chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to an unspecified number of patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. The patients received unspecified doses in PROQUAD (lot # M029595 with expiration date of 10-DEC-2017, and lot # M004892 with expiration date of 25-JUL-2017, dose and route unknown) immunization series that were improperly stored, for prophylaxis. The vaccines were exposed at minus 10 degrees Celsius for 24 hours. The excursion occurred on 08-JUN-2016 and the vaccinations occurred from that point through 07-OCT-2016. No adverse effects were reported. This is one of two reports received from the same reporter. All telephone attempts to obtain follow-up information on 29-NOV-2016 have been unsuccessful. On 01-DEC-2016, a return call was received from the certified medical assistant. She was unable to provide any additional information. The Merck  correspondence process was received with her, should information become available. Additional information has been requested. Narrative was updated.; Sender's Comments: US-009507513-1610USA004335: MERCK 1610USA004337:Mfr number.
This case was reported by a physician via sales rep and described the occurrence of myalgia in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced myalgia, fatigue, headache, shivering, fever and gastrointestinal upset. On an unknown date, the outcome of the myalgia, fatigue, headache, shivering, fever and gastrointestinal upset were unknown. It was unknown if the reporter considered the myalgia, fatigue, headache, shivering, fever and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Within an hour after receiving SHINGRIX, the patient experienced myalgia, fatigue, headache, shivering, fever and gastrointestinal upset. The physician agreed to receive follow up from GSK.
Information has been received from a licensed practical nurse concerning a 19 year old female patient with allergy to sulfa drugs and a history of ruptured ovarian cyst, who on 29-OCT-2010 was vaccinated with a first of three doses of GARDASIL (Lot # 666596/0097Z) in the left deltoid IM. Concomitant therapy included SPRINTEC. Nurse reported that between the date of administration and 02-NOV-2010 the patient developed a rash at the injection site that progressed down her left arm, across her chest, onto her right arm and was now on her chin. Patient would use BENADRYL. On an unspecified date, a PAP smear was performed (results not provided). The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow up information was received from a physician who indicated that that patient was a homemaker female with no pre-existing allergies, birth defects or medical conditions who experienced a rash beginning at site of injection (left deltoid) which spread to the chest and to the other arm. There were no illnesses at the time of vaccination or diagnostic laboratory tests performed. On 07-NOV-2010, the patient recovered. No further information is available.
hours after jab developed chills, fatigue, fever, "tightness of chest, no Sob, numbness r arm and leg. went to ER 0n 9-25-21 and released after normal labs. 2 days after visit sx's resolved
Moderate vomiting x 2 approx 15-20min following an adult DT IM inject; Pt rested 15-20min, fine afterwards;  All VS WNL;
Patient?s dad brought patient in for vaccination. Patient is not 16 yet and received the Moderna vaccine. Does not have any symptoms or side effects. Just wanted to report.
was light headed @ administration of vaccine laid down 15 min, was given a Decavac Pt laid down an additional 15 minute-Left office and was near syncope-before reaching car-For next 2 days dizziness, nausea, and general malaise
Right eye swollen and a stye on the upper lid of the eye.  It is very sore.
rash onset 8/2/99 lasting 7 days;positive fever x8 days;temp max @ 103;APAP given for about 6 days;seen by MD;stomach virus complication accompanied by vomiting episodes;no meds given;had less than 50 pox on entire body;
EPI ADMINISTERED 0.5 ML IM & BENADRYL 50MG IM; TRANSPORTED TO LOCAL HOSPITAL ANAPHYAXIC RASH PRESENTED BY RASH AND GI DISTURBANCE
I had little sticky throat. I gargled and noticed I was having a lot of congestion in my nose. I took at home COVID-19 test to go to a party and tested twice. I went to the urgent care and tested positive to make sure. I went to the urgent care, and they gave me PAXLOVID. So far I have been taking it for three days, I am about the same cause but I do not feel congested.
Sore at injection site, expected side effect. Unexpected effect - one hour after shot, fingers were cold and stiff, especially left index finger.  Got progressively cold until it was numb, other fingers were cold, then numb, but less numb.  Left index finger got white/yellow in color and looked waxy, other fingers less so.  (Similar to Raynaud's syndrome finger appearance.)  Later, right thumb was almost as numb and waxy as left index finger.  Hand numbness and discoloration lasted for 90 minutes after injection.  (Time of injection above was approximate.)  I did hand clenches and hand stretches and shook arms to improve circulation.  Temporary (minutes) mildly elevated heart rate, probably as panic reaction to numb fingers.  No increased breathing, no nausea, no hives etc.
doctors said for her not to takethe second dose because of her symptoms from the 1st dose of the Moderna vaccine.; dizziness; fell; had to use a walker; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (doctors said for her not to takethe second dose because of her symptoms from the 1st dose of the Moderna vaccine.), DIZZINESS (dizziness), FALL (fell) and GAIT DISTURBANCE (had to use a walker) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced DIZZINESS (dizziness), FALL (fell) and GAIT DISTURBANCE (had to use a walker). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (doctors said for her not to takethe second dose because of her symptoms from the 1st dose of the Moderna vaccine.). In February 2021, DIZZINESS (dizziness), FALL (fell) and GAIT DISTURBANCE (had to use a walker) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (doctors said for her not to takethe second dose because of her symptoms from the 1st dose of the Moderna vaccine.) outcome was unknown.        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.   No Treatment information was provided.  No concomitant product information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant follow up appended to AER On 04-May-2021: no new information On 16-Jul-2021: No new information received.
On approximately 10/01/2022, my legs started to look like my veins were inflamed in both my shins. It didn't hurt.  A week later, the insides of my legs felt like they were on fire.  I called my doctor. They put me on a topical steroid cream and referred me to a Dermatologist. The Dermatologist gave me a stronger cream and Prednisone and four biopsies. There was no diagnosis. My skin was blistering.  He sent me to Clinic, who put me on a chemotherapy medication that they think will help. They did two more biopsies. I have been referred to oncology and neurology. We are awaiting pathology.
One and a half days after the injection, I had severe chills for about 5 hours. Chills started on Feb. 15 around 2 am and stopped around 7am.
Pt started to feel diaphoretic at 12:43pm, RN informed. Pt also states that he felt dizzy for a little bit. Pt states that he got scared and started to feel symptoms. RN assessed, took vitals and gave ice pack and orange. After 1 minute, pt feels a lot better. Patient stated for extra 15 minutes.  RN monitored, reassessed, and cleared pt. . V/S 140/83,73.
Seen in clinic 9/17/09 with L arm injection site swollen, red, hot, 25 x 50 mm. C/o pain radiating to post neck and jaws bilaterally increasing with hand movements. Full ROM, sensation, the ROM limited by pain with movement. Recheck 9/18/09. Referred to PCP. Initial rec. ice packs, observe.
ADACEL given IM (L) delt. on 4-26-13. Pt noticed redness, bumpy areas to LUA starting 5-2-13. Skin appears pink from below the injection site to the elbow. Area is warm to touch and swollen but soft to touch. Pt c/o itching. Pt seen by doctor on 5-3-13. See attached note.
Around 5:00 pm that same night of my three vaccines. My second COVID-19 shot was in my left arm; flu and pneumonia shots in my right arm. I suspect my symptoms are from my right arm. I cannot move my right arm at all, and have not slept for two nights. Lightheadedness. No appetite. Headaches. Raised temperature. Cold sweats. Very painful. Missed work due to my symptoms. Very ill.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: throat hoarseness, blister on mouth-Medium
The first day I just had soreness in my arm, slight body aches and a headache. I took Motrin. The following day I had to same symptoms and was fatigued, along with other symptoms. Tuesday, I was lightheaded, dizziness, chills body aches, a headaches. I called my doctor and was given prescription for Zofran for nausea and I had to go back Wednesday to take another COVID test. From there until February 5th, I had nausea, a headache and felt lightheaded. On the 6th, I woke up fine. I've had a headache at least twice a week since then and sometimes, it's accompanied by nausea.
Fever, chills, blinding headache, body aches and pains, vomiting
I had Covid on 09/07/2020. I had extreme fatigue and neuropathy. I lost my voice for about a week. It is not fully back yet and I have to force myself to talk. I tested positive for Covid on 02/03/2021 with a home test. The doctor said I could take some supplements and vitamins, he gave me some medication for my cough.
Angioedema about 12 hours after vaccine, hospitalized for one nigh unknown - done at a Pharmacy,
Employee developed redness around injection site 1 day after given, spreading redness and induration 2 days after given--also noted warmth and tenderness. Redness and induration worsened 3 days after injection given (about 6cm in size). The employee was advise to use ibuprofen or acetaminophen for comfort as well as cool compresses on and off the site. There was no change 4 days after the injection, but she noticed improvment on days 5-6 after injection. I re-evaluated her on day 7 post-injection and the redness, induration, warmth, and pain were gone. ROM in shoulder was normal.
Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 11-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on (date); no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2109USA006019: US-009507513-2109USA006020: US-009507513-2109USA006021: US-009507513-2109USA006022: US-009507513-2109USA006023:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 11-AUG-2013 the patient was vaccinated with ZOSTAVAX, (lot # expiration, dose, route unspecified). On 13-AUG-2013, the patient experienced "redness, pruritus, warm and blister at the injection site, redness, pruritus, warm and blister" at the injection site following the administration of ZOSTAVAX. Pharmacist stated the blister appeared to be a histamine/inflammatory response to the vaccine and did not appear to be shingles related Pharmacist mentioned the patient's blister popped and was now an "open, raw and tender" area. No lab diagnostics studies performed. The patient sought medical attention via contacted pharmacist. CAMPHO-PENIQUE liquid was given for treatment. At the time of report, the event was not recovered. Additional information has been requested.
11 year old patient was inadvertently given FLUBLOK QUADRIVALENT, no AE; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from the pharmacist.  This case involves a 11-year-old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2044 and expiration date 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   The patient did not receive any other vaccine concomitantly.  This was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  At the time of reporting, no adverse event was reported to the patient.  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 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.
On 03/16 he developed progressive onset of symmetric lower extremity weakness. He states this is similar to the weakness he experienced with his Guillain-Barré syndrome in 2019. Currently on IVIG (Gamunex) day 4 of 5 and his weakness is improving.
No additional AE reported; temperature excursion on PROQUAD/ had been administered to three patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 07-APR-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # T023918, expiration date 09-JAN-2022 (exact dose, injection site and route of administration were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of -58 and 5 degrees Fahrenheit (6.3 F) for 6 hours and 30 seconds and of -58 and 5 degrees Fahrenheit (10.9 F) for 7 minutes and 30 seconds. The digital data logger was involved in recording the temperature excursion details. Administered dose of vaccine experienced the previous temperature excursion (no details provided). There was no additional adverse events reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA008219:01916440 US-009507513-2104USA008134:01916457
her arthritis flared all over, everywhere except for feet; This is a spontaneous report from a contactable consumer reporting information for the same patient. This is the second of two reports. The first report is a solicited report from a non-Pfizer sponsored program (marketing program name not available) based on information received by Pfizer from Amgen (manufacturer control number: AMGEN-USASL2021106605), license party for etanercept (ENBREL). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included etanercept (ENBREL) from 2002 for rheumatoid arthritis. It was reported that patient got covid vaccine, and her arthritis flared all over, everywhere except for feet. Patient HCP had told her that he had heard from other patient's that their conditions flared after getting vaccine. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2nd shot 24 hours of fever, aches, flu-ish symptoms; BOOSTER #3 - 10 hours after had fluish symptoms again.  Got up in the night at 3 AM....went into shock blacking out and collapsing onto the floor for who knows how long (I live alone).  Very disoriented upon waking.  Limbs were mangled under me....feeling for where I was in the dark.  Suddenly felt like vomiting yet didn't - sudden profuse sweating - need to get to the toilet and was able to manage that.  Back in bed confused for a while.  Twisted and stretched tendon all up back of left leg.  Scratch on right thigh assuming from left toenail.  Mainly the fact that I SUDDENLY blacked out and had symptoms of being in shock.  I have a history with trazadone and nitroglycerine taking me  into anaphylaxis.
it got more swollen/worse and it has been like that since/ face swelling; it got more swollen/worse and it has been like that since/ hand swelling; it got more swollen/worse and it has been like that since; This is a spontaneous report from a contactable consumer (patient). A 72-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 24Feb2021 (at the age of 71-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COVID Pfizer vaccine) on 02Feb2021 for covid-19 immunization and the next day she had little swelling in her face and hands and it kind of went away and came back and forth since she received it. It didn't go away really but it was just less. It came back before her second dose. She received the second dose of the vaccine on 24Feb2021, and it got more swollen/worse and it had been like that since. She was noticing the swelling in her veins ever since she had the shot. She had gone through blood tests, PT and everything (unknown results), her doctor was at a loss. They said they had not seen anyone who had events for this long. She stated it was going on since 5 months and it was affecting her. She had spent a bunch of money trying to figure out what was going on and she was getting no answers. She spoke with the CDC and they referred her to Pfizer. She stated she knew that there had been face swelling, but it supposedly goes away within a couple days. She wanted to know if anyone had experienced the events for this long. The outcome of all the events was not resolved.  Information on batch/lot number has been requested.
about 30 min after vaccination pt reported feeling "out of it", weak, spacy, and dizzy, appeared to be in hypoglycemic state, but is not diabetic and eating doughnut at time of event, sx resolved about 20 min later
moderate to severe abdominal cramps and drop in blood pressure to 60s/40s; duration 15-20 minutes; treatment included heating pad and tylenol
Injection arm tightness; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection arm tightness) and VACCINATION SITE PAIN (injection arm soreness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Colitis. Concomitant products included MESALAZINE (LIALDA) for Colitis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS, FISH OIL and INFLIXIMAB (REMICADE) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Injection arm tightness) and VACCINATION SITE PAIN (injection arm soreness). At the time of the report, VACCINATION SITE INDURATION (Injection arm tightness) and VACCINATION SITE PAIN (injection arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided by the reporter. Patient is taking additionally unknown Immunosuppressive medications as a concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Concomitant Medication and medical history updated. On 23-Jun-2021: Non-significant Follow-up appended
Went home; felt a bit tired. By night arm was sore as expected. Next day, in the morning, felt very fatigued, arm was sore, and noticed bruising at the site of vaccination. Vaccine was administered high up in arm. Took TYLENOL for the pain. By night, arm was very sore to the point that it was hard to put on a jacket, tingling and numbness in right arm then it started moving to other parts of body. Felt really bad so called back vax administrator; was asked to come to the office since reported chest started feeling heavy. Went to pharmacy but there was a long waiting line so ended up going to walk-in medical center across the street. Per healthcare provider, symptoms could be related to the shot; patient told that if the breathing gets worse to come back. Next day, went to the ER. Testing included: EKG, chest X-ray and blood work. Patient was released. Recommended TYLENOL for pain, X-ray was good. Symptoms continued and getting worse; thought they were spreading. A couple of days later went to Dr. (who ran another set of tests (sonogram, EKG)). Went to specialist the same day, neurologist, Dr. who ran an MRI and nerve tests. Just provided recommendation for another doctor--not sure of test results. Went to another neurologist for a 2nd opinion; Dr. Per neurologist, symptoms indicate a mild GBS case; but patient told that she had to wait more time before testing--wait a month. By the time got to this doctor felt a little better--less of the tingling. Currently patient has pain in wrist, ankles, back pain and arms; feels weak. Before tingling was predominant now has pain. Patient is taking TYLENOL as often as needed. Pain is worse when lay down; 3 per day. When patient takes a shower she gets rashes on legs and feet--more sensitive to heat.
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. On an unknown date, the unknown number of patients may have received M-M-R II, GARDASIL or ROTATEQ that was stored improperly. No adverse effects reported. Additional information has been requested.