chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightmares; Sweats; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 25Jan2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was none. The patient was not diagnosed with covid prior to vaccination. He had no known allergies. Concomitant medications were not reported. On 26Jan2021 01:15 AM, the patient experienced fever, chills, sweats, body ache, pain in face, pain in back, pain in hip, headache for 2 days, vivid nightmares. 2 days later (at the time of report, 27Jan2021), the patient still had low grade fever, sweating, body ache and headache. No treatment was received for the reported adverse events. Outcome of the events was reported to be recovering. The patient was not tested for covid post vaccination.
Taken to ED with c/o numbness tingling to hands, feet & face nausea and vomiting. Was treated for symptoms and sent home. Brought back to ED on 9/26 with same and increasing symptoms and was admitted to neuro unit with preliminary dx of Guillain Barre syndrome.
This spontaneous report was received from a physician regarding patients of child age group. The patient's concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (dose, route, strength, lot, batch number and expiry date were not reported). Other suspect therapies included sterile diluent (dose, route, strength, lot, batch number and expiry date were not reported) for unknown indication. On an unknown date, the patient's experienced formation of autism and autism spectrum disorders such as Asperger's Syndrome (autism spectrum disorder). The outcome of the event was unknown. The causality assessment of the event was not reported. Upon internal review, the event autism spectrum disorder was determined to be medically significant.
SkinRash & UrticariaPruritus Narrative: 9 days after first (2/7/2021 rash developed) COVID-19 vaccine developed pruritic warm macular rash, that was pruritic x 6 hours, then remained remained and warm, it took 5 days for rash to fade. Mild rash present today, non-pruritic, not warm, not painful (rash is faded).
Son became very sick and threw up for going on 24 hours now. It's still on going. He also is dizzy and sleepy. No fever or sickness.
Tachycardia 180 to 200 rate approximately 36 hours post second dose of vaccine. Extremely sore arm at injection site.  Pain to jaw.  Lump in throat, difficult to get a deep breath.  Went to ER, monitored, IV fluids given, increase BP, 170/ 72.
I developed COVID-19 symptoms on 01/24/2023 starting with a fever; the next morning, I took a test which came back positive. The second day, I called my doctor because the fatigue started kicking in. I was prescribed Paxlovid for treatment; by the time I was on my fifth day of COVID-19, I had recovered. By the 8th day, I couldn't taste anything when I went out to dinner with my sister. I took another test which came back positive again. I had began developing IBF pretty severely as well. I was prescribed something that helped and was fine until a couple of months later. I tested on 03/16/2023 after some heavy congestion and sinus pressure; the test came back almost immediately positive. I thought I had pneumonia, but of course it was COVID-19 again. My doctor re-prescribed me Paxlovid again, but I declined taking it again. As of now, I'm slowly making a recovery with slow residual symptoms.
tenderness at the injection site; head to toe full body rash; This is a spontaneous report from a contactable consumer (reported for herself). A 60-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6200/Batch number was not reported), dose 1 via an unspecified route of administration on 16Feb2021 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient experienced tenderness at the injection site on 17Feb2021 and head to toe full body rash on an unspecified date in 2021. The outcome of the event tenderness at the injection site was resolved on an unspecified date in 2021 and head to toe full body rash was not resolved.  Follow-up attempts are completed. No further information is expected.
ended up in the hospital with pneumonia; ended up in the hospital with pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (174934).  A 70 year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant), outcome "unknown" and all described as "ended up in the hospital with pneumonia". The lot number for pneumococcal 20-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.
ASSESSMENT and PLAN Visit Diagnoses and Orders: 1. Postoperative hypothyroidism (Primary)   2. History of thyroid cancer   3. Adverse effect of COVID-19 vaccine   4. Arthritis of carpometacarpal (CMC) joint of both thumbs -     diclofenac (VOLTAREN) 1% gel; Apply 2 g topically 4 times daily as needed (Upper extremity pain) Apply to affected area.  Do not occlude.  Do not apply to broken/inflamed skin..  Dispense: 100 g; Refill: 0   5. Hearing loss, unspecified hearing loss type, unspecified laterality     Discussion:   - follow up with Endocrinologist regarding referral to ENT referral for surgery. Discussed ENT options. On the local Clinic 2 Dr.'s   - consider different brand of COVID vaccine with 2nd booster which would be due June 2022. She was pleased with this idea and reports it helped her to feel she had options.   - trial of Voltaren Gel on thumbs. Continue acupuncture.   Approximately 30 minutes were spent on this visit:             Pre-visit work: 0 Documentation: 5             Face-to-face exam/evaluation, education/counseling, orders: 25             Referral/communication with other healthcare professionals: 0 Review of separately obtained history: 0 Independent Results Interpretation: 0
body aches; diarrhea; stomach cramps; fever; felt like tongue was on fire; diarrhea.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea.), PYREXIA (fever), TONGUE DISCOMFORT (felt like tongue was on fire), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach cramps) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIARRHOEA (diarrhea.). On 12-Mar-2021, the patient experienced PYREXIA (fever) and TONGUE DISCOMFORT (felt like tongue was on fire). On 15-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach cramps). On 15-May-2021, the patient experienced PAIN (body aches). On 12-Feb-2021, DIARRHOEA (diarrhea.) had resolved. On 15-Mar-2021, TONGUE DISCOMFORT (felt like tongue was on fire) had resolved. At the time of the report, PYREXIA (fever), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN (body aches) outcome was unknown.            Concomitant medication information not provided.  Treatment information was not provided.   This case was linked to MOD-2021-047859 (Patient Link).
First headache, then arm stiffness, then body aches within 24 hours. Within 36 hours vertigo,  instability, nausea, vomiting, sweating still continuing just past the 72 hour mark but manageable with minimal activity. Not able to do regular work. Answering item 21 as recovering.
Pt stated that they never received a COVID vaccine and marked as such on their paperwork. Explained everything to patient who discussed vaccine hesitance about this first vaccine he was receiving. When the vaccination was billed, insurance showed previous history.  shows they received the Pfizer vaccine 08/05/21 at a different site.
PPROM at 36 weeks and 4 days - 3 days after vaccine. High risk pregnancy  due to a marginal cord insertion.  EDD 11/16/2023. Birth weight - 5lbs 10oz
102 fever, sore arm, body aches, migraine, chills and tremors and odd heartbeats.  Better after 36 hours
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling and pinprick feelings of hands, feet, and neck. Felt dizziness, generally unwell, and like he could fall asleep.
patient stated she took the vaccine on Monday 5/3/21 @930 and around 1pm patient stated she got home and just crashed (took a long nap). She felt very tired after the vaccine and on 5/5/21 she started feeling a lot of head pressure, light headed, blurry vision, and headache. No other c/o of symptoms.
Severe dysmenorrhea and dysfunctional uterine bleeding following first vaccine dose, and ongoing as of today, January 26th, 2022.
Started as a itching rash on my neck continuing down my chest and around to cover back . Very itchy then on to burning  like a sunburn and continuing today August 7th 2021 onto my arms half way to my elbows.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The highest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
About 8 hours after i began to feel tingling in my legs and feet. And a sense of numbness as well as losing feeling. I then went to the hospital to see what was going on.  This is still going on, I have had an EMG done at the clinic in another area where the doctor says i have autonomic periheral neuropathy, Idiopathic progressive neuropathy, and lumbosacral Plexpathy. Took cymbalta to relieve numbness and tingling, didnt help, now taking Lyrica,
Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022 at 6:25 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Jun-2022 at 6:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient received a full dose and no adverse events occurred at time of administration or were reported thereafter. No treatment medication was reported.
Vaccine administered (KINRIX) on 4/18/13 3pm. Noticed swelling and redness on 4/19/13 at night (8pm). Mother called 4/1/13 - 10:30 pm. Seen in office 4/22/13 at 3:45 pm. 10 cms x 9 cms indurating, fading pustules, tender, no localized lymphadenopathy. No fever father gave cold pack at home- relieved with oral antibiotics from 4/22/13.
Pt bit in head by bat - per his report - on 8/10/18 - Initial treatment started in ED . 8/13/18 - Received 2nd dose as noted above. 8/15/18 at 4:45 pm calls with c/o "pressure in head", visual disturbance - black spots in peripheral vision and heart pounding. Added has had memory problem since 1st dose - ie - can't remember why he went into a room. Recommended urgent care for evaluation. Pt reported to clinic on 8/17/18 for next dose of Rabies for post exposure (Day number 3). No complaints or concerns verbalized at that time.
Redness to left deltoid. Redness extends past deltoid area, and is approximately around 4 inches wide, and like 6inches long. Oval shaped. Redness is a little raised. Itching noted the evening prior. Redness totally subsided on 1/13/20
Developed a pinkish macular pruritic rash appearing mostly in patches on back, trunk and legs. It is most prominent on the back side of his kneejoint. The rash started approximately 72 hours after the second dose of Trinrix.
Pain in calf of left leg.  Two blood clots lower left leg, being treated with blood thinner Xeralta
PATIENT VOMITED AND BECAME LIGHT HEADED/DIZZY AND WAS TAKEN BY AMBULANCE.
This nurse attempted to vaccinate pt in L deltoid with pfizer vaccine needle. Needle punctured skin then retracted immediately. Vaccine was released where needle meets hub. Entire vaccine spilled onto pts arm. Pt did not receive vaccine. This nurse placed bandaid onto L deltoid puncture site. Reviewed situation with head nurse and MD, was advised to give pt new. Pfizer vaccine into R deltoid. Pt in no distress.
Patient was complaining about nerve pain he was experiencing shortly after the vaccinations took place. He is still receiving medical treatment for this.
The day after my booster shot the lymph nodes on that side got swollen, the second-day things got worst and now it has been three days and I cannot use my arm. It hurts to move it. I cannot sleep to the side because when the arm puts pressure on the nodes it hurts a lot.
Client is a 73 yo F with PMH of HTN, HLD, ESRD/CKD s/p renal transplant x2 (1994 and 1995, on immunosuppression) s/p bilateral AV fistulas, DVT on Coumadin, hypothyroidism, who tested positive for COVID on 9/7/2021 who then presented to Hospital with AMS and hypoxia to high 80s. She was vaccinated with Pfizer and got a booster dose given her transplant history. She was treated with dexamethasone x10 days and ceftriaxone and azithromycin for COVID PNA. She was weaned from 6L to 1L NC. She was ready for discharge 9/24 but labs showed elevated d-dimer 4739 from initially 388 from admission. CTA chest showed aneurysmal enlargement of the ascending thoracic aorta to 5.0cm c/f Stanford type A ascending aortic dissection without significant luminal compromise, extends into the aortic arch but is not extending into the brachiocephalic arteries. She was subsequently started on esmolol gtt transferred to hospital for further management. Upon reviewing images it was determined she was a poor surgical candidate and that the dissection was chronic. She has remained on Lopressor for adequate impulse management of the dissection, and has been followed by the Renal Transplant team during her admission for continued immunosuppression therapy and monitoring. She has been medically managed and is stable and ready for discharge to rehab on 9/29/2021.
possible administration of invalid dose to patient; never reached an acceptable range and was always warm by at least 2 degrees C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. There were 4 days temperature data for the freezer storage unit between 1-APR-2022 and 4-APR-2022, however it never reached an acceptable range and was always warm by at least 2 degrees C.   Treatment information was not provided.
Rash on right leg, where she got Prevnar & MMR. Rash surrounds the injection site at the top & outer side of her thigh. She has little red dots;  was itching @ rash.
Information has been received from a pharmacist concerning a hospitalized 63 yr old female pt who on 10Sep04 was vaccinated with two doses pneumococcal 23v polysaccharide vaccine. The pharmacist reported that a nurse administered the two doses of pneumococcal 23v polysaccharide vaccine to the hospitalized pt by accident. There was no product quality complaint reported. No other information was available. Unspecified medical attention was sought. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist, received via a Pfizer sales representative. A male patient of an unspecified age receive PREVNAR 13, via an unspecified route of administration on unspecified date at single dose for immunization. Medical history included kidney transplant. The patient's concomitant medications were not reported. On unspecified date after having a pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot, the patient had swelling at the injection site. Since the patient had had a kidney transplant, he couldn't take Ibuprofen. The outcome of the event was unknown. Information on the batch number has been requested.
had stroke after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FL3127) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: Unknown,MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "had stroke after booster".  Follow-Up (09Feb2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200223241 same drug/reporter, different patient, similar event
tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included polycystic ovarian diseases from an unknown date. Concomitant medication included metformin, omeprazole, apremilast (OTEZLA). Patient stated she got the vaccine on the 18th. She took the vaccine on 20Dec2020. Yesterday (25Dec2020) she started to feeling sick and today (26Dec2020) patient got tested and she have Covid. She reported to have tested positive for COVID today (26Dec2020) with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms yesterday at around 4:00pm. This was the first time she has taken the Covid test. The physician stated she didn't know the causality between the event and vaccine. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive test for COVID based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.