chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness on left side of face including lips/Numbness on whole left side of body-arm; Numbness on left side of face including lips; Pins and needles in feet and heals; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness on left side of face including lips/Numbness on whole left side of body-arm"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "Numbness on left side of face including lips"; PARAESTHESIA (non-serious), outcome "unknown", described as "Pins and needles in feet and heals". The events "numbness on left side of face including lips/numbness on whole left side of body-arm", "numbness on left side of face including lips" and "pins and needles in feet and heals" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: No prior Vaccinations (within 4 weeks). No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Mom-received Pfizer and went to hospital. Heart issues and now autoimmune issues.  No follow-up attempts are possible; lot/batch number is not available despite the follow-up attempts made. No further information is expected.
At intake and on consent form, patient did not disclose any prior COVID19 vaccine doses, and she indicated she was presenting for her first dose.  Moderna was administered as the presumed first dose.  When entering her dose information into the Immunization Registry, staff discovered that the patient had received a dose of Pfizer COVID19 vaccine in April 2021 at a different site.  Patient was contacted and upon questioning she then disclosed that she had received Pfizer as stated above.  When asked why she did not disclose this at the time of vaccination on 9/8/21 , she stated that she thought because the Pfizer dose was given 6 months ago she did not need to disclose that.  She has not reported any adverse effects to us at this point. This was identified as a "mixed dose" error and is being reported to VAERS as such.
24 hours after injection left arm swollen and sore. 36 hours after are is more swollen and sore with left armpit sore and lymph nodes swollen. Body aches, headache, nausea and lightheaded. Brain feels fuzzy
Gout; This spontaneous case was received on 16-Mar-2021 from other non-health professional (consumer) via Communication (reference number: SEQW21-01003) and concerned a 48-year-old male patient.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified day in Apr-2019, the patient was vaccinated with Flucelvax Quadrivalent (dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On an unspecified day in May-2019, unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed gout, but got over it quickly.  On an unspecified day, the patient recovered from the event gout.  The reporter did not provide causality assessment.  The case is linked with case 202102013 (the same patient).  Company comment: A 48-year-old male patient developed gout after vaccination with the suspect product, Flucelvax Quadrivalent. Exact dates of vaccination and onset of event have not been provided. Therefore, chronology needs more clarification. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to lack of information, causality for the reported event is unassessable.; Sender's Comments: A 48-year-old male patient developed gout after vaccination with the suspect product, Flucelvax Quadrivalent. Exact dates of vaccination and onset of event have not been provided. Therefore, chronology needs more clarification. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to lack of information, causality for the reported event is unassessable.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a seven-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had not adverse events at the time of the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006659; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006673L MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
This spontaneous report was received from a pharmacist and refers to a 63 year old patient. The patient had no pertinent medical history and drug reactions or allergies. On 29-JUL-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiry date were not specified) to prevent shingles. Concomitant medication included unspecified eye drops. On 31-JUL-2016, the patient developed gout and increased uric acid level. The patient received treatment for the event (details were not specified). It was unknown if lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The reporter did not provide the causality assessment. Additional information has been requested.
Dose 1:   Second day, leg muscles ached, pink splotch at shot site but no swelling, wasn't tender at shot site.  By the third day, some rashes started-some blister blotches which itched and some pink splotches which itched.  Large sized blotches. Hips started hurting with right hip really strongly hurting-was thinking hip surgery until I realized it might  be the Covid shot.   Pain went away after five more days. Dose 2:  Got shot in morning on Thursday, by the afternoon, shot sight swollen and very tender, pink splotch at shot sight & about 2" below pink splotch it felt like the bone was sore and hurt.  By Friday morning at 3 am, woke up with a feeling of nausea, ribs hurt, leg muscles and back hurt, more areas itching, fatigue, gums in mouth really hurt.  Friday p.m. - chills for about 2 hours and when the chills went away, the rest of the symptoms went away except for slight fatigue and leg muscles hurting.  Itching stayed also.  Today it is one week from 2nd shot.  Itching is less-hoping it goes away.  Leg muscles in right leg still ache but not as bad as at first.  Headaches off and on but those could be part of Vertigo.   It was rough.
A non-serious spontaneous report of administration of expired product was received form a health professional concerning a four-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 05-Feb-2011. On 01-Feb-2011, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. Approximately in January 2016 (reported as "10 months ago"), patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date, dose, strength, vaccination site, route not provided). The reporter stated that, the patient has received another dose of ZOSTAVAX on 13-OCT-2016 (reported as "3 weeks ago") (lot #, expiry date, dose, strength, vaccination site, route not provided). Product quality complaint (PQC) was not involved. No adverse symptoms were reported. No further information was provided. Additional information has been requested.
6/24/11 Reported temp. 101 degrees. Rash on head and neck 6/25/11. On 6/26/11 had rash on torso and legs. Went to Immediate Care 6/26/11.
EE received Booster Vaccine on 9/25/2021, at TCH Vaccine event in PFW, sides effects were swollen lymph nodes, redness and swollen at injection site, has taken Tylenol/ibuprofen and cols compress to help with pain. Advise to rest and drink fluids
Left upper arm bright red and warm to touch. Red area included upper 1/3 of arm and around to the underside. Slightly swollen, no c/o burning or itching. Advised to see DR of go to ER.
About 7 hrs after receiving vaccine felt tired, vomited x 1, chills, body aches-felt better around 2p next day.
Intussusception  1/6/09 Reviewed hospital medical records of 10/11-10/12/2008. FINAL DX:ileocolic intussusception Records reveal patient experienced vomiting, irritability, decreased oral intake, bloody stool w/some clots.  Noted to have dehydration, nasal congestion, cough & sneezing.  Admitted overnight for observation & d/c to home in AM.
Completed the course of Vivotif which was left at room temperature; Spontaneous report received on 05FEB2020.  A consumer's mother reported that her son "completed the course of Vivotif which was left at room temperature" (PT: Product storage error). He was receiving Vivotif for immunisation. The consumer got Vivotif from the pharmacy on 17DEC2019 and left that at room temperature. He started taking Vivotif on 24DEC2019 and took the last dose on 30DEC2019. It was reported that he did not refrigerate the Vivotif since the day he got that from pharmacy until the day he finished his last dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer completed the entire course of Vivotif which was left at room temperature (Product storage error). Vivotif must be stored at the recommended temperature in a refrigerator and not be left at room temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer completed the entire course of Vivotif which was left at room temperature (Product storage error). Vivotif must be stored at the recommended temperature in a refrigerator and not be left at room temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Expired 04DEC91; medical examiner called Health Dept - death not due to vax;
heart problem; did not have any appetite; fatigue; overall body aches; little fever about 24 hours 100.4F; headache; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches) and PYREXIA (little fever about 24 hours 100.4F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, MONTELUKAST SODIUM (SINGULAIR), IBUPROFEN and MULTIVITAMINS WITH IRON [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PHOSPHORUS;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL] for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches), PYREXIA (little fever about 24 hours 100.4F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches), PYREXIA (little fever about 24 hours 100.4F) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 °F (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not have an email and prefers to be contact via fax.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up document received contains NNI.
Fever, chills, shaking, joint muscular ache, HA 5 PM - 2 AM following day.
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted after 10 minutes after the vaccination. He HAS ALWAYS fainted after ANY shots. Patient confirmed it himself. The nurse look after him for 5 minutes after the shot but the patient fainted after he walk for 2 minute to the staff member and fainted. We checked his blood pressure 5 times with blood pressure elevation 3 times. We checked his blood pressure until the blood pressure was normalize back to safety level. patient left the pharmacy after being counseled about dangerous sympt
Patient received Moderna (NDC 80777-0273-10) booster. Patient only received half of the adult dose.
The patient indicates she has 4 vaccines last one on April 23, 2022, she brought her vaccination card with her. Later on the day, family members come to the clinic and notify us she had a fifth dose administered on December 15, 2022. Normal recomendations where given and to seek attention in case of emergency.
Patient presented 4 days post injection with localized swelling near elbow, injection site was in left deltoid and was marked by a yellowish bruise. Patient claimed the swelling was warm and was itchy.
3/3/21  3 hours after injection I  experienced severe right foot pain I cannot bear any weight on my right foot and severely painful to touch. Some friends massaged my foot and applied some warm compress and I was able to walk with a limp.  3/4/21 at 1:30 am and 4 am, I had severe chills  but no shaking.  Whole day 3/4 I felt lousy with lots of belching but able to walk better after some more massages with menthol/eucalyptus rub. On 3/5 today, my blood pressure was elevated to 150-160/78-74. I have headaches and pain on my neck. My blood pressure before 3/3/21 has been ranging from 126-134/70-80. My temperature was running 97.8.
noticed redness at  both sides waist on 2nd day, it kept spreading until both sides of my ankles, back of knees, and buttocks and inside of thighs  were also covered with a rash, small red dots and or a welt .
Small, itchy, raised bumps appeared in an irregular patter around the injection site after 12 days.  The injection site is warm and hard to the touch.
6 hours after vaccination, began to have moderate body and muscle aches.  Tenderness was also at the vaccination site.   After 8 hours began to have uncontrollable chills and shivering in a 76 degree home.   After dressing in warm clothing (Denim jeans, sock, boots, beanie cap, mittens and fleece jacket) and applying a heating pad, the chills were controlled and muscle aches diminished.  After 12 hours, experienced hot and cold flashes, weakness in the body.  After 24 hours, symptoms were mostly diminished and was symptom free after 36 hours.   The above symptoms were experienced on both first and second Shingrix vaccinations.
"strong reaction" redness and swelling / at the injection site; "strong reaction" redness / at the injection site; is not sure if they were both in the muscle because; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and wrong technique in drug usage process. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved and the outcome of the wrong technique in drug usage process was unknown.   The reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Addtional deatils provided as follows: The patient was vaccinated with 1st shot of Shingrix. After vaccination patient had strong reaction" redness and swelling which was quite uncomfortable at the injection site. The patient  received the Shingrix two shot series. They were both given at the same pharmacy but were administered by two different pharmacists. The pharmacy should have that information on file.  The both shots were  in the deltoid but patient was  not sure if they were both in the muscle because "one was deeper and one was shallower" which led to wrong injection technique. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR191352:same patient same reporter 2nd dose
MENSTRUATION CHANGES; HORMONAL CHANGES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced menstruation changes, and hormonal changes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the menstruation changes and hormonal changes was not reported. This report was non-serious.
Postural orthostatic tachycardia syndrome (POTS); Presyncope; Fatigue; Dizziness; Headache; Orthostatic Intolerance; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 39-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. Additionally it was reported that the pt received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (SLIGARD)  (lot#, expiration date, dose, route of administration and anatomical location were not reported).  On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, headache, dizziness, fatigue and presyncope. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007498: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
4MAY93 c/o sore arms APAP given; awakened from sleep w/temp unk; 5MAY93 awakened crying, elevated temp ? unk mom states felt like t102, given APAP; went to clinic instructed to keep on APAP; had upset stomach; c/o crankiness, sore arm;;
ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/15/2022 -- RECURRENCE OF SAME SYMPTOMS
Patient refers that two days after receiving her second booster dose of Pfizer vaccine she experience inflammation under the arm.
red rash and hives developed on both inside arms from wrist to shoulder quite quickly and moved up to beginning of chest. I contacted my physician who diagnosed covid arm. I treated it with benadryl. The same event happened the next day, but less intensely, also treated with benadryl. The third day there was a smaller reaction and I treated with allegra.  This had nothing to do with the injection site. The site was sore to the touch for about a week.  I am wondering what will happen with the second dose.
enlarged heart, mesentery sclerosis, episodes of high fever, lower stomach pain, nausea, vomitting, loss of appetite
blotchy rash; 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 RASH MACULAR (blotchy rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (blotchy rash). At the time of the report, RASH MACULAR (blotchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
non-immunocompromised patient received 3 doses of MOderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (non-immunocompromised patient received 3 doses of MOderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (non-immunocompromised patient received 3 doses of MOderna vaccine). At the time of the report, OFF LABEL USE (non-immunocompromised patient received 3 doses of MOderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Patient was not immunocompromised. HCP did not have info on first 2 doses.
Patient reported that about 12 hours after the immunization she began "shaking" (upper half of body only; hands visibly shaking) and this lasted about 2.5 hours.  She reported feeling like she had a stiff neck and potentially a fever (she did not feel cold though, only "hot" like a fever was breaking
Chronic hives starting 10 days after administration of 3rd dose. No apparent trigger (no new pets, detergents, soaps etc.). Relieved by oral Zyrtec. Hives started on random body parts and remain for anywhere from 20 minutes to several hours at a time.