chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Crying and limp about 1/2 hour after immunization. Cried all day. Labored breathing, fever 8 hrs after immunization, and most of night OK the next day.
Patient had difficulty lifting her arm next morning after administration of vaccination. She saw MD on 11/17/16. Got Rx for Meloxicam and referred to Physical therapy. Has to do MRI in 1 month if no progress.
Initial unsolicited report received from a physician on 27-Jan-2016. This case involves a patient (age and gender not reported) who was vaccinated with Fluzone (batch number: unknown, dose, dose in series, route and site of administration were not reported) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date, after vaccination, the patient experienced knee pain. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
Large, raised, welt like rash between scapula and radiating up to back of neck.  Rash synonymous with burning sensation and painful
patient received a double dose of Menactra; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 15 years old male patient who received double 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6204AA) via intramuscular route in the right deltoid (first dose) and left deltoid (second dose), on 11-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was an actual medication error case due to extra dose administered.   It was reported that the caller did not realize a dose of Menactra had been given and gave a second dose.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
This spontaneous report as received from a physician refers to a 12 year old female patient. On 03-DEC-2003 the patient was vaccinated subcutaneously in the left arm with the first dose of VARIVAX (Merck) (lot # 647241/0894N, expiration date 19-AUG-2015, dose not reported). On 18-FEB-2009 the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot # 662146/1562X, expiration date 27-OCT-2010, dose not reported). On 24-AUG-2014 (also reported as "2 days ago") the patient developed papules and vesicles. It was reported that the patient had low grade fever and headache on 25-AUG-2014 (also reported as "yesterday"). It was also reported that 11 month old sibling tested positive for varicella PCR in an approximately August 2014 (also reported as "last week"). The outcomes of the events and relatedness between the events and VARIVAX (Merck) were not reported. Additional information has been requested.
30 year old male with a history of drug reaction to Tedrol who 10 weeks ago, on approximately 05/31/2005, was vaccinated with a dose of Hepatitis B virus vaccine.  Concomitant vaccination that day included a dose of Hepatitis A vaccine.  About 8 weeks ago, on approximately 06/14/2005, the patient developed a sore throat, fatigue, rash, fever of 101.4 degrees, headache, and muscle pain.  He was still having transient pain in hands and top of feet at ten weeks post vaccination.  It was reported that he had viral syndrome and will be seeing an infectious disease physician soon.  The patient was seen in urgent care on 07/29/2005, strep was negative, and was sent home.  Other laboratory diagnostic tests included:  UA - normal, CBC - normal, Sed rate - normal, Alt-slightly elevated and AST slightly elevated.  At the time of the report the patient was not recovered.  There was no product quality complaint involved.  Additional information has been requested.
Back ache; Fever; Plaque psoriasis; COVID-19; COVID-19; This is a solicited report FACILITATED COLLECT from a contactable consumer (patient) based on information received by Pfizer from regulatory authority (MFR Control No. # 21K-163-4129870-00).   A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 in Dec2020, back ache, fever, plaque psoriasis on an unspecified date. The action taken in response to the events for risankizumab was unknown. The outcome of event plaque psoriasis was not resolved, outcome of other events was resolved. The reporter's causality for the event of covid-19 with risankizumab was no reasonable possibility. The reporter's causality for the other events with risankizumab was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The events of Drug ineffective, COVID-19, Back pain, Pyrexia and Psoriasis are related to the suspect product BNT162B2 based on plausible temporal relationship.
She has always been able to take amoxicillin, but after her Moderna shot she had an anaphylactic allergic reaction to Amoxicillin. She believes it could be related to the vaccine.
Ischemic Colitis, one week after injection.  One day after IVIG of Gammunex.
I will call back to provide LOT number for vaccine. Immediately still at the pharmacy after having the vaccine my tongue went numb and felt really dizzy my vision was cloudy  waiting the 15 mins and I was itching and rash. I went home and still had an itch and numb. Noticed I had 2 bruises underneath my eye. Purple spot on my shoulder. Went away after 4 days but noticed they had developed in other parts like in my wrist and top of my feet, all over my arm and tops of my shoulder.  Showed my doctor and thought it was from the shot. During that time I had migraines and it was severe I couldn't drive.  Extremely dry mouth. The remainder of 2021-2022 missed a lot of work. Had a stroke and paralyzed half part of my body.  12 mini strokes since last year.  My blood is thicken and don't know why. My heart is unable to process the blood clots. On blood thinners to help.   march 15, 2022 hospitalized frequents emergency visits for mini strokes  I see cardiologist as specialist.
Basically after being given the shot, I sat down for 15 minutes and when I went to get up I was dizzy, They gave me crackers and water yet remained. I attempted to get to my boss office when I arrived at work and was stopped by a supervisor who had me put in a wheelchair and I was taken to the ER. Once I got in my vitals were checked and I was given IV fluids. They advised me that I was dehydrated and sent me home.
She tested positive for COVID-19 on 12/5/22. She had a runny nose, sneezing, low grade fever, sore throat, brain fog, and fatigue. She was not prescribed medication, but we did give her Tylenol. Since getting well she keeps getting sick all the time and went through a period with increased heart rate. She has anxiety too and it seems to have gotten worse. She is better from COVID-19 but still dealing with her increased anxiety, brain fog, and fatigue.
Bruise above shot location on 2-10-2021. On 2-20-2021 injection site started to itch and turn red and felt warm to the touch.
SWELLING IN THE CHIN; SWELLING IN THE DOWN THROAT; SWELLING IN THE NECK; THROAT IS GOING TO CLOSE; LUMP IN THE FRONT OF THE NECK; UNABLE TO TURN NECK OR SIT; PAINFUL TO LIE DOWN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient had given the plant based trigger shot for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 10/JUL/2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced lump in the front of the neck. On APR-2021, the subject experienced unable to turn neck or sit. On APR-2021, the subject experienced painful to lie down. On 06-APR-2021, the subject experienced swelling in the neck. On 06-APR-2021, the subject experienced throat is going to close. On 14-JUL-2021, the subject experienced swelling in the chin. On 14-JUL-2021, the subject experienced swelling in the down throat. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL, Diagnostic ultrasound (NR: not provided) NORMAL, and X-ray (NR: not provided) NORMAL. Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat is going to close, lump in the front of the neck, unable to turn neck or sit, and painful to lie down, and had not recovered from swelling in the neck, swelling in the chin, and swelling in the down throat. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
This spontaneous report was received from a nurse, concerning a 62 year old male patient with hypertension, hyperlipidemia and with no drug reaction/allergies. On 26-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H015780, expiration date 11-JUN-2014, 0.5 ml), intramuscular in the left arm. Concomitant therapies included losartan potassium (manufacturer unknown) and atorvastatin. The nurse reported that on 27-FEB-2014, after received PNEMOVAX23, the patient developed pain, redness and swelling of his left upper arm "that extends down past the elbow". The patient was seen in the office on 28-FEB-2014, at which time an unspecified physician prescribed cephalexin and BENADRYL as treatment. At the time of the report the outcome was reported as not recovered. Patient seek medical attention with and unspecified physician that prescribed cephalexin and BENADRYL as treatment. No labs diagnostics studies were performed. Additional information has been requested.
digestive issues; Diarrhea; Vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPEPSIA (digestive issues), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     The patient had no known allergies. The patient never had COVID positive test or diagnosis.  The patient's past medical history included Ear operation (Ear tube surgeries) in March 2022. Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 25-Jun-2022 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2022, the patient experienced DYSPEPSIA (digestive issues). 28-Jun-2022, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 28-Jun-2022, DYSPEPSIA (digestive issues), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient received first dose on 25-Jun-2022 around 9 am. On 28-Jun-2022 around 9 patient had digestive issues, diarrhea and vomiting reactions and those reactions were short lived lasting from 9 am until noon. Patient had not experienced similar events in the past. The adverse events did not cause patients to seek medical care. As a treatment patient received Bland diet.
PATIENT HAD BLISTERS ON FACE; SWOLLEN FACE; SHE STARTED FELLING ILL IN THE SAME EVENING SHE GOT THE VACCINES;
Eight hours after 2nd dose of Moderna was sitting at my desk in study and felt a "hot flush" start at my ankles & move slowly up both legs to waist. Over the next several weeks had bouts of severe pain in legs & feet. Sometimes felt like sunburn, especially on top of feet.  Three months later still have bouts of pain in legs, feet, lower back, hips, but do not last as long. Has crossed my mind that the vaccine may have somehow made an existing medical condition immediately worse.  Just had an MRI and have an appointment scheduled with a Neurologist for early July.
Mom states patient has plantar warts to feet bilaterally, occurred approximately 1 month of 2nd dose of HPV4 vaccine administration. Being treated at home for removal.
Swollen lymph node under left arm/ in armpit area; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 01May2021 at 11:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medications within two weeks of vaccination. Past drug included latex. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 10Apr2021 11:15 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 at 17:00, the patient experienced swollen lymph node under left arm/ in armpit area. The clinical outcome of the event swollen lymph node under left arm/ in armpit area was resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sore arm after all three covid vaccines; Minor fatigue; Muscle soreness; vaccine related issues/vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccine related issues/vaccination site pain), PAIN IN EXTREMITY (Sore arm after all three covid vaccines), FATIGUE (Minor fatigue) and MYALGIA (Muscle soreness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Achilles tendonitis (right), Bone spur, Rheumatoid arthritis (moderate to severe) and Meniscus tear (right).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-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 started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (vaccine related issues/vaccination site pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after all three covid vaccines), FATIGUE (Minor fatigue) and MYALGIA (Muscle soreness). At the time of the report, VACCINATION SITE PAIN (vaccine related issues/vaccination site pain) and FATIGUE (Minor fatigue) outcome was unknown and PAIN IN EXTREMITY (Sore arm after all three covid vaccines) and MYALGIA (Muscle soreness) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  The patient had very minor fatigue. Her muscle soreness had improved. Right achilles tendonitis/bone spur that was longstanding had greatly improved since being on RINVOQ. She had vaccine related issues, sore arm after all three Covid vaccines. The 3rd COVID-19 vaccine was unspecified.   This case was identified as part of a retrospective clean-up activity  received in the Moderna were missed to be booked-in.   This case was linked to MOD-2021-626071 (Patient Link).
Information has been received from a vaccine administrator (unspecified HCP) via a company representative referring to multiple unspecified patients of unknown age and gender. The reporter reported that more times than not, when he/she administered GARDASIL (lot#, dose, route not reported) to these patients, on a daily basis, the patients not only experienced syncope, but their eyes also 'rolled back' and they nearly passed out on unspecified dates. The reporter asked the patients to sit for longer than 15 minutes observation after receiving GARDASIL. Outcome of the events was not reported. The causality was not provided. Additional information is not expected as the reporter did not want to be contacted.
pt recvd vax on 17SEP92 & w/in 24 hrs pt exp cold sx by nasal congestion & scratchy throat; 26SEp92 pt exp cold sweats, nausea, syncope;
Tender and sore muscles at the back of both thighs and calves; Tender and sore muscles at the back of both thighs and calves; Also cannot hike without severe pain after; This is a spontaneous report from a contactable consumer or other non hcp. A 54-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 13:00 (age at vaccination 54 years) as single dose for COVID-19 immunisation at hospital. The patient medical history was not reported. Concomitant medication includes Steroid pills. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced tender and sore muscles at the back of both thighs and calves so much so that she could no longer squat without pain or get back up from that position, also cannot hike without severe pain after, on 06Apr2021. No treatment received. The outcome of all event not recovered.  No follow-up attempts are needed. No further information is expected.
ZOSTAVAX administered on 10-2-09 @ 11:10AM. On Sunday 10-4-09 @ 3:15pm - Patient called stating that a rash developed on Sunday morning about 3 inches in diameter around the injection site, recommended taking CLARITIN or BENADRYL and monitor - contact MD as needed.
Injection site R post triceps area swollen, red 12cmx 8cm, very painful awakened me f/b fatigue, headache, naps required, Tylenol, Erythema decreasing by today 11/10 12noon but still movement or light pressure is painful.
After I came home from work and went to sleep, I was up coughing. I felt congested. It was all in my head, but I didn't have a headache. I was having a hard time sleeping. Around 05:00AM, I had a 102 temperature. I took a COVID-19 test, and it was positive. Then, I started to get worried and called the doctor. I was congested and coughing. She said they had Paxlovid for free to pick up. I felt tired and congested. After I took the Paxlovid and Ibuprofen and fell asleep again, my fever went down. I also used my nose spray from a previous sinus infection. It helped clear up the congestion. By the 3rd day, I started feeling a lot better. It felt like it was in my chest. I kept coughing, but I am getting better.
Severe migraine, swelling of lymph nodes, rash over arms that were size of a quarter with a pimple looking white center, stomach flu-like symptoms, chills, aches over body, sore arm of injection within five hours of shot. Symptoms progressively worsened and lasted 30 hours. Horrible symptoms and feeling! This only happened with second dose. First dose was just a very sore arm for several days. The first shot I also had a flu shot. I am not sure which one.
Information has been received from a pharmacist and  physician concerning a female who was vaccinated with a dose of varicella zoster virus vaccine live. Subsequently the pt experienced swelling and soreness at the injection site. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested.
High fever (103 F), aches, and chills began within 3 hours and lasted about 36 hours. Following the shot, the pain in the left arm muscle has continued to be significant, for two months at the time of this report.
Severe sore on the injection site, Fever of 101.5, severe muscle aches, and severe headaches
Itching on right arm; Pain at injection site; Vaccination site urticaria; Swelling at injection site; Exhausted; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer, Brain tumor, Immunocompromised and Surgery (on left hand).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE URTICARIA (Vaccination site urticaria). On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching on right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE URTICARIA (Vaccination site urticaria) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  ; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.