chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse (R.N.) concerning a 7 month (currently age "10 months 2 days") old patient who on 16-APR-2010 was orally vaccinated with the first dose of ROTATEQ suspension (dose, route and lot# not reported), the second dose of 05-OCT-2010, the third dose on 13-DEC-2010 at age "10 month and 2 days". No adverse reactions reported. Additional information has been requested.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: Other medical history: Htn obesity; "obesity" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN, start date: Nov2003. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid. Treatment start and stop date 01Mar2023 and 06Mar2023 for Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine, cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300109616 Same patient, different product/ event;
Covid19 breakthrough.  1st Vaccine received on 02/24/2022.  88 y/o male with PMHx of AFib on Eliquis, CEA on Plavix, HTN, chronic diarrhea presents to ED with c/o significant blood in stool, feeling weak, poor po intake and vomiting.  Pt with multiple electrolyte abnormalities, afebrile, room air sat 98% and CT A/P with mild degree of interstitial fibrosis of lungs.  Pt with no treatment at the time as mainly asymptomatic with normal O2 sats per MD note.
Headache and other Flu like aches started at 9:30 the next day and continued into the night. Chills and low grade fever (99.5) on the first night after the shot. The next day the headache and other aches were better but I did still get chills the 2nd night while sleeping. These side effects went away the 3rd day. May arm was sore for 5 days.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY  11/17/2022 - treated again for same adverse effects
For a month the patient has experienced limited range of motion in her left arm, along with soreness. She has tried icing and stretching with little results. Patient says the pain has decreased by about 50% since the shot but still has limited motions in activities such as yoga. Patient is following up with her primary car physician.
Rash all over face and chest; Nauseas; Flushing; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing), HYPOTENSION (Low blood pressure), RASH (Rash all over face and chest) and NAUSEA (Nauseas) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Anaphylaxis.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FLUSHING (Flushing), HYPOTENSION (Low blood pressure) and NAUSEA (Nauseas). On an unknown date, the patient experienced RASH (Rash all over face and chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, FLUSHING (Flushing), HYPOTENSION (Low blood pressure), RASH (Rash all over face and chest) and NAUSEA (Nauseas) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JUL-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 4 times with the following lowest recorded temperature: 34F (1.11 celsius degrees) for 88 hours, 32 F (0 celsius degrees) for 152 hours, 31F (-0.555 celsius degrees) for 120 hours and 33 F (0.555 celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Fatigue for 12 hours Headache for 2 days off and on Injection site discomfort not pain Nausea
This case was reported by a consumer via sales rep and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. On 5th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 5th August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th August 2018, the patient experienced feeling cold, shivering, fever and tiredness. In August 2018, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of and swelling arm were recovering/resolving and the outcome of the feeling cold, shivering, fever and intramuscular formulation administered by other route were unknown and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of, swelling arm, feeling cold, shivering, fever and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Sunday the SHINGRIX vaccine was administered subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. Twenty four hours after getting the SHINGRIX shot, the patient was freezing shivering in bed then she had a fever of 101.6 and the patient was so tired that she remained in bed for 48 hours. This was her third day and she was tired on the reporting date. In Aug 2018, less than a week after receiving SHINGRIX, the patient's entire upper arm was red hot and swollen and it was just starting to resolve after three days. The patient did call the pharmacist who administered the shot so that she would not continue to administer it incorrectly. The nurse read the pamphlet and apologized and said she would administer it intramuscularly from now on. The patient did not imagine this was just an isolated event since the original shingles shot was given subcutaneously. That route was what medical personnel were used to. The patient thought that, there should be more education or something on the box written over to alert personnel while giving the SHINGRIX injection intramuscularly. The patient was asked if she would have adequate protection with the SHINGRIX booster that was given subcutaneously.
tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 039K20A and 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.    This case was linked to MOD-2021-340745 (Patient Link).
Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9.
She got vaccine and still got shingles/suspected vaccination failure; She got vaccine and still got shingles; Neck pain; Skin rash; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 vaccination failure (Verbatim: She got vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: She got vaccine and still got shingles), neck pain (Verbatim: Neck pain), rash (Verbatim: Skin rash) and pain (Verbatim: Pain).The outcome of the vaccination failure was unknown and the outcome of the shingles, neck pain and rash were not reported and the outcome of the pain was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, neck pain, rash and pain to be related to Shingrix.   It was unknown if the company considered the vaccination failure, shingles, neck pain, rash and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-AUG-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and it did not help. The patient had shingles twice since. The patient never imagined that what started as neck pain was actually shingles. The patient thought shingles was just a skin rash, so she was surprised by how much pain it caused her. The pain was so intense and it lasted for months. The patient wish she would had learnt more about shingles sooner. The reporter further stated that would not wait and talk to a doctor or pharmacist today about shingles prevention people aged 50 plus. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule , time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a 67 year old female patient refers to herself. The patient's medical history included drug reaction/allergies to sulfonamide (also reported as sulfa). On 20-AUG-2014, the patient was vaccinated with ZOSTAVAX 1 injection (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included TOPROL XL TABLETS, SYNTHROID, ZOCOR and PREVACID. On 20-AUG-2014, the patient experienced redness "about the size of a quarter" after being administered the ZOSTAVAX. The patient also had itching at the injection site along with pain and a headache. As a treatment of adverse events the patient received TYLENOL. On 22-AUG-2014, at the end of the same week, the patient also experienced a urinary tract infection which was treated with CIPRO. The outcome of the events was unknown. The relatedness between the events and vaccination with ZOSTAVAX was unknown. The patient did not seek medical attention. Additional information has been requested.
approx 45 mins p/inject of vax in lt deltoid pt had episode of diaphoresis, mild lightheadedness, & frontal h/a; sx lasted 20-30 mins;
Seizures X 2 1-5-09.  First time seizures.  1/23/09 Reviewed hospital medical records of 1/5-1/6/2009. FINAL DX: new onset seizures Records reveal patient experienced tingling in feet, stiffening movements while at school & had generalized convulsion, apnea, jaw clenching, loss of consciousness & postictal behavior.  Had witnessed seizure in ER.  Neuro consult done.  Tx w/meds & no further seizures while hospitalized.  D/C to home on continued oral meds.
On 4/6/2022, I received my second Pfizer booster for COVID-19. On 6/28/2022, I began almost constantly coughing and had sore throat with throat congestion and extreme fatigue. On 6/29/2022, I took an at-home test for COVID-19, and the result was positive. I called my doctor's office. They asked me if I wanted an antiviral, and I let them prescribe me Paxlovid. However, I only took a couple of the Paxlovid, as they are huge pills, and I'm afraid of choking. I contacted my doctor to let her know, and I was prescribed molnupiravir in place of the Paxlovid, I took a couple of the molnupiravir capsules, but I also had difficulty swallowing those. I informed my doctor of this, and she was fine with my discontinuing the medication. I saw my doctor on 7/5/2022 for an annual exam. I actually felt well that day, but 7/6/2022, I was extremely fatigued. Since 7/4/2022, the coughing has greatly diminished. At the time of this writing, the sore throat and congestion are gone. The only lingering symptom is the fatigue, and I have good and bad days. There are days in which I feel fine and have my normal level of energy, but then are also days in which I am wiped out.
onset of gen hives,peri-orbital swelling devel 4hrs post vax w/MMR;concurrent contact w/horse immed prior to onset of sx;no prev hx of allergy to horses;no prev contact w/horse;pt took cool shower p/returning home p/onset of sx;
Nausea/malaise, extreme fatigue. Pain, swelling, fever at inj site. Fever/chills. All symptoms lasting 3 days.
Scalp disorder; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Scalp disorder) and VACCINATION SITE PAIN (Vaccination site pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (Scalp disorder) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, SKIN DISORDER (Scalp disorder) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   No concomitant medication information was  provided.  It was reported that on an unknown dates, the patient experienced scalp issues and sore arm after COVID -19 vaccine and sore arm after COVID -19 vaccine resolved . The suspect drug humira daily dose was reported as citrate free.   No treatment medication information was provided.
Patient describes continued pain at injection site days and weeks following administration.  She sought medical attention and is currently receiving NSAI therapy.
shingles; post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On an unknown date the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after injection, the patient suffered multiple painful blistering rashes, and pain after rashes subsided. As a result of her symptoms, patient presented to a medical provider and was diagnosed with shingles and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition.   The events of shingles and post herpetic neuralgia were determined to be disable by the lawyer.
tiredness x5 days; muscle tension in her neck/ muscle tension in her back/ muscle tension in her jaw; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscle tension in her neck/ muscle tension in her back/ muscle tension in her jaw) and FATIGUE (tiredness x5 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced MUSCLE TIGHTNESS (muscle tension in her neck/ muscle tension in her back/ muscle tension in her jaw). On 08-Jan-2021, the patient experienced FATIGUE (tiredness x5 days). At the time of the report, MUSCLE TIGHTNESS (muscle tension in her neck/ muscle tension in her back/ muscle tension in her jaw) and FATIGUE (tiredness x5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment information were provided.   Reporter did not allow further contact
I got the shot on a Friday and I woke up on Saturday morning to let my dogs out and I had a headache and I was nauseous and dizzy. I let dogs out and laid back down and slept for 2 hours and woke up about 10AM feeling achy and at that point I took Tylenol or Motrin. I was just tired and achy but continued throughout the day. Around 2 or 3PM I had a fever and was super tired. I had a fever of 101.6 degrees at that point. I was cold and had the chills. I took Motrin and went to bed again but woke up at 1AM in a sweat and had a fever of 101.5 degrees Sunday morning I woke up feeling a little bitter but still had fever of 99 degrees and then I hung low on Sunday. On Monday I still had a low grade fever and went to work anyways and shortly after I noticed my glands were swollen and was sore underneath armpit area and it almost felt bruised. My throat around collar bone region was super swollen but then I started feeling better a week later. Around my throat area it does hurt a little bit.
When I woke up, I had headache and nausea. Started throwing up. Ran a fever - up to 103 the first day. The nausea didn't get much better. I saw the doctor the 3rd day and he gave me Zofran for nausea. The headache and fever didn't go away though. The fever didn't break and I had a bad headache so on Thursday morning ER - headache cocktail  IV - that helped me so I could sleep and I did but was still in bed for another two days after that. The worse was the five day fever and the headache was severe. They renewed my prescription for my intercranial hypertension since they thought that might have triggered it.
Patient stated that he started a new medication this morning. When he was seated for observation after receiving the vaccination, he stated that he has felt dizzy even before he received the vaccine, but did not inform the vaccinator. Patient asked to have his B/P taken .Patient stated that he just had a stent placed on Monday, Patient stated that he took sotalol 80mg and cardizem 120 mg at 10 am before coming in to get the vaccine. B/P taken 150/105, heart rate 117. Chest pain denied, no shortness of breath noted. Color pink. Patient stated that this usually happens, and that it usually passes.  1:40pm Blood pressure retaken, ?150/106, heat rate 121. ?denies chest pain and shortness of breath, O2 sat 96% on room air. It was advised that the patient be seen and evaluated in the ER. Patient put in a wheelchair and escorted to ER triage at 1:52pm.
severe case of Vertigo,, Unknown if related to vaccine...  first treated with medication , no improvement,,  Second treatment was with physical therapy which relieved the symptoms within 24 hrs..   still have some symptoms of dizziness..
By the evening of the shot my arm began to throb. (Pain level 6-7). By bedtime pain level was at 8. Around 12am I began to experience dizziness and nausea. This was followed by overall body discomfort of soreness and cramping. In an attempt to get to the bathroom I quickly found out that I was unable to stand or move without my wife's assistance in supporting me. By the time I got down a short hallway and into the bathroom my wife was no longer able to support me and I fell onto the bathroom floor. I lost bowel control. I was on the floor for 2 hrs unable to get up. Finally still dizzy and nauseous I got up with help to get back to the bed. I felt miserable for the next 6hrs and then started to get a feeling that I could possible stand. With help I again made it to the bathroom. The pain in the arm lasted for another 2 days along with the weakness and instability. Information was relayed to Dr and neurologist and followed up in letter to Dr on 12-17-2017.
I received the following: Tdap-09/09/09, then seasonal flu on 09/17/09, then H1N1 on 10/26/09. I began having stiffness in both wrists in November, excruciating pain by January 2010 in both wrists and hands, carpal tunnel surgery x2, March all large joints became stiff, inflamed, and swollen. Being treated with methotrexate and prednisone for possible seronegative RA.
2/11 6:00 am - woke up with severe (R) foot pain. After 3 hours, pain began to radiate up (R) calf to below knee. No other sxs. Took 600 mg IBUPROFEN which decreased pain. 2/12  - Pain is now minimal. Only feels it on (R) plantar lateral area.
temp  100.4     HR 105   pulse ox 96    severe upper arm pain  (both arms)    Hallucinations !!   severe Headache  neuropathy   SEVERE     Hands were like frozen
the patient missed the second and third dose; no adverse effects; This spontaneous report was received from a physician refers to a patient of currently 8 months of age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength, lot number and expiration date unknown) orally for prophylaxis. On an unknown date, the patient missed the second and third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). No adverse effects were reported. No product quality complaints were involved.