chrisvoncsefalvay/vaers-outcomes huggingface dataset:
levels were too low; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that a 19 year old female patient had serologic testing completed for work to check immunity for Hepatitis B.  Despite completing the Hepatitis B series as a child, the patient's antibody levels were too low, so she received a 1ML booster dose of Engerix-B on 28th April 2020. The reporter consented to follow up.  No further details provided by nurse.      Lab Comments: on an unknown date patient's serology test showed Antibody titre level low
This spontaneous report as received from a physician refers to a 75 year old male patient with high blood pressure, alcohol use and bipolar. The patient had none drug reactions/allergies. On 17-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) for "interested in getting vaccinated". Concomitant therapies included lisinopril (manufacturer unknown), lithium, paroxetine and naltrexone hydrochloride (manufacturer unknown). The physician reported that the patient received a dose of ZOSTAVAX on 17-JUL-2014 and "within a week" developed shingles on an unspecified date in July 2014. The physician reported on 08-AUG-2014 the patient was admitted to hospital with "altered mental status". The physician stated the patient was diagnosed with meningoencephalitis. While in the hospital, the patient started acyclovir therapy and had "a lumbar puncture and several other laboratory tests" (result not provided). The patient was discharged from the hospital on 18-AUG-2014 and was in an unspecified Rehabilitation Center because he hadn't fully recovered. The physician considered this AE was life threatening and caused significant disability because the patient hadn't fully recovered. The outcome of shingles was unknown. Upon internal review, meningoencephalitis was considered as medical significant. Additional information has been requested.
FEVER, CHILLS, LUNGS HURT, MUSCLE ACHES, SNIFFLES, COUGHING. TOOK ACETAMINOPHEN FOR PAIN AND FEVER. FEELING BETTER DAY 2 AFTER VACCINE (1/21/21)
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of (Merck) VARIVAX (dose and route were not reported, lot # L017146, expiry date 13-MAY-2017; lot # L008270, expiry date 11-MAR-2017). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills,; body aches; 99.3 fever; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EL3247) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcers. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), aleve (MANUFACTURER UNKNOWN) and dexilant (MANUFACTURER UNKNOWN) for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 13:30 as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests which included body temperature on 19Mar2021 and the result was 99.3 (unspecified units). The patient experienced chills, body aches and 99.3 fever on 19Mar2021 at 12:00. The patient did not receive any treatment for the adverse events. The clinical outcome of chills, body aches and fever were resolving.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician and a health care worker concerning a 13 year old female patient who on 04-SEP-2008, was vaccinated with her first dose of GARDASIL (lot # 660555/0279X).  The physician reported that after receiving GARDASIL, the  patient waited for 15 minutes and then went home.  When the patient got home, she felt numbness in her legs, severe nausea, dizziness and vomiting (also reported by the office manager as occurring 15 minutes after being vaccinated).  The physician and office manager reported that the numbness in her legs resolved in 30 minutes and the physician stated that the the severe nausea, vomiting and dizziness resolved sometime in September, 2008.  The patient sought unspecified medical attention.  Additional information has been requested.
Felt burning for 2 to 3 minutes; Hives all over the body; Itching a lot; Sore arm; This spontaneous case was reported by a dentist and describes the occurrence of PAIN IN EXTREMITY (Sore arm), URTICARIA (Hives all over the body), PRURITUS (Itching a lot) and SKIN BURNING SENSATION (Felt burning for 2 to 3 minutes) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Jan-2021, the patient experienced URTICARIA (Hives all over the body) and PRURITUS (Itching a lot). On 25-Jan-2021, the patient experienced SKIN BURNING SENSATION (Felt burning for 2 to 3 minutes). At the time of the report, PAIN IN EXTREMITY (Sore arm), URTICARIA (Hives all over the body), PRURITUS (Itching a lot) and SKIN BURNING SENSATION (Felt burning for 2 to 3 minutes) 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 relevant concomitant medications were reported. Treatment details included Diphenhydramine and Cetirizine
The patient received the flu shot on 09/01/09 at 1450 and withtin 15-20 minutes she started having symptoms.  The patient complained of dizziness, lightheadedness, inability to concentrate.  The patient stated that she felt as if she was having an exacerbation of her MS.  The patient left work and went to see her neurologist.  Her doctor is now observing her Guillain-Barre.  10/21/09 Neurology consult records received service date 9/4/09. Assessment: Multiple sclerosis with flu vaccine-induced exacerbation. Patient complains of feeling poorly. Fever and chills, feeling foggy, unable to think straight, weak and dizzy. Burning in right leg worse.
After administration of 3rd vaccine (HPV), client pale and started to pass out. Put her head between knees - was always responsive. Helped her to lie down on exam table and put ice pack behind neck. Took BP and pulse x 2. Condition rapidly improved. Left in good condition with mother and sister. Only had PopTart in AM - gave her 2 cups of water and told her to rest today and go home to have meal including protein. See PMD if problems.
Sneezing, cough, body aches, fever of 100.6, nasal and chest congestion, headache, fatigue
I woke up with pain on my neck head and left side. During the day wasn't that bad , but it was worse at night. It took about a month for it to go away.  I saw my doctor, and they gave me a Cortisone shot , and prescribed Prednisone and Tylenol.  I usually have pain, but after the injection the pain increased.
No additional AE/PQCs reported; administration of improperly stored PROQUAD; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 08-SEP-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) lot # T015598, expiration date: 02-NOV-2021 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported.   Administered dose of vaccine experienced the temperature excursion of 20.5 degrees Fahrenheit (F) for 1 hour 54 minutes and the previous excursion of 6F to 14F (12.3F) for 23 hours. Digital data logger was involved.
Knot on arm. Barely can move arm. Patient is taking ADVIL for pain. By 1/22/18 patient fully recovered.
Symptoms: Rash in the vaccinated arm (Burning sensation) was treated with Benadryl, Tylenol and Ibuprofen. Up to this day 02/02/2022 - I have joint pain in my right arm and fingers ( cannot sleep or lay on it) having difficulty moving and gets stiff.
Client was sitting for 30 min after receiving COVID-19 vaccine #1--due to her history of anaphylaxis with Bactrim. After about 20 minutes client states that her face and tongue was becoming tingly. EMS was on-site and began monitoring her. For about 5 minutes, client states that she did not feel worse just "numb/tingly feeling face", client then began to cough and state that she was having difficulty breathing. EMS administered 1 EpiPen injection into her thigh and then transported her to a local hospital.
Approximately 2-4 minutes after injection I began to get hot. Once sitting down I noted my hair under my hat was sweaty. Noted elevated HR at this time (did not check). No sweating anywhere else. Not clammy.   I have a history of anxiety...was thinking that maybe I got hot due to room temperature / size and then my mind reacted. Symptoms started to settle around minute 12 - 15. Sat in my truck for a few minutes after the 15 minute holding time. Started to feel back to baseline. I have had no issues since.  Again, thought it was anxiety however I did talk to my Aunt who experienced similar symptoms after her injection. Decided to report.   No chest pain No SOB No angioedema  No rash or hives No swelling
herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to an elderly patient of unknown gender. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On 30-APR-2010 (at approximately 70 years old), the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequently), the patient was treated by providers for the following injury resulting from patient's zoster vaccine live(ZOSTAVAX): herpes zoster. The outcome of herpes zoster was not provided. The lawyer considered herpes zoster to be related to zoster vaccine live(ZOSTAVAX).
Expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 7:11 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The dose volume was provided as 0.5 with an unknown unit. On 16-Dec-2021 vial was initially stored in the refrigerator. 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15-Jan-2022. Patient was notified of the error and patient denied adverse effects.  Treatment information was not provided.
This case was reported by a physician via call center representative and described the occurrence of nausea in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, pain and fatigue. On an unknown date, the outcome of the nausea, pain and fatigue were unknown. It was unknown if the reporter considered the nausea, pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the adverse events. This reporter would not provide any additional information. The reporter was not their doctor. They were her friends and she would give them the agency phone to call themselves. This case has been linked with US2018GSK130861, reported by same reporter.
No additional AE reported; administered expired PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 01-MAR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) subcutaneous injection (lot#: U024507, expiration date: 02-FEB-2023; strength, dose, route of administration, and anatomical location were not reported) which was reconstituted via corresponding sterile diluent (lot#: U006619, expiration date: 09-JUL-2023) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Severe pain in shoulder and shoulder blade.  Weakness in the shoulder.  Inability to move arm or do basic things such as lift, tuck in a shirt, etc. without severe pain.  Swelling in arm, chest, and shoulder area.
Fatigue, headache, light headed,Chills, fever/cold sweat, joint pain/muscle weakness. Throbbing pain at injection site. Upset stomach.
On the day of the shot, I experienced mild chest pain and feelings of a fast-beating heart. Over the course of the evening and night, I also experienced a temperature (100.4), joint pain (especially in knees), fatigue, headache, mild nausea (but no vomiting), and chills. The injection site was sore for that day, but I moved the arm frequently, so it was fine the next day. However, in the arm pit under the injection arm, it felt swollen and tender. 24 hours after the shot, I continued to have symptoms of racing heart, joint pain, a temperature, arm pit sensitivity, and fatigue.  48 hours after the shot, I have joint pain in my knees and sensitivity in my left arm pit.
I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, fever up to 100, severe fatigue, went home after work and slept til the next morning, went to work, took ibuprofen, and the myalgias improved and felt better. But around 3 pm, Jan 6, I got mild vertigo. By about 7pm Jan 6, I noticed my L ear didn't hear well. I changed the battery in my hearing aide and cleaned it but It made no difference. I woke up on Jan 7 with severe vertigo and hearing loss. I did Epley's maneuvers with no effect. I have had similar episodes. I went to work, but gave up when I could not hear patients talking to me. I went to the Emergency Dept and got admitted. I was too unsteady on my feet. Audiogram showed profound hearing loss both ears and almost complete loss of discrmination in R ear. I was put on high dose steroids. Also having tinnitus (mostly whooshing sound of my own pulse). MRI negative. Blood work negative. Some mild improvement now, after 1 dose steroids.
Patient is 12 y/o and should receive the adult Pfizer first dose, but when I checked her in, accidently put the Pediatric sticker on her consent form. The patient ended up getting the pediatric dose. Have contacted with the parent, patient hasn't experienced any ADRs, will receive an adult Pfizer second dose when she is due.
Rashes/hives on left wrist, left elbow crease, upper right collar bone, right bicep, right elbow crease, back of the neck, various locations on the back, largest rashes on left and right inner thighs.
This spontaneous report as received from a nurse, a female patient of unknown age (via company representative) reporting on herself. The patient's medical history and concurrent conditions were unknown. ON 02-AUG-2016, the patient was subcutaneously vaccinated with the single dose of ZOSTAVAX (dose, frequency were not reported, lot # M013377 with expiration date: 25-MAY-2017). Concomitant therapy was unknown. On an unknown date in August 2016, the patient experienced local reaction of redness, warmth and there was slightly raised area of 30 Millimeters. The patient sought medical attention. It was unknown if the patient had any lab diagnostic studies performed. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Received flu vaccine and approx 20 minutes later experienced chest tightness, itching- not sure if rash, a little nausea and diarrhea.  Approx 5 min later took 25-50mg of PO Benadryl and symptoms subsided apprx 30-40 min. later.
Exasperated GERD/ increased episodes of reflux; Reflux related chest pain.; Increased episodes of vomiting; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 02Sep2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic gastro-oesophageal reflux disease (GERD) which was ongoing. It was unknown if the patient had any allergies. 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 included proton pump inhibitor (PPI) omeprazole (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021 at 00:00, the patient experienced exasperated GERD symptoms such as increased episodes of vomiting, increased episodes of reflux, reflux induced vomiting, and reflux related chest pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with an increased dose of unspecified PPI. Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent a nasal swab test and the result was negative. The clinical outcome of the event exasperated GERD/ increased episodes of reflux, increased episodes of vomiting, reflux related chest pain was unknown at the time of this report.
Fatigue; Chills; Hand pain; Painful hips; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Painful hips) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Painful hips). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Painful hips) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. the daily dose were reported as citrate free for the co-suspect drug. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Menactra was believed to be in shipment to long and administered with Menactra shipment that was still cold when it arrived; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 18 years old female patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6346AA, expiry date: 30-Aug-2020) via intramuscular route in the left arm on 04-Jun-2019.  The patient's past vaccination(s) included MENACTRA on 03-JUN-2013. The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage it was reported that Menactra was believed to be in shipment to long. Before being told about this, the Menactra was administerd. It (Menactra shipment) was still cold when it arrived.  It was unknown if any adverse event occurred.  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.   List of documents held by sender: none.
Develope hives on neck and torso, went to MD tx hives with antihistamine.  This clear the hives.  16 hrs later got some pox lasted only 3 days and went away.
Employee stated she has "always developed a heavy, swollen, numb and reddened arm after flu vaccine. Doesn't matter which arm is used. Today the symptoms are different because she is having pain with small electric shocks and constant burning between her shoulder and elbow of the left arm.
Fever started 04/25/2018. Febrile seizure 04/26/2018 around 430pm. Still with fever at present but hasn't had another fever.
Headache stomach issues and arm pain Thursday chest pain and shortness of breathe went to the er had blood clots
developed a purplish red discoloration to front and side of right and left leg from knees down; skipped ankles and then top of both feet with redness. no itching, pain, or raised area. no blanching. did not appear to be a rash. slowly faded by 3rd day, and almost gone by 4th day
Spotted itchy rash from scalp to knees. Covers head, face, arms, torso, and thighs.