chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 22-JAN-2008, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of shingles or severe herpes zoster. On or about 30-MAR-2015, the patient was treated by a physician for the onset of a rash, which was diagnosed as shingles. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. Additional information has been requested.
Blister appearing rash on both forearms; rash on right trunk area; family physician contacted; family physician recommended urgent care visit.
pt recv vax & devel hive-type , pruritic rash back & arms onset the day p/vax;
A company representative reported that the patient developed a local reaction at the injection site. The reporter indicated that 5 patients from this facility experienced this event; however, they are not presently identifiable.
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been more than 8 weeks since that clinic and this child has been offered an additional dose.
Where i got the shot i have a ball; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Where i got the shot i have a ball) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 SITE SWELLING (Where i got the shot i have a ball). At the time of the report, VACCINATION SITE SWELLING (Where i got the shot i have a ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No information about treatment medication was given
Warm; The enlarged patch is a hard lump area; firm to touch; Itchy; Enlarged patch area around the injection; Red; Headache; Tired; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection) and VACCINATION SITE ERYTHEMA (Red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection), VACCINATION SITE ERYTHEMA (Red), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection), VACCINATION SITE ERYTHEMA (Red), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Chills and sweating occurred around 4:00 AM on 4/24/2021. Bad headache occurred around 2:00PM that same day.
Pt recvd a series of 3 Engerix-B vax on 29OCT90, 21NOV90 & 16MAY91 & was a poss non-responder;
the patient was given the wrong dose of the Moderna vaccine for his 4th dose - booster dose.  he was given 0.5ml 100 mcg rather then 0.25ml 50 mcg.  patient did have a sore arm but otherwise  did not have an adverse event due to this error
Initial unsolicited report received from pharmacist on 26-Oct-2015. This case involves a patient (age and gender was not provided) who was vaccinated with a dose of High Dose Flu Shot (batch number, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient had experienced adverse event after administration with Fluzone high dose vaccine. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
ACUTE NON ST ELEVATION MI  7/12/2022 &  10/5/2022  -  RECURRENCE OF SAME SYMPTOMS
Urticaria, coughing, mild wheezing. Urticaria started on face and neck and spread to trunk and upper extremities. Epi 0.2 SC, Benadryl 37.5mg IM, Pediapred 2.5 tsp PO qd x 5 days. Pt recovered well. Kept in observation for 2 hours.
headache, body ache, lethargic, temp of 103.9 peak, chills, joint aches, vomiting
This spontaneous report as received from a physician via a company representative refers to a 13 year old female patient. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1, intramuscular (dosage regimen, lot # and expiry date unspecified) for prophylaxis. On an unknown date, the patient received dose 2 of GARDASIL. On an unknown date, two months after receiving the second dose of the vaccine series, the patient experienced headache. On an unknown date, the patient underwent an Magnetic Resonance Imaging (MRI) on the head (results unspecified). It was reported that the patient sought medical attention by contacting the physician. Patient did not receive treatment for the event. The outcome of headache was reported as not recovered. No product quality complaint (PQC) was involved.      Additional information has been requested.
Can't breath; tongue swollen; throat is real red; Itches all over; rash on the upper part of body; Fever; eyes are burning; feels like she got pneumonia; arm felt numb; heada che; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Can't breath) and SWOLLEN TONGUE (tongue swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Bronchitis and Sinusitis.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOAESTHESIA (arm felt numb) and HEADACHE (heada che). On 07-Apr-2021, the patient experienced EYE IRRITATION (eyes are burning), CHEST DISCOMFORT (feels like she got pneumonia) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPNOEA (Can't breath) (seriousness criterion life threatening), SWOLLEN TONGUE (tongue swollen) (seriousness criterion life threatening), PHARYNGEAL ERYTHEMA (throat is real red), PRURITUS (Itches all over) and RASH (rash on the upper part of body). At the time of the report, DYSPNOEA (Can't breath), SWOLLEN TONGUE (tongue swollen), HYPOAESTHESIA (arm felt numb), EYE IRRITATION (eyes are burning), CHEST DISCOMFORT (feels like she got pneumonia), PHARYNGEAL ERYTHEMA (throat is real red), PRURITUS (Itches all over), RASH (rash on the upper part of body), PYREXIA (Fever) and HEADACHE (heada che) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 98.3 (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient have not taken medical care at the time of report. No treatment information available. advised to seek medical care immediately.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine administered 4-29-03.  Client saw MD 5-1-03.  MD's office called to report reaction 5-2-03.  Left posterior tricep area red with heat - 7x11 cm.  Keflex prescribed.  Client also had sinus infection.
4 months after getting the vaccine I had a 4 hour long fever. I also had chills, but no other symptoms besides the fever. Then the fever went away. A few days later i started getting mental fatigue, brain fog, and also physical fatigue. That lasted for 6 months. I felt like I had covid but I tested negative for it. I stated going to the doctor on October 21, 2021. I found out that I might have crohn's disease. I had lost 20 lbs. within the first month of getting sick and then 30 lbs. all together. I feel like I had recovered from those symptoms around the time I had got the booster which was 12/3/2021.
Pt given flu shot x 1 day ago. Pt arrived this AM with fever, chills and stomach ache.
Severe swelling, pain and redness of upper left arm at injection site for 5 days and redness, swelling and pain in left elbow for 7 days to date.
On Thursday (4/22), I got hives all over the front of my body from chest down around 4pm.  Took Benadryl. Woke up and rash mostly subsided.   On Friday afternoon, hives started to come back all over body (this time neck and face). Also had some facial swelling, chest/facial pain. First spoke to a doctor through virtual appointment. Said reaction may be from Moderna vaccine since no other evident causes (no change in diet, medication,etc) Rash started spreading to my face and my lip started to swell so I went to the ER. Given fluids, steroids, and Benadryl. Hoping after the round of steroids the hive breakouts are over.   Nurse at hospital suggested I report my reaction through this portal.
Somebody died on 10Feb in his family; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 10Feb2023, outcome "fatal", described as "Somebody died on 10Feb in his family". The patient date of death was 10Feb2023. The reported cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Somebody died on 10Feb in his family
Patient likely received mixed vaccines for her COVID-19 vaccination series, Pfizer for 1st dose and Moderna for 2nd dose. Pt received Pfizer for 1st dose on 12/19/2020. For 2nd dose on 1/11/21, she confirmed receiving green piece of paper (which indicates Moderna dose in our workflow), and her CDC immunization card also states Moderna 2nd dose. Error likely caused by workflow/operational issues and not screening patient carefully for 1st vs. 2nd dose, as vaccinators were administering both vaccines in the same clinic space (Pfizer for 2nd dose only, Moderna for all 1st dose). During f/u today, pt did not report any s/sx or ADRs other than sore arm. No tx required.
Restless legs; burning feet; anxiety and they did gestational Diabetes test and I was really high. I am still having all of these symptoms.  I am taking magnesium to see if it will help but it hasn't.   Pregnancy history - my second pregnancy - and I did not have gestational diabetes the first time. Estimated date of delivery - July 29, 2021 (maybe sooner now because of the gestational diabetes)
Per pt report she developed a fever of 103, had a headache and general malaise approx one hour after being given the injection. She also reports taking Ibuprofen 400 mg. No other treatment received.
Not to receive the second dose; Brain fog; Numbness; vomiting; tinnitus; lack of eye focus daily; Lightheadedness; Extreme vertigo; Stiff neck; Swollen neck glands; Nausea; Fatigue; Chills; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Extreme vertigo), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Lightheadedness), DIZZINESS (Dizziness) and PRODUCT DOSE OMISSION ISSUE (Not to receive the second dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy bilateral (Double mastectomy) and Thyroidectomy. Concurrent medical conditions included Thyroid cancer. Concomitant products included LEVOTHYROXINE and CANDESARTAN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (Dizziness). On 03-Mar-2021, the patient experienced VERTIGO (Extreme vertigo), MUSCULOSKELETAL STIFFNESS (Stiff neck), LYMPHADENOPATHY (Swollen neck glands), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills). On 12-Mar-2021, the patient experienced HEADACHE (Lightheadedness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not to receive the second dose), FEELING ABNORMAL (Brain fog), HYPOAESTHESIA (Numbness), VOMITING (vomiting), TINNITUS (tinnitus) and VISION BLURRED (lack of eye focus daily). On 12-Mar-2021, VERTIGO (Extreme vertigo), DIZZINESS (Dizziness), LYMPHADENOPATHY (Swollen neck glands), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Lightheadedness) and FEELING ABNORMAL (Brain fog) had resolved with sequelae and PRODUCT DOSE OMISSION ISSUE (Not to receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In follow up patient reported that patient did not take the second dose of vaccine The patient sought medical attention and a physician examined the patient's ears and sinus and there was no sign of infection.  Patient was prescribed Meclizine to treat her symptoms however, she had not taken any of the medication at the time of the report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Significant follow up received on 22-jun-2021 , with events added , event updated and reporter details updated
Loss of appetite -3 days, Fever 1 day, Headaches still having, Fatigue still having Going to Dr. on April 21, 2021
Very dizzy; Fatigue; Fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), VACCINATION SITE PAIN (sore arm) and DIZZINESS (Very dizzy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046321A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever) and VACCINATION SITE PAIN (sore arm). On 15-Apr-2021, the patient experienced DIZZINESS (Very dizzy). On 14-Apr-2021, FATIGUE (Fatigue), PYREXIA (Fever) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, DIZZINESS (Very dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Within 24 hours of vaccines administration patient began to experience fever and chills and achiness. Went to clinic to dr and was prescribed TYLENOL or ADVIL and told to watch for signs of rash.
Patient reported feeling tingling in arm and lump under the skin that was oblong and 4-5 inches to the lower, left of where the shot was given. Patient continuing to feel lump and has redness on the surface of the skin. Patient followed up with another healthcare provider who advised her to come back to the pharmacy to have it evaluated.
1st dose pfizer vaccine was given to patient on 07/08/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/10/21, mother came to the pharmacy on 07/10/21 to let us know is out of town. She will give us a call if she is interested in getting vaccination again.
Next day developed a headache which lasted well in excess of one week. Shortly thereafter (2 weeks) developed shingles on my right side with extreme pain culminating in an emergency room visit and follow up care by primary physician. Unknown if shingles were related to vaccine.
Hispanic female accompanied by  her father.  Filled out paperwork and was allowed through by clerical person to receive inj.  Nurse vaccinated client.  Clerical supervisor saw DOB after vaccination completed by nurse and informed her.  Client was kept 20 minutes.  No adverse reactions.  Father informed she was underage and we can not administer her second vaccine and to not get any other vaccines for covid unless notified by us or her personal physician.  Father spoke little English, daughter translated.
Recieved @ 2:45 p.m. immediately left arm hurt, stinging moving from left arm across thru right arm.  All of left arm to fingers in pain.  3 hours later lost hearing in left ear, high pitched ringing for about 2 mins.  Could not move left arm without extreme pain, flu like symptoms.  headache, stining in neck.  Sunday- was woken up covered in sweat and both legs immediatly had spasms at back of legs. Dizziness, nausious.  Was out of work Friday, 10-8-21 thru Tuesday, 10-12- 2021 due to exhaustion, boths arms in extreme pain. flu like symptoms.  Menstrual cycle has extreme blood clots very short cycle.  To date my left arm has pain that is intolerable.  (My whole arm)  Muscle cramps in both arms, shoulders, neck & legs.  Extreme exhaustion and anxiety.  Dizziness and lightheaded.
06/27/15 Child was brought to urgent care with decreased appetite, diarrhea and vomiting. Transported to ER via 911. Admitted at hospital. Dx-small bowel obstruction. 06/28/15-Transferred to another hospital undergone surgical intervention due to ruptured appendicitis.
Patient received 2nd dose Pfizer youth 3 days early form allotted time frame. No reported adverse event at this time. No Treatment needed at this time. Patient feeling fine. No concerns expressed by patients parents. Report made as per CDC for any vaccine error.
high fever 3 days + 4 days of rash all over body;put on Zythromax;
pt recvd vax & exp nausea; p/dose 3 seroconverted;
Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes when she alerted staff that she was feeling numbness and tingling to lips that was moving up face and down to throat. Pt stated that she also had slight difficulty breathing which was relived when she took off her mask. She stated that she has allergies to papaya and cantaloupe and this reaction was similar. Pt was given 50mg Benadryl and stated that she was feeling much better about 15 minutes later. Vital signs WNL. Pt d/c home with instructions on when to seek medical care.
temporary difficulty with breathing; This spontaneous report was received from a lawyer and the patient and refers to a 66-year-old female patient. Medical history, concurrent conditions or concomitant therapies were not provided.   In February 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. In February 2019, the patient experienced temporary difficulty with breathing.   The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).   This is one of two reports concerning the same patient (# 1902USA000883).; Sender's Comments:  US-009507513-1902USA000883:
pt presented to ER for complaints of depression Covid testing is done ans part of admission process to unitl . pt has only received one dose of the pfizer vaccine on 6/11/21.