chrisvoncsefalvay/vaers-outcomes huggingface dataset:
APPROXIMATELY 4 DAYS AFTER 2ND SHOT OF SHINGRIX, I DEVELOPED MAJOR WEAKNESS IN MUSCLE MOVEMENT RESULTING IN HOSPITALIZATION OCT 5-OCT 8, 2018, MEDICAL CTR OCT 8, 2018-OCT 16, 2018, REHAB HOSPITAL OCT 16- OCT 26, 2018. IT WOULD APPEAR THAT I HAD A RELAPSE OG GUILLIAN BARRE. AFTER ALL ELSE WAS ELIMINATED, THE ONLY THING DIFFERENT WAS THE 2ND SHOT OF SHINGRIX. I DID EXPERIENCE SOME FEVER-CHILL FEELINGS ON THE EVENING OF OCT 1 AFTER 2ND SHOT, SOMETHING I DID NOT EXPERIENCE AT 1ST SHOT (JULY 12, 2018).
Sick; Initial information received on 02-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who was sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, administration site, lot number and expiry date was unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious  event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Sick).  At time of reporting, the outcome was Unknown for the event sick.
The patient presents with right, arm swelling. The onset was 1 days ago. The course/duration of symptoms is worsening. Type of injury: unknown. The location where the incident occurred was at home. Location: Right posterior proximal arm. Radiating pain: none. The character of symptoms is pain, redness, swelling and tingling. The degree of pain is moderate. The degree of swelling is moderate. Exacerbating factors consist of activity, movement palpation. There are relieving factors including immobilization and position. Risk factors consist of recent hospitalization and recently immunized in that arm
a 16 year old that received the FLUBLOK instead of the Quad,with no reported adverse event; a 16 year old that received the FLUBLOK instead of the Quad,with no reported adverse event; Initial information received on 23-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old (unknown gender) patient who received the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] instead of the quad, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation) and a 16-year-old that received the flublok instead of the quad, with no reported adverse event (wrong product administered) and (product administered to patient of inappropriate age) (unknown latency).  It was reported, Pharmacist asked Does the child need to be re-vaccinated. I just couldn't find anything in the literature. The only thing I could see was that it was egg-free and I wasn't understanding why it's only for 18 years and up. This was a mistake on my part, I just want to rectify and take it from there. This situation is reported as a medication error due to administration to a patient under 18 years of age.   Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  At time of reporting, the outcome was Unknown for both events.  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 the 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.
Pt diagnosed with Guillain- Barre syndrome pt was hospitalized 3 weeks after receiving first dose of Moderna vaccine. Pt did not receive second dose d/t being hospitalized. Pt was hospitalized for 91 days. Pt was vented for over a week. Pt is wheelchair bound and unable to walk. Pt states feet are numb and can't move them
I am the epidemiologist reporting on behalf of 88-year-old male patient. The patient received two doses of the Moderna vaccine on 3/21 and 4/18. The patient later took three antigen tests. The first two were on 8/16 (one was negative and one was positive) and the third was on 8/17 (positive). The patient died on 8/27 and the cause of death is not listed although it is considered a probable COVID-19 death according to state guidance. Pre-existing conditions are listed as ?CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD), CARDIOVASCULAR DISEASE, CHRONIC RENAL DISEASE.?
Adverse reaction nos; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse reaction nos) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse reaction nos). At the time of the report, ADVERSE EVENT (Adverse reaction nos) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  No treatments were reported.
On 5/10/07 I received the 2nd dose in the series of Hepatitis B Vaccine. Within 30 hours I was in the Emergency Room with symptoms of a heart attack massive sweating, pain in upper chest. All tests- including stress test - were negative for heart problem and tentative diagnosis was a flair up of my GERD - reflux. After physician followup I changed GERD medication and basically forgot about it. Then on 11/19/2007 I received my 3rd Hep B shot and within 30 hours had the exact same symptoms. Deciding I was not having a heart attack, I waited it out and symptoms abated somewhat but some pain in chest remained. All scans showed stones. After additional tests - surgery recommended. My own personal thoughts - perhaps I did not have a bad reaction directly to the Hep B vaccine, but instead it exacerbated/triggered an already existing gall bladder problem. Another piece of relevant history - The one thing that precipitates this reporting by me is the fact that both of what appear to be a flair up of an existing gall bladder problem occurred 30 hours after a Hep B vaccine. Additional data - I did have a similar attack that caused an overnight emergency room stay in or around the year 2002. That incident was not connected to a Hep B vaccine. That attack was also diagnosed as heartburn. I am guessing that was the first indication of gall bladder issues which went undiagnosed.  12/19/2007 MR received for DOS 5/13-14/2007 with DX: Chest Pain. SOB. Pt presented to ER with 90 minute hx of sub-sternal chest pain/pressure with associated diaphoresis. Admitted to Chest Pain Unit for observation. Negative cardiac eval.
This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a male patient who received FLUARIX Quadrivalent. Concurrent medical conditions included mental disability. In October 2015, the patient received FLUARIX Quadrivalent. On an unknown date, less than a month after receiving FLUARIX Quadrivalent, the patient experienced tingling of extremity and mobility decreased. On an unknown date, the outcome of the tingling of extremity and mobility decreased were not recovered/not resolved. The reporter considered the tingling of extremity and mobility decreased to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient stated he had the FLUARIX shot about two weeks ago and was losing mobility in his right arm. He also indicated his arm was tingling all the way down his right arm into his hand. He said he had been to 3 therapies and nothing was working. The patient was demanding to have any reports of adverse events with this medication in the last few months to be mailed to him.
Information has been received from a pharmacy technician referring to a patient of unknown age and gender. There was no information about medical history, concomitant medication or concurrent condition. On 18-JUL-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose and route unknown, lot# N009167, expiration date 02-FEB-2018) for prophylaxis. Properly stored sterile diluent (STERILE DILUENT) (dose and route unknown, lot# N008378, expiration date 08-JUN-2018) was used to reconstitute ZOSTAVAX. The vaccine was exposure to 6 Fahrenheit degree (F) to 14F for 7 days, 15F to 46F for 3 days. No previous temperature excursion involved. No data logger involved. This is one of the reports received from the same reporter (MARRS# 1707USA009982).; Sender's Comments: US-009507513-1707USA009982:
She stated her right arm became swollen and was unable to move it for a few days. Stated the medical assistant gave her the vaccine in her bone. Our medical assistant supplied a heat pack after vaccination. Member did not divulge this information until her most recent appointment on 5/5/23.
Severe onset of flu like symptoms in an hours time Friday 3-4 pm.  Fever, chills, stuffy nose, muscle aches, head ache, difficutly taking deep breaths.  Symptoms became much worse by Saturday and on Sunday needed to start using rescue inhaler every 2-3 hours, due to inability to breath properly.  Tremendous pain in the chest and back (left side more then right).  Took Zyzal, Tylenol, Advil, Nyquil at various times on Sunday and Monday.  Unable to go to work on Monday.   Today, Tuesday Oct 17, 2023, still have muscle weekness and severe coughing due to congestion and productive yellow mucus.
Left posterior-lateral mid upper arm with about 2x3 cm red, warm site, non tender. Well demarcaated area of involvement with no red extending from area with full ROM of arm.
Right arm at site of injection, red, inflammed and blister/vesicle. Zovirax ointment Rx given to use every 3 hours X 7 days.
Mother called office 09-13-2017 at 1530 stated that patient was feeling nauseas, felt like throat was closing up with pain and stinging down the (R) arm. Patient was directed to ER per nurse practitioner whom alerted ER prior to patient's arrival.
1st day after vaccines administered had itching and swelling at site of varicella vaccine. 2nd day after vaccine administered had pain in her arm. 3rd day after vaccine administered her body felt tingly all over.
Information has been received from a physician concerning a 23 year old female with sulfonamide allergy and no pertinent medical history who on 20-OCT-2006 was vaccinated with Gardasil. Concomitant therapy included YASMIN. On 22-OCT-2006, 48 hours after receiving the immunization, the patient developed itching without a visible rash. The patient sought unspecified medical attention. No laboratory tests were performed. The itching persisted for 3 weeks. At the time of reporting, the patient had recovered from the itching on approximately 10-NOV-2006. No other information was available at the time of reporting. Additional information has been requested.
The day of the vaccine and the day after, he suffered a lot of pain in his arm where the injection was given. The day after the vaccine, he developed a hard, swollen, red area that was hot to the touch. The red area spread a great deal over his upper arm for the next 2 days. By the 3rd day after the vaccine, it began to decrease in color and size. There was no longer any pain.
Patient complaining of heart racing post day 1 and after vaccine administration.  Pulse at pharmacy on 8/12/2021 1:45 pm was 94 bpm.   Advised patient to report to urgent care evaluation.
Sore arm; This is a spontaneous case received from a contactable consumer. A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number and expiration date were not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient had also administered acetylsalicylic acid (ANACIN 81, formulation: unknown; Lot/batch number were not reported) via an unspecified route of administration on an unspecified date for an unspecified indication. Medical history and concomitant medications were not reported. It was reported that the patient has been non-stop on Anacin. He lives off of Anacin. The caller states maybe 2 or 3 hours after the first shot he had a sore arm but he has had no reactions because he was taking Anacin and had Anacin in his system. She read to not take anything prior to receiving the vaccine and she believes Anacin has aspirin in it. She believes it has aspirin on the bottle. She was just telling him he should not have been taking the Anacin prior to the vaccine. She mentions he was 70 years old. She had no idea if he was on his first bottle or maybe on his bottle when he received the vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Had chest pain and came into ED, found to have NSTEMI went to cardiac cath, no stent needed at this time. given aspirin 81 mg daily for life and plavix 75 mg daily for 1 year discharged home
LOSS OF SMELL; LOSS OF TASTE; NECK STIFFNESS; VOMITING; LIGHTHEADEDNESS; LOW POTASSIUM; BACK STIFFNESS; MIGRAINE WITH LIGHT SENSITIVITY; INTERMITTENT COUGHING; BURPING; CHEST PAIN; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical issues or known low potassium prior to receiving vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced loss of smell. On MAR-2021, the subject experienced loss of taste. On MAR-2021, the subject experienced neck stiffness. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced low potassium. On MAR-2021, the subject experienced back stiffness. On MAR-2021, the subject experienced migraine with light sensitivity. On MAR-2021, the subject experienced intermittent coughing. On MAR-2021, the subject experienced burping. On MAR-2021, the subject experienced chest pain. On MAR-2021, the subject experienced fatigue. Laboratory data included: Potassium (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of smell, and loss of taste on 2021, and the outcome of neck stiffness, intermittent coughing, vomiting, lightheadedness, fatigue, burping, low potassium, back stiffness, chest pain and migraine with light sensitivity was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
fever; headache; Chills; feeling foggy; Tired; A report was received from nurse concerning a 53-year-old, a female patient who developed a foggy feeling, fatigue, headache, fever and chills after receiving the Moderna COVID-19 vaccine.  The patient's medical history was not provided. Concomitant medication reported include vedolizumab and rosuvastatin.   The dosing descriptions were not provided.  The patient received her first of two planned doses of mRNA-1273 vaccine 30 DEC 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 DEC 2020 and 01 JAN 2021, the patient reported to have experienced fogginess and a feeling of tiredness.   On the night of 02 JAN 2021, she suddenly developed a fever, headache and chills. The intensity and duration of the headache, fever, and chills were not provided. There was no complaint of any localized discomfort or weakness in the patient's left arm.  On that same night, the patient reported that she took acetaminophen.   However, the outcome of the events was not reported. Any action taken regarding the completion of the second dosing of the vaccine was not communicated.; Reporter'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.
At the time of the shot, there was a little bit of redness. Approximately 18 hours after the shot, the redness had increased to the size of my hand, it was hard underneath and hot to the touch. I began placing cool washrags on the spot, took Tylenol for the pain and contacted my doctor. He advised to take 10mg of Zyrtec daily and use ice packs three times a day.
15 days After vaccination, patient is unable to walk comfortably (partial paralysis of left leg) went from walking with cane to needing a walker.  Prescriber thinks may be Guillain barre syndrome but has not officially diagnosed in chart.
Chills starting at 3:00 AM on 12/21/21. Fever of 101.8 degrees at 7:45 AM on 12/21/21. Cold compress and one Tylenol taken at 8:15 AM on 12/21/21.
12cm x 11cm erythema and induration at injection site.  Patient given Keflex and Zyrtec.
vaccine given at 10:30am in treatment room. soreness of right arm at injection site within 4 hours, painful to lift overhead. within 8 hours suffering headache, neck stiffness & several (3) periods of tingling sensations in the left leg (lasting 10 minutes each or so)and a spell of itchiness. 12 hours after injection, went to bed with headache (still), fever & chills. restless night. fever of 102F at 7AM (22 hours after shot).  went back to sleep and was difficult to wake. i called doctor -- mentioned my concerns over a reaction of some sort & was told this vaccine did not cause these symptoms. i scheduled an appointment because this was not normal for patient and i was not quite sure what to do. by noon, most symptoms were gone except for the headache. we saw the doctor who pronounced her fine & told us to watch for other symptoms of illness. he told us that it was not the vaccine, but would note my concerns on her file as a precaution. this was the 3rd and final injection of this vaccine, she had only soreness at the injection sight with the first two shots. she took an aleve around 8pm the night of the shot & 2 motrins - 6 hours apart - the next day because of the headache. no relief was provided by the pills.
Day 1:  Within hours of vaccination symptoms of fatigue and muscle pain and achiness began to appear.  Also, a slight perception of tightness in the throat that was alleviated by taking a claritin pill.   Day 2:  The next day produced significant fatigue, muscle pain and achiness throughout the whole day that began to decrease in the later evening.  A fever of 99.9 started in mid-afternoon and continued through about 9PM. Day 3:  The following day all symptoms disappeared.
Rapid onset hearing loss - left ear about May 19, 2022. Had a cold & suddenly got severe ringing in left ear & feeling of head under water. Had travelled by plane previously. Thought ringing in ear & loss of hearing would clear up, but 6 weeks later had hearing  test & left ear has had sudden large dip in hearing which seems permanent.  MRI scheduled. Doctor suspects Autoimmune Hearing Loss.
Patient contacted pharmacy on 11/19/14 to inform the pharmacy manager that his physician stated that he had an adverse reaction to the flu vaccination that he received. Patient had initial soreness after receiving vaccination that went away after a few days. Then left shoulder pain came back  got to a point where patient seeked M.D. Follow up on 10/28/14. Patient shoulder pain is where he is having trouble lifting his arm over his head. Patient went to MD again on 11/12/14. Last flu vaccination for patient was in 2012.
Had swelling, redness, heat, rash, pain, itching at injection site x3 days. Also developed headache, sinus pressure, cough immediately after shot.
After receiving vaccination, patient was out of it for approximately ~15 mins, after that period seemed lethargic but otherwise normal.  Patient showed no other adverse reaction until time for his nap at 12:40p, when he felt warm to the touch but underarm temperature reading was 98.7.  He woke up atypically early at 2:50p, but laid in crib seemingly playing quietly.  At 3:56p, mother heard whimpering sound and went to check on patient who was convulsing and unconscious until EMS arrived at 4:03p, he was very hot but EMS was unable to get an accurate temperature reading.  Convulsions stopped when paramedics arrived at approx. 4:03p and patient was unresponsive for an additional approx. 10 mins.  Patient was placed under ice by EMS and had a temperature reading of 102.4 when he arrived Hospital in  approx 20-30 mins later.
He had the flu, there is no treatment he just laid low, and I hydrated him and kept him home.
Pt recvd vax & lab eval revealed that had seroconverted; lab eval on approx 20OCT93 revealed a neg rubella titer; no further details were provided;
Patient reports same day onset of muscle tenderness to right arm and 2 days after receiving injection noted red welts to left arm that were painful to touch. Came to clinic the next day and red wheals noted to left upper arm below deltoid muscle, wheals are slightly raised and warm to touch.
This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 85-year-old female patient who received SHINGRIX (batch number 79N59, expiry date January 2019). Concomitant products included AMBIEN, LYRICA and metoprolol. On 12th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced contusion, pain in arm, itchy limbs, swelling arm and erythema of extremities. On an unknown date, the outcome of the contusion, pain in arm, itchy upper limbs and erythema of extremities were not recovered/not resolved and the outcome of the swelling arm was recovering/resolving. It was unknown if the reporter considered the contusion, pain in arm, itchy upper limbs, swelling arm and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: At 2:00 p.m. the patient received SHINGRIX on left deltoid. The patient experienced swollen left arm that protruded like the shape of an orange. The day before the date of reporting, the arm was very red, itchy and bruised and very painful to the touch. The swelling had gone down but it was still red and bigger than a softball in the shape of the redness and the area was bruised in the center.