chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CLOUDY VISION; FEELING HORRIBLE; This spontaneous report received from a patient concerned a male of unspecified age of unknown race and ethnicity. 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 not reported, batch number: 1805025 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient received the Janssen COVID-19 vaccine on 13-MAY-2021 but that patient had tested positive for COVID-19 recently and has been feeling horrible for 4 to 5 days which included headache, cloudy vision, and body aches. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cloudy vision, feeling horrible, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186711; Sender's Comments: V0: 20210743638- COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS..
Hospitalization for GI bleed, syncope, acute on chronic renal failure, COVID-19 infection, elevated troponin level, uncontrolled diabetes, nausea and vomiting, fall, skin tear on dates 11/4/2023- 11/11/2023. Treated with  vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Swelling, blue/bruised.  Patient received vaccines 9/9/20 and reported symptoms 09/13/20 (Unable to get in touch with patient to clarify exactly when symptoms started so just put 09/09/20) Patient stated at time she is fine.  On 09/13/20 arm looked blue/bruised, Slight swelling if any.
Patient states her arm has redness, swelling, itching, and also has some blisters. Patient saw her doctor today and was prescribed a steroid and antibiotics. Patient stated symptoms started yesterday 5/21/23 and received vaccine on 5/15/23.
throat swelling after one hour took 50mg of benadryl   continued to swell at slower rate for next 15 min took 25 more mg benadryl  swell started to slow down and stopping after a2hours
Patient noticed leg buckling beginning 2 days prior to hospitalization, lasting a few seconds and then resolving. This continued to happen throughout the following days. The next early morning patient awake to find he had a hard time lifting his left arm, and when he was able to lift it the arm would drop like a dead weight. Morning of hospitalization, patient had left lower extremity weakness and passed out, spouse found him on the floor and alerted EMS. It took some time for him to get back to his normal self. Tongue bite was noted, but no bladder/bowel incontinence.   Patient with cerebral venous sinus thrombosis of unclear etiology, treated with heparin and discharged on Eliquis.         During hospitalization, patient had breakthrough seizures on Depakote. Medication was discontinued, Dilantin was initiated, though through the course of titration patient developed Phenytoin Toxicity. Medication was weaned and Keppra was initiated.        Fluconazole initiated to manage coccidioidomycosis.
pt recvd vax 6OCT93; subsequently devel swelling & bruising @ inject site, & a fever which lasted for 3 days;
Flushing after an hour of receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 21Dec2020, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 21Dec2020, the patient experienced flushing after an hour of receiving the vaccine and on 22Dec2020, the episode was lasting quite a bit longer. Clinical outcome of the adverse event was unknown at time of this report.   Information on the lot/batch number has been requested.
Evening of injection vaccine had an achy left arm. Took Tylenol. Next day noticed 1/2 inch welt next to injection site.  Arm is very achy going into shoulder.  Notice about two inch discoloration of left arm near injection site.   Have been taking Motrin/Tylenol for achiness.
This is the third time of covid that he got; he has shots and everything; This is the third time of covid that he got; he has shots and everything; pressure in his eyes; he can barely see right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "This is the third time of covid that he got; he has shots and everything"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "pressure in his eyes"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "he can barely see right". The patient underwent the following laboratory tests and procedures: chest work: Unknown results, notes: he has chest work so, he knows he has it; SARS-CoV-2 test: Positive, notes: This is the third time of Covid that he got. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: he prescribed that Paxlovid. Reporter stated My son called last night, he is 29 years old and this is the third time of Covid that he got and he has chest work so, he knows he has it. He has shots (Later clarified as Pfizer covid29 vaccine) and everything, so I really don't understand but anyhow this time he just got this great pressure in his eyes, he can barely see right. I didn't know that was, I mean Is that a sign. Reporter stated, Yes, is eye pressure a sign of Covid. I have never heard that before. Yes. Reporter further stated, "Okay but this time he had a virtual which I don't understand, I am too old to understand that's virtual doctor appointment and he prescribed that Paxlovid (Further clarification unknown, hence, suspect captured conservatively) and that's your right, Pfizer's. Okay, would you prescribed that for that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom reports that client woke up in the middle of the night not feeling well and with a fever of 102F. Per mom, fever broke at around 7AM, then client vomited/"retched" at around 10AM. Mom instructed to continue to monitor and call family doctor if symptoms worsen regardless of whether they are side effects or a separate infection/illness.
1in raised bump, red, warm silver dollar sized, irritable;lump & redness lasted 5 days in lt thigh
t102-105 fever on 17AUG pt dev sl rash; mom gave pt DPH & rash disappeared; pt seen by MD on 18AUG;
Pt developed redness and swelling (about 2cm X 2cm in diameter) around the site of Hib vaccination during the 1st 24 hours then resolved during the next 24 hours. No pain.
2 aggressive nose bleeds over 3 days.  Each lasted about 30 minutes.  (As a "ex" SCUBA diver and Sailplane pilot.  This is abnormal for me.
She experienced dizziness; Headache; Fatigue; Body ache; Muscle pains on her neck to her shoulder; Muscle pains on her neck to her shoulder; Muscle pains on her neck to her shoulder; This is a spontaneous report from a contactable consumer. A 48-year-old female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number: UNKNOWN) via an unspecified route of administration on 16Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, headache, fatigue, body ache, muscle pains on her neck to her shoulder. Patient asked if this was normal and for how long would these side effects last. Outcome was unknown for all the events.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided.  On 23-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally (lot # 1684157, expiration date 26-JUN-2021) for prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (1.3 degree Celsius) for 24 minutes recorded by a data logger. The previous temperature excursion was reported as below 2 degree Celsius (1.6 degree Celsius) for 24 minutes. No additional adverse event (AE) details.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA001046: US-009507513-2101USA001003: US-009507513-2101USA000963: US-009507513-2101USA000908: US-009507513-2101USA001280:
6-8-10 four vaccines given.  Patient stated reaction started 6-9-10 morning.  Returned to clinic 6-10-10 cellulitis to outer aspect right arm.  Placement of VARICELLA vaccine.  Annular erythematous.  Measured 85 mm X 65 mm.  Warm to touch.  Patient prescribed BACTRIM DS X 10 days.
Extreme lethargy and tiredness, bad headaches, muscle soreness and overall aches throughout body. Slight fever. Lasted full day after the vaccine, but less than 24 hours. This was my 2nd vaccine shot. Did not have this reaction after first shot. Took lots of tylenol and ibuprofen and rested/slept almost all day.
3 patients received a dose that was exposed to low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number AE2J4, expiry date 30th March 2023) for prophylaxis.   On 1st April 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.       Additional Information: GSK Receipt Date: 5th April 2022 Reporter's Comments: The pharmacist reported the patient received a dose of Shingrix that was exposed to low temperature excursion of 31.5 degree F. The reporter did not consent to followup. Additional Supportive Information: As the Shingrix was exposed to low temperature excursion, which led to incorrect storage of drug. The case has been linked with the case US2022060313 and US2022060315 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060313:same reporter US-GLAXOSMITHKLINE-US2022060315:same reporter
Information has been received from a company representative concerning a female who was vaccinated with Gardasil. there was no concomitant medication. Subsequently the patient fainted. No additional information provided. No lot number provided. Physician's name was not specified by Representative. Additional information has been requested.
24 hrs after getting flu/pneumo shot. Chest had cough and cold s/s, paralysis of left side, loss of balance and stiff neck lasting 1 1/2 wks. Prostate and urinary probs.Medical records disprove paralysis, abnormal gait. Does confirm fatigue. msv
At 16:07, 12 minutes following administration of the Pfizer COVID-19 vaccine (dose #2), patient presented with a swollen lip, hives, and itching. Patient denied shortness of breath, difficulty breathing, tightness in throat. 25 mg diphenhydramine was administered orally at 16:08. Patient was admitted to ED for care where IV methylprednisolone, IV diphenhydramine, and IV famotidine were administered between 16:30-16:36. Patient reported decreased swelling and itching at 17:15. Provider at bedside and cleared for discharge with home meds at 18:00.
This case was reported by a nurse via other manufacturer and described the occurrence of swelling arm in a infant male patient who received INFANRIX for prophylaxis. Co-suspect products included PEDIARIX for prophylaxis. On an unknown date, the patient received the 2nd dose of INFANRIX (intramuscular) and the 2nd dose of PEDIARIX (intramuscular). On an unknown date, less than 6 months after receiving INFANRIX and PEDIARIX, the patient experienced swelling arm and injection site mass. On an unknown date, the outcome of the swelling arm and injection site mass were unknown. It was unknown if the reporter considered the swelling arm and injection site mass to be related to INFANRIX and PEDIARIX. Additional details were provided as follows: The reporter was patient's mother. The patient age was reported as in the range of 4 to 6 months. It was not reported if the patient received any other vaccine or medication. The reporter reported that the patient received a DTaP vaccine but it was not a Sanofi Pasteur product. The reporter was not sure if the DTaP vaccine given to the patient was INFANRIX or PEDIARIX. The patient received DTaP vaccine on an unknown arm. After receiving DTaP vaccine, the patient's arm was swollen and had a knot at the site of injection. No additional information was provided.
I have had the same reaction with all four doses. The night of the shot, I developed a rash. It went from the left arm and traveled across my chest to right arm and down to my legs. Prior to getting the vaccine, I took Benadryl as suggested to help elevate the symptoms but it didn't help. I took Benadryl at home for a day and I knew it wasn't working. I called the doctor and he prescribed prednisone. The prednisone help elevate my symptoms. I have since the vaccine developed pancreatic and stomach issues.
mom reports that child has redness & swelling greater than fifty cents piece @ rt inj site;also c/o pain used aspercream to site;
ed patch about the size of his palm around the injection site; Mildly unwell; Did not feel like doing anything; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Mildly unwell), LAZINESS (Did not feel like doing anything) and VACCINATION SITE ERYTHEMA (ed patch about the size of his palm around the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 13-Feb-2021, the patient experienced MALAISE (Mildly unwell) and LAZINESS (Did not feel like doing anything). On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (ed patch about the size of his palm around the injection site). The patient was treated with IBUPROFEN for Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), MALAISE (Mildly unwell), LAZINESS (Did not feel like doing anything) and VACCINATION SITE ERYTHEMA (ed patch about the size of his palm around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Eleven days after the first shot, I developed shingles.  The day after the second shot, I developed fever, severe headache, vomitine, diarrhea which has lasted four days.  I could neither eat nor sleep.  It felt like I had been poisoned.  This is not a small reaction!
No additional AEs; patient received the first dose on 30JUN2021, and the second dose was administered on 22JUL2021; This spontaneous report as received from a nurse prescriber refers to a 56 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.     The patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 1 time dose (strength, route, lot number, and expiration date not provided) for prophylaxis on 30-JUN-2021. Then, the patient received the second dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 1 time dose (strength, route, lot number, and expiration date not provided) for prophylaxis on 22-JUL-2021. No adverse events were reported.
Pt has 1 1/2" x 1" raised erythmic area to L arm.  Warm to touch.  Burning sensation.  Denies itching or elevated temp.  No temp. today.  Denies nausea vomiting or diarrhea.  9-18-09 at 12:00.
5" x 5" - red area sore/hot - headache, itching, lethargy x 2 days with fever 99 - 100 degrees. TYLENOL and ice, sleep.
This spontaneous report was received from a Physician via a company representative referring to a female patient of unknown age. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. (Lot #, expiration date, strength, dose and route were not provided). On an unknown date, approximately one week after receiving the vaccine, the patient experienced herpes zoster. The patient  received an unspecified treatment and recovered from the shingles. The reporter did not assess causality between the event and the use of the medication. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In 2016 (reported as on unspecified dates in September 2016 and October 2016), the patients were vaccinated with an improperly store dose of ROTATEQ, administered orally; lot # L33694, expiration date 16-JUN-2017; lot # M016238, expiration date 07-DEC-2017 and lot # M017514, expiration date 07-NOV-2017 (dose, strength and anatomical location were not provided). No symptoms were reported. The vaccine had previous temperature excursions of 30 minutes at 57 Fahrenheit (F). Temperature: 54 F. Time frame: 1 hour. With a data Logger involved. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a approximately 71 year old female patient. The patient was allergic to penicillin and codeine. The patients current condition included Lyme disease and high blood pressure. Approximately in 2012 (reported as about 2 years ago) the patient was vaccinated with PNEUMOVAX23 after being diagnosed with Lyme disease. Concomitant therapies included DIOVAN HCT (reported as DIOVAN HCTZ). The patient's whole upper arm swelled up, was red and inflamed after receiving the PNEUMOVAX23 (reported as unspecified pneumonia vaccine). The patient sought medical attention and was treated with ibuprofen. The outcome of whole upper arm swelled up was red and inflamed was reported as recovered after a week. The causality of the events was not reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information has been requested.
did not take second dose, suppsoed to take it today; big itch hive that started a pink spot; Itchy; pink spot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE URTICARIA (big itch hive that started a pink spot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (pink spot) and PRODUCT ADMINISTRATION INTERRUPTED (did not take second dose, suppsoed to take it today) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (big itch hive that started a pink spot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (pink spot). On 28-Jan-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (did not take second dose, suppsoed to take it today). On 26-Jan-2021, VACCINATION SITE URTICARIA (big itch hive that started a pink spot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (pink spot) had resolved. On 28-Jan-2021, PRODUCT ADMINISTRATION INTERRUPTED (did not take second dose, suppsoed to take it today) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No relevant concomitant medications were reported. Treatment details included Zyrtec and Steroid cream Patient was scheduled to take second dose 28jan2021 but did not take it as she wanted  to see her allergist next week Thursday before she can decide whether to take it or not.
Patient was given Pediatrics dose of Hepatitis B instead of the Adult dose.  Patient has not had any adverse reaction yet.
Adult dose of Pfizer given instead of pediatric dose of Pfizer. No S/S after 20 min observation
This case was received on 27 September 2011 via a third part query tool search on the VAERS database, under reference number 427842. A 28 year-old female patient had received on 16 June 2011 a left arm injection of ACAM2000 (lot number VV04003A), a subcutaneous right arm injection of YF VAX (lot number UH272AA) and an intramuscular right arm injection HAVRIX (lot number AHAVB459BB) and 30 days later on 16 July 2011, the patient noticed three papular bumps around the smallpox vaccination site that were intensely itchy and progresses into pustular lesions. A culture was conducted to confirm if the smallpox was the causative agent however results were not reported. Current illnesses and history were reported as none. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Immediately after, felt fine except for a sore arm. I exercised as normal and it went away after two days. Five days after the shot, I felt a painful, pea-sized lump in my armpit, on the side that I received the injection. It hurt every time I moved my arm. Six days after the shot, my arm got very itchy, hot, and red at the injection site. The rash lasted 2 days. Ten days after the vaccine, my menstrual cycle was to start. On day 1, I had stabbing, debilitating pelvic pain and abdominal cramps, acute nausea, and felt feverish for a day. This is not normal for me. Then I experienced alarmingly heavy flow of bright red blood for 4 days. The blood gushed constantly. More forceful than a miscarriage. I may not have connected this to the vaccine, but my husband noted that the vccine was the only change from last month to this. And then I later read that other women had reported similar symptoms. I cannot stress how worrying and terrifying this experience was. If it is at all vaccine-related, it would help women tremendously to know this could be a side effect, so they don't panic about their health.