chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LITTLE PAIN IN THE ARM; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced little pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little pain in the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211154673 and 20211155653.
Information has been received from a lawyer regarding a case in litigation concerning a male 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 27-NOV-2013, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) 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 10-NOV-2016, the patient was treated by a physician 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 to 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.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267282, 2018SA267253, 2018SA267293, 2018SA267295, 2018SA267304, 2018SA267274, 2018SA267294 and 2018SA267305 (same reporter). This case involves a 56 years old female patient who was vaccinated with an expired dose of 0.5 mL vaccine FLUZONE QUADRIVALENT lot UI815AA, expiry date:30-Jun-2018 via unknown route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expire vaccine used. It was reported that 9 doses of expired FLUZONE QUADRIVALENT single dose vials exp. date: 30-Jun-2018 given inadvertently to employees for routine vaccination with no adverse reaction reported. 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 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. Documents held by sender: none.
Extreme head pressure approximately 1 hour after yellow fever shot. red (extreme) head, nausea, slightly lasted 2 hours then over the next day slowly got better.
Immediately after receiving her second varivax in her L arm she began to have hives that would come and go. She was given 2 tsp of diphenhydramine orally and 4mg of decadron IM. No pain, swelling, or itching at the injection site. She had mild itching of L popliteal area. No pallor, cough, wheezing, tachycardia, or swelling of tongue was noted. She denied headache and abdominal pain. In fact she was still very active and talkative as she had been prior to her inhection.
Testicalls itching and hair Skin. Poking like stabbing in the different part of the body.
the day after the shot was given patient had dysgeusia (bad metallic/ medicinal taste in mouth) nausea and change in appetite. these adverse events are still affecting the patient as of the time of reporting.
08/18/2021 Routine Covid19 Testing = Positive/Asymptomatic
Pt with swelling report by parent from shoulder to wrist of right arm, and dizziness.  Mom states patient has never had an adverse reaction to any vaccinations previously.
I felt fine after the shot, with only a sore arm for a few days. I'm not sure if the blood clot is related, but since I've heard reports of others with similar issues after getting the shot, I thought I should report it. About three weeks after getting the shot, I started noticing a pain in my right calf. I thought maybe it was just a sore muscle at first. After a few days I noticed it wasn't getting better, and I was getting short of breath doing simple tasks. That's when I suspected a blood clot. I drove myself to the ER and got it checked out. It turned out it was a blood clot, but fortunately it wasn't a deep one. I was prescribed an antibiotic, and told to use a heating pad, and take an aspirin a day to help alleviate the symptoms.
tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.            No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.   This case was linked to MOD-2021-291719 (Patient Link).
Moderna COVID-19 Vaccine EUA. Patient  came to get his first dose of the vaccine. He fainted while sitting at the post-vaccine observation area.  I called 911 to ask for paramedics while the nurses from MinuteClinic checked up on the patient. After a few minutes, the patient's  alertness came back, his color returned to normal. When paramedics arrived, patient could verify his infomation and whereabout. He denied help from the paramedics.  Immunization pharmacist recommended him to be obsereved for at least 30 mins, and check in with the ER or primary care physician for check-up for any delayed response. Patient said he will follow up with his primary care physician.  After 30 mins, his wife came to get him.
mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patients mother). A 14-year-old male patient received BNT162B2 (formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as unknown dose number, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received the Pfizer vaccine that afternoon on an unknown date and developed mild soreness at the injection site. The outcome of event was unknown.  Information about lot/batch number has been requested.
Reporter states that patient had a sharp pain on the right side of his rib cage and on October 12th, 2022 patient was diagnosed with Shingles; Reporter states that the injection was administered "way too high in the shoulder area." Reporter states that this caused pain and soreness on the shoulder area; This spontaneous report was received from the patient's spouse and refers to a male patient of unknown age. The patient's medical history included ""old shingles vaccine" administration. Concurrent conditions and concomitant therapies were not reported.   On an unknown date in 2018 and in October 2018, the patient was vaccinated with the first and the second dose of zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis in right arm (dose, strength, lot #, expiry date, and route of administration were not provided). Reporter stated that the injection was administered "way too high in the shoulder area" and this caused pain and soreness on the shoulder area. Still this day, the patient has pain in the shoulder. The outcome of the event was reported as not resolved.  On 12-OCT-2022, the patient had a sharp pain on the right side of his rib cage and was diagnosed with shingles. The patient sought medical attention. Treatment included valacyclovir. The outcome of the event was unknown.  The causal relationship between the shoulder pain, shingles and zoster vaccine live (ZOSTAVAX) was unknown.
Vomited from Wednesday to Friday afternoon; PA prescribed Ondansetron ODT 4mg tablet
This spontaneous report as received from a nurse refers to a currently 18 years old female patient. On 20-APR-1997, the patient was vaccinated with a first dose of M-M-R II dose 0.5 ml, subcutaneous, (lot number and expiration date not reported). On 17-FEB-2000 the patient was vaccinated with a second dose of M-M-R II, 0.5 ml, subcutaneous (lot number and expiration date not reported). On an unknown date, reported as recently the patient had negative titers for mumps, measles and rubella. The patient was recommended to receive another dose of M-M-R II. The patient sought medical attention. Titers laboratories were performed. No treatment was given for the events. At the time of the report the outcome of the events was unknown. The patient subsequently was inadvertently vaccinated with PROQUAD (Merck) instead of M-M-R II (MARRS 1409USA013852). Additional information has been requested.
8mins post vaccination pt had a syncopal event w/ associated flushing/sweating. Vitals: 17:55 75/41, 86, 24, SpO2 100% -- > 18:02 77/50, 84, 22, 100% -- > 18:09 92/64, 84, 22, 100%. Pt stable and released from the vaccination site w/ parents.
Patient contacted immunizer on 11/06/2009 regarding "egg shaped" raised area below injection site. Followed up 11/11/2009 - still prevalent. Patient had contacted PCP for evaluation.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 22-year-old male patient who received BEXSERO for prophylaxis. In November 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In November 2018, several hours after receiving BEXSERO, the patient experienced pain, feeling abnormal and feeling unwell. On an unknown date, the outcome of the pain, feeling abnormal and feeling unwell were recovered/resolved. The reporter considered the pain, feeling abnormal and feeling unwell to be related to BEXSERO. Additional details were reported as follows: This case was reported by the patient's mother. At the end of November 2018, the patient received a dose of BEXSERO at school in the health clinic. The reporter could not be confirmed which arm the vaccine was given and did not have the exact date and time in November 2018. Just a couple of hours, after receiving BEXSERO the patient experienced very achy, felt out of it and he did not feel well. These symptoms lasted for 24 hours and then resolved on their own. The reporter provided limited information regarding the 1st vaccine but information provided had been documented. Unable to obtain the physician's name and phone number. This case was not associated with a product quality complaint (PQC).
This spontaneous report as received from a registered nurse (reported as primary contact) refers to an approximately 9 week old patient. On 04-DEC-2013 the patient was vaccinated with ROTATEQ 2 ml, orally from lot number H010322, and expiry date 30-NOV-2013 for routine vaccination. Additional information has been requested.
About 24 hours after receiving the vaccine she was running 100.8 temperature, aching to the point of soles of her feet hurt, wanting to sleep.  Went to bed at 4:00 PM and stayed asleep until 11:00 AM the next morning.  Her arm swelled very high, there was a bruise at the site of the injection and itching all around it with a rash.  Arm is still swollen and tender to touch, but the rash is not bothering her to the point of scratching.  She did take Tylenol for the fever several times.
24 hours after injection hives observed over entire body. Zyrtec did not affect hives. Benadryll 4 hours later did not affect hives.
Client received Cansino covid vaccine lot #: A020121, no reaction on 04/24/21. Previous vaccine unavailable, Janssen given as an alternative 10.20.2021 approved by clinical lead via text per CDC guideline. Client denied any chronic conditions, medications, or any known allergies. On 10/20/21, client received his Janssen covid vaccine lot #: 1822809 exp. 03/07/22 without any symptoms on his left arm.
Within 10 minutes after immunization recipient became limp and unresponsive to efforts to wake him up. Speaking to him, moving his arms and legs, touching his face produced no reaction. His hands, arms and legs were completely limp with no muscle tone/resistance felt. His head was forward over his body and his body was curled forward (supported by the harness of the child seat). After rushing him back to the doctor's office he was woken up by one of the doctors through a firm massage in the right chest/shoulder area. His face appeared slightly blue. Examination showed normal breathing at the time. Doctor recommended to avoid future/ repeated Polio vaccination.
I had vaccination on 09/22/2022. I started to experience COVID-19 symptoms on 11/26/2022. I tested COVID-19 positive on 11/26/2022. I went to a clinic while overseas and given TYLENOL and decongestant. I do still have some fatigue and lingering cough on 12/28/2022.
This is a spontaneous report from a contactable nurse. A 30-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EL3247), intramuscular, administered in left arm on 15Feb2021 (at the age of 30-years-old) as DOSE 2, SINGLE and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EL3247), intramuscular, administered in left arm on 25Jan2021 (at the age of 29-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced lack of efficacy and tested positive for covid19 with symptoms on 23Aug2021. It was unknown if patient had other vaccine in four weeks or if Covid prior vaccination. The patient underwent lab tests and procedures which included SARS-COV-2 & Influenza A/B PCR molecular test. Nasal swab test positive on 23Aug2021. Treatment for AE was unknown. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors, however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) and COVID-19 event cannot be ruled out. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
Information has been received from a pharmacist concerning a 73 year old male who on 09-APR-2007 was mistakenly vaccinated with varicella virus vaccine live (Oka/Merck) in place of zoster vaccine live (Oka/Merck). The pharmacist reports that confusion was made between the zoster vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) was dispensed instead of zoster vaccine live (Oka/Merck). The nurse did not notice the difference and administered the varicella virus vaccine live (Oka/Merck) rather than the zoster vaccine live (Oka/Merck). There were no problems reported. Unspecified medical attention was sought. The product was properly ordered by the physician. There was no product quality complaint. Additional information has been requested.
This case was reported by a physician and described the occurrence of anemia in a 48 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history was notable for good general health prior to the onset of these events.  The pt received injections of Engerix-B on 12/05/02, 01/14/03 and 06/03/03.  At an unspecified time after the third dose, the pt developed a fever of unknown origin, throbbing headaches, poor sleep, and fatigue.  She was seen by a physician.  Laboratory investigations revealed "mild" anemia, elevated white blood cell count, elevated sedimentation rate, elevated platelets, fibrinogen, and C-reactive protein.  The outcome of the events was unknown. The physician noted that the events jeopardized the patient. The events resolved on 23 September 2003. The physician considered the events to be possibly related to vaccination with Engerix-B
Rash & UrticariaPruritus Narrative: Pt c/o moderate amount of itching on neck and hands, noted to have red blotches on back. Pt states she is sensitive to benadryl and requesting 1/2 dose. Assessment complete, moderate itching notes. No difficulty breathing, voices no other complaints. 0805 Benadryl 12.5 mg PO given. 0818 symptoms remain, another 12.5 mg PO Benadryl given. 0845- no relief in symptoms, consulted with pharmacist who recommended Benadryl 25 mg IM. Benadryl 25 IM given L glut at 0845. 0905. Pt had complete relief of symptoms. pt given instructions to go home, no driving or operating machinery for 24 hrs. supervisor notified and will have escort bring pt home. 0920- pt left in stable condition with escort.
First night and following day, extreme headache....nothing would take it away. Second Day - Extreme Burning and Itchy hands and wrists. Third Day - Extreme itching and burning all over body - feet, back, head, hands and wrists. Also, very large rash on back side...very itchy and irritated.
Received rabies booster due to low titer. Had post-exposure treatment in 1998. Joint pains within 24 hrs. of administration. 13 days after administration hands and knees were swollen, knees were red. The next day, face was swollen, knees were more swollen and she had a fever of 100 degrees. She was seen in ER, given epinephrine and started on a 5 day course of steroids. Saw her PCP on 1/2/08 with persistent symptoms and was started on another course of steroids.
hives appeared on pt legs p/vax;hives on arms today;denies hives on trunk or any other c/o;
Initial report received from a health care professional on 05 December 2013. A 65-year-old female patient had received a dose of FLUZONE HD (Lot number U4785AA, site of vaccination not reported) intramuscularly on 15 November 2013. The patient does not have any illness at the time of vaccination. The patient was allergic to codeine and barbiturates. On 15 November 2013, after vaccination the patient experienced 'trouble breathing' described as rapid breathing, nausea, stomach pain and headache. The patient had not received any corrective treatment and laboratory details were not reported. On 16 November 2013, the patient was recovered. Documents held by sender: none.
immediate symptoms of light headiness, dizziness, stomach ache, nausea, headache, rash
1st dose before pandemic, 2nd not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown time before the pandemic).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose before pandemic, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter reported that a patient had not yet received the 2nd dose of Shingrix. Adverse event report contained all reported information.  The patient information, LOT number, expiration date and date of administration unavailable for this patient as per healthcare professional.  The reporter gave consent for safety team follow up.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023048004, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023048004:same reporter
Localized redness at vaccine administration site very tender to touch, with time question of infection raised as site began to track in a lymphangetic spread medially. Treated with Keflex 500mg tid x 7 days.
Tested positive on rapid antigen 8/29/2022. Reports symptoms of chest/nasal congestion and cough. Visited physician and diagnosed with pneumonia.
Patient presented with chest pain and elevated troponins 48 hours following his second covid vaccine dose. Elevated troponin and ST segment changes on EKG. Normal LVEF on ECHO and normal coronary anatomy. Troponin, EKG changes and chest pain resolved at the time of discharge.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, current conditions and concomitant medications were not reported. On multiple unknown dates, the patients received improperly stored LIQUID PEDVAXHIB (lot # N008080, expiry date: 02-DEC-2019) via unspecified routes, for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 32-35 degree Fahrenheit for 24 hours. There were multiple previous temperature excursions: 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 24 hours. No digital data logger was reported. No side effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005455: US-009507513-1708USA006125:
Day after Menactra injection-twitching at site of injection-would even wake pt from sleep. Lasted 2 weeks-on or off.
Developed headache, neck pain, myalgia and joint pain, followed by non-petechail rash and fever to 100.5. Treatment: ibuprofen 400mg-600mg po prn q 6 hours and Allegra180 mg 1 po q day x 5-7 days
Pain at left knee and right leg shortly after vaccine, then hand and foot pruritus, nausea with mild emesis, temp to 101, ? hallucinations and insomnia (keeps jerking up from sleep, saying he feels the bed is tilting and he is falling), feels throat swelling, walking on lateral edges of feet (?secondary to pain).