chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness/Body aches; Feverish; Chills; Fatigue; This is a spontaneous report from a contactable consumer (non-healthcare professional reporting for a patient). A 59-year-old male patient received BNT162B2 (COVID 19, Pfizer BioNTech, Solution for injection) via an unspecified route of administration, administered to his left arm on 05Mar2021 01:30 PM (at the age of 59-year-old) as single dose for Covid-19 immunisation. The patient's medical history included blood pressure. Other medications in two weeks: blood pressure, anti-acid. No known allergies. No Covid was tested prior or post vaccination. The patient previously took BNT162B2 (Pfizer BioNTech) to his left arm on 13Feb2021 as single dose for Covid-19 immunization (other vaccine in four weeks). On 05Mar2021 03:30 PM, the patient experienced soreness, feverish, chills, body aches and fatigue. The patient did not receive any treatment in response to the events. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Covid vaccine clinic was held at elementary school, March 10, 2022.  Pt received his 1st vaccine on 1/4/2022, 2nd vaccine on 2/22/2022, and  third booster on 3/10/2022.  Spoke with the patients school nurse she reported that pt has not experienced any adverse reactions while in school at this time. Spoke with the pt's father he denies any Covid symptoms ex:( SOB, chest tightness, blurred, vision, chest palpitations, headache, fatigue) at this time. Provided father with number to contact and report any adverse reactions, father verbalized understanding.
Nausea, headache, fatigue, pt. states gets "dehydrated quickly"-all symptoms x 10 days.
Pain at injection site, muscle pain across shoulders involving previously stressed arm on opposite shoulder 24-36 hours after injection, muscle pain occurring in arm of original site of injection beginning 3-4 days after injection.  Pain was severe enough that it precluded sleep.  It tapered off beginning several days after onset.  At this time, a week after injection, pain is still quite noticeable and not responding well to acetaminophen.
1st dose I had a sore arm the first couple days but very mild I didn't take anything.  I had a lot of pain and tenderness on my left upper chest, outer breast notable swelling and lumps. Above my armpit I had pain there as well, I had a lump in my outer breast area.  This lasted about a week, but the lumps stayed and I could feel just a little bit.  Three weeks after the symptoms they sent me to an ultrasound  and it was a lipoma and I did  do breast imaging that came back negative.  I did start taking  OTC Ibuprofen with some of the pain and it got better.  I did see a Dr and he felt they were Lymph nodes.   Second dose:  I had similar symptoms to the first dose ad flu like symptoms.   I never ran a fever but was taking medicine. With in 24 hours it did resolve. I did get pain in my armpit, like a goose egg and it has gotten smaller but still there. If they don't go away I will see the Dr.
Patient reported red face on right side and large amount of heat feeling.  This lasted 2 days and then she reports that her left arm got a lump in the armpit area and was hot the touch.  Patient reports fever the day after shot, but did not get a reading.   Then she reported that swelling  just above the left elbow with a roughening of her skin in that area and redness as well.  She reports that the lumps did not go down for about 1 week .  Patient also reports diarrhea starting the day after the shot and continuing until 8-24-21.  Arm is still sore at the time
Woke up next day with beginnings of redness in the right leg, by the afternoon, it was twice the size in redness and hard to the touch.
Positive for Influenza type A after Flu vaccine on 09/28/2013.
p/vax pt exp rt leg became swollen to twice the size of nl; hives appeared on bilateral lower legs; lower grade fever of 99.6; seen @ hosp by MD;
Syncope after injection only.  Recovered.  Pt has hx of syncope with fear of needles
Pt received 2 doses of Pfizer Tot monovalent vaccine, prior to this visit with last dose on 10/20/22. Mom informed that the clinic they went to before, reported they ran out of that vaccine and unable to finish primary series there. Our facility only has Moderna Tot bivalent boosters available for this age group, and do not carry the Pfizer Tot bivalent booster. Pt was given the Moderna Tot bivalent booster at today's visit, and they left before assessment at 15 minutes post injection.
Information has been received from a physician concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL. The physician reported that a month after the patient received GARDASIL, she still had pain at the injection site. No treatment required. At the time of the report, the patient had recovered. The patient sought medical attention. Additional information has been requested.
This spontaneous report was received from a healthcare worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL lot # K023432, expiry date 18-JUN-2016 (dose, strength, route, dose numbers, vaccination site unspecified). The previous temperature excursion was reported at a temperature of 34 degrees F for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
SHE EXPERIENCE TIGHTNESS IN HER CHEST AND LIGHTHEADEDNESS 10 MINUTES AFTER VACCINATION. OUR ONSITE EMS WAS REQUESTED. NO VITALS PATIENT REFUSED SAID SHE WAS FEELING BETTER. STATED SHE TOOK HER MEDICATION THIS MORNNG AND DID NOT EAT BREAKFAST BEFORE HAND. PATIENT HAD A B-12 INJECTION 3 DAYS PRIOR TO VACCINE AND FLU VACCINE APPROXIMATLY 2 WEEKS BEFORE. NO RECORD OF FLU VACCINE IN MICR. HER SYPTOMS RESOLVED AND PATIENT WAS RELEASED TO GO HOME.
Received vax on 3/17/03. Mom reported child felt "warm" around 3:00 on 3/18 then witnessed to have generalized tonic ?? seizure lasting approx 2 mins. Brought to ED where work up (-) including CT brain. Thought to be febrile seizure.
Sore arm where the shot was; sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm where the shot was) and ARTHRALGIA (sore shoulder) in a 91-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm where the shot was) and ARTHRALGIA (sore shoulder). At the time of the report, PAIN IN EXTREMITY (Sore arm where the shot was) and ARTHRALGIA (sore shoulder) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-440044, MOD-2022-443499 (Patient Link).
Soon after sitting down after vaccination, PT reported feeling pain in her lower sternum area. She said it was like heartburn. She denied any other discomforts. Nurse checked her vital signs: BP 163/83, Pulse 125, Pulse Ox 99%, T 98.3F. Nurse offered her to a gurney but PT preferred sitting. Vital signs at 11:57AM 118/93, Pulse 83, R 16, at 12:08 BP 142/101, Pulse 80, at 12:14 BP 121/68, Pulse 83. PT continuously converse with nurse and other staff at the Center without showing signs of difficulty breathing. She denied having tightness in her chest or throat. She walked out of the Center at 12:20PM stating that her husband and son were waiting in the car. Nurse recommended her to continue monitor her symptoms and consult her pcp as needed.
Two hours after flu vaccine her eyes became red, watery with thick mucous from eyes. Eyes and face became swollen and she had flu like symptoms with cough. These symptoms continued through the night. She took ALEVE at 1 pm on 10/28/13. Today she awoke with eyes and face swollen, but not as bad as yesterday. She took ALEVE at 09:00 am. Above reported to nurse on 10-29-13 at 08:50 am.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The registered nurse reported that an unspecified number of patients were administered an unspecified number of doses on unspecified dates of GARDASIL (lot#, expiration date, dose, strength and route not reported) that were improperly stored. No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Rheumatoid arthritis flare up; This is a solicited report (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-4111476-00).A contactable consumer (patient) reported for herself. Solicited report from a consumer of an adult female with an event of non-serious Rheumatoid Arthritis flare up with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Rheumatoid Arthritis flare up. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The patient received 1st dose Covid-19 Vaccine manufactured by Pfizer via intramuscular on an unspecified date at single dose for COVID-immunization. The outcome of event was not recovered. Causality between event Rheumatoid Arthritis flare up and bnt162b2 per reporter was possible. Causality between event Rheumatoid Arthritis flare up and Adalimumab per reporter was not reported.  No follow-up attempts possible, information about batch number cannot be obtained. No further information expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported event..  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Upset stomach; Nausea; Mild headache; This is a spontaneous report from a contactable nurse reporting for herself. This 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) on 22Dec2020 14:25 at a single dose intramuscularly in the left arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT).  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced upset stomach, nausea and mild headache on 23Dec2020. The events were non-serious, no treatment received for the events. The patient was recovering from the events.
Pt. had shots 8-9-10. Mother called 8-11-10 stated child not running temp > 99 degrees has knot (area size of quarter) still fussing cold pack wasn't tolerated, Ibuprofen doesn't seem to help. Going to try TYLENOL. Told if any changes call Doctor's office. Called spoke with grandmother on 8-12-10 knot gone child no fussing. Told to call with any questions or concerns.
Starting at 9:00pm (approximately 6 hrs after vaccination) I experienced:  Sudden exhaustion at end of day, lasting 24 hrs Chills/shaking for about 3 hrs Mild headache for 24 hrs Body aches, especially lower back pain, lasted 24 hrs Frequent urination (3 times) throughout the night  Increased thirst, 2 days Wobbliness/loss of balance 18 hrs (worst symptom for me) Feverish symptoms (sweating but cold), 24 hrs
Provider discharge summary "Brief Summary of Hospital Stay: ( Sepsis 2 to combination of covid+ aspiration pneumonia  resolved   Covid pneumonia( pfizer x2 received) -clinically improving and stable after 3 days IV remdesvir and decadron with rx for likely aspiration pneumonia. Oxygen needs are decreasing and he is eating, up walking looks and feels better.   Active Problems:    Aspiration pneumonia Patient was clinically aspirating on arrival he improved significantly with tx for covid, IV hydration and Zosyn. He is AO and discharged on Augmentin    Acute metabolic encephalopathy resolved    AKI superimposed on chronic kidney disease, stage III resolved   HyperK, hyper Na/CL-dehydration resolved   Schizophrenia restart PTA medications   Urinary tract infection Pseudmomas zosyn-augmentin 7 day tx   Diabetes mellitus start diet, Lantus 20 HS monitor pt of care   Hyperkalemia resolved   Metabolic acidosis resolve   Patient is Alert, conversant, pleasant VSS tolerating diet with baseline physical exam."
proquad improperly stored and administered/ -14 C for 35 h 43 minutes; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.     On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recoant Human albumin (rHA)(PROQUAD) lot # U002535, expiration date 24-JUL-2022 (dose and route of administration were not provided)  for prophylaxis. The dose was improperly stored in temperature excursion of -14 degress Celsius for 35 hours and 43 minutes. There was no previous temperature excursion. Data logger was involved.  The report is linked to MARRS # 2106USA001746, received from the same reporter.; Sender's Comments:  US-009507513-2106USA001746:
Ever since I got the COVID vaccine I have been having blurry wavy vision that makes my head hurt. My first dose was 4/5 and second was recently on 4/26. It has happened 4 times since the beginning of the month.  It starts off with waves and blurs and then gives me a massive migraine. I cant see straight when this happens and get bad brain fog. I have to chug water and take 800+ mg tablets of migraine relief to make it better, but it takes a good 2 hours to feel any better at all.  I have NEVER had this issue before or have a history of migraines.
Patient came in and said his arm is still sore. It started the day after getting the flu-shot and has continued. Suggested the patient try ibuprofen for the pain.
Patient was not given his usual Concerta am dose. He was giggly, had a "drunken" gait and erratic behavior. After eating his behavior was normal for him. Later in the afternoon during PE he again has a similar gait when escorted to the nurse's office but when held by a staff person he had full strength in all extremities to attempt to get away from her.  Physical exam in this office was normal. He spoke clearly.
p/vax pt devel memory loss, lesions that turn into moles all over body (neck to legs), pt states no sunbathing, gray outs x 45min, numbness in joints, tingling on arms, & constipation;pt tired & irritable d/t insomnia;earache;migraine;
STROKE OCCURRED AT 11:30 ON TUESDAY NIGHT. WE DIDN'T RECOGNIZE SYMPTOMS UNTIL 3:00 AM WEDNESDAY MORNING WHEN HE WAS TAKEN TO HOSPITAL .  SLURRED SPEECH, UNABLE TO GET UP, DROOPING MOUTH.
Headache, Myalgia, Fever, NauseaVomiting, chills Narrative:  Other Relevant History:
I experienced many adverse side effects from the 1st Moderna dose, but the most serious and long-lasting was the aggravation of my long-term cardiac symptoms that I developed after my COVID infection in April 2020. However, I will list all relevant symptoms and their duration.  1. Intensely sore arm; arm had to be immobilized (onset: 5h after shot; duration: 48 hours) 2. Nausea and loss of appetite (onset: 8h after shot; duration: 48 hours) 3. Fatigue requiring bed rest (onset: 8h after shot; duration: 72 hours) 4. Fever ranging from 99F to 102F (onset: 10h after shot; duration: 48 hours) 5. Violent chills, preventing normal movement and activities (onset: 11.5h after shot; duration 6h) 6. Pounding headache (onset: 12h after shot; duration: 72 hours) 7. Dizziness and loss of balance (onset: 20h after shot; duration: 5 days) 8. Mild fatigue requiring reduction in daily activities (onset: 72h after shot; duration: 10 days) 7. Tachycardia and heart palpitations (onset: 24h after shot; duration: still continuing 3 months later)  Specifically, my heart symptoms are characteristic of POTS: my heart pounds whenever I lie down or stand up, with the abnormal sensation continuing for many minutes at a time (sometimes preventing sleep). My heart also races abnormally during exercise or stress. Furthermore, I occasionally feel irregular palpitations and chest pain. I first developed this dysautonomic pattern shortly after contracting COVID-19 (confirmed by 2 PCR tests) on April 13, 2020. At that time, my cardiac symptoms persisted for about 8 months, until November 2020, at which point they seemed to fully resolve. The 1st Moderna shot in April 2020 made all my cardiac symptoms reappear and persist. For that reason, I declined the second shot.   I wish to note that I have never had any prior cardiac problems, nor have I ever been diagnosed with anxiety or other mental health conditions. Prior to contracting COVID, I was a completely healthy marathon runner and triathlete.
From provider: Patient with hypertension. 5 mn post vaccination. Pt c/o throat tingling and palpitations.  Initial examination lungs CTA, mild tachycardia.  Pt moved to observation area. Initial vitals: 158/94, 78, 99% 07:55 Benadryl 25 mg po given Approximately 3 mn post benadryl pt began getting facial edema, oropharyngeal edema and feeling faint.  EMS notified and Epi pen injection given. 7:59 911 called. 8:08 vitals:147/80, 76, 100% Pt continued to have facial edema and increased oropharyngeal edema and began to faint.  Pt placed on stretcher and 2nd epi pen given at 08:05 Post 2nd epi pen, patient with decreased facial edema and oropharyngeal edema.   patient tansported Via EMS TO ED.
sore throat; Viral fever; Viral fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization.  The following information was reported: VIRAL INFECTION (non-serious) with onset 30Sep2022, outcome "recovered", described as "Viral fever"; OROPHARYNGEAL PAIN (non-serious) with onset 30Sep2022, outcome "recovered", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient clarified that the patient was her son who was almost 4 years old. She clarified that he got 2 doses of Pfizer Covid-19 Vaccine. He was scheduled for his 3rd dose of Pfizer Covid-19 Vaccine on 28Sep2022, but they canceled that by mistake so he missed that dose; not because of patient's sore throat as provided by inbound transfer agent. He was then supposed to go on 30Sep2022 to get the third dose of Pfizer Covid-19 Vaccine; but that was the day he started having symptoms so they cancelled that dose because of his symptoms. They were afraid his symptoms were COVID, but they weren't. They tested him for COVID and strep throat, and it wasn't COVID, it was a viral fever. The patient has now been over 48 hours with no fever or symptoms and is negative for COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt developed w erythema, and swelling. Area warm to the touch. Knot present at injection site. The affected area w erythema and redness measured at 7.0x 8.5 cm. Tenderness to the touch.
Fever 101.2F, wet cough, low appetite, rash on face, right jaw, lungs clear, maculopapular rash on trunk-viral exam, cellulitis right ear.
DECREASE IN RANGE OF MOTION OF  RIGHT ARM; DIFFICULTY SLEEPING; ARM SORE / PAINFUL RIGHT ARM; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced decrease in range of motion of right arm. On 20-MAR-2021, the subject experienced difficulty sleeping. On 20-MAR-2021, the subject experienced arm sore / painful right arm. On APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore / painful right arm, decrease in range of motion of right arm, and difficulty sleeping. This report was non-serious.
Muscle pain; joint pain; nausea; Headache; weakness; fatigue; injection site pain; flu like aches; Pains; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Pfizer6207) via an unspecified route of administration in the arm left on 05Apr2021 at 13:15 (at the age of 63-year-old) as dose 2, single for COVID-19 immunisation. Medical history included Known allergy: penicillin. Concomitant medications included buspirone, omeprazole and escitalopram. The patient previously took zithromycin and experienced stomach cramps. The patient also took amoxicillin, and experienced drug allergy. The patient received first dose of BNT162B2 on 16Mar2021 at 12:45 (lot number: EN6202, Location: left arm) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Apr2021 at 12:00, the patient experienced muscle pain, joint pain, nausea, headache, weakness, fatigue, injection site pain, flu like aches and pains. No therapeutic measures were taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office, or clinic visit and emergency room or department or urgent care. The outcome of all the events were resolved on Apr2021. No follow-up attempts are needed. No further information is expected.
3 days after the shot I broke out in hives on my torso only.  I tried to use benedryl and calamine lotion to ease the symptoms to no avail.  The hives lasted almost 4 months.  I did not have insurance at the time and did not go to a medical professional or hospital. I have had hives before as I am allergic to other medicines and know the symptom and how to resolve.
Within two minutes of receiving the injection, my heart rate increased and my chest became tight.  The heart rate lowered, but the chest remained tight for multiple days, though lessening.   Because there was no pain associated with it, I continued my normal activities and assumed it would return to normal.  On the night of 04/26/21, I had palpitations the prevented sleep, needing to sit up to lessen them.  This continued on subsequent nights and not having a primary care doctor, I went to the emergency room on 04/30/21.  I was able to have an appointment with a primary care doctor on 06/10/21 and a cardiologist appointment on 06/17/21.
Red, warm area over left deltoid (site of injection) observed at 48 hrs after inj. Advised parent to treat with Benadryl if worsens or itches.