chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-DEC-2015 at 11:01, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.9 and 6.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
My daughter started stuttering soon after receiving her flu vaccine. Prior to the vaccine she was above average with her vocabulary and speech.
Reaction 11:20 AM swelling of eyes with itchiness, swelling of lips, nose, ears, developing hives and redness on skin, disorientation, sleepy followed by swelling of tongue, throat difficulty breathing. 11:35 AM Treatment Epinephrine Auvi-Q auto injector.
Fever, chills, body aches, headache appeared approximately 11.5 hours post injection.  Treated with ibuprofen, then Tylenol.  Resolved after 60 hours post injection.  Tics in the torso developed approximately 16-18 hours post injection.  No treatment has been found.  Still occurring 6 days later with no improvement in symptoms
Tinnitus, loss of hearing acuity, ear pain/fullness onset several hours after vaccine (along with fever, fatigue, injection site pain). Improved after several days but never fully resolved.  Second dose  vaccine received 5/4/21. Same auditory symptoms  returned/intensified approximately 6 hours after dose. Again improved after several days but remain at present.
Child received vaccines listed below approximately 11am. Mom called about 4pm to state that the child had what appeared to be hives over body. Treated with Benadryl. Child appeared at the after hours clinic and MD disagreed with the 'hive' diagnosis and felt that uticaria was more likely.
A disc shaped macular rash about 5 cm by 3 cm  at the injection site. Pain and tenderness at the site.  Site of injection is getting better   Slight dull pain in the lower back about an hour after injection subsided next day. took Motrin 400 mg.
pt recv vax & 1-2wk later pt devel sx that appeared consistent w/infantile papular acrodermatitis;the reporting dermatologist made the dx p/observing the pt in late JAN, early FEB98;
Immediate pain and  swelling of injection site, not previously noted with first vaccine dose. Onset of fever and muscle aches/weakness 12 hours after vaccination; symptoms continued for 24 hours.  No other symptoms developed.
Tested positive for COVID-19; Tested positive for COVID-19 / mild cough and loss of taste/smell; Congestion; Headache; This is a spontaneous report from a contactable nurse (patient herself). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration in left arm on 25Feb2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was none. No known allergies. Concomitant medications included levonorgestrel (MIRENA IUD). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269) on 04Feb2021 (at the age of 29-year-old) as a single dose in left arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, patient received the second dosing of her Pfizer COVID-19 vaccination on 25Feb2021. On 19Mar2021, patient tested positive for COVID-19. Her symptoms include congestion, headache, mild cough, and loss of taste/smell on 19Mar2021. The adverse events resulted in emergency room/ department or urgent care. On 19Mar2021, the patient underwent lab test and procedure which included nasal swab / rapid COVID-19 swab: Positive, COVID-19 PCR: Positive. No treatment medications was received for the adverse events. The outcome of the events was recovering.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure cannot be excluded.
After my vaccine the Aid didn?t have any chairs or places to wait so they suggested I go to my car and wait 10 min.  I went to my car and about 5 min after my shot I began to feel tingling in my cheeks like they were going numb  and weak and constriction in my throat.  Swallowing water took effort.  I was scared my throat was closing so I immediately went to urgent care.  They took my vitals and gave me Benadryl and steroids (medrol dose pack).  I went home and had flu symptoms (chills, fatigue etc, which was expected).  But the tightness in my throat didn?t release.  Could breathe through my nose but more difficult through my mouth.   My cheeks and face were numb making it difficult to chew food for at least  2 weeks and I had tightness in my throat as well during that time including difficulty swallowing due to weakness.
Pt lying in mom's arms after vaccines given and fainted after 3rd vaccine. Patient recovered after ammonia ampoule held under nose. Pulse was 88. Color did not change. Recovered fully after 5 minutes.
Within 5-10 minutes of receiving MMR #2, pt. developed erythema and induration of approximately 4-5cm surrounding vaccination site.  Pt. received 3 other vaccinations at the same time, none of which developed this rxn.  Pt was given 12.5mg diphenhydramine po and within 20 minutes, her symptoms had improved.  Pt. was discharged home 30 minutes after receiving diphenhydramine.  No further need for medical tx has been reported since.
Behavior Changes. Significant lack of response, not remembering words and hard time communicating. Very Aggressive.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-OCT-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. On or about 17-DEC-2012, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
I am pregnant and received my two doses of the Moderna covid vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and received my two doses of the Moderna covid vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and received my two doses of the Moderna covid vaccine). On 23-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and received my two doses of the Moderna covid vaccine) had resolved. Not Provided          No concomitant medications were provided No treatment medications were provided  COMPANY COMMENT: This case concerns a 30-year-old, female patient with no medical history disclosed, who experienced vaccine exposure during pregnancy with no other adverse events. The patient received the first and second dose of Spikevax (Moderna COVID-19 vaccine) on unknown gestation period. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 30-year-old, female patient with no medical history disclosed, who experienced vaccine exposure during pregnancy with no other adverse events. The patient received the first and second dose of Spikevax (Moderna COVID-19 vaccine) on unknown gestation period. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Headache.  At 10:34 am  BP 137/71. At 10:39 am 112/78.
Pain in joints, bil. lower legs, bil. arms, chills, slept for 24 hrs, on & off. Started at 11 pm on 4-15-11. Symptoms gone 4-17-11 at 8AM.
swelled up at injection site down to elbow; red; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelled up at injection site down to elbow), ERYTHEMA (red) and MYALGIA (muscle soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE SWELLING (swelled up at injection site down to elbow), ERYTHEMA (red) and MYALGIA (muscle soreness). At the time of the report, INJECTION SITE SWELLING (swelled up at injection site down to elbow), ERYTHEMA (red) and MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Acute cellulitis. Appeared evening of administration. Patient hospitalized for 3 days.
it recurred as a severe headache; mild headache/lingering mild headache; This is a spontaneous report from a sponsored program support via a contactable consumer (patient) reported for herself. A 78-year-old female patient received second dose of BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 13Feb2021 (age at vaccination was 78 years) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included prednisone acetate. The patient previously took first dose of BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. The caller declined transfer as she had already given all of her information. She was open to being followed-up with by the safety department and indicated that email was the fastest way. The caller was a consumer who completed her COVID-19 vaccine series on 13Feb2021.  On 16Feb2021 and 17Feb2021, she woke up with a mild headache, which resolved. On 19Feb2021, it recurred as a severe headache, and caller stated she was worried she had a brain tumor.  She went for an MRI, which came back normal.  Her headaches persisted, and her provider prescribed Prednisone 20mg for 5 days, which she thought cured her headache. The headaches had persisted, but she reported they were "minor" and "annoying". Typically her headaches were present in the morning and resolved throughout the day.  Her headache, today, persisted which prompted the call to report. She asked whether they had reports of this happening to anyone else. She received a response stating that headaches are commonly reported AEs, which are more common after the second dose. Provided usual duration from attached "CONS -How long side effects last final (v2.0)". Directed caller back to HCP for treatment advice,  if she were to experience additional symptoms, or if she forgot anything in her report. The caller called because she took the vaccine in February and has had a lingering mild headache since then. She wanted to know if it was because of the vaccine because she never had headaches. The outcome of event mild headache/lingering mild headache (first occurrence) was recovered on an unknown date in 2021. The outcome of the event it recurred as a severe headache (second occurrence) was unknown. Follow-up #01 (14May2021): New information received from support via a contactable consumer (patient) included: Details regarding reporter's contact information availability and medical questions addressed by the program forwarded/referred to Medical Information. Follow-up #02 (14May2021): New information received from support via a contactable consumer (patient) included: No new information and adverse event added. Follow up attempts are completed. No further information is expected.
This spontaneous report was received from a Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot L039660, expiry date 04-FEB-2018 (dose number, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effect were reported. There were no product quality concerns (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M038846 with expiry date: 26-APR-2018 (dosing details were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 0 C to 1C for 15 Hours and below 0C (-1C) for 47 Hours 30 Minutes. Previous temperature excursion included 9C to 25C for a duration of 16 hours. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006518.
she had terrible pain and it was in her right arm where they gave the shot; where they gave the shot was red; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263), via an unspecified route of administration, in right arm, on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included allergic to shellfish, like crabs, cancer of 21 years. There were no concomitant medications. On Her and her husband both got it and she thought maybe she had a pulled a muscle and her husband said it might be the shot because where they gave the shot was red and then a couple days later the shoulder and the arm hurt, she had terrible pain and it was in her right arm where they gave the shot. She is supposed to go 03Mar2021 to get the second shot. She says it is a pain in her shoulder and it goes down her arm. She first noticed it about 3 days ago (13Feb2021) and it comes and goes. She did have shot in that arm and she can see the faint color of it, it was red in that one spot. She has been taking Tylenol and putting a heating pad on it but it doesn't do much, it helps for a while then it comes back. There was a red spot right after she got home from getting it, it was a little red. She could see it. It lasted a couple days later and she can still see it faint, where she got the shot but it is not really bright. The redness was a dime size where they gave the shot. it may have been a little wider, it is hard to tell. Description of Product Complaint: Patient reporting her experience after having the first dose of the Pfizer COVID 19 vaccine. She has had pain in her right shoulder and going down her arm. She has red spot where they gave the injection about a dime size in diameter. She has been taking Tylenol and putting a heating pad on it but it doesn't do much, it helps for a while then it comes back. Lab test included weight is between 145-147 lbs. The outcome of event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201550 Same reporter, different patients/ events.
Student received IM H1N1 vaccine at 1:50 pm, complained of dizziness, nausea at 2:00 pm. Color pale. No wheezing, rash or swelling of throat. Vital signs stable. Student observed at school for 1 hour mother contacted, student to home with mother at 3:10 pm.
Axillary lymphadenopathy with neuropathy to hand and fingers requiring nsaid, topical analgesic.  Off work x3 days after onset on 1/4/2021
Registered Nurse Specialty:  Registered Nurse ED Triage Notes    Signed Date of Service:  10/19/21 0236 Creation Time:  10/19/21 0236        Hide copied text  Hover for details  Pt states got booster 3pm Saturday, developed fever at 8pm, has had fever, headache, chills, body aches ever since.  Not hungry, but drinking.  States takes ibuprofen and feels better but then it wears off and the temp comes back.  Temp prior to coming in 104f
arm soreness; arm soreness,body aches; headaches; 39°C fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), MYALGIA (arm soreness,body aches), HEADACHE (headaches), PYREXIA (39°C fever) and CHILLS (chills) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033f21a) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (lot# w0158) on 09-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (lot# eu00171) on 26-Apr-2021.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and MYALGIA (arm soreness,body aches). 02-Nov-2021, the patient experienced HEADACHE (headaches), PYREXIA (39°C fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm soreness), MYALGIA (arm soreness,body aches), HEADACHE (headaches), PYREXIA (39°C fever) and CHILLS (chills) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Headache, Myalgia, NauseaVomiting, malaise, chills, sore throat
When the patient was seen at his June doctor appointment, he was diagnosed with A fib. This was the first time he has had A fib and was concerned it developed after  his COVID vaccine and patient requested a report be made.
swollen glands; sore throat; body aches; headache; arm sore; very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (ongoing); "sensitive to medications and has to take the "child dose" of most OTC medications" (ongoing). The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "not recovered", described as "swollen glands"; OROPHARYNGEAL PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "sore throat"; PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "not recovered", described as "arm sore"; FATIGUE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "very tired". Additional information: The events were reported as mild and ongoing. The patient was concomitantly taking unspecified antihistamine for seasonal allergies. Dose 2 was scheduled on 08Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 9NOV92 noticed knot & redness 10NOV92; itching localized to erythemic area; upon exam large are of upper arm is reddened & warm to touch, sl induration where vax given;
fever to 101 A 3 hrs p/vax; generalized sz activity 12 hrs p/vax w/short post ictal state;
This spontaneous report as received from a registered nurse. The reporter reported than at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
flushing, nausea, vomiting, diarrhea, chest tightness. Gradually improving over subsequent 30min. Treated in ED with 1 liter IV fluid, ondansetron 4mg, acetaminophen 1000mg.
65-year-old female received COVID-19 vaccine at the Urgent Care Center.  She waited around 15 minutes after the vaccine and had no reaction.  About 10 minutes later while in her car she noted a numb feeling of her tongue and that the tongue felt swollen but was not necessarily swollen.  She subsequently felt that her lips were tingling and had swollen feeling.  She returned to the facility and was given an EpiPen shot at around 10:15 AM.  Patient was transferred to ED via ambulance. Gradually the symptoms resolved and was discharged from the ED in stable condition
pt recvd vax & w/in 20mins high pitched unconsolable crying;fever started rising peaked @ 104 ax w/in 4hrs stayed 7hrs total w/APAP & tepid bath, w/in 3 dasy p/shot;started occassional periods head jerking, eye blinking; called MD 3x's