chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000213538
I received the second dose of the vaccine on august 21, 2021. on september 26, 2021, I started my menstrual cycle and as of today, october 16, 2021 I am still bleeding. it has been 21 days with occasional cramping. I will see my gynocologist for an exam on thursday, october 21, 2021
lump in her vein on the neck part; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration on 12May2021 as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 21Apr2021 for COVID-19 immunization. The patient reported that a lump in her vein on the neck part just appeared in the morning of 15May2021 with the outcome of unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant medications were provided by the reporter.  Patient received half dose.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergone any temperature excursions.  No treatment medications were provided by the reporter.
Achy - muscle cramps legs, nausea - diarrhea - headache.
day after shot felt chills, muscle aches, and headache.  Two days after shot felt dizzy.  The dizziness has persisted until present
RECEIVED EXPIRED VACCINE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced received expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of received expired vaccine was not reported. This report was non-serious.
Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4666936.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Patient's concurrent condition included: Multiple Sclerosis. Patient's concomitant medication included: Ocrevus We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with policies and procedures.  Follow-up attempts are completed. No further information is expected.
Approximately 12 hours after the injection, chills and shivering began followed by fever and headache. The same reaction occurred after receiving first dose in September 2018.
Nausea after 6 hours.  Temperature rise of 2 degrees at 12 hour mark that lasted for 36 hours.
patient was sitting in chair in observation room.  approximately 3 minutes after his vaccine, he had a syncopal episode, fell out of the chair, hit is left jaw and left hip on the floor.  Upon immediate assessment, he was hypotensive (83/28) bradycardic (P38), and pale.  He has whole body "shaking" for about 10 seconds.  He was responsive almost immediately after that, AOx4.  assisted to a gurney where he rested.  No SOB noted.  His VS improved.  He was sent to the ED via ambulance.  d/c'd from ER without treatment.  (ct jaw negative for fx)
within minutes tingling of face, slight headache.  Later in the day metal taste in mouth.  Tingling in face didn't stop until in the evening
the patient also had a positive HPV Pap Smear test; Non-Hodgkin's Lymphoma; This spontaneous report was received from a nurse practitioner and refers to a 22-year-old female patient. The patient's medical history and concurrent conditions were not provided. Historical drug included chemotherapy. The patient did not refer concomitant medications and drug reactions or allergies.         13-MAY-2008, the patient received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) intramuscular injection, lot number 0089U, for HPV prevention (anatomical location, and expiration date were not reported).  On 18-SEP-2008, the patient received the second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dosage schedule, route, anatomical location, lot number and expiration date were not reported).  On 05-FEB-2009, the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection was received (inappropriate schedule of product administration)(anatomical location, lot number and expiration date were not reported).          On unspecified date in 2015, the patient developed non-hodgkin's lymphoma after completing the human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) series on  05-FEB-2009 (conflicting information, also reported as patient's concurrent condition). The patient seek for medical attention andreceived an unspecified chemotherapy on an unspecified date in 2016. The patient had been in remission (recovered) since an unspecified date in 2016 after finishing her chemotherapy.  On 22-MAY-2019, the patient had a positive human papilloma virus (HPV) Pap Smear test (human papilloma virus test positive).   At the time of the report, the outcome of human papilloma virus test positive was not provided.   The causality between the aforementioned events and human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.   Upon internal review, the event non-hodgkin's lymphoma was considered as medically significant.
BUMP ON UPPER RIGHT LIP; CUT ON LOWER LIP; VERY SORE LIP; SWOLLEN LIP; LIPS WERE DRY AND CHAPPED; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced lips were dry and chapped. On 15-MAR-2021, the subject experienced very sore lip. On 15-MAR-2021, the subject experienced swollen lip. On 15-MAR-2021 07:15, the subject experienced cut on lower lip. On 16-MAR-2021, the subject experienced bump on upper right lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips were dry and chapped, cut on lower lip, very sore lip, and swollen lip on 18-MAR-2021, and had not recovered from bump on upper right lip. This report was non-serious.
Initially faintness, nausea.  Then redness, swelling and rash at the injection site.
I had hot and cold chills. Nasal headache and lost my sense of taste and smell for 5 days. Shortness of breath for a day or two. Very very lethargic. Breathing was very severe. I'm a hot natured person and I've never been that cold in my life. Taste and smell was awful and certain things still to this day doesn't smell right. Headache lasted well over a month after testing negative Dec 20th. The lethargic feeling lasted almost 3 months.
8OCT stomach ache-stomach cramps; 10OCT 4PM cold, chills, shaking, t102, went to ER: 11OCT 9Am diarrhea, vomiting, heart palpitations, went to ER:
Dad called office today as patient received covid vaccine from pharmacy. About 7 pm patient started to cry uncontrollably and c/o feeling nauseous, did not vomit. She also was feeling anxious as Dad states this behavior was unlike her, unsure of fever. Did proceed to bed and slept all night- contacted us today her primary care and provider advised to fill out VEARS form
On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned.   This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits.  The event lasted more than 15 minutes with constant massaging.   This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.
Swollen, red, painful left arm after Td on 2/21/03. Seen in urgent care w/an MD on 2/28/03. Tx with Tequin, Claritin with Mediol Dose Pack.
Person was 16 at the time and was mistakenly given Moderna instead of Pfizer vaccination.  Experienced expected general post COVID vaccine symptoms for about 4 days post injection .  No other adverse reaction noted as reported by his mother.
This spontaneous report as received from a physician refers to a 20 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 injection (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date, the patient complained of not feeling good, was pale and very dizzy, and had to lie down immediately after receiving her first dose of GARDASIL 9. No treatment was received for the events. The outcome of events was reported as recovered/resolved (reported as: symptoms resolved after a minute). The relationship between the events and GARDASIL 9 was not provided. No product quality complaint was involved. This is one of the same report (reported as: different patient, who was also patient's sibling) received from the same reporter.
cellulitis tx w/Ceftin;17MAR97 pt returned to work was off 3 days;
strange discoloration more like a blister on their right hand; woke up today with a strange discoloration more like a blister on their right hand; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (strange discoloration more like a blister on their right hand) and SKIN DISCOLOURATION (woke up today with a strange discoloration more like a blister on their right hand) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced BLISTER (strange discoloration more like a blister on their right hand) and SKIN DISCOLOURATION (woke up today with a strange discoloration more like a blister on their right hand). At the time of the report, BLISTER (strange discoloration more like a blister on their right hand) and SKIN DISCOLOURATION (woke up today with a strange discoloration more like a blister on their right hand) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Relevant concomitant medications included Blood pressure pills.  Treatment information was not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney stones", start date: 2017 (unspecified if ongoing); "viral meningitis", start date: 2001 (unspecified if ongoing); "post menopausal" (unspecified if ongoing), notes: post menopausal x5 years. The patient's concomitant medications were not reported. Past drug history included: Marcaine, reaction(s): "known allergies: Marcaine"; Carbocyanine, reaction(s): "known allergies: carbocyanine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (12Feb2023) Positive, notes: positive home COVID test beginning 12Feb. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with Paxlovid, from 13Feb2023 to unknown date.
This spontaneous report was received from the patient's wife referring to her husband, a 74 year old male patient. The patient's medical history included heart bypass; and the patient's concomitant therapies included unspecified therapies for high blood pressure (HBP), cholesterol and prostate which had been taken for years. The patient had no allergies. On an unknown date in January 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 one shot once in the arm (strength, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in January 2017, the patient started to experience a combination of itching and a spreading rash (rash pruritic) that occurred  within hours of getting of getting vaccinated with PNEUMOVAX 23. The patient had been to the physician five times since this started; and the physician gave to the patient an unspecified shot which the patient was told that it should fix it; however, the shot did not work and the itching and rash became worse. On an unknown date in 2017, the itching was on his full body (the worst itching where the rash was), including legs, arms, back and chest (pruritus generalised); and the worst part was that the rash that occurred within the last few weeks, spread between legs and privates (rash and genital rash). no laboratory diagnostics/studies were performed. The outcome of genital rash, rash, pruritus generalised and rash pruritic was reported as not recovered. The reporter did not assess a causal relationship between the aforementioned events and PNEUMOVAX 23.
Spastic convulsions that occurred in every muscle in my body lasting for more than 4 hours. Hands now tingle and spasm from time to time.
Pt states that at 9pm 11/28/01 she broke out in hives, which started at the injection site & spread all over her body. By 11pm she was itching all over. At 2am 11/29/01 she put cortisone cream & alcohol on for relief of itching. Presented to H.D. at 1:45pm 11/29/01.No rash at present has had flu vaccine x last 5 yrs annually.
Patient received PNEUMOVAX on 10-22. On 10-23-12, she developed a rash from shoulder to elbow in the left arm. Rash was red, raised and warm and covered arm - not just injection site.
arm has swelling approximately 2" and raised approximately 0.25", counsel husband to treat symptoms: apap, nsaid, ice, benadryl , get further vaccines in series in different arm
5 minutes post vaccination, Pt. stated, 'she's feeling dizzy" Hx of anxiety, offered fluids and snacks.  Reassessed pt after 15 minutes, Mom by side, patient stated, 'she feels much better', educated mom to nearest ER if any further adv rxn occurs.  V/S 116/74, 94, 18.
Suspected vaccination failure; Bad case of shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's sister in law. The age at vaccination was not reported. The reporter stated that the patient got shingles shot and had a bad case of shingles after it. The reporter was afraid to get shingles shot.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided
Information has been received from a physician concerning a 36 year old Caucasian male with asthma and a history of gun shot wound to the chest, with prolonged time on a ventilator in 1992, and subsequent ARDS.  On 01/15/2003 in the PM the patient was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M), SC (also reported as IM) in the right arm.  There was no illness at the time of vaccination.  Concomitant therapy included fluticasone propionate (+) salmetrol xinafoate (Advair Diskus 150), which reportedly on 01/15/2003, "he has been having a worse time breathing.  Initially he did well.  It was only in recent months he has had a problem."  Upon physical examination the patient's blood pressure was reported to be 120/70 and pulse 80, with respirations 20.  The patient was reportedly afebrile.  The patient had diffuse wheezing in his chest.  He had fairly good air exchange, with slightly prolonged expiratory phase.  There was "no severe distress at this time."  The patient's heart had a regular rate and rhythm.  There was no peripheral edema in the extremities or cyanosis or clubbing.  The patient's asthma was classified as "moderate".  Subsequently, 5 minutes after vaccination at 2:00PM, the patient was standing at the check out counter, he had a severe onset of throbbing sensation in his back, followed by back pain, back spasms in the lumbar area.  His legs became weak and they sat him down in a wheel chair and brought him back into the room.  He was having severe pain in his legs and were described as stiff.  It was reported that "when we gried to bend them they caused severe back pain."  He was not nauseated or diaphoretic.  The physician ruled out vasovagal reaction (BP 120/80 and pulse was 90 and regular).  His skin was pink and he was fully awake.  After about three to four minutes, he was sitting in the chair, it reportedly began easing up and within five minutes, he was standing back up on his feet and back to normal.  It was reported that "etiology of his problem remains (?) unknown."  The patient's severe low back pain with bilateral leg numbness lasted 5 minutes and then resolved, "it passed and the patient felt fine."  The patient was observed for another ten minutes and "he did well, and was released."  The patient sought unspecified medical attention.  It was noted that the patient did not have any adverse reactions following prior vaccinations.  It was also noted that the patient had a flu shot "back in October".  There were no relevant diagnostic tests or laboratory data.  No further information is expected.
Very serious chicken pox; This case was reported by a consumer and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chickenpox (serious criteria other: Serious by reporter). On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.     Additional Information: GSK receipt date: 17-JAN-2023 Reporter's comment:  The reporter asked about what does the research show for adults who had very serious chicken pox then they receive the Shingrix vaccine. The reporter asked about potential side effect for this type of person.
pt recv vax 22FEB99 & 3 days later pt devel irritability w/constant crying;