chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Signs and Symptoms Painful bumpy, crusty, vesicular, and red rashes that looks like shingles. Patient was treated for Shingles.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Mild side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Mild side effects). At the time of the report, IMMUNISATION REACTION (Mild side effects) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No relevant concomitant medications were provided. No treatment information was provided. This case was linked to MOD-2021-262513 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field.
Pt recvd Pneumovax 23 27NOV90; w/in 7 hrs following vax, devel fever, chills & a sore arm; condition required pt to be in bed approx 1 day; On 05DEC90 arm still painful; Pt recovered;
Seizure-like activity, tremors, nausea, vomiting, bradycardia
aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to hands, denied difficulty breathing. 11:25 client denies any tingling at this time. She was released to her husband and told to monitor her symptoms.
Symptoms: fever,  back pain, increased heart rate (on day 2);  treatment suggestion after consult from Medical Director for COVID Vaccine Clinic: Tylenol 500mg tid prn; increase fluids, report any chest pain or shortness of breath, if occurs after hours report to the ER Outcomes: declined office visit
shortly after vaccine, I started stomach cramps. Over the next hour, they subsided. That night I felt a little 'odd'.  The next morning I was fine until about 11am. Then I started feeling exactly like I did when I had Covid (cold chills, exhaustion,  trouble breathing, upset stomach, horrible headache). This lasted almost exactly 24 hours.  Also had/have a sore arm at the injection site.
This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 6-month-old subject of unspecified gender who was vaccinated with Rotavirus vaccine (manufacturer unspecified). DTaP vaccine, Hepatitis B vaccine, Hib vaccine, PCV7 vaccine (non-gsk) and IPV (non-gsk). Concurrent medical conditions included febrile illness. On an unspecified date, the subject received an unspecified dose of Rotavirus vaccine (route unknown, batch number not provided), an unspecified dose of DTaP vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Hib vaccine (administration site and route unknown, batch number not provided), an unspecified dose of PCV7 (NON-GSK) (unknown) and an unspecified dose of IPV (Non-GSK) (unknown). 5 days after vaccination with DTaP vaccine, Hepatitis B vaccine, Hib vaccine, PCV7 vaccine (NON-GSK), IPV (Non-GSK) and Rotavirus vaccine, the subject experienced acute disseminated encephalomyelitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case has been linked to case B0739797A: same literature article.  Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.  The author's conclusion stated that the CCCR provides advice about AEFO to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
She received 2 vaccines I don?t not know what brand or lot number  Dtap vaccine and meningococcal ACWY   On 10/29/2020  Shortly after waking up about 6:30 am she had a neurological episode what seem to be seizures . We found her on the floor shaking jerking  jaws locked making a horrible gurgling sound . After she came thru she was very scared and disoriented  Her lips and Tongue looked swollen  She kept slurring her words. She confused me with her dad ( I?m mom ) .  Took me a while to calm her down tried to get her to have a drink she couldn?t swallow it came right back up . I took her to her Dr office they run blood work urinalysis nothing showed besides slight anemia  She hurt her face falling her lip is very bruised she hurt her middle finger falling on it there is also a bruise on her forehead  She didn?t have fever the day before the seizure she complained of arm hurts and she was very crabby   As of right now I was advised just to monitor her and if more seizures happen to call the dr office back
SHORTNESS OF BREATH, COUGHING, SNEEZING, FATIGUE, FEVER, SORE THROAT, WHEEZING.  MAB INFUSION
Swelling over time on right shoulder (urticarial in origin). Fluid collected over time of the right elbow. There were no signs of infection and movement of elbow remained normal.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 17-NOV-2015, the patient was vaccinated with ZOSTAVAX. In November 2015, the patient experienced herpes virus infection referred as "herpes outbreak". On 22-NOV-2015, the patient stated taking VALTREX for the "herpes outbreak". Pharmacist reported that patient just stated that it was "herpes outbreak" and pharmacist did not clarify with patient if "herpes outbreak" was herpes simplex (cold sores), herpes zoster (shingles) or genital herpes. VZVIP was mentioned to pharmacist since shingles could not be ruled out but pharmacist was adamant about not receiving VZVIP packet because he was not sure if patient was having shingles or other types of herpes outbreak. The outcome of herpes virus infection was unknown. Additional information has been requested.
Next day after receiving the shot pt. started to break out in what looked like an allergic reaction all over both legs and continued to get worse through out the night of the 15th and went to a local Urgent care. Pt also was experiencing severe joint pain and could barely walk for weeks after getting the shot. They were unable to assist. From there pt. went to a local Hospital as his legs were developing more blood type blisters. The hospital was unable to help and they advised that pt. go and see a dermatologist. from there pt. went to the dermatologist and they advised that he had developed what they believed to be vasculitis--the vasculitis was not getting any better with medication and pt ended up in the Hospital a few days before his birthday--which is April 30th and he was on high does intravenous steroids after already being on a high dose steroid at home for the almost 2 weeks prior.
They gave the expired Fluzone High Dose injection from this basket to the patient, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 87 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ052AB, expiry date: 09-Jun-2019) via unknown route in the left deltoid.  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 expired vaccine used.  At the time of reporting, the patient had no adverse event.  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.
hematomas; bruising on knees, ankles; intense headache; fatigue; some minor body aches; bruising on knees, ankles, and thighs; This is a spontaneous report from a contactable consumer, the patient. A 41-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Apr2021 at 09:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 17Apr2021 at 08:00, the patient experienced hematomas, bruising on knees, bruising on ankles and thighs (more appear throughout the day), intense headache, fatigue with some minor body aches. Therapeutic measures were not taken as a result of the event. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hematomas, bruising on knees, ankles and thigh, intense headache, fatigue and some minor body aches was not resolved/ongoing.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for Covid-19 immunization; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: IVERMECTIN, start date: 26May2022, stop date: 26May2022; AZITHROMYCIN, start date: 29May2022, stop date: 31May2022. Other medication in 2 weeks was reported as yes. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: COVID-19 Treatment. Therapeutic measures were taken as a result of Covid-19. Anti-viral details: Product: COVID-19 Treatment, Brand: Paxlovid, Indication: Treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
When the technician was vaccination the patient, she came to take out the needle and the needle  came seperated from the plunger with 2 to 3 drops streating From patient arm. CDC was  Called and advised if more than 1/2 the dose was injected not to repeat.
Headache, Myalgia, Arthralgia, 1st does - fatigue and headache; 2nd dose- headache and body aches; sore arm at injection site with both doses Narrative:  Tylenol as needed  Other Relevant History:
pt reported getting hives in various parts of the body from 10:30pm on 6/6/22 to 2:30am on 6/7/22.  He did not take anything for it and it resolved on its own.  He had difficulty sleeping during that timeframe, but was able to go back to sleep later.  He is unclear which vaccine could have caused the reaction.
swollen inj site rt deltoid 55mm x 65mm reddened area @ site;
06/15/2022- vaccination given.  06/16/2022-child c/o arm bothering her. 06/17/2022- mother looked at arm, 4 inch red area all the way to the elbow to the top of the shoulder. It was red/ itchy and swollen. Child had hives on the side of the arms to the armpits. Mother gave her Benadryl for itching. 06/21/2022- completely resolved.
Elevated blood pressure. Brother picked him up after it went down a bit. He felt hot after the vaccine and has a past history of heart problems.  Heart rate and pulse were normal.
Nausea; diarrhea, arm red and puffy. Patient reported x1 week later. No Tx. Patient states mother allergic to Tetanus.
Narrative: COVID infections following completion of COVID vaccine series 02/12/21 COVID vaccine dose #1 03/05/21 COVID vaccine dose #2 07/30/21 Pt presents to screening reporting diarrhea that is increased from baseline IBS-D, headache x3-4 days (07/26), loss of smell, muscle pain x3-4 days, congestion and sneezing x3-4 days, and states likely exposed to COVID person due to nature of work; COVID POSITIVE; rx given for loperamide 07/31/21 Pt reports headache that is improving and resolved symptoms of chills, loss of taste/smell, muscle aches, and runny nose 08/04/21 Pt reports fatigue and headache but is improving
This spontaneous report as received from a consumer via Clinic refers to a currently  6 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of ROTATEQ suspension 2, lot # L000571; 26-Jul-2016, expiry: and L008574; expiry: 22-NOV-2016 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Started feeling jittery about 4PM, then dizzy around 8PM, by 10PM I had almost a 101.5 fever, chills that were incontrollable, sweating, my whole body felt sunburnt and was bright red, I was freezing and burning up, and crying, whole body was aching and headache and eye ache that was pounding. Slept four hours and woke up the next day feeling lethargic, sore, achy, bad headache. Then two days later most the symptoms went away but i still got waves of heat flashes
chills, low-grade temperature, muscle and joint pain.  Lasted about 6-8 hours.
Patient received Moderna COVID vaccine primary series on 3/3/21 and 4/6/21. On 11/13/21, patient received the booster dose (1/2 dose) instead of the 3rd dose (full dose). Patient is immunocompromised (has pulmonary sarcoidosis and on chronic prednisone) and qualified for 3rd dose instead of just booster.
Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injection, I started to experience daily episodes 4 or 5 times per day in most cases; Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injection, I started to experience daily episodes 4 or 5 times per day in most cases; This is a spontaneous report from a contactable consumer who reported for herself, a 77-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9262), via an unspecified route of administration in the left arm, on 09Feb2021 at 07:30, at the age of 77 years, at a single dose for COVID-19 immunization. Medical history included diabetes, spinal stenosis, and ongoing PVCs. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medications included metformin, statin, and hydrochlorothiazide. The patient previously took codeine and had allergy; and received the first dose of BNT162B2 (Pfizer, Lot number: EL1284) on 19Jan2021 at 03:00 PM, at the age of 76 years, in the right arm, for COVID-19 immunization. It was reported that patient have had benign PVCs in the past - usually maybe 3 episodes a month. On 13Feb2021, reported as "four days after 2nd vaccine injection", patient started to experience daily episodes - 4 or 5 times per day in most cases. From day 4 to day 11, experiencing these episodes. On day 11 they started to subside. Patient was taking essential electrolytes and extra magnesium to help. The events were reported as non-serious. The outcome of the events was recovering.
Chills, vomiting, muscle pain, chest pain, accelerated heart rate, light headed
One week after 1st dose (3/8/21) my left arm became very sore, starting at 9:00 a.m. followed by a raised rash, the size of a baseball and warm to the touch. Taking Tylenol and using ice pack on the area. Tuesday, 3/9/21: On/off soreness and rash is less raised and only slightly pink. Wednesday, 3/10/21: On/off soreness
Very sore arm. Fever 100.3 for 24 hours. Severely sore muscles all over for 24 hours. Very stiff neck for 6 hours. Ache all over. Weakness. Severe headache for 12 hours. Diarrhea x 2 and GI distress for 24 hours.
Pfizer covid vaccine was reconstituted with 1.4 ml of diluent instead of 1.8ml. This was realized soon after the patient's dose was given. CDC was called and after consulting with the CDC pharmacist. I counseled the patient that they might experienced more severe arm pain, body aches, fever, etc,
She reports not having any symptoms other than a tender deltoid area after her vaccination. She reports feeling fine the morning of 12/24/2020 when she went to work. Pt. reports approx. 4 hours after being at work that she became dizzy, clammy, noted head pressure and spots in front of her eyes as if she were going to pass out. She reports that she did have breakfast prior to coming to work. Noted her blood pressures to be elevated 141/102. She was monitored for 45 mins. taking BP every 15 mins. ranging from 155/112 with the lowest obtained being 150/90. With the drinking of fluids at the end of the 45 mins. she did feel like she was getting back to her normal self. She was instructed due to elevated BP to seek care at her clinic with her PCP. She did return to work on 12/25/2020 reports that she felt much better.
Hives all over.  Hives.  No respiratory problems.  No other problems.
13 min. after injection I had dizziness, feeling faint and sweating.  Clinic gave me water and cold rags.  Pharmacist let me stay until I felt I could drive.  I came home and took Tylenol for headache.  5 hrs later I felt extremely ill with joint pain , fever , dizziness.  Vomiting occured during the night along with fainting.  Next morning drank tea, no food. Slept all day until 5pm.  Slept through night.  Sun. still had extreme joint pain and headache.  Was able to eat a light meal. Today I ate normally, went to physical therapy with a reduced routine.  I still have a headache as of Mon. night. I know these seem like Normal side effects, but these were like having the worst Flu ever.
Patient called stating that her arm where she received the injection has been sore for 3 weeks now. She stated "I think they gave it to me in my muscle." This vaccine (Fluarix) is an intramuscular vaccine.
I got the shot around 2 pm and the next day at 4:08 am I woke up and took my dog to potty. Within 5 minutes of waking up I got dizzy, felt like I had to throw up, my heart felt weird and my lips were going numb. I fell and blacked out for a few seconds. I fell so hard I scraped my knees really bad. After that I went back inside and fell on the couch because it was difficult to breath for about 5 minutes. I ended up falling back asleep for about 4 hours. And during all this my head was pounding like crazy and my vision was kind of blurry.
Rash surrounding injection site; Red rash; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX771AA, expiry date 31st July 2020) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Bexsero. On 7th July 2019, 6 days after receiving Bexsero, the patient experienced injection site rash and injection site erythema. On 11th July 2019, the outcome of the injection site rash and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero on left arm and developed a rash. The reporter described rash as surrounding injection site and red. The reporter consented to follow up. This case has been linked with case US2019151262, same reporter.