chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness all over, and feelings of being intoxicated?slow to speak hard to gather my thoughts. Was taken to ER and given Benadryl shot and another IV medication. While in ER both my hands swelled.
received the second dose of Shingrix earlier than recommended / first dose was administered on 5-JAN-2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R45T, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows: The patient received the 2nd dose of Rotarix earlier than the recommended schedule, which led to shortening of vaccination schedule. On 5th January 201, the patient received 1st dose of Shingrix. The reporter consented to follow up. The case is linked with the case number- US2021033003, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021033003:same reporter
Flu-like symptom(s): Serious body ache, increased body temperature, muscle soreness.
No c/o at site of injection - developed dimed sized clusters of pustules under same arm, on upper back and chest on same side as vaccine administered. Spots painful to touch as is his upper body on left side. Pt told to go to private MD for diagnosis.
Itchy, red patches on the inner side of the left forearm, close to the armpit that lasted for close to 2 weeks
Swelling, redness, tenderness at site of injection on left hip. Erythema/ swelling mearured ~5cm in diametr. Left gluteal muscle.
Patient received FLUARIX PFS flu shot in left arm. After vaccine patient felt light headed and fainted. Stated she had not eaten in the morning. BP was taken 136/93, 132/92, 126/82. Gave orange soda, chocolate and peanut butter cracker to help increase blood sugars.
Regular Moderna CoVid 19 Vaccine Booster without the Omicron Strain was administered not the Moderna CoVid 19 Bivalent Booster medication/vaccine error.  No harm to employee discovered same lot number after mining data from the Software Program to transfer information to database. Discovered same lot # AR5186C. Notified employee of error who reports has had no concerns since vaccination and has not been infected with CoVid after this vaccinationwas administered.
Left arm pain for > 3 days after injection.  She experiences sporadic pain since injection in left arm.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included INSULIN and METFORMIN for Diabetes, WARFARIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant medication includes blood pressure pills. treatment information not provided
Water tastes like metal. I keep smelling things that aren't there, for instance, my laundry smelled like breakfast cereal even though I haven't been around breakfast cereal in at least a year. My bathroom smells like salted peanuts, there's never been any peanut products in my entire apartment as I don't like peanuts. My hallway smelled like a taco and I haven't had tacos in months.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO (batch number 166201, expiry date 30th October 2018). Co-suspect products included MENACTRA. On 14th July 2017, the patient received BEXSERO and MENACTRA. On 14th July 2017, 45 min after receiving BEXSERO, the patient experienced injection site erythema, injection site blisters, injection site pain, injection site swelling, labeled drug-drug interaction medication error and drug administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site blisters and injection site pain were recovering/resolving and the outcome of the injection site swelling, labeled drug-drug interaction medication error and drug administered at inappropriate site were unknown. The reporter considered the injection site erythema, injection site blisters, injection site pain and injection site swelling to be probably related to BEXSERO. Additional details were provided as follows: The health care professional reported that the patient received both BEXSERO and MENACTRA in the right deltoid at the same time, which led to labeled drug-drug interaction medication error and drug administered at inappropriate site. The patient came back to the doctor's office on 20th July 2017 and the site was still sore an red. The patient visited emergency room.
Redness/swelling at site (lat), size of tennis ball, slightly warm to touch. No temp elevation.
One day after receiving immunization in left thigh, mom noted rash around injection site. Rash also noted on right upper outer arm and shoulder (no injection administered warm). Patient complained of itching of rash: two days later noted 3 loose very dark stools. No abdominal pain.
This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. In April 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient came down with a case of Shingles in September 2018. The physician described it as very mild, lower right abdominal area and was treated with VALTREX and had not seen the patient back for follow up. The physician did not agree to be contacted for follow up. This case was considered as suspected vaccination failure as confirmed laboratory test was not provided.
This spontaneous report as received from a pharmacist via a company representative refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medication was not reported. On an unknown date, the patient developed shingles post vaccination. The outcome of patient developing shingles was unknown. Causality was not reported. Additional information has been requested.
Resident began having a general decline in condition on 1/8/21 and continued to decline until her passing on 1/10/21.
2 days, post vax, the pt is brought in by her mother with her left arm swollen, painful and warm. The event started approx. 6 hours, post vax. Left arm swelling was treated with ice and Tylenol. Not yet recovered.
This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (Lot# L037339 and expiry date 09-FEB-2018) (dosing details unspecified). No adverse effects were reported. Details of temperature excursion: Temperature: 33F for 9.5 hours; 35F for 14.5 hours; 35F for 0.5 hours; 35F for 14.5 hours; 34F for 72 hours; 34F for 9.5 hours; 35F for 48 hours. Cumulative: 33F for 177.5 hours; Previous temperature excursion: No; Data logger: yes; No additional doses administered since 07-MAR-2016. This is one of the two reports received from the same reporter. Additional information has been requested.
Developed hives on my torso; Itching; Rash on my legs; This is a spontaneous report from a contactable consumer (patient herself). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal, Sjogren's which gave her dry skin. The patient was vaccinated at a clinic. Concomitant medications included lisinopril for blood pressure abnormal and furosemide as diuretic for polyuria. On 18Jan2021, the patient developed hives on her torso, itching and rash on her legs. Therapeutic measure was taken as a result of the events that included antihistamine Benadryl. Clinical outcome of the events was not recovered.
About 4-5 hours following the injection started to feel aching at injection site and including entire upper arm. Still concerns regarding tenderness at this date.
Patient had chest pain, NonCardiac. Onsite EMS was called vitals BP 180/90 HR 64. Patient refused evaluation/care  and released against medical advise.
fever at 100.4; Headache; Nausea; Sniffles; Chills; he was beated down with sweat; body aches; does not have an appetite; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, intramuscular in the left arm, on 08Jan2021 16:30 at 0.3 mL, single for COVID-19 immunization.  Medical history included ongoing high blood pressure and spinal surgery in Jan2019. Patient's eyesight was not the greatest. Patient previously received flu vaccine on an unspecified date (the last couple of years). Concomitant medication included amlodipine besilate for blood pressure. He was scheduled to get second dose on 29Jan2021. The Saturday before he was scheduled to get the second dose (23Jan2021), he started feeling sniffles and stuff. He went to urgent care and he was tested for covid and the test came back negative. He then kept feeling bad. He clarified that on 24Jan2021, he had headache and nausea. He had chills and he was beated down with sweat; body aches which are constant and he  would try to blame it on the position he was laying in while on the couch and it was not that; and does not have an appetite on an unspecified day in Jan2021. He has been in really bad shape for the last 9 or 10 days. When he went to go get his second shot, they would not give it to him due to his symptoms that he was experiencing since she had a fever at 100.4 the night before (28Jan2021). They scheduled him to get his second dose the following which was this Friday. He was asking if his side effects are totally normal. He cannot even sleep, reported that he will sleep an hour and then up for two or three hours. It really has him, and he feels miserable. The outcome of events Chills, nausea and fever at 100.4 was not recovered. Outcome of sniffles was recovered in Jan 2021 while the outcome of the remaining events was unknown. Therapeutic measures were taken as a result of sniffles; he went to urgent care and they gave him something like zyrtec, states it was an allergy medication and it wiped out the sniffles for fever, he will take Tylenol and it will break the fever for a few hours and then his fever comes right back.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.
The patient received the vaccination, roughly 10 minutes later presented to the pharmacy stating he felt light headed and immediately collapsed. Patient was conscious within 15 seconds and had a normal pulse and blood pressure. Patient appeared diaphoretic but that resolved in about 15 minutes.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Pt was given vaccine too high in the arm and developed tingling and numbness, nerve damage, bursa as diagnosed with an MRI by the doctor. She has had many doctor appointments and has to have physical therapy for months as well as missing work for doctor appointments.
Pt got "red circle" at injection site that lasted few days, but also got "hard lump" under skin. He said it still feels sore, like a bruise several weeks after immunization.
lump, erythema, tenderness lt thigh, warm to touch, cont 9 days post vax dx cellulitis;
1/27/07- Mom called me at home. Patient started with a twitching. Different parts of body. No temp, slight increase respiratory infection - less frequent Sunday and Monday - none on Tuesday 1/30/07. Mom had to have 2nd MMR after sons delivery and did something she said she never told me till after the fact.
This spontaneous report was received from a licensed practical nurse and refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Lower extremity pain and numbness and pins and needles, fatigue.  Also with hand and lower arm weakness, multiple consults.  Rheumatology, Psych, Emg - normal, MRI of head and spine - normal.  6/3/08 Reviewed PCP medical records. FINAL DX: (+)ANA syndrome w/arthralgia/alopecia; allergic rhinitis; exercise induced bronchospasm. Records reveal patient experienced alopecia areata (from age 2), arthralgia, lethargy, tiredness, eczema & joint stiffness in 2002.  Episode of Lyme disease 9/2007 & developed tingling in hands & feet.  Seen in ER 1/2008 w/increased weakness & tingling in hands & legs & difficulty walking.  Had been on antibiotics for pyuria.  Neuro & rheum consults done.
Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Caller reported patient has had migraine for over 30 years and this was not unusual for her.).    On 10-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had not resolved.            Concomitant medications were not reported.. Treatment medications were not reported.   Reporter did not allow further contact
Patient waited in our waiting area for around 10 minutes. His mother asked if they could leave because he felt fine. While walking to their car in the parking lot the patient apparently experienced symptoms of syncope. They made it to their car and after sitting the patient felt much better.  His mother took him to hospital and according to the patient was released after some testing.
Day 1:  Pain in Left Arm, Redness, Swelling, and Itching. Day 2 - 3: Chills, light fever, Muscle Aches (Left Arm), Fatigue, and Allergic Reaction on Left Arm (14 X 10 cm red patch with purple ring around circumference. Day 4:  no problems Day 5-12:  Light Pain around injection site, Allergic Reaction (same as Day 2-3) accelerated/increase.  Body aches, light fever
Report 20010058381 described palpitations in a female vaccinee of unspecified age who received hep B vaccine. The vaccinee had no known drug allergies. She had hypertension. She tok unspecified concomitant medications. On 02/28/2001, the vaccinee received her first left deltoid "adult" dose of Engerix-B. Three hours later, she experienced palpitations, weakness, and dizziness. The vaccinee contacted her physician, who did not feel that a doctor visit was medically necessary. As of 03/01/2001, the outcome of the events was unresolved.
Red, raised, warm area measuring 50mm x 35mm noted left posterolateral fat of upper arm. Redness & discomfort started 3-22-11 & increased today.
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored ZOSTAVAX (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of ZOSTAVAX underwent temperature excursions at 7 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 31-MAR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection (lot # M034894, expiration date: 11-NOV-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of between 32 to 36 degrees Fahrenheit for 6.5 hours. The digital data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007859.
Patients received vaccine with silver metal particles; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT QUALITY ISSUE (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 015M20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT QUALITY ISSUE (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On 30-Nov-2021, PRODUCT QUALITY ISSUE (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that patient had not experienced any side effects. No concomitant treatment was provided. No treatment medication was provided.   This case was linked to MOD-2021-403083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received Reporter confirmed patient details(Race) and product details.
Patient lost conscious and fell to the ground. hit back of head. Patient is alert and oriented. Brought to ED.
This case was reported by a consumer and described the occurrence of developmental delay in a 7 month old male subject who was vaccinated with Hep-B (Engerix-B) and Infanrix for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject received Engerix-B on 6/11/03 (lot number unknown, 7/11/03 (lot ENG5375A2) and 3/16/04 (lot ENG5396A2). This represents a 0, 1 and 9 months schedule, rather than the recommended schedule of 0, 1 and 6 months. The subject received Infanrix on 8/18/03 (lot DTPA610A2), 10/10/03 (lot DTPA610A2), 12/12/2003 (lot DPTA616A2) and 12/17/04 (lot DTPA632A3). On unspecified dates, the subject also received HIB influenza, MMRII, Prevnar and IPOL. On an unspecified date in January 2004, approximately 6 months after the 2nd dose of Engerix-B and 1 month after the 3rd dose of Infanrix, the subject experienced developmental delay. At an unspecified time later, the subject's mother stated that her son "stopped speaking" (impaired communication). The subject was seen at a physician's office. The mother stated that "blood work" had been performed, including unspecified tests for lead poisoning and analysis of organic acids and amino acids, however, "blood analysis" did not reveal any "toxins". The mother also stated that the subject was receiving unspecified therapy to "remove toxins". At the time of reporting, on 7/7/05, the events were unresolved.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received a dose of SHINGRIX about 3 weeks before the date of reporting and experienced a sore arm (site reaction) for 2 days. The healthcare professional was unaware of when it began but it had resolved. The suspect vaccine lot number, expiry date and the patient's date of birth were unavailable. This case is 1 of the 3 cases, reported by the same reporter.