chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As soon as I got the shot I felt ?strange? . all over.  We waited a bit and then the nurse took my BP. It was sky high. 210/180 They took it a couple of times and even changed machines.  Then the took me in a wheelchair to the ER. On the way I could not answer some questions  or my answers were slow. According to my husband I slumped a bit. And answered questions in my native tongue. In the room they did all kinds of  tests.  BP was still high, but came down . After a few hours my ?fog? in my head cleared and I felt ? normal ? again.  They let me go around 11 pm. The doctor said it was NOT the vaccine, but I disagree with her. I felt good till I got the shot. She says I had a syncope vasovagal. But that occurs with low BP. I had high BP.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 6-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918:
Heart palpitations; sore injection site; body aches in the back; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: 013L20A) via an unspecified route of administration on 05Feb2021 08:45 in left arm at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient had heart palpitations after vaccine - only lasting a few seconds, sore injection site and body aches in the back - both of which were relieved with naproxen sodium (ALEVE), small headache - went away shortly after getting out of bed. Event onset date reported as 05Feb2021 12:30. Treatment received for the events. The outcome of the event heart palpitations was recovered on 05Feb2021, of other remain events was recovered in Feb2021.
COVID-19 antibody test positive; This is a spontaneous report from a Pfizer-sponsored program from (patient).  A female patient of an unspecified age received the two doses of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, both on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Jan2021, she got her blood sample results as a part of community research. Blood sample results showed that the patient was exposed to COVID-19. Clinical outcome was unknown at time of this report.   Information on the lot/batch number has been requested.
Pt had hives and Angioedema symptoms. Onset within hours of administration of vaccine. He took Benadryl at home that seemed to lessen his symptoms but they lingered for greater than 1 week.
Fever, erythematous, papulovesicular rash, varying stages : face, trunk, arms
Fatique; Headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and FATIGUE (Fatique) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache). On 12-Mar-2021, the patient experienced FATIGUE (Fatique). On 11-Mar-2021, HEADACHE (Headache) had resolved. On 14-Mar-2021, FATIGUE (Fatique) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was provided.  No treatment was given for the symptoms.
Student present approx 5 hours after vaccine administration with high temp 102 degrees and swollen lymph. Later diagnosed with tonsil abscess. Likely not RA.
Information has been received from a nurse referring to a female patient of unknown age. There was no pertinent medical history, concurrent condition, concomitant medication or drug allergy described. On an unspecified date in November, 2015, the patient was administered a dose of improperly stored dose of RECOMBIVAX HB lot # K019502, expiration date unspecified (strength, dose and route were not reported). The vaccine was stored under an unspecified temperature for 3 weeks. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Increase in Crohn's flare ups.  2 in a one month span following vaccination.  Also worsening of hidradenitis suppurativa symptoms
Arm felt heavy in few hours after. Few hours (1-2) cold, shivers, 1 emesis, fell asleep, next day low grade headache, fatigue, slept all day. Normal d #3.
The morning after I had my shot, just as I was finishing taking a shower, I felt an awful wave come over me that made me feel like I was going to pass out. I quickly exited the shower, and laid down on my bed where I wouldn't fall. Within a minute, I knew I was going to vomit, which I did. As soon as the vomiting stopped, I felt 100% fine. The only other reactions I had were the usual sore arm and redness at the injection area, and less energy than normal for a couple of days.
Patient noted tenderness and edematous at site of injection without redness. Patient also noticed under left axilla without lump noted. Patient had breast exam 10/15/06 without tenderness noted at that time. Patient due for mammo 11/15/06.
pt recv vax 10APR96 & on 27SEP96 pt inadvertently recv 2nd dose of vax & exp tremors;also exp episodes of body stiffening for 10-15min;irritability, clenched fists;inc susceptibility to noc terrors;pt seen by neuro-vesicular lesions
swollen lymph nodes in axillary under right arm where had shot at and armpit area as well; pain; cannot raise her arm all of the way up / where she had the shot; having pain or pressure in the arm area / where she had the shot; having pain or pressure in the arm area / where she had the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Apr2021 11:30 (Lot number: ER8731) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EM8733 in left arm at 11:30 as dose 1, single), administration date: 27Mar2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 17Apr2021, outcome "not recovered", described as "swollen lymph nodes in axillary under right arm where had shot at and armpit area as well"; PAIN (non-serious) with onset 17Apr2021, outcome "not recovered", described as "pain"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 17Apr2021, outcome "not recovered", described as "cannot raise her arm all of the way up / where she had the shot"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 17Apr2021, outcome "not recovered" and all described as "having pain or pressure in the arm area / where she had the shot". The events "swollen lymph nodes in axillary under right arm where had shot at and armpit area as well", "pain", "cannot raise her arm all of the way up / where she had the shot", "having pain or pressure in the arm area / where she had the shot" and "having pain or pressure in the arm area / where she had the shot" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, pain, vaccination site movement impairment, vaccination site pain, vaccination site discomfort.  Additional information: It was further reported that the lymph node swelling has gotten larger and patient was in pain. Patient cannot raise her arm all of the way up without having pain or pressure in the arm area. Patient stated that she cannot wear her bra. The patient called her physician (where she got the vaccine) and her doctor said to wait a week because it may not be from the vaccine. Patient stated she doesn't know how she stated that, because she was healthy, and she has been working with no problems until she took the vaccine.   No follow-up attempts are possible. No further information is expected.
Patient was given pneumovax in right deltoid and within a minute he complained of itching at the site.  After 15-20 minutes, site was red, hot to touch.  Swollen and had an indurated white area 1/4x1/4 inch in center.  Red area was 1.5x2 inches.  Resolved after 30-35 minutes with ice pack.
About a little over a month after receiving my second dose of Moderna, my mouth started having very weird reactions. It started with my upper lip starting to go dry on the inside of my mouth. Over the course of about a month, it got more severely dry, and started moving to my lower lip, again inside my mouth. It got so bad that my lips would get stuck on my teeth as I tried to talk. Nothing would quench the dryness. I tried water, juice, other drinks, foods, hot things, cold things, I tried the dry mouth mouthwash, nothing helped.  Then around the beginning of September, the dryness moved to my tongue as well. My mouth was so dry all of the time. My taste buds started being weird, food and drinks just didn?t taste right. Water tasted dirty. Even filtered water tasted like I was drinking dirt. I finally went to my dentist it got so bad. He couldn?t find anything wrong, my salivary glands were working, but he couldn?t figure out why I had dry mouth. He recommended I get tested for the auto immune disease Sjogrens as my first step. It took several weeks, all while having this terrible dry mouth were I couldn?t speak properly and everything tasted bad, before I could get in with my primary care doctor to get tested. They tested many auto immune diseases. About a week or so later, everything came back normal. She had no idea why it was happening, and sent me on my way saying to just wait it out and see what happens. This brings me to around the beginning to middle October. Still no answers. I started noticing the dryness not being so bad. Over the course of October, I finally got my tastes back, and starting to go back to normal. By mid-November I was back to normal. When I went in for my 6 month cleaning with my dentist, they asked how it was going. I mentioned it was back to normal, thank God, and I never figured out what it was, but never want to go thru that again. She asked if I?d gotten my vaccine previous to this, and I said yes, about 6 weeks prior. She mentioned they have seen a significant increase in weird mouth things like this following the vaccines. This is the only explanation that ever made sense. So here I am reporting it.
Vaccine administered expired 3-25-22.  Informed patient once mistake was discovered on 4-4-22.  Offered for patient to redo the dose and patient refused.
I finally tested positive for Covid in Apr2022; I finally tested positive for Covid in Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old patient received BNT162b2 (BNT162B2), on 28Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "I finally tested positive for Covid in Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: I finally tested positive for Covid in Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Temp 104, continuous crying, limp seen @ ER dx as having early ear infect- Amox given;
Narrative:  Pt was a 73 YO male with PMH of CHF, peripheral neuropathy, DM2, HLD, HTN, OA, hypothyroidism, depression, and sleep apnea who passed away on 11/1/2021. No details provided about patient's passing; Facility was informed of death by his wife. No evidence that death was caused by COVID-19 vaccine.
pt recv vax & exp shingles w/vesicles overlaying lt deltoid muscle;there was a maximum T99;pt also exp diff in elevating the lt leg;
pt recv vax 7NOV95 & 17NOV95 pt devel lt testicular mass which was non painful;a scrotal sonogram was performed & a lab eval revealed an alpha fetoprotein of 4,000, inc lymphocytes & WBC 6.2 w/53% lymphocytes;MD reported poss yolk sac tumor
face felt hot; burning lips; lips dry; achiness; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (face felt hot), ORAL DISCOMFORT (burning lips), LIP DRY (lips dry) and VACCINATION SITE PAIN (achiness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HOT FLUSH (face felt hot), ORAL DISCOMFORT (burning lips), LIP DRY (lips dry) and VACCINATION SITE PAIN (achiness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Ache, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (face felt hot), ORAL DISCOMFORT (burning lips), LIP DRY (lips dry) and VACCINATION SITE PAIN (achiness) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Right shoulder arm pain/muscle pain for the past 4 weeks. No changes, no rash.
p/vax pt devel severe pruritus;had hives @ inj site-now generalized;recv DPH, solumedrol & resp therapy tx as devel  SOB p/arrived in ER; adm to ICU;Annual follow-up dated 11/22/00 provided no additional data.
Fever to 102 degrees. Nausea, vomiting, body aches. RUE swelling/localized. Improved N/V temp-decreasing as left.
Felt warm, felt like I was going to pass out. Shaking, heart racing - went to ER. SVT meds: face red, chest red - no rash.
Administered vaccine to upper left arm, IM, FLUZONE HD on 09/21/2015, patient developed a severe rash on lower tricep (right above elbow), that started to clear gradually.
Itching, erythema and soft tissue swelling on (L) upper arm, warm to touch. Night sweats. V/S: BP = 153/74, PR = 74; RR = 17, T = 97.1, O2 sat = 98% RA.
L arm of injection hot to touch; L arm of injection hardness; L arm of injection itchy; L arm of injection redness; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (L arm of injection hot to touch), VACCINATION SITE INDURATION (L arm of injection hardness), VACCINATION SITE PRURITUS (L arm of injection itchy), HEADACHE (Headache) and PYREXIA (Low grade fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS and CROMOGLICATE SODIUM (CROMOLYN SOD) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Low grade fever). On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (L arm of injection hot to touch), VACCINATION SITE INDURATION (L arm of injection hardness), VACCINATION SITE PRURITUS (L arm of injection itchy) and VACCINATION SITE ERYTHEMA (L arm of injection redness). At the time of the report, VACCINATION SITE WARMTH (L arm of injection hot to touch), VACCINATION SITE INDURATION (L arm of injection hardness), VACCINATION SITE PRURITUS (L arm of injection itchy), HEADACHE (Headache), PYREXIA (Low grade fever) and VACCINATION SITE ERYTHEMA (L arm of injection redness) outcome was unknown.            The patient did not take any treatment medication. Action taken with the mRNA-1273 in response to event is not applicable.
Catatonia-like symptoms - started approximately 2 d post vacc. - incoherent speech.
Started to get body aches around neck at 9:30PM, took Nyquil to help sleep. Woke up around 1AM with severe chills and body aches, tried to keep cool and took temperature around 2:30AM - it was at 100.4. Took Motrin at this time and took temperature again at 3:15AM, it was 101.2. It finally started to go down around 3:45AM and was 100.8. I was able to fall back asleep and didn't wake up until 10AM. I have had a bad headahce all day on 04/08 and have to keep alternating Tylenol and Motrin to keep fever down. Also very lethargic all day and slept most of the day.
Fussy for 3 nights (started about 1 week after vaccine). Rash maculopapular diffusely over whole body started about 10 days after vaccine - nonpruritic
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Medical history and drug reactions or allergies for the patients involved were not reported. On an unknown date the patients were vaccinated with PEDVAXHIB lot # M027882 (Expiration date: 14-APR-2019), M032147 (Expiration date: 14-APR-2019), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: Temperature: 32°F to 35°F; Time frame: 8 hours. Previous temperature excursion: No. No adverse were events reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008707.
Arm felt like it was broken. In the last 2 1/5 months I could hardly use it. I treated with ice, heat and Tens, For a couple days f months I laid  in bed and babied it. I finally have gotten where it is not hurting on a pain scale of 10 even with the Meds I am on
pain; soreness; pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness), PAIN IN EXTREMITY (pain) and PAIN (pain) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunization.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRALGIA (soreness) and PAIN IN EXTREMITY (pain). On 01-Mar-2021, the patient experienced PAIN (pain). At the time of the report, ARTHRALGIA (soreness), PAIN IN EXTREMITY (pain) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Mother called and complained of patient vomiting in the morning after vaccine administration for three hours non stop. Mom made appointment, but then canceled when patient got better later in the afternoon per mom. Patient has had vomiting episodes in the past.
10/8/08 patient received flu vaccine.  10/13/08 patient states she was itchy all over with a rash, and had burning sensation.  10/15/08 patient has hives and woke up with eyes swollen shut.  10/16/08 patient had hives in morning, but clearing up as day progressed.
Itchiness, Swelling of the arms, hives mostly all over the arms - upper chest- upper back; hives on lower extremities. Minimal swelling of the throat.
Information has been received from the Merck Pregnancy Registry from a physician concerning a 17 year old female with no pertinent medical history who on 06-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot # 656049/0187U). The patient was prescribed ethinyl estradiol (+) norgestimate (ORTHO TRI-CYCLEN) on the day she received the vaccination, but the reporter did not have any information regarding whether the patient was taking them or not. It was later learned that the patient was pregnancy when she received the vaccination. On 07-APR-2007, the patient experienced shortness of breath. On 14-APR-2007, she was hospitalized due to shortness of breath. It was later determined that the patient was experiencing a blood clot in her left leg, deep vein thrombosis (DVT). On 16-APR-2007, the hospital determined that the patient was 11 weeks and 1 day pregnant. The estimated date of delivery was 04-NOV-2007. Subsequently, the patient had an abortion performed for personal reasons not related to the vaccine. On 14-JUN-2007, the patient had not recovered from the blood clot and the reporter indicated that an unspecified blood thinner was recommended as treatment. At the time of the report, the blood clot persisted. The physician considered shortness of breath, abortion and blood clot in left leg to be other important medical events. The physician considered shortness of breath and blood clot in left leg to be immediately life threatening events. Additional information has been requested. 7/11/07-ER records received for DOS 4/14/07-DX: Recently diagnosed deep venous thrombosis. Possible pulmonary embolism. DX of blood clot 2 weeks prior. 4/14/07-attempted to terminate pregnancy, 12 weeks pregnant. Procedure not performed. C/O dyspnes on exertion. RX with Lovenox. No chest pain. Left let swelling and tenderness especially in popliteal fossa this has been ongoing for 2-3 weeks.  8/24/07-records received for DOS 04/07-04/10/07- DC DX: Deep venous thrombosis, left lower extremity. Intrauterine pregnancy. Status post trauma. Hypercoagulable state. Found to have a DVT of the lower extremity. Seen on 4/07/07-HX of few days before admission falling off the tub in the bathroom and hurting her legs.  PE: tenderness and swelling in left lower extremity at level of calf and distal area of left thigh. Peripheral pulses present.
pt recv vax AUG95 & 2 days p/vax pt devel an area which was 6 inches by 6 inches under the inj site that was red, swollen, & irritated;no further details were provided;