chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was received from 15Aug2023 to 20Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient received 0.5mls of shingrix into left deltoid.  Patient immediately complained of painful infection and then slumped in chair while still conscious.  Patient stated did not feel well. Asked patient if she was aware of her location with no answer.  Repeated questions were not acknowledged.  Asked patient about medical conditions (heart condition, diabetes, ect) Patient looked at me at one point and stared blankly at me for 15-20 seconds.  Answered after long pause has had issues with fainting after vaccines before.  Patient proceeded to have additional multiple periods of blank staring.
Patient received her Vaccination today. She reported dizziness and foggy head feeling and felt like her BP was high at 0520 pm.  She has h/o HTN which is controlled as per pt with medication as noted in her records. Pt has taken her BP today as well. Pt denied headache, nausea, vomiting, abdominal pain, rash, shortness of breath, chest pain, dysphagia, wheezing.  Pt was monitored for over 30 mins given her recorded allergies in past  VS checked at 0520 pm:BP: 129/76 HR: 76 sats : 100% VS checked at 0535 pm: BP: 121/72 Hr: 73 sats : 100% Pt remained stable and reported that her sx have improved and left in stable condition at 0535 pm.ER precautions given to pt - if her sx worsen or new sx start which were discussed with her she will need to go to nearest ER or call 911.
Vertigo and tinnitus occurred day after 1st vaccine. Was improving when I received second and then got much, much worse
Immediately after injection, patient fainted. She came to within a minute. Gave her a beverage and she seemed fine.
Injection 3 days ago in right anterior thigh. Next day, increase in redness and swelling; began yesterday. No fever. Complains of tenderness with walking and touching spot.
FEVER HIGH PITCHED SCREAMING UNTIL ABOUT 4:00 AM.  TYLENOL GIVEN PER DOCTORS INSTRUCTIONS.
Exercised. Racing heart for extended period following exercise - approx 40 bpm higher than normal.
Patient present to ECC with 2 day history of diplopia, dysequilibrium, headache, bad taste in mouth, upper extremity paresthesias and weakness, vertigo/dizziness.  Determined to have acute diffuse ocular motor palsy.  Over several days/weeks his ataxia an paresthesias worsen. Progression to worsening weakness, unable to open eyes, difficulty swallowing, descending paralysis. Many differential diagnosis ruled out via consult, lab work, imaging and physical exam.  Determined to have the Miller-Fisher variant of Guillain-Barre. Treated with plasmapheresis x6 treatments. Symptoms improve but patient continued to have issues with vision, speech, swallowing and weakness. Send to rehab for intensive physical, occupational and speech therapy. Patient continued to improve and was sent home to continue outpatient rehab. 1/15/08-records received for DOS 11/5-11/23/07-DC DX: Miller Fisher syndrome with ophthalmoplegia/ataxia/dysphagia. Presented to ED on 11/2/07 with C/P diplopia and ataxia.  Flu shot 10 days prior to onset of symptomalogy. After admission symptoms worsened and developed ophthalmopelgia, difficulty swallowing and clearing his secretions.  PEG placed.
Developed a pea size ganglion cyst in the left hand. My vaccine shot was always administered in my left arm.
Pt. developed  fever of 102.2 and was irritable later in the day after receiving vaccines.  Fever lasted 4 days and pt. was very irritable and inconsolable for most of the 4 days.
My "shot arm" (left, above elbow, underneath my arm on soft skin) felt like a string of sore defined nodules  (raised lumps) were rotating between fire and ice; My "shot arm" (left, above elbow, underneath my arm on soft skin) felt like a string of sore defined nodules  (raised lumps) were rotating between fire and ice; Under my arm from elbow to half way up that under-arm was so extremely sensitive.; This is a spontaneous report from a contactable other Health Care Professional. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 09:30 as 2ND DOSE, SINGLE for covid-19 immunization. Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EN6198 and Expiry date: Unknown) dose 1 via an unspecified route of administration, on 06-FEB-2021 for COVID-19 immunization. Medical history included allergy to arthropod sting from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not received any treatment and was not diagnosed with COVID-19 since the vaccination, the patient had not been tested for COVID-19 as well. Concomitant medication included trazodone taken for an unspecified indication, start and stop date were not reported. On 01Mar2021 16:30 the patient experienced  "shot arm" felt like a string of sore defined nodules were rotating between fire and ice, under arm from elbow to halfway up that under-arm was so extremely sensitive. It was reported that, first shot on Saturday, 06Feb2021 at 1:45 pm, she had no adverse effects. Second shot on Saturday, 27Feb2021 at 9:30am, she had one adverse event on Monday, March 1 (52 hours after second shot) from 4:30pm until patient went to bed/sleep at 10:30pm. My "shot arm" (left, above elbow, underneath my arm on soft skin) felt like a string of sore defined nodules (raised lumps) were rotating between fire and ice, like someone had beat me up there only, like  must surely be black and blue there but was not. Under my arm from elbow to half way up that under-arm was so extremely sensitive. Patient did not take any RX for it or put on an ice pack, so she was really grateful to be able to sleep. Symptoms did not cause her to awaken and were mostly gone when she woke up in the morning, she could feel the nodules but there was not much sensitivity or pain at all. The outcome of event nodule was not recovered and other events were recovered.  No follow-up attempts are possible. No further information is expected.
No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11.  This continued for two weeks with increasing symptoms of loss of appetite, nausea, abdominal pain, tingling sensation on scalp before going to ER.  Visited urgent care on June 16 and bloodwork results indicated elevated white blood cell count and eosinophil count.  There was a question as to whether patient had been subjected to a tick bite, so doxycycline was prescribed.  After several days, patient returned to urgent care for follow-up bloodwork (June 20th).  Results showed WBC and eosinophil count continued to escalate.  He went to ER on June 25th and was admitted to the hospital for 5 days.  During his visit at Hospital, he was seen by a team of specialists:  cardiologist, pulmonologist, hematologist, infectious disease doctor.  Multiple tests were run, as the doctors started broad to eliminate certain diagnoses - i.e., bone marrow biopsy, heart cath, CT scans, x-rays, thoracentesis, etc.  Patient had fluid around his heart and lungs and was diagnosed with myocarditis.  He had no previous heart issues nor family history of heart issues.  Test results indicated no abnormal  blockage or other issues, other than inflammation and his heart strength was at 27%.  I am unable to access his account, as it was disabled after his death.  An autopsy is being performed and results are pending; however, the question(s) at large:  what was the condition of his heart at the time of his death and was this vaccine-related?  Did his myocarditis get worse?  Did his heart muscle weaken further and rupture?    Please let me know if the autopsy results are needed and where to send them.
This case was reported by a other health professional and described the occurrence of expired vaccine used in a 29-year-old male patient who received BOOSTRIX (batch number AC52B094AA, expiry date 8th November 2014). On 24th December 2014, the patient received BOOSTRIX. On 24th December 2014, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided. Answers to seriousness criteria questions was no to all. Called indicated there was nothing abnormal with the administration of the product except that the product was expired.
Shortness of Breath; This non-serious case was reported by a physician via sales rep and described the occurrence of shortness of breath in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shortness of breath (Verbatim: Shortness of Breath). The outcome of the shortness of breath was resolved.   It was unknown if the reporter considered the shortness of breath to be related to Shingrix.  It was unknown if the company considered the shortness of breath to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter called to report an adverse event for her healthcare professional that she learned of at close of day yesterday.  The reporter reported that the healthcare professional stated that one of her patient received a Shingrix vaccine and after he left the office, he experienced a lot of shortness of breath. The reporter said that the patient drove himself to the ER where he was checked out and was fine (No other information was known). Minimal information was available. The reporter consented to follow up.
I woke from sleeping that night very very hot and with excruciating aches and pain in my body: hips, neck, shoulders, arms. I took Tylenol. At 6am I got up and was very dizzy. I had a bath to reduce the pain.  Dried off and blacked out. I awoke a few minutes later on the floor with a concussion which I am still not recovered from.  I do not know if there will be permanent damage.
Woke up to severe chest pain, then vomited. Appeared to be extreme gas buildup in my chest.
Redness and swelling and soreness - went to ER. Prescribe CLINDAMYCIN - 450 mg TID.
INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1822809 expiry: UNKNOWN) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 11-JAN-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649045, 20220649137, 20220649417, 20220649488, 20220649421, 20220649626, 20220649704, 20220649804, 20220649915, 20220649804, 20220649803, 20220649884, 20220650014, 20220650111, 20220650014, 20220650185 and 20220650111. This report was associated with product quality complaint: 90000237043.
Covid positive 1/29/21.  2/1/21, hypoxia, tachycardia.  Admitted to hospital 2/1/21.  Diagnoses:  UTI, Covid-19 infection, hypoxia, sepsis.
Fever, fatigue starting 9AM.  Tylenol taken at 4PM.  Fever broke at 7PM.  No further fever
Per telephone call from the child's mother; on 1/8/01 the pt was seen by MD and received OPV, DTAP, Hib and Hep-B. Mother called the health dept "a few days later concerned that #3 Hep-B had been given before 6 months of age. Was advised that it would need to be repeated after a 2 month interval. Does not recall who she spoke with. On 1/31/01, the pt was seen by MD for a fine rash with fever and was told it was viral. On 2/1/01, the pt had a very brief period where eyes rolled back and child was unresponsive. On 2/2/01, he had a recurrance of the same and was seen by MD. On 2/3/01, he had a recurrance of the same followed by an hour later by a grand mal seizure. Called 911 and was taken to the hospital ER and was admitted to the hospital for 3 days; 2/3/01 through 2/6/01. He had 2 more grand mal seizures while in ER. Had a fine red rash all over his body and a temperature of 100.3F (ear). He was started on Phenobarbital in the hospital which the mother elected to discontinue after child's discharge from the hospital. On 2/28/01, he had 3 more grand mal seizures and was seen at ER; he had a rash then too. Has had no further seizures since restarting on Phenobarbital on 2/28/01. Has been well except for minor URI, which resolved without incident.
Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous report from a contactable nurse.  A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 02Jan2021 16:00 at single dose for COVID-19 immunisation.  Medical history included COVID on an unspecified date. The patient's concomitant medications were not reported.  The patient stated, "fever, fatigue, uncontrolled headache, eye pain, chill, joint pain. nausea. Get more worst and worst". The patient received treatment. The outcome of the events was not recovered.
Hives; Chest tightness; Pulse elevated; Low grade fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 25Jan2022 07:00, outcome "not recovered", described as "Hives"; CHEST DISCOMFORT (non-serious) with onset 25Jan2022 07:00, outcome "not recovered", described as "Chest tightness"; HEART RATE INCREASED (non-serious) with onset 25Jan2022 07:00, outcome "not recovered", described as "Pulse elevated"; PYREXIA (non-serious) with onset 25Jan2022 07:00, outcome "not recovered", described as "Low grade fever". The events "hives", "chest tightness", "pulse elevated" and "low grade fever" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria, chest discomfort, heart rate increased, pyrexia.  Additional information: No known allergies reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications patient received within 2 weeks of vaccination. Since the vaccination, patient has not been tested for COVID-19. Patient had hives chest tightness pulse elevated for over 2 weeks low grade fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient fainted while sitting next to her mother after vaccine administration. Patient was unconscious for about 5 seconds in her mother's arm. Patient came to again quickly. No treatment was necessary. Patient stated that she faints after all vaccines before the vaccine was administered so staff and mother were ready to deal with the situation
Case previously recorded as MA2009-5165. Initial case report received from a physician via agency on 19 NOV 2009. 2-year-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 NOV 2009. No adverse events were reported. Agency reference no.: NA09-008308.
Pt. received Gardasil vaccine on 10/29/2007 at around 8:30 a.m.  Also received Plan B oral medication at the same time.  There was not adverse response to the immunization.  Patient returned to clinic this morning (10/30/2007)complaining of feeling extremely weak, having body aches and having some diffuse mid-sternal chest pains.  Patient stated these symptoms came upon her fairly quickly the previous night (10/29/2007) about 12 hours after the immunization.  She took 2 Tylenol without body-ache relief, and 2 more Tylenol this a.m. without relief.
Rash developed on upper chest, underarms, forearms, under breasts,  stomach, and  pelvic area over a period of three days, progressing  in area coverage and intensity of itchiness.  Physician diagnosed it as "old age skin" problem, recommended using Eucerin lotion to hydrate skin. Did not prescribe any medications and said it was not related to the Covid vaccine, since the rash  took a week to appear after the second dose.
Patient claims arm pain from rotator cuff down into fingers. Patient reported adverse event on 12-13-13 (9:30 AM approx).
After having bad reaction to 1st vaccination, I took Tylenol and went to bed early - about 10PM - before feeling any adverse symptoms. I woke up at about 4AM to use the bathroom and felt my whole body hurting like the last time.  I took more Tylenol and went back to sleep. I slept til about noon and when I got up then, everything hurt terribly. This time more pronounced in back of neck than the last time; could not move head to look up. Also tremendous pain in  left hand area of thumb and right heel of hand. All pain continued until evening, then mostly subsided - except for the hand pains; I definitely still have those though not as bad as they were. (P.S. I've had occasional Herpes cold sores since the 80's  (rarely)  - but since I had Covid in December 2019 and/or the vaccines, I have had 8 outbreaks, one after another (I have one now).
Starting the day after receiving the vaccine, I developed a swollen lymph node around the left clavicle. It became really large and I ended up calling my PCP. They said given my history of allergies and asthma, and research regarding the vaccines, they said to monitor it and if it doesn't get better in a few days to call and make an appointment. It eventually got better on its own.
Information has been received from a consumer concerning her son who in approximately March 2006, at 15 months of age, was vaccinated with the first dose of MMR. There was no concomitant medication. The patient experienced high fever about 7-9 days after vaccination. The patient's symptoms included fever of 104-105f for 3 days. The patient sought medical attention. At the report time the patient fully recovered. Additional information has been requested.
On left side of face: Cheek heavy . Numbness and heaviness down the cheek to the jaw around the ear and top of the neck on the side, left side.  Left side Jaw aches like the numbness is trying to come back from a dental shot of novocaine. Been like this for over an hour no signs of letting up just continues. Left side of back shoulder blades feels heavy, and aches and warm from back of the shoulder to the shoulder blade, this happen within 20mins from the shot  and hasn't let up.  The neck down the back of the ear feels really numb and slightly swollen. No signs of dizziness or brain fog but the numbness really aches and continues with no signs of letting up.  Top of should hurts too, small ache then it occurs in front above the breast then the shoulder like a drum beat then stops for a while.
Developed shingles with symptoms starting on 1/10/21 including lesions along dermatome T5, neuralgia, and fatigue.
Red rash mostly under right eye, but small place under left eye as well. Does not hurt or itch, just swollen and red. Also developed a fever blister/cold sore on upper lip at the same time. It's been about 23 days since first shot and I still have the rash under my right eye, but cold sore is gone. Did not see doctor. Treated cold sore with Blistex and just put vaseline on rash at night.
Patient developed urticaria at vaccination site and on arms, legs, and head. Hives resolved spontaneously within 2 days of both vaccinations.
My arm started aching right away,then my left arm too. The following day I had flu like symptoms,achiness,extreme fatigue,slight fever. Felt better the next day,just a bit run-down. I woke up around 3am the morning of the 27th very nauseated and aching all over,could not go back to sleep. Slept most of the day and felt better,just residual aches in my arms and shoulders.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-SEP-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Mild headache, at temples and mid-forehead (no analgesic needed or taken), a few hours in duration. Began approx 4 hours after administration; noticeable partial recovery within 4 (more) hours; complete recovery a few hours later (by the time I went to sleep). At all notable only because I so VERY rarely get random headaches and despite being specifically advised of the possibility by the vaccine administrator, I really didn't expect it given my general lack of susceptibility to them.  For completeness' sake, I'll also mention the mild discomfort in my left deltoid muscle upon exertion but not at rest (not specifically at injection site), but with no visible or palpable inflammation, starting about 3 hours after administration. Slight increase in severity and slight spread in area of discomfort over the next 8 hours or so; further increase upon waking the next morning, but which dissipated quickly with use of the arm. (Complete recovery within 24 hours, with no "treatment" other than minimizing use of arm.)
pt c/o soreness, limping, cold touch; pt not moving arm; involuntary movement of arm;
Fever of 102. 0 (reported via patient). Left arm pain/shoulder pain. Mild nausea (intermittent).
Hives withiin 24 hrs of vaccination. Treated with OTC Benadryl, and resolved within 24 hours.