chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 31-OCT-2018 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about August 2016, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about November 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 vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention  of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include 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; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
11:20 Friday vaccine  8PM shooting pains in chest/ back, arm very sore  overnight: shooting pains all over my body, fine shaking, feet felt frozen  2AM headache began, progressed to worst of my life.  eventually relieved by Tylenol in AM  7/8 AM extreme exhaustion  mid day: chills for hours, temp to 103, abated with Tylenol  Sunday: tired, loss of appetite continued, arm sore but better, erythema noted over upper arm, lymph node left axilla, neck pain and limited neck range of motion  Monday: arm soreness and erythema improved, neck ROM improved, still decreased appetite but feeling mostly normal
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received SHINGRIX (batch number 97H72, expiry date 8th February 2021) for prophylaxis. On 10th August 2018, the patient received the 2nd dose of SHINGRIX. On 11th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness and shivering. On an unknown date, the outcome of the muscle pain, tiredness and shivering were recovering/resolving. It was unknown if the reporter considered the muscle pain, tiredness and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left arm. The patient experienced muscle aches, shivering, fatigue and tiredness which began 1 day after receiving the SHINGRIX vaccine. The events are improved. This case has been linked with US2018151119, reported by the same reporter.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 8/12/2022 Discharge Date: 8/15/2022   PRESENTING PROBLEM: Weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE:  Patient is a 90 y.o. male who presents today with COVID weakness.  Patient evidently started becoming weak today and unable to ambulate independently, as is baseline.  He was brought to the emergency room from his  facility because there is no nursing to assist with his decline in activity.  He was supposedly hypoxic at facility down to 86% on room air, but he has maintained 95% in the emergency room.  In the emergency room he was felt to have edema and crackles was given 40 mg of IV Lasix.  His chest x-ray was pending at the time.  His proBNP was found to be 475. He also has apparently confused from his baseline. His CXR was negative   During hospitalization he was addressed by Physical therapy and Case Management.  He slowly improved in his strength.  I did have a conversation with the family on August 14th in the evening and they were concerned about him possibly needing to go to SAR.  I discussed this on the morning of August 15th with the case manager and according to physical therapy is at his baseline willing to go back to his previous facility.  There he will get home care with physical therapy.
Patient was given the wrong vaccine for his age.  He received the Pfizer 5-11 year old vaccine instead of the 12 and up vaccine. After consulting the health department and patients primary care provider no additional vaccine doses were given.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In March 2011 (reported as 3 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route unspecified), and then patient developed a bulls-eye rash. The reporter did not know where the rash was located on the patient. Patient contacted pharmacist for medical attention. Treatment, BENADRYL, cold compresses, was given for the event. The outcome of the event was reported as recovered/resolved on an unknown date. Additional information is not expected.
one day after the second dose, he developed itching then discoloration of the right leg of which he has pictures.  He sought care and was diagnosed with cellulitis and given Rx for atb, area resolved.  A few days after the second shot he began to note the fatigue that has escalated since to the point that it takes too much energy to chew solid foods such as steak.  he reports no appetite and weight loss.  He notes that his sense of taste changed too and that he cites the change in the taste of soda that he no longer likes it.
THE VACCINE HAD LEFT A SIDE EFFECT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced the vaccine had left a side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine has left a side effect was not reported. This report was non-serious.
pt recvd vax;labored breathing became much more worse w/ shots; T 104; to er;
About 24-36 hours later hives on tops of the thighs. The hives spread down to knees. Benadryl helped reduce size and itching but the hives returned once Banadryl wore off. Hives lasted about 5 days.
FROM 1/8 3AM TO 1/8 7PM: CHILLS AND BODY ACHES. TOOK IBUPROFEN EVERY 4- 6 HRS.
the day after the vaccine, she began having multiple symptoms: pain at injection site, fatigue, knot on arm with swelling, rib pain/lung pain-bilateral- left more than right, headache, fever for 1st 2 days.
STUFFED NOSE; FELT TO LAY DOWN AND SLEEP; ARM SORENESS; HEADACHE; FELT VERY FATIGUED; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, tachycardia issues, gi issues, esophageal issues, post nasal drip issues, nausea, gerd, acid reflux, and seasonal allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced stuffed nose. On 10-MAY-2021, the subject experienced felt to lay down and sleep. On 10-MAY-2021, the subject experienced arm soreness. On 10-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced felt very fatigued. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) Abnormal, ECG (NR: not provided) Clear-Normal, and Vaginal biopsy (NR: not provided) Clear. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm soreness, headache, felt very fatigued, and stuffed nose, and the outcome of felt to lay down and sleep was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Hives X 3 days on right shoulder #10-12. Treatment with Claritin.
Patient has redness around the arm, very warm and hard. Patient states it is very painful to touch.
Really sick / had to stay in bed; Chills; itchy rash on her left leg near her ankle; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In November 2020, 2 days after receiving Shingrix, the patient experienced sickness, chills and itchy rash. On an unknown date, the outcome of the sickness, chills and itchy rash were recovering/resolving.   The reporter considered the sickness, chills and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix about 2 weeks ago.  2 days after vaccination, she states she became really sick and had to stay in bed. She also reports having chills.  About a week after vaccination, she then developed an itchy rash on her left leg near her ankle. She states this was starting to resolve but had not completely resolved. The reporter consented to follow up.
Information has been received from a female consumer who in January 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). On 25-MAR-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). The consumer mentioned that she developed flexion and extension difficulties with both her wrists for 48 hours after receiving her first and second dose. At the time of this report, the patient was fully recovered. The patient sought unspecified medical attention via office visit. No further information is available.
Patient said felt lightheaded and dizzy. Said that she had a migraine earlier in the day. She said she just felt a little off, nothing major.
Developed ache in arm of injection-site - but NOT at the site itself - rather all around it from elbow to neck to scapula. Started about 12hours after injection (woke me at 4:00am). Then over the next several hours developed fever up to 101.5, ibuprofen reduced only to 100.4. This cycle continued through the following day, when temp peaked at 102.2 around 48hr post-injection. Added Tylenol to the ibuprofen, temp then decreased to 100.4. Woke the third day with un-medicated temp between 99-100 all day, but L axillary lymph nodes now swollen. Spent all 3 days on couch, resting and pushing fluids. No GI symptoms at all.  Day 4 - Temp normal, but slightly dizzy. Pain and some edema from elbow to scapula to neck continued throughout and still continues now. Axillary lymph nodes still swollen and sore. Some nasal congestion, still a bit dizzy. Never had any pain (just tender to touch) at the actual injection site.  Also, I never had any symptoms at all with the first injection. I see nowhere else to put this - I received the injection at my workplace.
Since taking my second Pfizer vaccine, I have had several heart issues, loss of sight in one eye, burning pains which make my feet/hands like they are on fire, and now I've been told I'm infertile. I had NONE of these issues prior to YOUR vaccine.
2-3  days after my 1st shot on 3/23/21, my menstrual flow increased from light spotting, to moderate or heavy. This level of flow continues through today, 4/13/21
Chills; Sweating; Body aches; Poking sensation in bicep away from where the shot was given; Headache; Shaking/jittery; Extreme tiredness; Dizziness; Resting heart rate doubled from normally 40 to nearly 90bpm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 15Apr2021 at 11:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. It was reported that the patient was fairly healthy and the patient's family has history of heart issues. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate (FLONASE) for allergy from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 00:00 the patient experienced chills; then followed by sweating; body aches; poking sensation in bicep away from where the shot was given, not near it; headache; shaking/jittery; extreme tiredness; dizziness and resting heart rate doubled from normally 40 to nearly 90bpm (beats per minute). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 14Apr2021, the patient underwent nasal swab test (SARS-CoV2-test) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills; then followed by sweating; body aches; poking sensation in bicep away from where the shot was given, not near it; headache; shaking/jittery; extreme tiredness; dizziness and resting heart rate doubled from normally 40 to nearly 90bpm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
got his blood work with low platelets, first one and second one was even lower/blood platelets very low; got his blood work with low platelets, first one and second one was even lower/blood platelets very low; blood RBCs and blood platelets very low; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an un-specified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an un-specified route of administration in Jan2021 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In 2021, patient got his blood work done which showed low blood red blood cells count (RBCs) and very low blood platelets. The first one was low but the second one was even lower for platelets. Patient's wife stated that she understood that this was an issue but could lead to fatality because the platelets were not working properly and if patient found an injury he could be at risk. The outcome of all the events was unknown.  Information about batch/lot number has been requested.
Narrative:  Hospitalization; pt admitted om 2/1022 for alcohol withdrawal and Wernicke's encephalopathy. Found to be COVID positive on admission, fully vaccinated. No symptoms.
Symptomatic myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Symptomatic myocarditis) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.      The patient's past medical history included COVID-19 (Symptomatic myocarditis occurred in the patient during acute COVID-19 infection, followed by recurrence of symptoms after the first dose of mRNA COVID-19 vaccine).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Symptomatic myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Symptomatic myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging heart: Proven myocarditis after the second dose of mRNA COVID-19 vaccine..     For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Symptomatic myocarditis) to be related.    No concomitant and treatment medications were reported.  Symptomatic myocarditis occurred in the patient during acute COVID-19 infection, followed by recurrence of symptoms after the first dose of mRNA COVID-19 vaccine and subsequent recurrence of cardiac MRI-proven myocarditis after the second dose of mRNA COVID-19 vaccine. Company comment This literature-non-study case reported by other Health Care Professional concerning a 45-year-old male patient with medical history of COVID-19 infection with myocarditis, who experienced the serious, medically significant, expected event of Myocarditis (AESI). It is described that after the first dose of mRNA-1273, the patient experienced myocarditis symptoms that recurred after the second dose, where myocarditis was confirmed by MRI. It is uncertain if myocarditis due to COVID-19 before vaccination was full recovered. Treatment details of the event was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case reported by other Health Care Professional concerning a 45-year-old male patient with medical history of COVID-19 infection with myocarditis, who experienced the serious, medically significant, expected event of Myocarditis (AESI). It is described that after the first dose of mRNA-1273, the patient experienced myocarditis symptoms that recurred after the second dose, where myocarditis was confirmed by MRI. It is uncertain if myocarditis due to COVID-19 before vaccination was full recovered. Treatment details of the event was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fever 102.0 F for 6 hours, while having taken acetaminophen and ibuprofen alternating every 2 hours. Felt feverish for 24 hours after those 6, but fever was not high enough to feel the need to take an exact temperature, if there was a fever at all. Typical allergy wet cough shifted to dry cough for the same time period.
Patient presented to the ED and was subsequently hospitalized for bipolar disorder, cognitive impairment, mood disorder within 6 weeks of receiving covid vaccination.
2:10 pm  arms red bilat from elbows down.  No other sign or symptoms blood pressure 136/82 Pso2 99%     pulse 85   Respirations even and unlabored .   remaining skin pink warm and dry.   Imformed to seek medical attention if any further problems. sheet given to follow up.
Patient reported that she had itching eyes the afternoon of the vaccine that lasted till 09/13/2021... also felt very cold the same day she received the shot... injection site was red and itching
Myalgia, NauseaVomiting, sore in injection site Narrative:
Seasonal flu injection given, site immediately red and swollen (egg-size) hard, no neat. Observed ct for 20 min. Home to take BENADRYL, apply heat, F/U with PCP if worse, watch for swelling in throat. CHeck with PCP if should continue recieving flu shots.
Rt arm redness, swelling and pain at pneumo injection site to include axilla area and below injection site midway down upper arm. Hot to touch - painful. Symptoms noted 24 hours after injection. BENADRYL, ice, BIAXIN.
SHE FELT ACHY; Just lousy; Pain at the injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3BS44, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season .5 ml. On an unknown date, less than 2 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain, pain and unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, pain and unwell were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain and unwell to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient reported pain at injection site for a period of 24 hours. The patient took tylenol.  The patient reported that she felt achy and just lousy after receipt of vaccine. The symptoms resolved within 24 hours.
itchy rash red spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC. At the time of the report, RASH PRURITIC had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-221115.
Hives - started on her lower legs; The following information was received from a nurse on 29 July 2019.  A female received her second dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on an unknown date.  After administration she experienced hives starting on her lower legs.  Outcome was not reported.; Sender's Comments: Causality assessed as possible related, given the kind of event and time to onset (after administration).
nasal congestion; sinus pressure; nausea; extreme fatigue; tingling in hands and feet; Patient reported not able to get out of bed and sleeping most of the day; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This female consumer (in her late 30's) reported for herself that she received BNT162B2 single dose in Dec2020 for COVID-19 immunisation. Medical history included autoimmune disease (not disclosed). Concomitant drugs were not provided. The patient received vaccine on Monday and by Thursday began experiencing nasal congestion, sinus pressure, nausea, extreme fatigue, tingling in hands and feet. Patient reported not able to get out of bed and sleeping most of the day in Dec2020. At report, these symptoms had not subsided. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Had cold when came in for 3rd hep B 6/26/03 - developed more cough, sore throat, fever the night of 6/28 with shaking chills, now tired (exhausted), occ. parox. cough, very sore throat when coughs, says got a cold about 1 week after receiving 2nd hep B. Referred to clinic for follow up.