chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a patient (gender not specified) who on an unspecified date was vaccinated with PNEUMOVAX 23, Lot number 660685/0619X. It was reported that the patient developed cellulitis from PNEUMOVAX 23. The patient was hospitalized overnight. At the time of the report, it was reported that the patient had not recovered. Follow up information has been received from the medical assistant, who requested a lot check. No additional information was provided. A standard lot check was performed. All in process quality checks for the lot number 660685/0619 were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. This is one of several reports concerning the same source. This is an amended report. On the AE screen for the event of cellulitis, the criteria hospitalization prolonged was changed from yes to unknown. Additional information has been requested.
sore throat & loss of voice-took ATB;12 days later had cold & hot sensation on lt side of body from shoulder thru feet;shot on lt side in arm;dx has not been confirmed or refuted;still has some of same sensation but lessened;
Extremely sore injection site; woke me from sleep; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 03Feb2021 18:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. The patient experienced extremely sore injection site and woke me from sleep on an unspecified date. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported generalized rash to upper body, Nausea, Headache, achy joints and upset stomach
Father states 1 hr post vax devel severe h/a temple area, became pale, began shaking, t102, vomited; Taken to Hosp;
p/vax pt devel discomfort w/lymph node enlargement lt axillary area;devel chills;sx cont through 10/17/99;took APAP d/t pain & chills;10/18/99 nausea & diarrhea;10/19;99 red & inflamed @ site;
Felt light headed; Vertigo got worse; Couldn't stand up; Couldn't do normal job/ attempting to get short term disability from his job; Couldn't walk; Couldn't eat food; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job) and GAIT DISTURBANCE (Couldn't walk) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2021. Concurrent medical conditions included Diabetes.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-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 DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Couldn't eat food) and CHEST PAIN (chest pain). At the time of the report, DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Couldn't eat food) and CHEST PAIN (chest pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for diabetic. Treatment included motion sickness pills for dizziness and Brea inhaler for his chest.   This case was linked to MOD-2021-255387 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 1st November 2018, the patient received the 1st dose of SHINGRIX. On 2nd November 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The patient had no side effects except for might be a little bit of soreness the next day. The patient stated when they gave her the shot there was no burning there was nothing. The patient declined permission to contact her doctor. The patient consented to follow up. For tolerance to the 2nd dose of SHINGRIX, refer case US2019011766.
4 X 6 CM AREA RED, WARM, SWOLLEN AREA-RIGHT DELTOID, 24 HOURS AFTER DTAP INJECTION
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: pt called and complained that vaccine was given too high on her arm and she is feeling pain and swelling
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (exact dose, route of administration, lot# and expiry date were not reported) for routine vaccine. On two unspecified dates, the patient received doses of GARDASIL 9 injection (exact dose, route of administration, lot# and expiry date were not reported) for routine vaccine to complete the human papillomavirus (HPV) vaccination series. On an unknown date, the patient experienced genital warts. It was unknown if the patient received treatment. The outcome of the event was not reported. Causality assessment was not provided.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about late 2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient developed blisters on her chin, a rash on her left ear and scalp, both of which were accompanied by pain, weakness and fatigue. In response to these complaints, the patient presented to her primary physician and was diagnosed as suffering from herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, a diminished quality of life and diminished ability to work. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the herpes zoster to be related to ZOSTAVAX. The outcome of herpes zoster was unknown. The event of herpes zoster was considered to be disabling. Additional information has been requested.
I  had chills - severe- all night long. Couldn't sleep. Muscle joints and muscles were hurting me and fatigue. Next day, fatigue and muscle and joint soreness. It continued for almost three weeks. The third week I got calf pain that was very painful. I went to Urgent Care. It lasted until the next day (so for two days total). When I woke up on the 6th it was gone like it wasn't even there. The third day after the vaccine, the injection site started hurting - but not swollen or anything. The muscle at the injection site still hurts - the pain comes and goes.  I did get an iron transfusion (march 8th) before the vaccine - I had a doctor's pass to take the vaccine.
This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of M-M-R II (dose, frequency and route were not reported) lot # reported as M045393 with expiration date of 14-NOV-2018 and lot # reported as M034387 with expiration date of 19-JUL-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the M-M-R II were properly stored. The temperature of the M-M-R II was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002251: US-009507513-1705USA003154: US-009507513-1705USA003157: US-009507513-1705USA003158:
Red, Swollen arm, lightheaded, nausea, elevated temperature (100%). Follow-up physician appointment on 09/23/2015.  Physician thought it was an allergic reaction.  I said it looked like cellulitis.  I requested antibiotics, but request was denied. Arm is still red and very swollen--it is now 2 days later.  I will make a follow-up report in a few days.
Fever, chills, body aches, congestion started 12-24 hours after injection.
Fever; arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and INJECTION SITE PAIN (arm pain at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and SPIRONOLACTONE (SPIRONOLACTON) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever) and INJECTION SITE PAIN (arm pain at injection site). At the time of the report, PYREXIA (Fever) and INJECTION SITE PAIN (arm pain at injection site) outcome was unknown.            Patient took anti itch cream as treatment.   This case was linked to MOD-2022-438540, MOD-2022-438549 (Patient Link).
Swollen right hand two days after vaccine.; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in arm right on 18Feb2021 at 11:30 (age at vaccine 63-years-old) as dose 1, single for covid-19 immunisation. The patient was not a pregnant at the time of vaccination. The patient medical history included cerebrovascular accident on 11Aug2021. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced swollen right hand two days after vaccine. The patient did not receive treatment for the adverse event. The patient visited doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN concerning a male (age not specified) who on approx 26Oct05, the past 48 hrs, was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649981/0704P). On approx 26Oct05, the past 48 hrs, the pt developed a significant injection site reaction and cellulitis from armpit to wrist. It was also reported that symptoms started within 12 to 24 hrs of receiving the vaccine. The pt sought unspecified medical attention. There were no lab diagnostic studies performed. On 28Oct05, the pt was treated with IV ceftriaxone sodium (Rocephin) in the clinic. At the time of this report, the pt had not recovered from the events. Additional information has been requested.
Patient hospitalized 6/21/22 - 6/23/22 for labor/delivery (OB)
Patient came for sick visit on 11-1-07 and wanted us check thighs where shots were given, areas are red - maybe one papule at shot site, no vesicles. Lateral side 6-8 round raised papules, treat as if chicken pox. Dxc? chickenpox - vaccine related
Conjunctivitis in right eye; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date (24Dec), at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced conjunctivitis in right eye on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Woke up 04/08/2021 with "severe heart burn. I realized that the ingredient trimonodine was in the shot and this has given me heart burn before. I called my doctor and he told me to double up on my Prilosec."
Slight temperature of 99.6; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight temperature of 99.6) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A and 030L210A) for COVID-19 vaccination.     Concurrent medical conditions included Neck injury NOS. Concomitant products included HYDROCODONE for Neck injury NOS.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PYREXIA (Slight temperature of 99.6). At the time of the report, PYREXIA (Slight temperature of 99.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: high (High) High.         Treatment information was not provided by the reporter.
I had my J&J vaccine on 03-30-2021. I was supposed to get my menstrual cycle on 04-08-2021 but I did not get. I went to see my gynecologists on 07-09-2021 because of my missed period in April, May and June. I tried to get an earlier appointment but there was no date available until 07-09-2021. On 07-11-2021, I did get my menstrual cycle. I am now not sure and a bit concerned whether my menstrual cycle will be regular.
swelling hands and feet, itchy, blanching rash on legs.  macules on arms.
Progressive concentric rash on left arm with itchiing over the course of 36 hours. Called PCP and instructed to give Diphenhydramine- some relief. Seen today 48 hours post-immie. Rash continues. Otherwise no obvious signs of discomfort.
Was vaccinated at approx 4pm on 1/16/20.  1/17/20 Went to work but felt a little "off". Symptoms became worse by mid-day and she visited the SNT, no fever. She left work early and went to bed. She started with fever, 102.3 and overnight she started with flu like symptoms, shivering, muscle aches and nausea. She described the symptoms as "AWFUL".  1/18 she remained in bed and arm became sore, by 1/19 her arm was hot to touch with a red circle around injection site and around the whole arm.  1/20 arm remained painful. 1/21 Went back to work and saw the SNT who refered to PCP.  PCP gave Keflex for possible cellulitis and questioned injection site. (rash often seen above and below the injection site). PCP said she should still get #2. 1/22/20 followed up with patient and symptoms were improving. Systemic symptoms had resolved and local reaction was much better with the Keflex .
At 11:06AM shortly after vaccine was administered, patient experienced numbness and tingly arms. She was lightheaded and vitals were BP 138/88 mmHg, HR 58 beats per minute, PO2 98%, and temp 97.6 degrees Fahrenheit. At 11:15AM vitals: BP 168/110 mmHg, PO2 98%. Patient is dizzy, legs tingly/heavy, and experiencing hot and cold flashes. At 11:30AM upper lip tingly, patient denies difficulty breathing or swallowing. 12.5 mg Benadryl given at 11:30AM and second dose of Benadryl 12.5 mg given at 11:40AM. At 11:45AM EMS called. Vitals: BP 151/85 mmHg, HR 83 beats per minute. Patient states tongue is tingly and experiencing full body chills. Upon EMS arrival, patient transported to Hospital.
This is a spontaneous report  from a sales representative on behalf of a physician who reported for a patient. This around 75-year-old female patient received PREVNAR13 (lot # H34460) via an unspecified route of administration in MAR2014. Relevant medical history and concomitant medication were unknown. It was reported that on an unknown date in MAR2014 PREVNAR13 was injected on left arm of patient after which her left arm was warm to touch and had redness radiating down her left arm. Therapeutic measure taken in response to the reported events was not provided. Clinical outcome of the reported events was unknown at the time of report. Follow-up (25APR2014): Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a 15 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) and a dose of MMR II (MSD) (lot# not reported). Subsequently the patient experienced "neurological effects" after receiving VARIVAX (Merck) and MMR II on the same day. At the time of this report, the patient had recovered from neurological effects. This is one of several reports from the same source. Additional information has been requested.
Case number PHEH2015US020966 is an initial spontaneous report from a nurse received on 15 Oct 2015. This report refers to a 17-year-old patient of an unknown gender, who was inadvertently vaccinated with FLUCELVAX (batch number: 17087A) at a dose of 0.5 ml intramuscularly on an unknown date. No adverse event reported following this medication error.
Patient presented for first dose of infant bivalent moderna. The pink cap vial was used instead of the blue cap vial. The patient received a lower dose of vaccine than what is recommended. Patient received 10 mcg of bivalent moderna instead of the recommended 25 mcg dose. Patient did not have any adverse symptoms.
Information has been received from a registered nurse concerning a 5 year old white male with asthma (well controlled) who on 11/15/04 was vaccinated SC in the right thigh with a second dose of MMR (lot # 648465/0320P). There was no illness at the time of vaccination. Concomitant vaccinations included a fourth dose of poliovirus vaccine inactivated (batch # X1189) administered SC in the left thigh and a fifth dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (batch # DTPa614A9) administered IM in the left thigh. On 11/22/04 at3:30 AM the patient developed right parotid swelling, then the swelling developed on his left side. It was reported that the physicians believe this is not true mumps, but a side effect of the vaccine. Unspecified medical attention was sought. Laboratory tests performed included serum mumps immunoglobulin G antibody test and serum mumps immunoglobulin M antibody test, on 11/30/04 and 12/6/04 (results not reported. At the time of the report, the patient had recovered. There was no product quality complaint involved. Follow up information indicated that the patient developed right ear pain on 11/22/04 at 3:30 AM. On 11/23/04, a PS virus IgG AB was 4.56 (positive). It was noted that a measurable antibody titer may also reflect a positive response to vaccination. A mumps virus IgG AB was 4.56 (positive). It was noted that a measurable antibody titer may also reflect a positive response to vaccination. A mumps virus IgM AB showed 11 U/ml (equivocal). On 12/6/04, a mumps virus IgG AB showed 3.64 (negative) and a mumps virus IgM AB showed <8 (none detected). The outcome was reported as recovered. No additional information is expected.
mistakenly received a third dose of Shingrix a few months ago on an unknown date; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: mistakenly received a third dose of Shingrix a few months ago on an unknown date).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2023 The patient (initials and DOB was unknown) mistakenly received a third dose of Shingrix a few months ago on an unknown date, which led to extra dose administered. Nothing else was reported. The physician/reporter was driving and did not have access to details (patient identifiers, dates, lot number) at the time of the call. The reporter consented to follow up.
After receiving Hepatitis A #2 and Hepatitis B #4, client had a seizure. Mother states it happened about three hours following vaccination States he had a low grade fever at the time of the seizure. Pt had history of febrile seizures which started @ 1 year of age. Parents thought he had outgrown them. Usually set off by a spike fever, unlike the low-grade (fever). he had time. He went to bed after(wards)
This spontaneous report was received from a nurse practitioner regarding a patient of unknown demography. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection (dose, strength, route, lot # and expiration date unknown), that was mixed with sterile water diluent. No adverse effects were reported. Additional information has been requested.
Pt was given FLUMIST 10/14/09, although 7 mo. old. Mother informed 10/14/09. No apparent reaction noted.
The lady lost consciousness, not responsive, pale, dizzy, was evaluated on site by fire rescue.  Transferred to hospital by ambulance at 9:11 am and the lady and husband refused to go to the hospital.  Released home at 9:27 am.