chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cardiovascular event; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 60 year old female patient (pt). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On 17-NOV-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) ) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On 04-DEC-2014, the pt experienced an unspecified cardiovascular event (cardiovascular disorder) which resulted in her untimely passing on the same date, it was not reported if an autopsy was performed. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and will continue suffer severe and permeant personal injuries including but not limited to a cardiovascular event, as well as other severe and permanent health consequences; substantial pain and suffering, and emotional distress, as well as to incurred in substantial economic damages and loss and significant expenses for medical care and treatment, has lost past earnings and has suffered a loss of earning capacity. The pt's spouse filed for loss of consortium.. The event was considered related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: cardiovascular event
This spontaneous report has been received from a pharmacist who was referring to an 85 years old male patient. Information on medical history was not reported. On 12-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # H022280, expiration date: 16-JUL-2014 00) 0.5 ml, intramuscular for prevention of pneumonia. Concomitant medication included blood thinner. On 13-OCT-2013, the patient's arm was sore and numb. On 14-OCT-2013, the numbness and soreness resolved but the arm was hard to lift and was hurting a little. The outcome of arm hard to lift and hurting a little was unknown. No treatment was given for the adverse experiences. The patient sought medical attention by calling pharmacist. Product Quality Complaint (PQC) was not involved. Relatedness between the adverse events and PNEUMOVAX 23 was not assess by the reporter. Additional information has been requested.
Patient presented a vaccine Card with a single J &J vaccine.  He described having had a singular shot prior.  Pt was given a Pfizer Booster 0.3 ml in right deltoid. Upon return to office checked the database and found Patient had in fact 2 previous J& J Covid vaccinations, the last being 3/17/2022. Pt received an unnecessary 3rd vaccine. Pt had no adverse affects. Staff was notified of above information by phone at 11:50am on 04/14/2022. Staff advised this Nurse that he will make patient of event described herein.
Rec'd Menactra 10/10/07 starting 3 days later pt developed intermittent hive-like rash/itchy lasting until at least 11/16/07 No other symptoms
giving half doses of HD Fluzone and having the patient return a week later for the second half ; problematic on many fronts because the vaccine is only good for 24 hrs with no reported adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid non-serious case via health professional. Agency number: 01284655  This case involves patient of unspecified demographics who experienced giving half doses of Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] and having the patient return a week later for the second half; problematic on many fronts because the vaccine is only good for 24 hrs with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Fluzone High-Dose Quadrivalent half dose (lot number, route in unknown administration site) for prophylactic vaccination and having the patient return a week later for the second half; problematic on many fronts because the vaccine is only good for 24 hrs. with no reported adverse event (incorrect dose administered) at unknown latency. The reported enquired, if the patient returns should they receive another half dose and discard the rest or should they receive a second full dose?   Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I noticed I was having shortness of breath (mild) when I was riding a bike in mid-April through June/July. I did not think it was in relation to anything other than thinking my COPD was getting worse. In September I went to see my pulmonologist. I got a breathing test and a CAT scan and those were fine. He recommended seeing a cardiologist. At the end of October, I got the Pfizer booster shot 10/27/2021. By August I would say the SOB got worse, so by the end of September/middle of October, it was difficult to climb stairs without feeling completely out of breath. And last week 11/5, the cardiologist gave me a stress test and put a pulse ox and it would drop with exertion. And on Monday 11/8, I went and got a CAT scan with contrast dye and the determination was that I had pulmonary embolism, multiple. I noticed I was having shortness of breath (mild) when I was riding a bike in mid-April through June/July. Currently on blood thinners.
Patient received 3 doses of covid vaccine, 1st was from pfizer and number 2 and 3 were from moderna
One injection every 3 to 5 years; One injection every 3 to 5 years; "blacking out"; fell and hit his head/gash on head; perspiring profusely; he had flu-like symptoms; feeling lethargic; left arm was very sore after the injection; generally felt bad the entire day; feeling light-headed/ incredibly dizzy; began feeling light-headed and nauseous; This spontaneous report was received from a consumer concerning to himself as a 54-years-old male patient. The patient's medical history included quadruple bypass surgery. The patient concurrent conditions were unknown, drug allergies reported as none. Concomitant therapies included vitamins (unspecified), isosorbide, aspirin, metoprolol and atorvastatin.     On 05-SEP-2020 (also reported as on Saturday around 12:30pm), the patient was vaccinated with one injection of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), for prophylaxis (one injection every 3 to 5 years) (inappropriate schedule of product administration (+) circumstance or information capable of leading to a medication error) and with influenza virus vaccine (unspecified) (strengths, routes of administrations, formulations, lot numbers, and expiration dates were not reported) both in the left arm.   On 06-SEP-2020 at approximately 1:00 am on Sunday, the patient woke up and went to use the restroom and began feeling light-headed (dizziness) and nauseous; he was "blacking out" (loss of consciousness) and fell and hit his head (head injury). Subsequently, his wife came into the bathroom and helped him stand up and go back to bed. At approximately 2 and a half hours later, he woke up again and went to the restroom and the same thing happened again. However, when he began feeling light-headed (dizziness), he laid down on the floor, so he did not fall again.   He also reported that he was perspiring profusely (hyperhidrosis) and being incredibly dizzy (dizziness) for approximately 15 minutes. Moreover, he had flu-like symptoms including feeling "achy," having a low-grade fever, feeling tired (influenza like-illness) and lethargic and generally felt "bad the entire day" (feeling abnormal). Also, the patient's left arm was very sore after the injection (pain in extremity) (also reported as "soreness at site pain")  By Monday morning he felt better and by Monday evening (07-SEP-2020), he was fully recovered other than "gash on head" (head injury) which was a result of the fall. It was stated that the patient did not received any treatment and did not performed any laboratories or studies for the events. However, the patient saw his cardiologist.   The causal relationship between the events and the suspect vaccine was not provided.  Upon internal review, the event loss of consciousness was determined to be medically significant.
Headaches, Vision Changes, Inflammation in eyes, Dizziness, Fever, Muscle Aches and Pains
pt recv vax 13DEC95 & became violently ill & exp palpitations,nausea & flu-like sx;
After 2nd shot, right foot swelled up and toe of right foot is swollen and very painful, like needles.; After 2nd shot, right foot swelled up and toe of right foot is swollen and very painful, like needles.; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient himself) of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration on an unspecified date as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller was a, with a wound in his leg, pieces of rock etc. He received the 1st Pfizer vaccine BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 3-4 days later his big toe on right foot swelled. On an unspecified date after 2nd shot, patient experienced right foot swelled up and toe of right foot is swollen and very painful, like needles. Never had gout. Was verifying his personal information when the call disconnected. The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s).
This case was reported by a consumer and described the occurrence of decreased therapeutic response in a 32-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date ten years ago, the subject received unspecified dose of Hepatitis B vaccine (unknown). On an unspecified date, ten years after vaccination with Hepatitis B vaccine, the subject experienced decreased therapeutic response. The reporter indicated that the subject's titer was 0.60 and the subject was vaccinated ten years ago with an unknown manufacturer's hepatitis B vaccine. The reporter also indicated that another subject, who also received an unknown manufacturer's hepatitis B vaccine approximately 20 years ago, experienced a titer level of 0.40 (see case id A0778986A for more details on this subject).
Within 15-20 minutes of the vaccine I was Vomiting, diarrhea and had very severe stomach pains lasting a few hours
Fever low grade up to 102F. Generalized body aches and pains. 7/16/12 developed rash and still febrile.
COVID-19 Moderna vaccine was mistakenly given instead of  dose number 2 Pfizer COVID-19 vaccine. Patient was notified immediately, he was observed for 30 minutes, and experienced no adverse infections. Possible adverse events and side effects were discussed with the patient.He will be followed up by phone call. RN administering vaccine self reported the incident, and Was receptive to discussion surrounding the mistaken administration. Measures were taken to avoid recurrence of this event.
Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) had resolved.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: TCR : AE details and outcome.Patient's gender was added.
almost immediate swelling of uvula, back of airway/throat, sore throat, chest palpitations.  Gave 50mg of oral Benadryl, took vitals, called EMS, patient never described difficulty breathing, however, throat tightness and swelling was visible when looking at back of throat.  EMS recommended observing patient for one hour in the site and did not recommend transfer to a hospital ED.
Vaccine was exposed to storage temperature outside the recommended ranges. Patient did not need any treatment and did not have any symptom.
Same day rash and extreme fussiness. Rash showed up on her lower back that evening and continued to spread, redden and swell for one month. She was extremely fussy for one week. For two weeks starting the day after the shot, she did not sleep at all during the day. She took none of her naps. The same week as the shot, she began getting hives which would appear suddenly and cover her entire body. It is now almost two months, and the hives persist. She has been showing signs of being allergic to soy, gluten and dairy as well as eggs. Since receiving the vaccine, her left eye appears to be smaller, and she is unable to open that eye as much as the right eye.
Low grade fever, sore arm, diarrhea for 3 days, tiredness for 5 days,  entire body muscle cramps, entire body muscle pain,  no appetite for 5 days,  queasy stomach.  On 2nd day woke up with very stiff neck on the right side, couldn't move head to the right, this lasted for 4 days.
Post-herpetic neuralgia; Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 18-MAY-2012, at age 61, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles and post-herpetic neuralgia. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles and post-herpetic neuralgia is unknown.  Additional information has been requested.
After the vaccination I had pain in my entire hand it went numb and it stayed that way for a long time. I also had shingles after the vaccination.
Abdominal pain. Ovarian cyst.  Emergency surgery on 04/18/2021
side effects started about 3 days after then symptoms started and continues to get worse for 13 days until I went to the hospital emergency room 10/17
This is a spontaneous report from a contactable consumer reporting for the son (patient's mother). An 18-year-old male patient received TRUMENBA, via an unspecified route of administration at single dose in the right arm on 02Sep2017 10:45 for immunisation. Medical history included ear infection when he was child. Concomitant medications were not reported. The patient previously took MENACTRA in 2010 and in 2015 (at the age of 16 years), meningococcal vaccine on unknown date and TRUMENBA on 19Sep2016 and experienced peripheral swelling, vaccination site warmth, pain. On 02Sep2017, the patient experienced almost passed out/ he has passed out, had a fever/ was burning with fever/ basal thermometer that went up to 101°F, terrible back pain/ back pain and whole body ached, body aches/ back pain and whole body ached, dizziness/ he was dizzy, he felt like he was going to vomit, he was disoriented, he looked terrible, he looked exhausted, all with outcome of recovered. He did not look good, looking pale on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of fever included acetaminophen. The events were described as follows: That night 02Sep2017, she thought he was reading, when she went up to check on him, he had passed out, was burning up with fever. Only could find a basal thermometer that went up to 101°F, his temperature could have been higher. Was given acetaminophen. He was disoriented, he looked terrible, had back pain and whole body ached. When he tried to go to bathroom, he was dizzy and almost passed out and felt like he was going to vomit, but he did not lose consciousness. Had vaccine in the morning, unknown if he was feeling well at dinner. He had just went to college, he looked exhausted. She had read on (Online) that she should take him to emergency room. She had called doctor an hour later, by that time his fever had gone down to 99°F. He was ok the next day, fever had gone. Still did not look good, looking pale. First couple of days he was not a 100%. Unknown date when he fully recovered from adverse events.
Pt recv vax on 8/4/98; on 8/5/98 pt exp fever (103) & redness &edema of left thigh; pt to M.D.
can't get a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in 2021, the patient experienced can't get a deep breath. The outcome of the event was unknown.
Pt developed erythema multiforme minor with temperature of 103.5F which resolved by 8/20/01. She was given Biaxin on 8/14/01 for possibility of Mycoplasma infection.
Angioedema the following morning [ my lips were swollen +3] . No treatment sought .
This case was reported by a pharmacist and described the occurrence of myalgia in a 63-year-old male patient who received SHINGRIX (batch number DD43M, expiry date unknown) for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On 29th September 2018, 1 days after receiving SHINGRIX, the patient experienced myalgia and fever. On an unknown date, the outcome of the myalgia and fever were unknown. It was unknown if the reporter considered the myalgia and fever to be related to SHINGRIX. Additional details were reported as follows: The patient had myalgias and fever over the next days after receiving SHINGRIX vaccine. The patient described he couldn't get out of bed over the weekend and missed football game on Sunday. The reporter agreed to be followed up. This case was linked with case US2018GSK190867, reported by same reporter.
This non-serious spontaneous case, was initially received on 22-Sep-2017 from other non-health professional, concerning a 38-month-old, male child. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with FLUCELVAX QIV (dose, batch number: 195215, expiry date: 30-Apr-2018, route of administration and anatomical location: not reported) (explicitly coded as inappropriate age at vaccination since FLUCELVAX QUADRIVALENT have not been established in children less than 4 years of age). It was reported that, the patient had not experienced any adverse event after the vaccine administration. The outcome of the event was not reported. The reporter considered the events as non-serious. Follow-up received on 13-Oct-2017: The patient's date of birth and age were updated. It was reported that, the patient had not experienced any adverse event after the vaccine administration. Additional event 'no adverse event' was coded. The narrative was amended accordingly. Non-significant case correction received with IRD 22-Sep-2017: Batch number was updated on the screen. Narrative was amended accordingly.
Patient had rash on neck and upper chest after the vaccination that she says "hurts." Its red and elevated. It is still not completely gone July 25, 2018.
dizzy; struggles to breathe/ cannot take deep breaths/ short of breath; cannot tolerate exercise of any kind; I just want to know what it did to her lungs; This is a spontaneous report from a contactable consumer (patient's mother). An 18-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 22Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine and she struggles to breathe. She got dizzy, cannot tolerate exercise of any kind. She cannot take deep breaths despite taking inhalers (albuterol). She was also short of breath while wearing a mask. The reporter just wanted to know what it did to her lungs. Not to seek damages but to have answers. They did report her symptoms. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6X11 CM RED TENDER AREA LEFT UPPER THIGH WARM TO TOUCH, HARD.
MOTHER WENT TO MD OFFICE. CHILD DEVELOPED HIVES ON FACE AND BACK AFTER H1N1 VACCINATION. CHILD RECEIVED BENADRYL IM AT MD OFFICE.
3/22/06- Broke out with rash - 30-50 lesions mainly torso. Dr confirmed.
face freezing; something is wrong; Face numbness and tingling; left arm numbness; neck numbness; lips numbness; eyes numbness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (face freezing), DISCOMFORT (something is wrong), HYPOAESTHESIA (Face numbness and tingling), HYPOAESTHESIA (left arm numbness) and HYPOAESTHESIA (neck numbness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING COLD (face freezing), DISCOMFORT (something is wrong), HYPOAESTHESIA (Face numbness and tingling), HYPOAESTHESIA (left arm numbness), HYPOAESTHESIA (neck numbness), HYPOAESTHESIA ORAL (lips numbness) and HYPOAESTHESIA EYE (eyes numbness). At the time of the report, FEELING COLD (face freezing), DISCOMFORT (something is wrong), HYPOAESTHESIA (Face numbness and tingling), HYPOAESTHESIA (left arm numbness), HYPOAESTHESIA (neck numbness), HYPOAESTHESIA ORAL (lips numbness) and HYPOAESTHESIA EYE (eyes numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact