chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient been having a problem with ringing in ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Patient been having a problem with ringing in ear) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Patient been having a problem with ringing in ear). At the time of the report, TINNITUS (Patient been having a problem with ringing in ear) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.       No concomitant medications was reported.  Patient reported that having a problem with ringing in ear. HCP said it was probably a sign of hearing loss. However, she read on line that some of the Moderna vaccines were related to Tinnitus.   No treatment medications was reported.  Patient went to a Health related website where several people reported ringing in their ears and some mentioned tinnitus after receiving the Moderna booster.
It started hurting and I felt it and it was hot as it could be and it was very red, red, red. Very hot. My husband told me the area was swollen and hot. I took some Tylenol and I tried also ice compresses. It was then blue/red like it was badly bruised. It took about 3 days to start getting down and I had a kind of a line, an outline for at least 2-3 weeks. In fact I can still see a dark area an outline of where the redness was.
woke up with the shivers and headache and then got to work and had muscle pains and stomach problems
Right arm swollen, warm to the touch, tender to the touch with a small knot palpated. Child uses arm with slight difficulty. Ibuprofen administered by mother. 08/24/2005 phone call to home left message. 08/29 phone call left message.
Vaccine administered IM Left deltoid on 10/25/2006. Pt reported back to clinic and seen on 10/26/2006 with large erythematous induration, tenderness, and itching to left deltoid at injection site with red blotches all over body and facial flushing. Pt given prescription Atarax 25 mg PO Q4 PRN and instructed to go to ER if symptoms worsen.
FEVER, BEGAN EXPERIENCING AT 5:00 AND RESOLVED ON SAME EVENING; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUL-2021, the subject experienced fever, began experiencing at 5:00 and resolved on same evening. On 08-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, began experiencing at 5:00 and resolved on same evening on 08-JUL-2021, and had not recovered from headache. This report was non-serious.
Patient reports 2/10 headache following vaccination. Took patient vitals to find him hypertensive. patient refused transport to ED
itch; diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso; red spot on her right leg; a reaction to the moderna vaccine; rash; headache; tiredness; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine) and RASH (rash) in an 83-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Asthma.    Concurrent medical conditions included Asthma.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) administered at loading dose of 600 mg once followed by 300 mg every other week. On an unknown date, the patient experienced PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine), RASH (rash), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine), RASH (rash), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that dupilumab administered at loading dose of 600 mg once followed by 300 mg every other week for asthma  No treatment medications were reported.  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.
severe chills all night went away around 6 am. Vomit with dry heaves at 1:15 am last round at 5:30 am. Very severe at times. Shortness of breath started in the afternoon or the 6th of March, lasted for 14 days. Cramps in my legs periodically still get them not as often now. Still don't have the same energy I had before the shot. I still tire easily.
Pt.'s Sister states that after her brother received the 2nd dose of Phizer 09/22/2021, Pt. started experiencing shortness of breath and pain in the chest, Urgent Care visit 09/27/2021. Ultrasound preformed, treated with Updraft. Died 09/27/2021 2 Blood Clots located.
immediate numbing; swelling; really hurting; slight headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (immediate numbing), SWELLING (swelling), PAIN (really hurting) and HEADACHE (slight headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced HYPOAESTHESIA (immediate numbing), SWELLING (swelling), PAIN (really hurting) and HEADACHE (slight headache). At the time of the report, HYPOAESTHESIA (immediate numbing), SWELLING (swelling), PAIN (really hurting) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information included ice pack.
L arm pain for five days following vaccine.  Patient unable to raise arm above shoulder level due to pain.  Headache not responsive to conservative measures.
Left leg calf, ankle, and for pain started two weeks after 2nd dose; Left leg calf, ankle, and for pain started two weeks after 2nd dose; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 at 16:00 (Lot number: FC3180) at the age of 44 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FA7485; Anatomical location: Right arm; Administration time: 16:00), administration date: 06Aug2021, when the patient was 43 years old, for COVID-19 immunisation.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 17Sep2021, outcome "not recovered", and all described as "Left leg calf, ankle, and for pain started two weeks after 2nd dose". The event "Left leg calf, ankle, and for pain started two weeks after 2nd dose" was evaluated at the emergency room visit and the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the events pain in extremity and arthralgia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. She was still in pain (at the time of this report). Since the vaccination, the patient had not been tested for COVID-19.
3/28/06-Small headache, felt "queasy". 3/29/06-Large headache, backache/shoulder ache, elevated temp (104) elevated BP (150/105), nausea, sweats/chills, shaking. 3/29/06 Called early AM to report all these s/s. 14:15 T/C to her home. Temp. 97.7. States is feeling a little better. Still queasy.
1:25PM, a 49 year old received her second dose of Moderna vaccine 0.5ml at 1:23PM. 2 minutes later patient started fainting x anxiety attacks, dizziness, diaphoretic and weakness, rolling of eyes and feeling if warmth. Patient never lost consciousness and no respiratory distress exhibited. Patient and family denies any health  issues like diabetes, HTN, etc. Vital signs recorded BP 141/124, 50 pulse, 22 respirations. Paramedics called. Continued to far patient for air. 20 minutes later, paramedics arrived, patient was more alert before their arrival. They  assessed patients vital signs recoded and within normal. BP 118/74, HR 59, O2 Sat  100%, lung sounds clear. Patient refused further treatment by refusing to go to the hospital.
Am having intense intermittent neuralgia type pain in the side of right hand - occurs mainly in morning & evening. Pain very intense; wakes me up from deep sleep.
Started with a severe runny nose. Runny nose and sneezing lasted approx 48hrs. When nose stopped running breathing got more laborious and a cough persisted. Slight fever and muscle aches for two more days. Trouble sleeping and cough started to produce mucus. It has been over 1 week since symptoms started and I am still experiencing coughing and mucus, as well as a loss of appetite. This was what I have experienced before when I have had a severe cold.
Developed red rash with red induration about 10cm in diameter. Saw MD 6/24/06. No fever, no purulence. Started on Zyrtec. Area cleared after 2 doses of Zyrtec.
- Tinnitus onset approximately 1 week (between 7 and 10 days) after first Pfizer vaccine.  - "Brain Fog" onset approximately 1 week (between 7 and 10 days) after first Pfizer vaccine.  - Vertigo onset approximately 1 week (between 7 and 10 days) after first Pfizer vaccine.  - Confusion onset approximately 1 week (between 7 and 10 days) after first Pfizer vaccine.  - Chronic Fatigue onset approximately 1 week (between 7 and 10 days) after first Pfizer vaccine.
Pt reports an ongoing headache and an itchy, red rash on her chest (not at her injection site)
she only had soreness after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Verbatim: Allergy. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "she only had soreness after the first dose".  Additional Information: The caller stated that her daughter did not have this type of reaction after the first dose and states that "she only had soreness after the first dose.  No follow-up attempts are possible. No further information is expected.
This initial spontaneous report was received from a physician referring to a 9 weeks old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015, at 15:24 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. The 9 weeks old patient was vaccinated with the second dose of ROTATEQ (inappropriate schedule of vaccine administered). No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
The pt began having flu symptoms on 4/27/00 and got the measles rash on 4/30/00. Measles confirmed on 5/1/00 by primary care physician. Labs pending.
have side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (have side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (have side effects). At the time of the report, ADVERSE EVENT (have side effects) outcome was unknown.
This spontaneous report was received from a consumer refers to herself as approximately 56 year old female patient. Concurrent conditions included hypothyroidism. No drug allergies reported. On 01-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 one injection (lot number not reported) through an unspecified route. Concomitant therapies included SYNTHROID. On 02-OCT-2014, the patient experienced what felt like knives traveling throughout her body and she was exhausted for one day following her vaccine injection. The patient slept all day on 02-OCT-2014 and she experienced an elevated amount of fatigue. No lab diagnostics studies performed. The patient did receive unspecified treatment for the adverse events. The outcome of the events was reported as recovered on 03-OCT-2014. The causality for the events was unknown. Medical attention was not sought. Product quality complaint was not reported. Additional information has been requested.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Swollen bump immediately after injection given-Medium, Additional Details: Bled more than usual, swollen bump instantly after injection was given. Gave patient ice pack. She left and seemed to be fine, bump was going down and getting smaller by the time she left around 20 minutes after vaccine administration.
Moderna Booster dose was given instead of the Moderna Bivalent dose that was needed for the booster. No reaction noted.
had chills; had elevated fever to 99°F; felt tired; arms started to swell; felt cold; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she had her first shot on 04Mar2021, and her arms started to swell, she had chills, felt cold, had elevated fever to 99 Fahrenheit, and felt tired. She inquired if she would continue to experience the side effects until her second dose schedule. The clinical outcomes of arms started to swell, she had chills, felt cold, had elevated fever to 99 Fahrenheit, and felt tired were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to a male patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patient was vaccinated with (oka/MERCK) VARIVAX lot # K001389 expiration date 29-JAN-2016, dose 0.5 ml, route subcutaneous. The reporter stated that on an unknown date after 2 to 3 days, the patient was vaccinated with (oka/MERCK) VARIVAX the patient developed significant erythema and induration, pain at the injection site and macular vesicular rash. The reporter also stated that the patient had a single chickenpox lesion. The patient was taken to an unspecified emergency room where he received unspecified antibiotics for possible cellulitis and BENADRYL. The physician mentioned that the patient was still experiencing some of the reported symptoms. The outcome of significant erythema and induration, for possible cellulitis, he has a single chickenpox lesion, macular vesicular rash and pain at the injection site was reported as not recovered/not resolved. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
ITCHY RASH ON STOMACH TO RIGHT SIDE UNDER RIBS AND BREASTS AND ON RIGHT ARM ON THE TOP TO HER ELBOW/ ITCHY DOTS ON ARM; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 02-OCT-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced itchy rash on stomach to right side under ribs and breasts and on right arm on the top to her elbow/ itchy dots on arm. Treatment medications (dates unspecified) included: hydrocortisone, and calamine/glycerol/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rash on stomach to right side under ribs and breasts and on right arm on the top to her elbow/ itchy dots on arm. This report was non-serious.
The actual injection itself was so painful that I almost passed out. It hurts so badly while the needle was in my arm and when she took it out it was worse. I was in such pain that I began to sweat profusely and apparently I turned white and began dry heaving. This was all within a minute or so.  I really thought I was going to pass out. A woman with a tag that said pharmacist came rushing over. She got a reclining chair with wheels, they help me into it and then took me to a recovery room. After a few more minutes of sweating and dry heaving I began feeling better.  The pharmacist got me some paper towels so I could dry myself off as I was drenched in sweat. I asked her for a bottle of water. I waited the 15 minutes and came home.  They never checked my vital signs. Once I got home, I laid down and slept for 15 hours. I was fine the next day and my arm was never sore.  Could  the shot have hit a nerve? I?ve never felt such acute pain.
Mild headache; Mild fatigue; Didn't mix the vaccine properly / thinks I didn't get the proper vaccine; Didn't mix the vaccine properly; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced headache, fatigue, inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the headache and fatigue were recovered/resolved and the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, next day after vaccination, the patient experienced mild headache and mild fatigue. The reporter stated that, the pharmacist did not mix the vaccine properly and thought that did not the proper vaccine, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
little fatigue; sore arms; Initial information was received on 07-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown demographic) patient who experienced little fatigue (fatigue) and sore arms (pain in extremity) when received vaccine INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious little fatigue (fatigue) and sore arms (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I initially went in to get my flu shot and to schedule my booster shot for the following week. My pharmacist said I could get both at the same time so I went for it. Other than a little fatigue and sore arms, I was fine."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.