chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On or about 22-NOV-2013, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (herpes zoster) and on or about 25-NOV-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
FATIGUE; This spontaneous report received from a patient concerned an 86 year old of unspecified sex. 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, and batch number: WAG 50555 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Sore arm, sore throat over the next few days along with lymph node swelling.
On 12-14-07 pt received 1st HPV dose and parent noted flu like s/s.  On 3-7-08 pt recevied 2nd HPV dose and parent noted fever 101, nausea, body aches, dizziness, and h/a lasting for two days.
Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Shot was given on 07/23/09 at clinic - Pt was seen in office for WCC on 7/29/09 and told us about the reaction. Pt's (R) arm was swollen from shoulder to elbow (Per grandma).
Extreme fatigue, wekaness, fast heartrate, dizziness, sore throat, breathing issues (short of breath) high blood pressure, severe bruising t site. ER visit/overnight stay.
Pain at the site of injection on the day of administration. Fever spike to 100 with chills, body aches and joint pains for 2 days.
Information has been received from a registered nurse concerning a 10 year old male who on 08-JAN-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 627337/1057H). On 13-NOV-2007, the patient developed breakthrough, described as a rash on his neck, face, back torso and a fever. Rash was between 50 to 500 lesions. Patient was diagnosed by physician. No additional information was available. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. This is one of several cases from the same source. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot#, expiration date, route and dose were unknown) which had been stored improperly. No adverse effects reported. Additional information has been requested.
On March 5th client felt run down flue like symptoms, nauseous, feeling achy, fatigued chilled with joint pains and a temp fo 101.  This continued for 5 days.  On day 6 the client started coughing, felt warm with under arm glands felling swollen and arm was itchy.  On day 7 arms were really sore and swollen.  There is a rash around vaccination site, similar to erythema multiforme.  Client is taking benadryl.
Patient said the evening after she received the vaccine she lost bladder control and urinated about 7 times without her control. She said she had extreme muscle weakness/paralysis in her extremities and needed to be helped in and out of bed. She got a major headache. All of the previous symptoms lasted for about 24 to 48 hours. She also had a large amount of injection site pain which is still ongoing and started about 1 hour after receiving the shot. She states she had chills for about 24 hours after the shot, but no fever.
High fever (103.8) and twitching. Dr. visit the next day where they said it was a reaction to the flu shot.
Used a 5/8" needle tip instead of a 1" but gave in IM fashion. No adverse event reported.
severe pain; shaking chill; sick for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: ER8735) at the age of 79 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: PAIN (non-serious), outcome "recovering", described as "severe pain"; CHILLS (non-serious), outcome "recovering", described as "shaking chill"; ILLNESS (non-serious), outcome "recovering", described as "sick for a week". Therapeutic measures were taken as a result of pain, chills, illness.  Additional information: No Concomitant Products. No other conditions. The patient was supposed to get the second dose on that week and was wondering if she should get it on 21May2021. Clarified that caller is referring to the Pfizer Covid 19 vaccine. On the paper given when she left, after the first shot, there was an immune thing mentioned. It was noted that she had something with her immune system that she caught a year ago, wondered if that had anything to do with anything. Has been a year and a half since something to do with her immune system. If it was, she shouldn't be getting the shot. For the record, she was a very healthy person except for colds and things like that, no serious illness or anything like that. Thought that it was important that she reported she was having severe pain to where she couldn't even function. She was having violent shaking chill and that basically sick for a week. She got the shot on Friday and called the doctor on Tuesday. Was incapacitated and was told to take Tylenol and things like that. It is getting a little better but is still not up to par. The patient was afraid to get the second. Does not know why they are asking all of these things.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Patient started feeling congested on Sunday and then reported no small or taste the next day with fever 102F.
pt admitted w/platelet count of 11,000 (Thrombocytopenia);
chills, generalized weakness, sore rt arm due to vax; instructed to apply warm compress to site take APAP for fever & chills; pt felt much better the next day w/only a sore arm;
Joints and muscle aches; Joints and muscle aches; nausea; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in arm right on 21Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included allergies to dust, grass, and some weeds. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), estradiol, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), zinc. The patient experienced Joints and muscle aches for 15 days so far, nausea mainly in the mornings for 10 days on 23Dec2020 06:00. Outcome of events was not recovered. Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine.
Tingling and numbness from left elbow down to left hand. 2 days later, tingling and numbness in left foot. 2 days later, tingling and numbness from right elbow down to right hand. 2 days later tingling and numbness in right foot. 2 days later, tingling and numbness down calves and shins of both legs. 2 days later, numbness and tingling in left thigh. All symptoms built upon one another. Nothing has reversed.
Recieved the shot around 1pm on 8/13. Little less than an hour later patient started to feel tired. Arm was red and tender. Arm became painful overnight. Patient went to walkin around 1030 AM on 8/14. Doctor diagnosed it with cellulitits. The infection caused A-fib and a heart rate over 140. They brought her to Hospital where she recieved IV antibiotics and stayed over night. On 8/15 she was discharged and prescribed oral cephalexin 500mg three times a day for 7 days.
Patient was administered Janssen vaccine on 4/10/21, and received one dose of Moderna COVID-19 vaccine on 5/15/21. No reactions were observed on-site during the observation/monitoring period. Nurses will be contacting patient after 2, 24, and 48 hours to follow-up.
VARIVAX was administered via IM route rather than SC route; small lumps; This spontaneous report was received from a nurse and refers to a 29-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, lot #, expiry date, and route of administration were not provided). On 28-NOV-2022, the patient was vaccinated with second dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter/once, valid lot# W011622, expiration date 06-APR-2024, administered intramuscularly (IM) route rather than subcutaneously (SC) route. The reporter stated that patient had small lumps at injection site immediately after injection. No treatment for the event was given to the patient. At the time of reporting, the outcome of the events was not reported.   The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) regarding both events was not applicable.   The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Upon the delivery of Pfizer gray cap vaccine on 2/15/2022, pharmacy kept the vaccine in the freezer (average temperature at -23.9 C) for 10 days before the administration. No adverse reactions reported after the administration. Pfizer provided temperature excursion data to determine the vaccine was still viable.
Lightheaded/dizzy and very tired after both shots for approximately one hour.  In 3 days after first shot (July 27) and 2 days after 2nd shot, I had pain on my right side where my liver is.  The pain was mild to very strong.  The pain lasted 1 1/2 weeks after my first shot.  After my second shot (August 17), the pain started 2 days later and I have had one pain free day since then.  My pain has been the same - mild to very strong.  The pain was also going around to my back and for a few days down my back to my waistline.  For the past three days I have had more pain in my back where the pain would stop when it went around my back.  It doesn't feel like a muscle strain or pull, not a nerve pain, but and organ pain - something inside of me is not happy.  I had bloodwork done after my second shot because I had hepatitis A (from shellfish) when I was 21 and my liver enzymes were normal.  My doctor ordered a CT scan and  it came back normal.  If I don't wear a bra, my pain is much less and I don't wear tight clothing.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported having some numbness and tingling in the extremity they recieved the vacination and in their neck area. Patient discribed sensation as mild and did not worsen or improve while spending 30 minutes in the store after receiving the vacination.
Psoriasis aggravated; Drug effect decreased; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) in a 64-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). The patient was treated with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) at an unspecified dose and frequency. At the time of the report, PSORIASIS (Psoriasis aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  It was reported that patient was not enrolled in covid-19 vaccine trail. Company comment This spontaneous case reported by a consumer, concerns a 64 year old male patient, with no medical history reported, who experienced the unexpected, non serious events of psoriasis (psoriasis aggravated) and therapeutic product effect decreased (drug effect decreased) on an unknown date after receiving  the 1 dose of mRNA 1273 vaccine. patient also received Adalimumab (humira). it was reported that on an unknown date the patient experienced plaque psoriasis break out and took covid vaccine which affected the effectiveness of Humira. Details of clinical course, risk factors, co morbidities, labs, diagnostic investigations and treatment details were not provided. Patient was treated with Risankizumab. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   On unknown dates, the patient experienced plaque psoriasis break out and took covid vaccine which affected the effectiveness of Humira.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 64 year old male patient, with no medical history reported, who experienced the unexpected, non serious events of psoriasis (psoriasis aggravated) and therapeutic product effect decreased (drug effect decreased) on an unknown date after receiving  the 1 dose of mRNA 1273 vaccine. patient also received Adalimumab (humira). it was reported that on an unknown date the patient experienced plaque psoriasis break out and took covid vaccine which affected the effectiveness of Humira. Details of clinical course, risk factors, co morbidities, labs, diagnostic investigations and treatment details were not provided. Patient was treated with Risankizumab. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Secondary Transmission Nonvaccinee Limited information available. SPV vaccinee was wrestling with a male friend (another military service member). His friend developed lesions on his back. (friend had a remote history of atopic dermatitis). Occured in 2003 - no details as to date of vaccination, date of wrestling, or date lesions appeared.
Pt questionaire was not verified.  Pt is on deployment list and verified to need yellow fever vaccine.  Pt given yellow fever vaccine and PPD test.  After vaccination, administrator discovered in electronic medical record that pt had received the Flumist.  Pt instructed to return 4 weeks from Flumist vaccine to receive repeat yellow fever vaccine and PPD test.
Pt received second bivalent booster by error. First Bivalent vaccine was 9/15/2022. Pt was educated and Director of Clinical operation followed up with a pt the next day. No side effects. Pt feel ok.
Moderna COVID-19 Vaccine EUA Vaccine on Thursday 1/14 930:  at 1030 pins and needles in my arms down to my fingers with arthralgia.   1530: temperature 99 with a migraine and arm soreness beginning.  Developed what felt like swollen nares, a little more difficult to breath and developed a weird smell  that I can only describe as "dog poop".    at 1900 arm was so painful I could not lift it, like being stabbed.  Took 600mg ibuprofen and 2 tablets of  Benedryl to sleep.  Breathing just fine, still bad smells. Friday 1/15: 0600, pain in arm severe still and did not have full range of motion.  Weakness in hand.  Developed neck pain.  Temp 99.  No medications.    15:00, developed severe myalgia on right side of body and back (like a bad flu).  Temp 102.0,   Fatigue, and still bad smells.    Took 600mg ibuprofen for headache and neck pain. Saturday:  (sorry no times), temp remained at 99 until the evening then went to normal.  Injections site is red, hot, painful over entire deltoid.  Able to move arm more normal, just sore.  No medications needed.  The weird smell went away.  Mild-moderate fatigue Sunday:  Felt like I usually do after a vaccine, just a little tired and a little sore.
unspecified side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (unspecified side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (unspecified side effects). At the time of the report, VACCINATION COMPLICATION (unspecified side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
No side effects reported; HCP calling to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion. No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985; Information was received from a Medical Assistant referred to a patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.        On 27-JUN-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # W026137, expiration date 05-FEB-2024, oral (strength, dose, and dose number were not reported), for prophylaxis (product storage error). The rotavirus vaccine, live, oral, pentavalent(ROTATEQ) underwent a temperature excursion in a time frame of 35 minutes with a 8.74 Celsius Degrees of temperature. No previous temperature excursions occurred. No adverse event was reported. No more medical relevant information was reported.
Vertigo; dizzy; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 12Feb2021 13:00 (Lot number: EM9809) at the age of 62 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Type II Diabetic", start date: 2011 (ongoing). There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 26Feb2021, outcome "unknown", described as "vertigo"; DIZZINESS (non-serious) with onset 26Feb2021, outcome "unknown", described as "dizzy".  Additional information: The patient reported that the event occurred especially in the morning upon waking. Initial onset was at unknown time when he woke up in the morning and got out of bed and was super dizzy. The patient asked if he should or should not get the second dose of Pfizer COVID-19 vaccine as scheduled relative to the events. The patient has no history of all previous immunisations. The events did not result to an emergency room or physician office visit. He was not hospitalized due to the events.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant medications were reported. On 22-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L037356, expiration date 28-SEP-2017, albumin status, dose and route of administration not provided) for prophylaxis. The dose was exposed to a tenperature of 67F for 68 hours. Data logger was not involved. There was no prior temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009301:
Wiped out, extremely fatigued; broke out in rash on arms and back; very sore arm; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of an unspecified age received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. Patient had historical vaccine: COVID 19, lot unknown: False, dose number: 1. It was unknown that if other vaccine administered in four weeks prior to the COVID vaccine. It was unknown that patient was pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced wiped out, extremely fatigued, broke out in rash on arms and back and very sore arm on 27Jan2021. Reporter reported no for serious, seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-Caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. The patient was not diagnosed with COVID-19 prior to vaccination and also patient was not tested for COVID-19 since the vaccination. Treatment received for adverse events was unknown. The outcome of event was unknown.  Information on the lot/batch number has been requested.