chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom states child's arm is swollen, unable to move, warm, muscle on "inside of arm is hard" and arm is "curved" when hanging by her side. [Verbal report from mother].  She said she worries child has nerve damage.  Advised to take child to doctor.
Developed migraine headaches about 10  days after the vaccine dose.  The headaches are rebounding and the rescue medicine helps to dampen or alleviate the pain but the migraines return.
Case number PHEH2014US025054 is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 50 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Right away, I had a sore arm, but that went away for a period of time throughout the day. 08:00 pm soreness and heaviness again in the arm. About 12:00 midnight, I started feeling feverish, chills, body aches and an hour into that I took my temperature it was 104. I took Tylenol and that brought it down to 101 and 102. And so those chills and body aches lasted as long as the fever which lasted until 08:00 the night after the vaccine. I had insomnia that night with the fever and frequent urination, about 5 or 6 times that I night I had to get up. Two days later, on the 12th, I started experiencing significant itching and burning sensation. I thought it was a yeast infection. My doctor identified genital ulcers. Tested for herpes, etc. that came back negative. It looked like a friction ulcer. I saw two people for that, my PCP and my dermatologist. Both said they didn't look contagious. Dermatologist said a number of things could cause that, like maybe an autoimmune issues but I don't have any of those issues. My ANA had been tested and came out okay  before the vaccine (between the first dose of the vaccine and 2nd dose of COVID vaccine, September 23 (drew the labs). My ANA came back negative. She prescribed lidocaine but I didn't take it because the pharmacy was out of stock. I am not experiencing symptoms anymore but I haven't a follow up appt yet.
Extreme fatigue; This case was reported by a consumer and described the occurrence of fatigue in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR096836   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: Patient experienced extreme fatigue after the 1st twinrix dose received, but did not see a physician for it as patient wrote it off to the rigors of physical trainin; however, the fatigue did not go away even after being in less physical environments. Additional supportive information: For tolerance to the 2nd dose refer US2022AMR096836; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR096836:Same reporter
Pt was given 2nd set of immunizations on 05/01/2002. No adverse reactions at time. None reported later. Pt died on 05/08/2002. Death certificate states "SIDS." Per F/U 5/29/02, death certificate states date of death as 5/7/02 at 5:10 PM
I started getting hives on my stomach, arm, back and both ankles. I did have a low grade fever the first night and then a fever of 100.4 last night.
Patient presented to pharmacy on 9-28-17 with a large red spot on her (L) arm. She said it was raised and hard last night. It hurts less now but is now a large red spot bigger than a tennis ball. Advised her to take Ibu/BENADRYL and will check in w/her on Monday.
Red, itchy, rash over arms and legs. Saw MD who thought might be reaction to flumist.
Patient felt faint after abut 1 minute after receiving vaccine, patient took a sip of water, dropped the bottle and passed out then had a seizure. Ambulance and EMS were called they completed work up and patient signed a release and had a family member come pick him up.
Following day patient reported red, hot arm with red streaks under arm. Notified local MD placed on antibiotics given cortisone shot.
Dizziness, nausea, vomiting, diarrhea, arm pain, body aches, joint pain, headache, my period which is otherwise regular started two weeks early the day after the vaccine
5 days after 2nd vaccine I developed my first migraine ever. They then went on to persist until this day 4-5x a week around 2am and I developed pulsatile tinnitus. I also started reacting to foods I?ve never reacted to with red burning skin and hives. I have photos. These symptoms prompted visit to ER, neurologist, cardiologist for testing including head MRI, neck MRI, carotid ultrasound, ct scan of head  and a slew of medications to help control my migraines that did not work. I?ve had to cut out all histamine foods and histamine releasing foods, gluten, eggs, dairy and I stopped working my full time job as an RN May 2021.
had both shots and had outbreaks/Suspected vaccination failure; after 2nd shot, continue with outbreaks; Shingles shortly after 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had both Shingrix shots and had outbreak of shingles shortly after first shot and after second shot patient was continue to had outbreaks mostly in same place on back of leg. The follow-up could not be possible as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
About 12 hours after injection, I developed severe body aches and joint pain,, headache, chills, fever, nausea
After 20 minutes of observation patient left and was accompanied by another staff back to observation room and states that she is feeing dizzy and lightheadedness. on assessment BP 165/97 P98 R22, states that she hadn't eaten anything for today. Crackers and water was given well tolerated. Patient was reassessed for another10 minutes, BP still elevated with lightheadedness, was requested to have family pick her up for home or ER, but refused. Nurse call to patient at 13:15 and patient states she made it home safe and is preparing something for lunch.
Have gotten covid (likely tested positive); Have gotten covid (likely tested positive); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Have gotten covid (likely tested positive)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive. Reason why batch/lot is unknown: not available/provided to reporter at the time of report completion.Reported Event: Posted on social media as of two days ago that they have gotten covid (likely tested positive). I strongly believe they are at least fully vaccinated though I do not know with what vaccine. Age 23 or 24 years old, withheld female. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
I was completing our monthly medication review form today, 1/25/18, to be submitted to the pharmacy. Our clinic has had two doses of stock PENTACEL available since November, possibly even before, no additional stock PENTACEL has been ordered after November. Both doses of PENTACEL shared the same lot number and expiration dates. I found one complete dose of the two components, and one dose of only the DTaP-IPV. It appeared the Hib portion had been used. I found one patient within the appropriate time frame from December's medication review form until today's medication review form. I followed-up with the manufacturer. The manufacturer stated the dose received on 1/2/18 was not to be considered valid, and the patient is to repeat the dose.
When she came in for her second dose, she described her left deltoid muscle as a pain. A week after receiving the vaccine, her arm bruised in a strange line that went around the bottom of the deltoid.. ( around 3 to 4 inches from where the injection was given) and her arm hurt. At her appointment, she said it still hurts once in while in the entire muscle. it is not all of the time but it comes and goes every once in awhile.
No Adverse Event; They have given 13 patients an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case contains information for the 8 out of 13 Elderly patients described by the reporter.  No concomitant information was reported.  Vail never put in the fridge. Vials went from freezer to room temperature on days of administration. Dates of administration of vaccine were 14Apr2022, 21Apr2022, and 28Apr2022. Vial did not undergo any temperature excursions. 13 doses total given from 3 vials. Multi dose vials of 5.5mL. Age group of patients were mostly over 65 and they did report all of them in the VAERS website.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:Master case
A report was received from a consumer's wife on October 19, 2001 regarding an elderly male patient who experienced syncope and swollen and inflamed joints after receiving Inactivated Influenza vaccine in 1986 and 1987. The patient was vaccinated in 1986 and experienced syncope and collapsed approximately 48 hours later.  The patient was vaccinated in 1987 after which he experienced swollen and inflamed joints which lasted 5 weeks.  The patient has recovered from both incidents.
Abdominal pain started ~3 weeks after the 2nd dose. Went to the ER ~5 weeks after the dose and was diagnosed with mesenteric adenitis
Hives on chest, stomach, & legs; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via unspecified route of administration on 23Mar2021 (at the age of 49 years old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: EL9265) via an unspecified route of administration in right arm on 02Feb2021 at 12:00 (at the age of 49 years old), as a single dose for COVID-19 immunisation. The medical history of the patient included hypertension. The patient had not received any medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had no known allergies to medications, food or other products. The patient had not tested for COVID-19, since the vaccination. On 14Mar2021 at 12:00, the patient experienced tinnitus in both ears. The vaccine was administered outside the range of 19-42 days after the first dose.  No therapeutic measures were taken as result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the tinnitus in both ears was not recovered.   No follow-up attempts are needed. No further information is expected.
Diagnosed fibromyalgia 12/17/02. Diagnosed with asthma 4/3/01. A 60-day follow up report received 8/18/2003 adds: Continues to have myalgias and chronic fatigue syndrome. I do not know if it is from the immunizations. Mother believes it may be.
Pt vaccinated with DTP developed twitching followed by a 10 minute seizure. Temp prior to seizure 100. Hospitalized where temp has been fluctuating as high as 104. Nuerological exam normal.
AFTER GETTING SHOT , PATIENT WAS WAITING FOR 15 MINUTES. PATIENT FAINTED AND FELL ON FACE . CALLED 911  AND AMBULNACE CAME OVER, SHE WAS AWAKE AND RESPONDING. NEXT DAY ON DUTY RPH CALLED BOYFRIEND ( HE WAS  WITH HER ON 06/19/20 VACCINATION TIME) AND FOUND OUT THAT SHE HAD ANXIETY FROM VACCINE
PT presented to office w/reactive lymph nodes behind right ear and a chicken pox rash, which PT had for 3 days. No fever. PT c/o rash itching very much. PT was Dx'd w/chicken pox and reactive lymph nodes post auricular. Lesions of chicken pox were already crusted over at time of visit.
Patient called today to ask about some symptoms he was experiencing following receipt of the COVID vaccine. Patient received first dose COVID-19 Pfizer vaccine (lot FC3181 exp 10/31/2021 L Deltoid) Tues 8/17/21. Patient states he started experiencing nausea and vomited the following day 8/18 and again today 8/20/21. He has been feeling achy and hasn't had much of an appetite. I recommended he call his physician to let them know as well. He denied any issues with staying hydrated, as he had only vomited three times total since the vaccine. I told him he could take tylenol to help the achiness and he should stay on top of his hydration. He is going to let his physician know as well as ask their advice with regards to getting the second dose or not.
Initial misuse report received from a healthcare professional on 09 January 2014. A 69-year-old patient (gender: not reported had received  a dose of FLUZONE. No adverse event was reported. Documents held by sender: none.
erection problems / lost erection / c an't have sex; chills; fever; drinking more like 5 liters a day; couldn't sleep well; This is a spontaneous report from a contactable consumer (patient) from the Pfizer sponsored program . A 37-year-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Pharmacy, administered via an unspecified route in left deltoid on 19Aug2021 15:00, at 37 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical and family history was none. There were no concomitant medications. The patient didn't receive any other vaccination in the previous 4 weeks before COVID-19 vaccine. The day after vaccination (20Aug2021) the patient had chills, fever, erection problems and has been drinking more. The patient usually drinks 2-3 liters a day and now he was drinking more, like 5 liters a day. He stated that he had a "normal sex life before this and after the vaccine he lost erection and can't have sex". The caller did not have a fever on 22Aug2021, but he had it at the report date (23Aug2021), that's why he couldn't sleep well. No relevant test was performed. The reported events didn't require a visit to Emergency Room or Physician Office. At the time of the report the reported events had not resolved yet, except for Chills which were resolving and insomnia, whose outcome was unknown.  The lot number for BNT162b2, was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number L005297, expiration date: 17-AUG-2016, albumin status HSA; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Under the arm I got the injection in it has swelling the size of a grapefruit; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 20May2021 at 17:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 27Apr2021 at 13:00 (at the age of 40-years-old) in the left arm for COVID-19 immunisation. On 22May2021 at 05:00 the patient experienced under the arm he got the injection in, it had a swelling the size of a grapefruit. No treatment was received for the events. The clinical outcome of under the arm he got the injection in, it had swelling the size of a grapefruit was not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Fine for about 4 hours. Then neck, arm, and leg on the same side I got my shot on were all tingly and weird. The next morning the tingling/hot spread to the entire side of my body. I had extreme muscle weakness to the point where I thought maybe I was having a stroke. Joint aches were severe and lasted for months. Especially my wrist. Beefy part between my thumb and pointer finger were extremely tender. Lymph nodes on the side I go my shot in were extremely swollen. Neck and cheek and forehead were extremely sensitive but not sensitive to the touch - hard to explain. I wasn't feeling numbness it was more prickliness like when you sweat so much you feel like you have needles in your skin. (I wrote all my symptoms down which is why this is so detailed.)
BEGAN WITH FEVER, CHILLS, JOINT PAIN, RUQ PAIN ON 12/5/14. BEGAN FEELING NEURITIS TYPE PAIN BEGAN IN LOWER MID BACK, EACH DAY IT PROGRESSED AROUND MY RIGHT SIDE TO ABDOMEN, AND ON 12/9/14 FIRST HERPETIC LESION NOTED ON MY ABDOMEN. CONTINUED TO HAVE RUQ AND LOWER RIGHT RIB PAIN WITH THIS AS IF SOMEONE HAD KICKED ME IN MY RIBS. SEEN BY DR. PCP WITH DX: SHINGLES AND TREATED X 7 DAYS WITH ACYCLOVIR. REMAINED OFF WORK X 7 DAYS PER DR. ORDER AS I HAVE PATIENT CONTACT IN MY JOB. REPORTED THIS TO OUR EMPLOYEE HEALTH AS THIS IS WHERE I RECEIVED MY HEPATITIS B VACCINE ON 12/3/14. AFTER 7 DAY COURSE OF ACYCLOVIR, CONTINUED OFF AND ON WITH RUQ PAIN.
Severe low back pain, had to take muscle relaxers and pain meds. Couldn't stand up straight and needed help with adls. I also had chills at night a day prior to back pain.
I noticed as the evening progressed, on February 8, 2023, I had a dry throat, I also had chills. I went to lay down to cover up and get warm. I took a home COVID-19 test the morning of February 9, 2023, called my doctor to let them know I was positive and would like to get Paxlovid. I was able to pick that up within a few hours and by the evening I was already starting to feel better. By the next day I was feeling like myself. I don't feel this was as bad as having the flu.
A physician reported the occurrence of a dry cough in a 47 year old female who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history and concurrent conditions were not reported. The subject was described as being otherwise healthy. Surgical history included hysterectomy. The subject received no concurrent medications or vaccines. In March 2003, the subject received her first injection of Havrix. Twenty four hours post-immunization, she developed fevers as high as 102.2 degrees F, an extremely dry cough, a lot of nausea, dizziness, itching on the soles of her feet, myalgia, chest congestion, wheezing, tachycardia, and dehydration. The subject was seen by the physician. A complete blood count with differential was performed on 3/20/03; results were within the reference ranges. The physician noted that the subject had a history of recent travel and may have been exposed to severe acute respiratory syndrome. As of 3/21/03, the events had improved, but the subject still had a dry cough. The most recent information received was received on 5/20/03. The physician stated that she considered the events to be possibly related to the recent travel. However, the Havrix immunization series was discontinued. The physician also indicated that she considered the events to have placed the subject in jeopardy or to have required intervention. Therefore, this report has been reclassified as serious.
Pt experienced temperature of up to 104 noted for 6-7 hours post vax. Pt still had fever when seen one day post vax. Pt also experienced night irritability.
Patient reported redness, swelling and paint at the injection site on the left arm around 12-1pm on may 24th.  The injection in the left arm was the pneumovax 23 vaccination.  Patient reported taking a Benadryl and aspirin to help reduce symptoms. Patient stopped in next and showed me her arm.  There was mild redness and swelling.  She stated that the pain has subsided.  I advised her to continue regime of Benadryl and take an Ibuprofen to help with the swelling.  I advised her that if it got worse to seek medical attention.