chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In October 2021, the patient experienced COVID-19; ln Jul2020 and Oct2021, the patient experienced COVID-19; felt fatigue; horrible back pain; In 2021, she received booster dose of COVID-19 Vaccine manufactured by Pfizer and Biontech; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4203287-00 (Agency).  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster ), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, cf for rheumatoid arthritis. Relevant medical history included: "COVID-19", start date: Jul2020, stop date: Jul2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Patient route of administration: Intramuscular), administration date: 05May2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (2nd Dose, Patient route of administration: Intramuscular), administration date: 26May2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "In 2021, she received booster dose of COVID-19 Vaccine manufactured by Pfizer and Biontech"; COVID-19 (medically significant) with onset Oct2021, outcome "recovered" (2021), described as "In October 2021, the patient experienced COVID-19"; DISEASE RECURRENCE (medically significant) with onset Oct2021, outcome "unknown", described as "ln Jul2020 and Oct2021, the patient experienced COVID-19"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt fatigue"; BACK PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "horrible back pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. The action taken for adalimumab was unknown.  The reporters causality for the event(s) of felt fatigued and horrible back pain with Humira (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Covid-19 onset in July2020 and COVID-19 onset in October2021 was not provided. The reporter's causality for the event(s) of felt fatigued, horrible back pain and Covid-19 onset in July2020 and COVID-19 onset in October2021 with Pfizer Biontech Covid-19 Vaccine was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events fatigue, back pain, Covid 19, immunisation and disease recurrence and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101837470 same patient, different dose/event
Headache, UrticariaPruritus & NauseaVomiting  Narrative: Pt took diphenhydramine and hives resolved
Nurse reports VARIVAX administered after a temperature excursion; This spontaneous report was received from a licensed Practical Nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 28-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (route of administration not reported), lot # T024281 and expiration date 15-JUL-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 7.1 degree fahrenheit (°F) for 59 hours and 45 minutes on an unknown date; no previous temperature excursion were reported.; Sender's Comments:  US-009507513-2102USA000364: US-009507513-2102USA000622: US-009507513-2102USA000838:
Patient reported repeated episodes of dizziness while in observation. Vitals: 115/66, 65, 18, 100%; 118/70, 65, 18, 100%. Patient administered ammonia inhalant (taken to lay down); and symptoms resolved. She denied dizziness, but had a headache and "something felt stuck in her throat." Vitals stable. Patient sat up; color good; A&Ox3 and talking. Patient stable and released from the vaccination site.
fever, sore arm at site, flu-like symptoms for 32 hours following the vaccine  Today (7/6/21) I have dry mouth, dry eyes, sores on torso, tender thyroid, cracking skin, constant metallic taste in mouth, food tastes awful and irritates my mouth.  Water helps to calm but symptoms never go away.
ZOSTAVAX administered at 10 AM on 4/27/15. Arm is all red, swollen, and warm to touch. Reaction in above right elbow, site of injection, and even a little below elbow.
1 hour after immunization, very hot (unmeasured) and continued intermittently for 3 hours with decreased appetite.  Vomited 3 times in 1 hour/8 hours after shot.
On 5/19/2023, I had painless mild swelling around the left eye. On 5/29/2023, I woke up with worsened swelling and pain in the left eye. Since it was a holiday, and my doctor's office was closed, I went to the ER. At the ER, I was diagnosed with periorbital cellulitis. I was given a dose of clindamycin at the ER and then prescribed a week's worth of clindamycin to take at home. On 5/31/2023, I saw my PCP. She told me that the diagnosis was correct and that I was taking the right medication. However, she did say that my condition and that I should be taking antibiotics for a longer period, so she prescribed me another week's worth of clindamycin. At the time of this writing, my symptoms have improved, though I still have some swelling, which has dramatically decreased since I began taking the clindamycin. I also no longer have any discomfort.
sore arm; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient reported that with the past flu shots that she has received she has experienced fever and body aches. The patient experienced a sore arm for around 5 hours a several hours after receiving the vaccine on 14Feb2021 with outcome of unknown.    Follow-up attempts are completed. No further information is expected.
Severe pain in arm and shoulder could not lift arm. Went to dr gave me prednisone tool x-ray. Dec.30-15 went to orthopedic dr gave shot in shoulder and sent me to therapy.
Pt c/o of redness and soreness at injection site of Hepatitis B within 30 minutes of receiving vax. Mother states vax given with wrong needle. Nurse states given with 25 gauge 5/8".
I thought that my osteoarthritis was acting up because the tops of my feet will hurt when I walk. But by Mid-January my feet and hands were starting to swell and hurt. I went back in and had some blood work done on 2/3/23 and after getting those results they had me do more. They tested for Gout, Lupis, and Arthritis and some other tests as well. The only thing that came back was a high amount of inflammation. They sent me to the Rheumatoid specialist, and I saw them on 2/17/23. He put me on Prednisone. I was on that for about a month titrating down the dose. After that was helping, he added hydroxychloroquine. That would take about a month to kick in. I had been off the Prednisone for about a week and things flared back up, so I started it back up with this new medication. In the mornings when I am waking up before I take the medication my hands are swollen and hurt but once I get the medication going it gets better. I am seeing the Rheumatoid specialist but they cannot get me in until June 2023.
Appendicitis and appendectomy on Sept 24, 2021  My spouse had same 2nd dose, Pfizer same lot ER8731 and also experienced appendicitis and appendectomy on July 24, 2021
Bump at injection site and red streaks down the arm. Physician prescribed cephalexin 500 mg tid for 10 days.
approximately 10 days after influenza vaccine developed Headache, lassitude and fever to 104 and then mental status changes. Currently intubated with questionable early ADEM in our PICU. 12/10/07-interim records received-patient remains in hospital. DOS 11/20/07-altered mental status. Since Sunday, fever, then sleepy, clenching teeth for several days and unable to take oral medications. Unresponsive with short intermittant eye opening since Sunday.  In route to hospital had a 10-15 minute period of lost of consciousness and coded. PE: eyes fixed to left, teeth clenched, deceribrate posturing, unresponsive to painful stimuli, intermittently whimpers. Intubated.  2/5/08-DC summary received for DOS-11/20-12/27/07-DC DX: Hyper-IgE versus acute disseminated encephalomyelitis. Status epilepticus. Dishcarged to rehab.  Withdrawal symtpoms from Ativan with tachycardia. Per 60 day follow up: Partial recovered from the events. Pt remain on steroids, TRILEPTAL & KEPPRA but is now back in school. Lots of weight gain from steroids.
Patient vaccinated Friday 6/6/2008 and on Monday 6/9/2008 developed onset of flu-like symptoms with myalgias, malaise and fever up to 100.  She continued with fevers up to 102 through the week but no other localizing complaints.   On Friday 6/13/2008 she developed a diffuse non-prurulent erythematous rash.   She still had no localizing complaints.  Fever began to abate 6/13/2008.
tremors of hands, feeling like shaking inside all over, difficulty texting, typing, and signing my name
BRAIN FOG, DROWSINESS, FATIGUE Narrative:  Other Relevant History:
The reaction started with a large painful bulge at the injection site. Some six hours later a low grade fever of 100.2 set in. The following day the fever got much worse. It reached it's highest point at 102.7 on that following Saturday and remained so for about a 24 hour period. There were terrible body aches and profuse sweating. On Sunday 08/09/2015, at midday the fever finally broke. There is still a good sized knot at the injection site but it is no longer hurting.
3/9 MHN, admitted day after covid vaccine with weakness/SOB. Patient with history of small cell lung cancer metastatic on chemotherapy, COPD, diabetes, Sjogren's who presents with shortness of breath, confusion, and generalized fatigue as well as fall 1 week ago found to have recurrent pleural effusion, T7 fracture, new metastases, UTI. Shortness of breath: Suspicion is that this is related to malignancy plus effusion.  Shortness of breath markedly improved after removal of Transudative fluid, 470cc obtained on thora 3/10 with cytology negative. Encephalopathy: Daughter notes that she has been more confused.  The patient is off on her timeline of details.  CT shows no evidence of brain metastases nor does recent MRI.  Chronic hypoxemic respiratory failure: Patient is on 3 L of oxygen at baseline and she is currently at baseline. Generalized weakness: Her neuro exam is nonfocal aside from her confusion of timeline.  CT and MRI have been unremarkable.  I discussed her T7 fracture with spine surgery who recommends CT of entire spine which showed additional metastases.  Patient has no pain and has declined the need for brace. Metastatic small cell lung cancer: Patient admits that she does not like to talk much about the big picture however her daughter at bedside did speak with me outside the room and understands that she may have a poor prognosis.  UTI: With increased frequency/urgency/incontinence.  There is trace leuk esterase on UA.  She has been on ceftriaxone but urine culture showing 80,000 colonies of Enterococcus.  Changed to vancomycin.  I discussed with the microbiology lab who stated that sensitivities would not be available until 3/13.  Discharged with sensitivities pending initially with plan for amoxicillin but given interaction with methotrexate change to Macrobid. Normocytic anemia: Likely related to malignancy and chemotherapy.  No blood loss has been noted.  She received 1 unit RBCs prior to discharge.
Within 60-90 seconds after receiving J&J vaccine, patient became lightheaded, sat down, then subsequently passed out. Then had 2-3 jerking motions similar to seizure activity. Was lowered to the floor and called a CODE ASSIST. patient was not registered at the time, but was in a hospital. No previous reaction to injections. Patient taken to ED for workup.  Patient diaphoretic and bradycardic at 36. given IV fluids and performed EKG. was later discharged from ED
5/31: 4-inch diameter ring of red, swollen, hot tissue around injection site plus body aches, chills, and exhaustion. 6/1 and 6/2: swollen, painful lymph nodes in the left armpit and red, swollen, hot tissue around inj site. 6/3: same symptoms as prev two days; however, the diameter of the affected area is 5 inches in diameter, and a red streak extends into the armpit. 6/4 - 6/6: area of swelling, redness, heat, and now itchiness has increased to 4 inches by 8 inches and resembles a hive.
I started coughing. I had a recurrent dry cough, headache, fatigue and developed a brain fog. I took the COVID-19 test on February 01, 2023, and was positive. I was given molnupiravir for 5 days as well as benzonatate. It took 7 to 8 days to feel better. I used NASACORT allergy spray and DELSYM cough and congestion to treat the symptoms. My nose was also running. I still have some brain fog but I am getting everything back.
Pain on the right side, fast heartbeat, headache, unable to sleep, some swelling around the mouth and fever.  These didn't last too long but unset stomach, feeling tired and weak lasted a week and being constipated and trouble sleeping  lasted three weeks.
SUSPECTED CLINICAL VACCINATION FAILURE; STILL GOT COVID; This spontaneous report received from a patient via social media via a company representative concerned a male of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 30-DEC-2021. The patient's height, and weight were not reported. No past medical history and concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had no re-action and still got Covid 5 months later and had suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the still got covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209605.; Sender's Comments: V0: 20211266099-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt recv vax;exp high fever; RN questioned whether there was a problem w/ the particular lot of vax;
This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. On 09-DEC-2013 the patient was vaccinated with PROQUAD (merck) dose 1, subcutaneous. On 19-DEC-2013, the patient experienced 105.5 F fever (hospitalization, disability, medically significant and life threatening) and an altered neurologic status (hospitalization, disability, medically significant and life threatening) after receiving a first dose of PROQUAD and was hospitalized. The nurse mentioned the patient was limp (hospitalization, disability, medically significant and life threatening), unaware of her surroundings (hospitalization, disability, medically significant and life threatening), had a blank stare (hospitalization, disability, medically significant and life threatening) and had positive Kernig and Brudzinski signs (hospitalization, disability, medically significant and life threatening). The nurse further reported that the patient's fever was difficult to control with high doses of anti-pyretic medications (ibuprofen, TYLENOL, IV fluids with potassium) and the patient presented in her office with a heart rate of 203 (hospitalization, disability, medically significant and life threatening), respiratory rate of 48 (hospitalization, disability, medically significant and life threatening), a rectal temperature of 105.5F and had a brief seizure (hospitalization, disability, medically significant and life threatening) when her temperature was taken. The patient was sent to another hospital where she was admitted. The nurse stated that the patient had "signs of meningitis", the patient was dehydrated, and had a low potassium level (seriousness criteria for these events reported to be hospitalization, disability, medically significant and life threatening). On an unknown date in December 2013, the patient had the following lab/diagnostic studies: a glucose test, a urinalysis, CBC blood test, a chest x-ray, blood cultures and was tested for having the flu. The nurse mentioned all tests were negative except the patient's potassium with low. The nurse further stated that the IV fluids which the patient had received prevented the patient from going into metabolic acidosis. The outcome of all the events were reported as recovering/resolving. The relationship between PROQUD (merck) and the events was unknown. Additional information is requested.
pt tested positive for COVID on admission screening.  Admitted for non covid reasons, asymptomatic
Patient came in two weeks after IMZ stating his arm was still sore after two weeks. No knot at site of injection, no redness, or no heat only soreness. Patient has had shoulder surgery in that arm and was unsure if that has anything to do with the continued soreness.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; FEELING COLD; FEELING SICK; NO ENERGY; FEELING TIRED; This spontaneous report received from a patient concerned a 92 year old female. The patient's height, and weight were not reported. The patient's past medical history included dropped bladder, and concurrent conditions included non-alcohol user, non-smoker, penicillin allergy, hard time hearing, and hard time understanding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 28-JUL-2021) 1 total, dose was not reported, administered on left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  After vaccination, the patient had no side effects. On unspecified date in MAY-2021, the patient was sick and had cold (put a sweater while was 90 F). She felt tired and had no energy. The patient had stated that she was usually energetic. The patient had blood work done on 03-JUN-2021 and chest X-ray on 07-JUN-2021 for which results were not reported. The patient's physician informed that her test results showed that she did not get the COVID-19 vaccine. It was reported that, the patient had covid-19 antibody test which came back negative (suspected immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure, feeling cold, feeling tired, feeling sick and no energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630052-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
starting developing hives on back of my neck and head  6 days after the covid vaccine was administered. The hives progressed to my ears, arms, abdomen, groin, and upper thighs. I started taking Benadryl the first evening the hives started and continued benadryl for 2 more days. The benadryl did not stop the progression or  help much with the intense itching.  Had a telehealth visit via the telephone with Dr on Monday Jan 4. He ordered  Atarax prn. I also started taking Pepcid and Zyrtec. Today I still have hives that are developing but at a much slower pace. The itching is much improved.      DO I TAKE THE 2ND VACCINE?
Allergic Rhinitis; Reactive Airway Disease; Shortness of Breath; COPD exacerbation; Pneumonia; Churg-Strauss Vasculitis; Peripheral Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age with chronic obstructive pulmonary disease (COPD). No information was provided regarding medical history or concomitant medications. In or around 19-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered allergic rhinitis, reactive airway disease, shortness of breath, COPD exacerbation, pneumonia, Churg-Strauss vasculitis and peripheral neuropathy requiring several hospitalizations and rehab.The outcome of the events was not provided. The reporter considered the events to be related zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of pneumonia, Churg-Strauss vasculitis and peripheral neuropathy were determined to be medically significant.
PATIENT CALLED THE PHARMACY AT 06:00 AM ON APRIL 3RD, 2018. PATIENT COMPLAINED TO HAVE HARD TIME SLEEPING AT NIGHT DUE TO THE INJECTION SITE ON THE RIGHT ARM. THE PATIENT COMPLAINED OF SYMPTOMS THAT OCCURRED AT NIGHT ON RIGHT ARM OF MASSIVE SWELLING (TWICE IT'S SIZE), NIGHT CHILLS, DIARRHEA, AND FATIGUE. RECOMMENDED TO TAKE AN ANTI-HISTAMINE AND ANTI-INFLAMMATION MEDICATION AND TO CALL THE DOCTOR. WILL FURTHER FOLLOW UP THE OUTCOME.
starting 1 day after 2nd shot, red rash and inflammation appeared on pt's neck and chest, including a few bumps - today is 8 days after shot and rash is still there. he also ran a fever and had chills/aches for about 24 hours the day after administration.
Initial unsolicited report received from a Nurse on 28 Jan 2015. A 4-year-old male patient, whose medical history and concomitant medications were none, had received a dose of DAPTACEL (batch number C4645AA, expiration date 05-NOV-2016, route of administration unknown on right thigh) on 23 Jan 2015 and also received a dose of IPOL (batch number K1169-2, expiration date 26-MAR-2016, route of administration unknown on right thigh) on 23 Jan 2015. The patient had not received any other vaccination 4 weeks prior to DAPTACEL and IPOL. On 24 Jan 2015 morning it began looking red and puffy and on 26 Jan 2015 seen in the office the patient had 10cm swelling with redness tenderness, but no bruising. Laboratory investigations were none and corrective treatment included treatment with BENADRYL. The outcome of the events was not resolved. The patient required ER visit. Documents held by sender: none. Followup information received from a Nurse on 20 March 2015. It was reported that patient recovered on 30 January 2015. No further redness/swelling to right thigh reported by patient.
06/23/18 Had fever and chills throughout the day and part of night. 06/24/18 woke with rash on torso and under arms. 06/25/18 fever gone but still had rash. 06/26/18 all symptoms resolved and client says he feels fine. Client received no treatment for the reaction.