain restricted movement"; HEADACHE (non-serious) with onset 14Oct2021 12:00, outcome "recovering", described as "Headache"; PYREXIA (non-serious) with onset 14Oct2021 12:00, outcome "recovering", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, hypokinesia, headache, pyrexia.  No follow-up attempts are possible. No further information is expected.
Heart rate got raised; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEART RATE INCREASED (Heart rate got raised) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate got raised). At the time of the report, HEART RATE INCREASED (Heart rate got raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Left upper eye lied became swollen; Cannot take second dose; Tingling; Extreme nausea; Dizziness; Pins and needles all over the body; Numbing; Metal taste in mouth; Hurt a little at the site of the vaccine; Bump on the arm turned into a red patch; Bump grew at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), PARAESTHESIA (Pins and needles all over the body), HYPOAESTHESIA (Numbing), DYSGEUSIA (Metal taste in mouth) and PARAESTHESIA (Tingling) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (COPPER IUD) for an unknown indication.    On 22-Apr-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced DIZZINESS (Dizziness). 22-Apr-2021, the patient experienced PARAESTHESIA (Pins and needles all over the body), HYPOAESTHESIA (Numbing), DYSGEUSIA (Metal taste in mouth) and NAUSEA (Extreme nausea). On 24-Apr-2021, the patient experienced PARAESTHESIA (Tingling). On an unknown date, the patient experienced EYE SWELLING (Left upper eye lied became swollen), RASH ERYTHEMATOUS (Bump on the arm turned into a red patch), VACCINATION SITE MASS (Bump grew at the injection site), OFF LABEL USE (Cannot take second dose) and VACCINATION SITE PAIN (Hurt a little at the site of the vaccine). On 01-May-2021, RASH ERYTHEMATOUS (Bump on the arm turned into a red patch) had resolved. On 17-May-2021, DIZZINESS (Dizziness), PARAESTHESIA (Pins and needles all over the body), PARAESTHESIA (Tingling), EYE SWELLING (Left upper eye lied became swollen), VACCINATION SITE MASS (Bump grew at the injection site), NAUSEA (Extreme nausea) and VACCINATION SITE PAIN (Hurt a little at the site of the vaccine) had resolved, HYPOAESTHESIA (Numbing) and DYSGEUSIA (Metal taste in mouth) outcome was unknown. At the time of the report, OFF LABEL USE (Cannot take second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  The patient stated that she can not take second dose as per the report.   This case was linked to US-MODERNATX, INC.-MOD-2021-090380 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Additional information received on 27-may-2021. Patient demographics updated. suspect drug time, Event details and new events added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090380:
Immediately after pt received vaccine he told his wife (driver) that he was feeling dizzy. Wife then stopped vehicle in Lane #6 halfway down to observation and called for help from observation staff. Upon arrival of observation staff pt was found to be unresponsive but still had a pulse and was breathing on his own. Pt was in the passenger set. Observation staff alerted onsite medical professionals and MD and the crash cart was brought to the car. Vitals were taken. Within a minute pt became responsive and opened his eyes and began to communicate with healthcare staff. O2 sat was noted to be low so O2 was applied at 6L/min via facemask. Onsite Batallion Chief stated he had already called EMS and they were en route. MD remained at the vehicle with pt and continued to monitor until EMS arrived and assumed care. EMS  did an EKG and pt found to have sinus brady, with a pulse in the 50's. EMS decided to transport pt to hospital for further evaluation. Pt transported to ambulance via stretcher in stable condition, alert.
Immediately p/vax became pale in the office & very quiet, color improved prior to d/c home; A couple of hrs later @ home became quite pale, also limp & unresponsive & respirations were noted to be shallow;
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received Bexsero. On 06-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered).  The outcome of the expired vaccine used was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAR-2023 The reporter was a medical assistant. The reporter reported that they inadvertently administered an expired dose of Bexsero vaccine to the patient in their facility. The reporter wanted to know how to proceed. The reporter did not consent to follow-up. Additional supportive information: The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
Administered Flucelvax to 23 month old. No s/s of reaction.
Patient presented to primary care clinic on 12-3-18 with complaints of developing a skin reaction beginning the day after receiving the shingles (SHINGRIX) vaccine (11-30-18). The patient complained of an itchy rash on right side (flank) area. The patient also complained of systematic itching. Small pustule with surrounding urticaria wheal was observed.
Began with headache, several hours later, high fever began (104 degrees), lethargic, loss of appetite and joint pain.
Pt recv vax on 1/25/99; on same day pt exp achy feeling, headache, weakness, erythema/ warmth/ swelling at vax site
Red warm swollen area at injection site 1 week after first dose. Swollen area about 2.5-3.0?.
Swollen at injection site Nausea, vomiting Pain in abdomen Fatigue
Caller states the eye reaction didn't start until after the second shot, it started the next day.; 2 hard bumps under her eye; left eye completely sunken in; can't see that well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: EW0170) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "she got the filler injections", start date: 02Mar2021 (unspecified if ongoing), notes: she waited from the time she got the filler injections on 02Mar2021, 6 weeks. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), administration date: 01Apr2021, when the patient was 48 years old, for Covid-19 Immunisation, reaction(s): "one of her eyes looks all messed up and she will need surgery to correct that problem; filler had to be removed; left eye completely sunken in; can't see that well; 2 hard bumps under her eye". The following information was reported: EYE DISORDER (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Caller states the eye reaction didn't start until after the second shot, it started the next day."; EYELID THICKENING (non-serious) with onset 23Apr2021, outcome "not recovered", described as "2 hard bumps under her eye"; VISUAL IMPAIRMENT (non-serious) with onset 23Apr2021, outcome "not recovered", described as "left eye completely sunken in; can't see that well". Additional information;- Caller states she has 2 hard bumps under her eye and she cannot do anything more about them. Caller states she has pictures and documentation, but she is not going to provide any of that yet, she wants to see what Pfizer is willing to do and then proceed forward.  No follow-up attempts are possible. No further information is expected.
Pt had a fever of 102.7 F taken under arm at 11 pm, Saturday, August 22. The highest temperature of 103.6F was taken under arm at 2 am, Sunday, August 23. Pt was very tired, hot and uncomfortable, and she had trouble falling asleep. She kept waking up every 2-3 hours through the night. We gave her water and tried to cool her down. She still have fever of 102.3F when she woke up at 6:30 am August 23. The fever has come down by 12:00 pm August 23.
Patient said about 2 weeks after receiving vaccine, she developed a red, slightly itchy rash around her elbow area.  She said it did not hurt.  She did not take or  use any medications or products for it.  It eventually resolved on it's own.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  Patient age was reported as 20  years and 10 months.  Ndc Code was mentioned. It was reported that on 10-Jun-2022 was notified of an audit that was done and were then made aware of vaccines that were administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medication was provided by the reporter.
Pt received both doses of Pfizer COVID vaccine on 3/30/21 and 4/16/21.  On 5/11/12, patient experienced right lower abdominal pain, nausea, and decreased appetite and presented to the ED on 5/12/21. Pt was found to have acute appendicitis and was tested for COVID in the ED as part of standard procedure. Despite receiving both doses of COVID vaccine, patient tested positive for COVID (rapid test). Pt did not have any respiratory symptoms and his chest X-ray showed no active disease. Pt was admitted to the hospital for treatment for his appendicitis.
Case number PHEH2014US024995 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 54 years old female patient. Past medical history and concomitant medications were not reported. The temperature excursions of FLUVIRIN (batch number: 145701) began around 16 Oct 2014 and the patient received the vaccine intramuscularly at a dose of 0.5 ml on the same date. It was reported that the vaccine administered was at 49 F 12 times over a period of 34 days. There were 12 separate temperatures excursions lasting 30 minutes each in which the temperature was 46 to 49 F during each of those excursions. No adverse events were reported following the maladministration.
Pt to ED with worsening SOB, fatigue, headache, sore throat, body aches, hypoxic, respiratory failure secondary to COVID; positive COVID test; CHF exacerbation; O2 supplementation with NRB; Decadron and Prednisone; ABX; unable to receive BiPAP due to pneumomediastinum; DNI; respiratory status worsened; severe mediastinal emphysema, worsening subcutaneous emphysema dissecting into neck; transitioned to comfort care and hospice; pt passed away in the hospital under hospice care.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 9-weeks-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
SORENESS; PAIN AT THE INJECTION SIDE; SWOLLEN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and ace inhibitors allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced soreness. On 03-APR-2021, the subject experienced pain at the injection side. On 03-APR-2021, the subject experienced swollen at the injection site. The patient had not recovered from pain at the injection side, swollen at the injection site, and soreness. This report was non-serious.
she got a sinus allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGIC SINUSITIS (non-serious), outcome "unknown", described as "she got a sinus allergy".  Additional information: Caller and Wife have a 2nd dose schedule for tomorrow (10Apr2021) but his wife is not able to get the vaccine because she got a sinus allergy. The caller would like to reschedule their appointment and they want to get the 2nd dose at the same time.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Date of onset: 01/08/2021 - headache, chills and fatigue.  Intense headache and chills lasted most of the day on the  8th.  The fatigue was most of the weekend.  I slept 12 hours on Saturday night the 9th, and  preceded to nap in the afternoon on the 10th.  Both of these sleep  times are very much out of the ordinary for me.  I also took  3 doses of Ibuprophen for the headache on the 8th.
After receiving vaccine: arm was sore for a couple days, then started to become itchy.  After a week of receiving vaccine: got noticeably more itchy, and swollen.  Redness (seemed to be like a rash with no hives) started to grow in size everyday. Used Benadryl which didn?t seem to stop it.   Now it?s been two weeks since I?ve received the shot and rash is still here, currently using cortizone-10 to help with itchiness
4 hours after shot administered, felt chest pressure, heart pounding, congested chest & cough.  Breathing problems also which lasted about 25 minutes, rest of symptoms persisted for about 3.5 hours.
Experienced 1 hive close to the injection site in right arm. Hive is on the back of the right shoulder. Yhis is my first dose of Shingrix
Body aching Right arm discomfort soreness pain in antecubital inner aspect - continues to this date. Joint pain, nausea vomiting in AM neck discomfort, HA, feels like "flu" Feels like low grade fever. Patient statement, Pt stated she has been experiencing Joint pain in Antecubital area of Left arm. MMR vaccine was received on 7/2/19. Employee also stated arm pain, malaise, nausea, vomiting and feeling sick since 7/2/19. Employee did not contact Employee health regarding symptoms. Employee went to family doctor. PCP obtained Labs (CBC + platelets) which were normal. Employee stated see was screened for Lyme's disease also because last week she found a tick on her last week. It was not implanted. It has been almost 1 month since MMR vaccine.
feels a bit dizzy; started feeling funny; heart rate went up; really dizzy; weak; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling funny), HEART RATE INCREASED (heart rate went up), DIZZINESS (really dizzy), ASTHENIA (weak) and DIZZINESS (feels a bit dizzy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0416L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-Jan-2021, the patient experienced FEELING ABNORMAL (started feeling funny), HEART RATE INCREASED (heart rate went up), DIZZINESS (really dizzy) and ASTHENIA (weak). On 20-Jan-2021, the patient experienced DIZZINESS (feels a bit dizzy). At the time of the report, FEELING ABNORMAL (started feeling funny), HEART RATE INCREASED (heart rate went up), DIZZINESS (really dizzy), ASTHENIA (weak) and DIZZINESS (feels a bit dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   Treatment information was not provided.