chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache turned to migraine I middle of night. Felt delirious , couldn?t even sip water, dry heaves, extreme nausea, literally thought I was going to die, until after several hrs, was able to swallow an imitrex for migraines.
I developed a very large raised welt at the injection site which has been slow to resolve. Also headache, muscle soreness particularly around my upper back and neck, as well as fatigue.
Vaccinated with Pfizer in April 2021. Has hystory of liver cirrhosis and heart problem. Currently has sore throat, cough and weakness.
Dose 1- sore arm Dose 2- chills. Couldn?t get warm that night. Chills on and off all the next day. Fever 101 degrees. Lethargy  for 24 hours.  Needed to lie down and sleep all day.
PT HAD SYNCOPAL EPISDOE  WITH NAUSEA  VOMITING HYPOTENSOVE  AT 93/42 AFTER SEVERAL MIN OF RESTING PT BECAME MORE ALERT WITH  STABILITY  BP 106/53
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 119th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Small rash at injection site 5/13, vaccine adm 5/5/16.
(L.) anterior thigh with a 15-20cm diameter patch of erythema, centrally with 12-15 vesicular lesions, no drainage. Area warm and indurated, but no pain on palpatation. Temp-97.7 no itching, no discomfort. Treatment - Benadryl q 6 hours PRN.
Severe pain in the arm. Fever and chills with uncontrollable tremors. Severe headache, tiredness and sleepy. Migraine lasting approximately two weeks. It made me useless to work effectively and concentrated, as well as not being able to take care of my children responsibly for about a week.
Flu shot October 4th. Product of Sanofi Pasteur lot UT4721AA expiration 04/08/14. Onset 10/8 of mild malaise; shaking rigors 8/10 with severe myalgia and weakness (so severe I thought it was the beginning of polymyalgia rheumatica); October 11th very sensitive unable to sleep more than 1 hour having to adjust position due to sensitivity of muscles (pain) and nausea and anorexia still without fever but episodes of shaking chills (can't get warm) and full rigors. October 14th no endurance and decreasing malaise and aches.
This case was reported by a nurse via call center representative and described the occurrence of muscle soreness in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness, feeling unwell and pain. On an unknown date, the outcome of the muscle soreness, feeling unwell and pain were unknown. It was unknown if the reporter considered the muscle soreness, feeling unwell and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that the 2 or 3 patients have complained of muscle soreness, achiness, and feeling not well following vaccination with SHINGRIX. The healthcare professional stated this as a general statement and was not able to provide specific details concerning any particular patient experience with the vaccine.
Several hours later had one large hive on side of head.  Ran 101.7 fever while four hours after taking Motrin. Heart beat was really fast. We watched him closely through the night. Better by morning.
6/23/17 - 10:00 AM Adm. vac. PREVNAR 13 and PENTACEL (DTAP-IPV-HIB). 10:05 - Mom states baby (R) leg with blue. Baby unresponsive and in cold sweat. Dr. exam baby - glucose 123 - HR 110-90 - Resp 16-24. Baby responding to stimuli. EMS called. Baby sent.
9/13/2023 patient felt sick to his stomach, very nauseous all day. Noticed redness on face and hot to touch beginning last night 9/13/2023 and grandma gave liquid benadryl. This morning 9/14/2023 redness somewhat diminished but rash noticed on upper body. Pill form benadryl given today 9/14/2023. Injection site left upper arm deltoid now has a noticeably raised knot and is very sensitive and tender to touch. No known reactions to any other injections prior to this.
My right leg in the bottom, below my knees, it feels weird; My leg hurts; Leg is swollen and it feels soft to the touch; the back of my leg like the whole leg is swollen in the bottom; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW0150, Expiration Date: 31Jul2021) 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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "My right leg in the bottom, below my knees, it feels weird"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My leg hurts"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Leg is swollen and it feels soft to the touch; the back of my leg like the whole leg is swollen in the bottom".  Additional information: Last 3 days the patient was experiencing leg one of (incomplete sentence), right leg in the bottom, below knees, it feels weird, the last 3 days it hurts, the patient leg hurts. This started on an unknown date the patient feel like need to put legs wrap because they were in pain, the patient put them with like a warm comfort and then 29Apr2021, leg was swollen and it feels soft to the touch, it's like swollen more than the left leg (Clarification unknown) and the pain was like going up leg now and then in the back it feels weird. So, the patient don't know what to do, the patient asked whether to contact you guys or need to go to doctor or the patient can speak to someone that can help." The patient also stated, "Not the back but the back of the leg like the whole leg is swollen in the bottom. The patient can feel the difference between the left leg and right leg. The patient never had any medical issues and this is the first time this happens to the patient.  No follow-up attempts are possible. No further information is expected.
Injection site reaction in left arm.  3 days later started having similar pain in right arm deltoid muscle.  Pain in right arm got worse with pain limiting range of motion.  Even using left arm, could cause severe pain in right arm.  This has continued for 2 months.  Saw an orthopedic PA  on May 12, 2022 for the pain.  He said it could be bursitis or rotator cuff tendonitis.  He gave me a steroid shot in my right shoulder.  It didn't help.  I took a 5 day regimen of prednisone.  That did not help either.  He recommended that I get a MRI and see a shoulder specialist.
dementia; Shaking; chills; Headache; This is a spontaneous report from a contactable consumer (patient) via Medical information Team. A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number: unknown) via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient was having a reaction to the COVID shot. She had chills most of the day on 14Apr2021 (today as reported) and they just now subsiding. They were so bad she couldn't hold still she was on the phone for three hours waiting to speak to someone and she had chills for several hours. Upon follow-up received on 14Apr2021, the patient reported that she has dementia on an unspecified date. She was calling about the COVID shot that she got yesterday at (Vaccine facility name). She was having chills and shaking (on an unspecified date). Yesterday on 13Apr2021, she had a headache and she didn't think about attaching it to the shot. The patient was asking what does she do about it, should she go to the ER or what should she do? The outcome of the events was unknown. The event dementia was considered as serious (medically significant).  No follow-up attempts are needed. information about lot/batch number cannot be obtained.  Follow-up (14Apr2021): New information reported from a contactable consumer (patient) includes: new events (dementia, shaking, headache). Seriousness assessment was also upgraded as serious (medically significant).  Information about the Lot/batch number has been requested.
Headache & NauseaVomiting Narrative:  Stayed home from work with these symptoms
After patient finished 15 minute observation time he did his grocery shopping. He said he was out in parking lot (90+ degrees) feeling nauseous. He sat in car and felt better then again did not feel well. His girlfriend helped him back into the store. He came to the pharmacy yellowish in palor. I asked if he was ok then while I came around the counter he began to pass out. He fell back a customer prevented him from hitting his head. I approached him and checked his status. He opened his eyes and was breathing ok. He said he needed an Epi-Pen. I asked a customer to call 911, my tech stayed with him while a retrieved the Epi-Pens. When I returned he was still resting comfortably, realizing he breathing was regular and there were no signs of anaphylactic reactions, i did not give the EPI-Pen. He stayed laying flat describing how he felt, breathing well but feeling light headed. The First responder arrived and took over. After reviewing his vitals they opted to take him to the hospital.
After 1 week of no problems, Cellulitis in left hip (injection site) treating with Augmentin.
Received second Pfizer covid vaccine. Felt extremely fatigue, joint pain, and pain in the injection site Friday night at work. Saturday night felt extremely fatigue.
developed hives neck and abdomen. redness , swelling and induration at the site of the injection L arm. Tender and warm to touch. some SOB, anxiety, throat discomfort. No lips or tongue swelling, some difficulty swallowing? Prescribed antihistamines. Prednisone  and epi pen. Got better the second day
NONE. VACCINE WAS SIMPLY GIVEN EARLY 25 DAYS BEFORE HIS 4TH BIRTHDAY.
It started later that same evening. My throat and tongue started swelling and closing. I gave myself a shot with a Epipen. I didn't go to the doctor, I waited for the next day and I called and did a Teladoc. The prescribe my some steroids for 7 days. After taking the meds, I was fine after that. The doctor advised me not to get anymore vaccines.
severe headache; extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686), intramuscular in left arm on 28Dec2020 at single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included metoprolol. The patient was not pregnant. About 8 hours after the first shot  in Dec2020, the patient had extreme fatigue and a severe headache for about 24 hours. The facility where the most recent COVID-19 vaccine was administered was in the nursing home. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 2:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 2:43 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 83.78.  Concomitant products were not provided.  On 27-feb-2021, vials were stored in cooler 1, at following time and temperature respectively,  8 AM: 35, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34  and 5 PM: 35. Total doses given for the day was 199 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9AM vaccine was moved to fridge on 24-Feb-2021 and 9 AM. Vial was moved to clinic on 27-feb-2021 vials were sent to clinic. Vaccine BUD date was 26-mar-2021 for 9 AM respectively. On 27-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively,  8 AM: 48, 9 AM: 35, 10 AM: 35, 11 AM: 38, 12 AM: 43, 1PM: 41, 2 PM: 41, 3 PM: 41, 4 PM: 40. Condition of vaccine prior to administration was not frozen. 9AM vaccine was moved to fridge on 30-Mar-2021. Vial was moved to clinic on 03-Apr2021 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021 for 9 AM respectively.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
incontinence; fever of 102-102.4 Degrees Fahrenheit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever of 102-102.4 Degrees Fahrenheit) and INCONTINENCE (incontinence) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 013A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VALSARTAN, FELODIPINE (PLENDIL), METOPROLOL, ATORVASTATIN, OMEPRAZOLE, ALFUZOSIN, LEVOTHYROXINE SODIUM (SYNTHROID), FEXOFENADINE, FINASTERIDE (FENASTEN) and VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (fever of 102-102.4 Degrees Fahrenheit). On 09-Apr-2021, the patient experienced INCONTINENCE (incontinence). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 102-102.4 Degrees Fahrenheit) and INCONTINENCE (incontinence) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications included Flonase and tums.  On 09-Apr-2021 patient started having a fever of 102-102.4 Degrees Fahrenheit and later it was down to 99 but right no it was at 103.8 Degrees Fahrenheit. He stated he had outpatient surgery two weeks ago where he received anesthetic. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her second dose of the Pfizer COVID-19 mRNA vaccine and subsequently developed generalized pruritis five minutes after. She developed similar symptoms 6 hours after receiving the first dose, but this time was more severe. She arrived to the emergency department and after 15 minutes began to develop a cough, increased work of breathing, and voice changes. She received 0.3 mg epinephrine subcutaneously and albuterol nebulizers. Over her three hours in the department she received famotidine, 125mg methylprednisolone, diphenhydramine, an additional dose of epinephrine and 4x albuterol nebs. However, he dyspnea continued to return, and she was admitted. Improved overnight and was discharged HD2. widespread pruritis initially 5min post-Pfizer vaccination (2nd dose). Progressed to severe coughing, dyspnea requiring repeated doses of epinephrine and albuterol. Admitted to intermediate unit for further cares. Noted to have had mild delayed pruritis prior to first dose of pfizer vaccine.
Initial report received from a health care professional on 18 June 2013. This case represents one unidentified patient who is part of a cluster of a total of 4 patients from the same reporter, who received the same vaccine ADACEL (lot number of C4344AB). One patient, represented in this serious case involved a serious event of cellulitis. The other 3 patients involved non-serious events of redness, warm to touch and lump at injection site, that are captured in non-serious case number 2013-07027. An unidentified patient with no concurrent illnesses, and who is part of a cluster of a total of 4 patients from the same reporter, had received an intramuscular injection of ADACEL (lot number C4344AB) on an unspecified date. The patient returned to the office after vaccination on an unspecified date with symptoms of redness, warm to touch, and a lump at the injection site. The patient was treated for cellulitis with unspecified treatment. At the time of this report, the patient had recovered. Documents held by sender: none.
Information has been received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 05-JUL-2017, the patient was vaccinated with the third dose of ROTATEQ (lot # M002254, expiration date 15-NOV-2017) (oral, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) on 13-JUN-2017, which lasted for a 18 hours. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010591: US-009507513-1708USA005381: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012777: US-009507513-1709USA012776.
Patient took third dose of moderna COVID-19 Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient took third dose of moderna COVID-19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient took third dose of moderna COVID-19 Vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Patient took third dose of moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
On May 16, 2023, my wife was walking outside. She was limping, her helper was struggling to keep her upright, she has no control over her right hand or leg. She can no longer feed herself; she helps walking or she will fall. I called to get an appointment with her doctor, his office told me to take her into the emergency room. I will be taking her into the emergency room tomorrow.
Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.
Chills unable to get warm, loss of appetite, headache and congestion, fever of 101, fatigue