chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Manufacture's package: One 5ml multiple dose vial (10 doses). A single dose (0.5ml). On 12/13/2022, 10 full doses was administered to 10 patients. RN administered left over from the vial as a full dose to the 11th patient.
Unrelenting nausea, crushing headache, fatigue After 36 hours, went to urgent care and received IV fluids with nausea meds.  Not 100% but felt better. I HAD COVID APPROX 10 MONTHS PRIOR. TESTING SHOWED ANTIBODIES APPROX 6 MONTHS PRIOR
Erythematous papule rash both thighs developed 24 h after getting vaccines.
at approximately 6:45 PM. pt had a near syncopy episope from possible dehydration, did not eat or drink this date.  Pt vitals taken at 6:01 PM (BP: 130/100, P: 47), hydration via PO 4 (16 oz) H2O, repeated vitals at 6:15 (BP: 130/100, AOx3. Pt refused additional treatment and transport  at this time.  Pt walked out on his own with his father.
The day after the injection I noticed I had muscle aches and joint stiffness.  I read that this is a side affect so I thought it would go away.  It has not and if anything it has gotten worse over the past 5 weeks.  I Have to take Tylenol several times per day to be able to function.  While it does not stop the pain it does dull it somewhat.  Before the shot I was walking 2 miles per day for exercise but since that if I walk any distance my ankles hurt real bad.  I try to walk a couple of times per week but it hurts to walk any distance.  I do not know what to do.  I see my family care doctor next week and hopefully he can help me.
No additional AE reported; an expired PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 29-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S025133, expiration date not reported, but upon internal validation established as 15-SEP-2020) (dose, frequency, route and anatomical location not reported) for prophylaxis. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt recv vax 12JUL95 & pt awoke fr morning nap 13JUL95 @ 11AM cried like when had colic fr 11-4PM;stopped crying to nurse & for rice cereal;t101.3 (highest) -99.4;lethargic but awoke when placed in crib;
pt recvd vax;to hosp w/ suspected pneumonia 7 days;pneumonia confirmed by X-ray;rx:full ATB; blood cultures pos for HIB & RSV;HIB titers very high following hospitalization;
Couple weeks later, have experienced generalized weakness, chills, low grade fever, generalized muscle aches, unsure if related
Patient contracted COVID after being fully vaccinated fatigue, anorexia, muscle aches, chills, shortness of breath, weakness
Febrile seizure activity after dose. During the night pt was unable to sleep due to aches, pains, and chills. At approximately 0500 the pt developed a severe headache and took two ibuprofen to attempt to relieve the pain. Shortly thereafter the pt felt nauseous and light-headed, and began experiencing tunnel-vision. A short time after the pt began hearing his wife's voice from a distance and came to by being shaken by his wife. She explained that the pt was shaking uncontrollably, staring into the distance with a vacant expression and dull eyes. This state was experienced for approximately 1 minute. Following this experience the pt was nauseous and weak and unable to move for about 30-45 minutes.
seizure; The initial case was missing the following minimum criteria: Unidentifiable Reporter. Upon receipt of follow-up information on 16Jun2022, this case now contains all required information to be considered valid.  This is a literature report. The reporter is the parent.  A 13-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "seizure". The following information was reported: SEIZURE (medically significant), outcome "not recovered". It was reported that with first Pfizer dose the patient had a seizure within 30 days. Got the second vaccine in Dec, had another seizure. Had the third booster, and had 4-6 seizures a day. The patient was an active soccer player and a good student, now unable to play sports or attend class in person.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events seizures cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient said her arm became red and puffy 2 hours after vaccine was given on 9/10/19. She waited until the morning of 9/12/19 to go to an Urgent Care. She said she took Benadryl on her own at home in the meantime and it did not help. It was determined that she had a reaction and they prescribed a steroid taper and an antibiotic (she said she had a tooth or gum problem x 1 week prior and was told to f/u with dentist). They sent her home and she came to the pharmacy and told me about the reaction and showed me. Red and puffy from her shoulder to her elbow on the left arm. Said it was not painful unless touched. Said she felt fine otherwise. The area has not changed since she first noticed it. She has appointment with PCP on 9/18 and I told her to mark the area on her arm so she can see if it gets better. Told her to call us with any concerns in the meantime and that I would follow up with her over the next few days.
Patient fainted then started seizure immediately after receiving 3rd shot in right deltoid. EPI pen was administered soon as patient started to regain consciousness from seizure.
Received the shot around 6pm on March 26.  Went to sleep that night around 10:30pm, awoke around 4:30am on March 27. I went back to sleep at 7:30am, and after waking up around noon (this is not too unusual for me), around 1pm definitely noticed slight fatigue and body aches. Have taken extra strength Tylenol, and am continuing to drink lots of water.
Some flu-like symptoms; This is a spontaneous report received from a contactable nurse (patient's wife).  A male patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Some flu-like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2015 (reported as during the month of February 2015 vaccine exposed to 48 F) the patients were vaccinated with VAQTA (dose, lot number was unknown) which was improperly stored, exposed to 48 F for 26 days during the month of February 2015 (incorrect product storage). No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. No further information was provided. This case is linked several cases with the same reporter link. Additional information has been requested.
vaccine negatively effect someone who is nursing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (vaccine negatively effect someone who is nursing) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (vaccine negatively effect someone who is nursing). At the time of the report, EXPOSURE VIA BREAST MILK (vaccine negatively effect someone who is nursing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
This spontaneous report as receiving from a consumer referring on her husband refers to a male patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot and expiration date were not reported). Co suspect or concomitant therapies were not reported. The reporter stated that the patient experienced itchiness at the injection site after receiving ZOSTAVAX. The outcome for itchiness was unknown at the time of the report. This is one of two reports from the same source. Additional information has been requested.
Has had diarrhea since 2 days after taking the shot. Some itching/a few bumps here/there on body. Overall feeling of not well.
she was walking and was shaking, she had to sit down; low blood sugar; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she was walking and was shaking, she had to sit down) and BLOOD GLUCOSE DECREASED (low blood sugar) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 026A21A) for COVID-19 vaccination.     Concomitant products included FISH OIL, PARACETAMOL (TYLENOL), DEQUALINIUM CHLORIDE (HERPES) and VITAMINS NOS for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, 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 TREMOR (she was walking and was shaking, she had to sit down) and BLOOD GLUCOSE DECREASED (low blood sugar). At the time of the report, TREMOR (she was walking and was shaking, she had to sit down) and BLOOD GLUCOSE DECREASED (low blood sugar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No treatment information was provided.   This case was linked to MOD-2021-060716 (Patient Link).
Fever, vomiting x 2 days, lethargic, poor PO. Seen in hospital ED 2/8/09. Admitted, had diagnostic laparoscopy with ileocecectomy. Dx with intussusception with perforated colon on 2-9-09.  2/25/09 Received hospital medical records of 2/8-2/16/2009. FINAL DX: bowel perforation s/p radiological attempt to reduce intussusception; diagnostic laparoscopy; laparotomy; ileocecal resection w/primary anastomosis Records reveal patient experienced abdominal pain, oral intake reduced, sleepy, emesis, decreased UOP, constipation x 2 days.  Had been evaluated in outlying ER & had fever, looked unwell & had blood/urine/CSF c/s done.  Tx w/antibiotcs & transferred to higer level of care for ped surgery consult.  After admitted, had large bloody stool.  Progressed well postoperatively & d/c to home w/surgery clinic f/u.
Pt recvd 2 doses of Engerix-B FEB & 5MAR91; 11JUL91 pt exp rt arm & leg neuropathy & long bone & joint pain, jaundiced x 2 wks; dysesthesia;
Initial report involving a cluster of four cases received from a registered nurse on 10/31/05. This case involves Twin A. A five year old twin developed red, warmth and induration of 13/08 at the injection site after receiving the IM injection of Tripedia, lot number U1348AA in the right thigh on 10/18/05. The pt received in concomitant the IM injection of IPOL, lot number W1582-2 in the left thigh. The pt was diagnosed with cellulitis and treatment with Augmentin. Recovery status was reported as unk. Follow up information received on 6/5/06 from a physician. The onset of symptoms was 10/19/2005. The pt was examined by a physician. The pt fully recovered after treatments. Same reporter in cases 2005-02249, 2005-02250, 2005-02252. Case 2005-02252 involves Twin B.
PATIENT RECIEVED A VACCINE THAT EXPERIENCED A TEMPERATUR EXCURSION; VACCINE WAS KEPT IN REFRIGERATED CONDITIONS FOR OVER 30 DAYS.  NO ADVERSE REACTION WAS REPORTED.
pt recvd vax 21DEC92 & devel urticaria which was treated w/DPH; no further details were provided;
Approx 12hrs after vaccination, and lasting approx. 36hrs: Fever, chills, sweating, muscle and joint pain, nausea, vomiting, diarrhea, severe headache, dizziness, weakness.  Light headedness, fatigue and queasy stomach persisted from onset at 12 hours after vaccination until April 12, 2021.
I was outside in the yard & I started coughing & it got worse I got a drink of water & I couldn't swallow or breathe so I started getting weak so I sat down on the steps to try to catch my breath & calm down & it helped I also had chills & was achy so I called my dr. and made an appt.
The vessels are broken; broken blood vessels there; Eye was kind of itching; She used words like "inflammation"; Sclera the white portion of my eye, on the inside of the eye is red it is completely red; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on [16Apr2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had the vaccination on Monday, Monday afternoon. She has redness in sclera. She got the vaccination on Monday, Tuesday night, her eye started to itch, by Wednesday her sclera the white portion of her eye, on the inside of the eye is red it is completely red, the vessels are broken. she has broken blood vessels there, that is what that means, that's what she was reporting, so this is now 3 days that she has, had an eye as a nurse, put an eye patch on. She was putting antibiotics in her eye and eye patch,(Treatment). On Monday and by Tuesday night her eye was kind of itching and right now has eye patch on. She used words like "inflammation" and "irritation". She had a reaction the following night (02Feb2021) with redness in eye and also bleb in eye (which is still unresolved). Outcome was not recovered for redness in eye and unknown for other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, close temporal association  the event of Ocular hyperameia is assessed as related
Pfizer covid vaccine was administered to patient at around 2:10pm and was advised to stay in sight for 15 min before leaving the store. At around 2:15pm patient started to faint. Patient was accompanied by her mother. Rph on duty rushed to the scene noticed that patient had lost consciousness and started to have a seizure. I also noticed that the patient had passed urine while unconscious. I notified my technician to call 911. I quickly grabbed an EpiPen and administered one dose into the patient thigh. I assisted the patient along with her mother until the patient regained consciousness. Paramedic arrived to the seen few mins later. They checked all vital signs and patient was responding better and but still exhibiting some tingling effect in her hands. Patient decided not to ride with the paramedics. I advised her to stay for another 30 - 45 min so that I could monitor her. She was feeling much better and was released to go home along with a EpiPen.
Hives all over body, appearing and disappearing within a few hours. Treating with antihistamines for the past 2 weeks, no actual improvement but symptoms are controlled.
Immediately following vaccine I had a tingly sensation up neck and the right side of my face - into my right ear.  Skin on right cheek also had a slight tingle.  I still feel this tingle slightly.  On Monday evening , April 26, 2021 - I noticed a rash on my forehead, in a "v" shape around my eye and in front of and around my right ear.  I went to the doctor on Tuesday (4/27) and was diagnosed with Shingles. I was put on Valacyclovir.
Dizziness started several days following first dose. It has been 2 months and the dizziness continues daily.  I did not have this condition prior to the vaccine. This effect impacts concentration and reading. The dizziness is worse while laying down, but continues throughout the day. I am concerned this may be permanent.
Severe fatigue, mild fever (about 100°), loss of appetite, migraine headaches, lasting roughly two days from onset, fully recovered on third day
Symptoms began with severe chills at 10pm the first night of the shot. Symptoms progressed to 102 and up to 103.3 fever. Severe headache. Body aches. Nausea and fatigue. Fever and headache subsided on April 11th.
Fever, Chills, Shaking uncontrollably, Loss of appetite, needed assistance going to bathroom, Headache
Pt exp fever 101 A - 103.9 R; cough; dec appetite; Seen by MD told to take APAP;
Inserted needle into pt's deltoid.  When pushed plunger to administer vaccine, an equipment malfunction caused vaccine to leak out from around the needle instead of going into the muscle.  Vaccine ran down pt's arm.  Because it was estimated that pt did not receive at least half the dose, a full dose was administered in the opposite arm per CDC guidelines.
I went in for a scheduled MRI of my foot and the MRI found that I have a 7mm blood clot on my foot. It was found on my left foot plantar region (bottom of my foot). A few days after the vaccine I had swelling on the top and bottom of my left foot. I got two vascular images completed and the MRI was never sent to the vascular department. My podiatrist confirmed the blood clot on an ultrasound. I'm still experiencing swelling.
pt recvd vax 21FEB94 & exp immediate react of shaking, almost to the point of convuls as well as drop in BP, significant lightheadedness & stomach cramps; pt had a sister who devel the same sx following vax w/MMR;
Low grade fever for 2 days.  Red, papular and vesicular rash on torso.  Mild.  Appeared consistent with mild varicella.
1-2-09 Tdap administered R deltoid.  1-9-09 Soreness reported to Employee Health Nurse. 2-27-09 - Appointment scheduled due to report of persistent pain at injection site.  MD evaluation describes induration that is palpable.  Dx of chronic inflammation - advised to take Ibuprofen consistently. 3-20-09 Reports that the soreness persists.  No further phone contact from Employee Health - no further contact from the employee to today's date.
Pt called at day 9 to say that he was still feeling body aches and malaise. From the first day or two he noticed site soreness and swelling. Then headache (muscular type/scalp pain) started, but has now stopped. No fever but some chills. Alternating Ibuprofen/Tylenol seems to be helping. But still muscle aches upon awakening and in the evening. Also complained of "gait disturbances" that seem to originate from his sternum/back. RPh advised pt to follow up with physician.
lymph system overwhelmed; swollen injection site; pain in upper body; Shoulder pain; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of lymphatic disorder in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymphadenectomy (8 years ago on left arm prior to the vaccination). Concurrent medical conditions included lymphedema.   On 2nd February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, 12 hrs after receiving Shingrix, the patient experienced lymphatic disorder, injection site swelling, general body pain, shoulder pain and neck pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the lymphatic disorder was not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved and the outcome of the general body pain, shoulder pain and neck pain were recovering/resolving.   The reporter considered the lymphatic disorder to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, general body pain, shoulder pain and neck pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix injection and experienced side effects were worse than she expected and that the injection seemed to overwhelm her lymph system. She received the injection was given on her right deltoid due to removal of lymph node surgery in her left arm 8 years ago. About 12 hours after the injection, the patient started to experience swelling of the injection area, pain in her upper body from her Teres major and minor on her left side across her shoulders and into her neck. It took several weeks for the symptoms to resolve with the exception of upper body pain which has lessened but still continues. Her physician and pharmacist told her they do not know if she should get a second injection or if they could give the injection in her thigh.  The physician was treating her symptoms with Advil, compression garments, and massage therapy for lymphedema once per month. The reporter consented for follow up.
About 6 minutes post vaccination, patient reported that her feet felt tingly, no other reaction reported. Patient was given 50mg dose of diphenhydramine and decided to stay 20 minutes post vaccination for observation, but the reaction subsided. 24 & 48 hours post vaccination patient the patient did not report any other reaction.
Patient presented with hives and tightness on both hands. No difficulty breathing, no itching anywhere else on body.