chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Running a 101+ Fever; Running a 101 and half fever; Arm hurts, site of the injection hurts; Severe headache at the base of his skull; Arm hurts, site of the injection hurts; This is a spontaneous report form a contactable consumer. This consumer (patient wife) reported for a 41-year-old male patient that.  A 41-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 19Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on an 29May2021, as DOSE 1, SINGLE for covid-19 immunization and experienced Numbness and tingling in the arm. The patient experienced running a 101 plus fever, running a 101 and half fever, arm hurts, site of the injection hurts, severe headache at the base of his skull, and arm hurts, site of the injection hurts on Jun2021. Reporter stated He was running a 101 plus Fever at this time and he got it yesterday and his arm hurts but that was obviously normal, the site of the injection hurts but that was normal for any vaccine. But he was running a 101 and half fever and a severe headache at the base of his skull." For the side effects he took Excedrin Migraine on the day of this report in morning (stated as this morning). That Excedrin was a brand over the counter medication, which specialize in Migraine headache." Dosage: Reporter stated, "she thinks it is 500 mg but I am sure, it is an recommended dose for adults." Frequency was stated as "2, that is the recommended dose. Reporter wanted to know does Pfizer recommend any further action if the symptoms do not abate. The patient underwent lab tests and procedures which included body temperature: 101 and half on Jun2021. The outcome of events was unknown.  Follow-up attempts were completed. No further information was expected.
The vaccine was applied on Sunday March 7 and I had a slight headache that day, on Monday at 7am when I got up, it was hard for me to walk because I felt that everything was spinning, I went to emergency room and the doctor told me that it was vertigo and that it was not related to the vaccine, which I am sure it was, because I do not take any medication nor I did not do any activity nor was I exposed to any risk
Fully vaccinated patient admitted post fall with fracture.  Incidentally tested "detected" for COVID during routine admission testing, no COVID symptoms during stay.  Provider discharge note:  "91 YO female w/ history of Asthma, hyperlipidemia, Anxiety, Dementia, hypothyroidism who presented with low back pain following a ground level fall. No fractures seen on imaging but incidentally found to be COVID 19 positive. She was subsequently admitted due to intractable low back pain. During her hospitalization stay, she was evaluated by physical and occupational therapist who deemed her a candidate for skilled nursing facility for ongoing rehabilitation."
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L048465, expiration date 02-DEC-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
4/12/21  ER: Pt c/o palpitations onset 30 min pta. Pt states had second covid vac. At 0830 this am. Pt denies pain.  dc home DX: Palpitations, Sinus tachycardia
Mom states "Pt had a lump, (L) thigh, 5/22/02 a.m.  Lump progressed in size and fever present by p.m.  Saw M.D.-given antibiotic shot-Tylenol.  Fever progressed at home (104 degrees).  Child became unresponsive - 911 called.  Admitted to Hospital 5/22/02 for 2 nights."  "Cellulitis (L) thigh - on oral antibiotics." Per review of hospital discharge summary and hospital records Add to Box 7  Cyanotic lips,Unresponsive, Listless,Episode of vomiting. Discharge Diagnosis was fever and L anterior thigh erythema (possible cellulitis vs immunization reaction). The immunizations were given in L thigh.  No further medical records are expected on this case.
arm of injection hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm of injection hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm of injection hurts). At the time of the report, VACCINATION SITE PAIN (arm of injection hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rash, just progressed worse; This is a spontaneous report from a contactable consumer.  A 23-year-old female consumer reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), at single dose into left arm on 17Jan2021 6at :00 p.m for COVID-19 immunization. Medical history and concomitant drugs were none. The patient reported experiencing a rash. The rash started on her wrist and has just progressed worse in the past few days. She got her shot on Saturday. Her rash fist appeared on Sunday or Monday, she cannot totally recall. The rash has continued to progress worse. Caller states the rash was all over the body. The caller states she has to assume this is a reaction to the vaccine, it's too coincidental not to be. The caller is just wondering if there is any information on what she can do about the rash, if it is safe to get the second vaccine and if she can receive a steroid shot. The outcome of the event was not recovered.
This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On 03-JUL-2017, the patient received expired M-M-R II, lot# M032153 with expiry date of 22-APR-2017, subcutaneously, in left arm for prophylaxis (dosing details not reported). No adverse event reported. Additional information has been requested.
Patient received Moderna Dose #1 on 1/11/2021.  Later that day, her armpit had a swollen lymph node.  This was treated topically with clindamycin for hidrandenitis suppurative for about 2 weeks.   Then patient received Moderna Dose #2 on 2/8/21.  By 2/11/21, patient had some intermittent confusion noted.  Vitals were mostly WNL.  On 3/4, patient observed with SOB and restlessness.  SPO2 was 86%, Temp 98.4, HR 59, BP 136/59.  Oxygen started.  Later on 3/4, patient had change in mental status, lethargy, SOB and SPO2 90% on PRN oxygen.  Transferred to hospital.  Patient was admitted to hospital  on 3/4/21.  She was readmitted to nursing home on 3/12/21.  Discharge diagnosis included:  altered mental status, acute expiratory failure, fever, atypical pneumonia, CHF exacerbation, HTN, DM, dementia, asthma/restrictive lung disease.
Patient fainted post vaccination. Patient was seated in our post vaccine area in a chair with arms. Within a few minutes patient collapsed into the floor, was hot/sweating and a little disoriented. Patient regained consciousness, applied wet compress and tested in a seated position with head down. Began feeling better. Patient provided with a bottle of water. Patient remained on our site for another 30 minutes until felt better and stable.
2/8/21 2000 moderate body aches, fever 101.1 2/9/21 0001 severe body aches, sever joint pain, severe migraine, fever 102.1 2/10/21 0001 severe body aches, moderate joint pain, severe migraine, severe neck stiffness and pain, fever 101.0, night sweats 2/10/21 0930 moderate body aches, moderate joint pain, severe migraine, severe neck stiffness and pain, fever 100.1, heat rash on feet from fever and night sweats 2/11/21 0001 mild body aches, mild joint pain, fever 99.9, night sweats, heat rash on feet and hands, severe migraine, severe neck stiffness and pain, nausea 2/11/21 0800 moderate fatigue, moderate headache, severe neck stiffness and pain, temp 99.7, mild moody aches and joint pain, moderate heat rash on hands and feet 2/11/21 1200 severe migraine, severe neck stiffness and pain, nausea, mild moody aches and joint pain, severe fatigue, moderate heat rash on hands and feet 2/12/21 0900 moderate headache, moderate fatigue, moderate neck stiffness and pain, moderate heat rash on hands and feet
On Friday, April 15th, after receiving the vaccination about 2:43 p.m., I experienced soreness in the arm about 3:30  continuing until now (4/18/2022). About 10:30 that night the injection site also started itching and was red. The next morning my upper arm at and above the vaccination site was also red and itchy as well as all around the base of my neck/upper chest and back. I took medicine to counteract the itching and hopefully slow the spread. I still have the itchy rash. It took about 3-3 1/2 weeks for this same side effect to diminish after I had my first dose of Shingrex. I called my doctor's office and the nurse called back saying to continue Benadryl, Caritan or Zyrtek. The doctor's office called back again to say I could also take ibuprofen.
2:25 PM: Patient reported facial itching at 2:25pm, coughing and chest tightness.  Difficulty speaking.  BP 136/100 , HR 110, RR 24, SPO2 95%.   Alert and oriented, feelscold and calmy.    Medications:  EPI-pen administered per protocol at 2:28pm in L thigh. 911 called, ambulance dispatched.  Monitored until 2:34   BP 140/98, HR 108, SPO2 99.   EMS arrived 2:45pm. Transported to hospital.
20 minutes after shot, I experienced a warm sensation move across my chest. I began having a headache in the right temple. These two effects lasted 30-40 minutes. I began to feel a little better so I returned to work. On Friday 3-26-2021 I began feeling extremely weak and muscle aches. My heart rate was also elevated. I continued to feel bad and wasn?t able to return to work. I went to the Dr on 4-01-2021. Heart rate and blood pressure were both elevated. I had bloodwork and ekg done. Heart was in Tachycardia. All bloodwork was normal. I haven?t returned to work because of these symptoms
Vaccine given on 10/18/18. On 10/20/18 patient reports that he began to have a low grade temp, cough, chills, body aches, and poor appetite. Patient reports that on 10/20/18 his right leg began to swell and have blistering up to the knee with a red streak going up past the knee into the thigh. Temp at that time was a "little bit over 100 degrees F". Patient reports that he was admitted to the hospital on 10/23/18 through 10/26/18 for cellulitis in right leg and was treated with IV antibiotics.
"Reports that immediately after receiving the J&J vaccination on 7/30/21, he felt  a fever and diarrhea 1-2 days but then this was followed by persistent lower  extremity weakness for approximately one week following, so much so that fell  twice with involuntary knee buckling at work the following Monday, Tuesday,  Wednesday (August 2,3,4) at truck stop location. Since then these symptoms have  resolved after 5+ days but now reporting continuous bilateral frontal headaches  lasting one minute and then returning.  Also reporting "no energy" and severe  fatigue and difficulty getting up in the morning even after 8-10 hours sleep."
8 days after receiving the vaccine, I started menstrating . but I have been in menopause over a year; I'm also experiencing urinary pain; Not only was it painful but the rush was more than I've had in over 13 years; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 (age at Vaccination 50-year-old) (Batch/Lot Number: EW0-182) as dose 1, single for covid-19 immunisation. Patient was not pregnant at time of Vaccination. Medical history included hashimotos thyroid disease, latex allergy, ginger allergy, egg whites allergy, garlic allergy and patient had been in menopause over a year. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included levothyroxine, liothyronine, ergocalciferol (VIT D), magnesium taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26May2021, 8 days after receiving the vaccine, patient started menstrating but she had been in menopause over a year. Not only was it painful but the rush was more than she has had in over 13 years. She was also experiencing urinary pain. Patient was not hospitalized. She did not received treatment for adverse events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Edema; cyanosis; of unilateral lower extremities. lasted several minutes before spontaneous resolution
The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it was on fire.  I had a rash on the opposite arm that i had the injection.  I took benadryl to help with the rash in the morning and at night. That night i was freezing and i woke up in a sweat.  This morning i woke up and the rash looks worse.
31 Years Female Never smoker here with about 2+mo  history of localized left shoulder pain starting the day of her HPV vaccine and never went away. About 1+mo later started noticing changes with ROM of left shoulder and subtle left arm weakness. She works as a vet tech and states that when she has to restrain a cat for procedure or lift a dog weighing 20 or more pounds, can no longer rely on left arm due to give away weakness. She stresses that these symptoms are not severe nor intolerable but interfere with her job and cause her to look for work around to perform a task and aren't going away.  One of her main concerns is if and how to finish the HPV vaccine serious as it was her first in the series. She also wonders if the fact that she had her second mRNA COVID-19 vaccination 2 weeks prior to the HPV vaccine is at all related.  HPV vaccine = 8/18/21 mRNA COVID-19 vaccines = 6/30/21 and 8/4/21  P- ROM makes pain worse, staying still makes pain better Q- sharp pain/ feels like in the muscle or tendon with certain movements R- no radiation S- 4/10 when pain is present T- 2 months, constant associated with arm weakness and give away weakness with certain tasks
Pharmacist realized that she forgot to dilute the dose and sent patient to emergency room to prevent possible outcome.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 02-OCT-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Red, itchy rash on inside elbows, wrists, neck and chest.  Claritin and topical Benadryl, plus coconut oil with CBD.   Still increasing as of November 17, 2022 - two weeks.
Expired vaccine used/Expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/Expired dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0321B21A, 101M20 and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/Expired dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Pt felt normal until 3:00 pm. Started with heavy head feeling similar to allergy's, progressed to pain in (L) side arm and flank. 5:45 - unable to move arm due to intense ache. 6:30p pt lays down with shivers and is in and out of sleep 8:p. went to BR to void; LOC. Doesn't remember falling on floor. Husband helps her up - unable to walk. Nausea and chills continue. Does not want to go to ER. Next day back to baseline except pain in posterior head and neck d/t fall.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 06-NOV-2014 the patient was inadvertently vaccinated with ZOSTAVAX (lot # K006439, expiry: 05-AUG-2015), single dose, subcutaneous for prophylaxis that had been improperly stored. No adverse effects were reported. No product quality complaint was involved. No further information provided. Additional information is not expected.
This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of MMRII (lot # L004656, expiration date 11-FEB-2017) (dose and route of administration were not reported). No adverse effect reported. There was no product quality involved. This is one of two reports from the same reporter (1512USA011947). Additional information has been requested.
has 3 spots on her right upper thigh and back of her leg; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2020, the patient received Shingrix. On 28th June 2020, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient had 3 spots on her right upper thigh and back of her leg. She did not visit the doctor yet. The reporter consented to follow up.
Headache,nausea,vomiting, diarrhea pain in extremities aching
Pfizer 5-11 primary dose was order for the patient listed. The patient was given Pfizer 5-11 Bivalent.
Pt c/o left deltoid swelling, radiating up neck,enlargened lymph nodes in neck,bilat. leg weakness, and sob x 3 days.
Patient states arm is swollen and tender 28 days after injection of IMZ. No heat or pain present. Left arm noticibly larger than right arm.
The patient could not remember if received second primary dose 28 days later; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The patient could not remember if received second primary dose 28 days later) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The patient could not remember if received second primary dose 28 days later) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The patient could not remember if received second primary dose 28 days later) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (The patient could not remember if received second primary dose 28 days later).    No concomitant medications were reported. It was reported by the pharmacist that patient had received two primary series doses of Moderna COVID-19 vaccine. The patient had lost vaccination card and could not remember if ever received second dose of the Moderna COVID-19 vaccine. It was further stated that the patient believed to get second dose, but there was no record. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2022: Follow up received includes non-significant information.
Case number PHEH2014US008239 is an initial spontaneous report from a nurse received on 23 Apr 2014. This report refers to an 11-year-old female patient. The patient received only liquid component of MENVEO (batch number: unknown) and TDAP (other manufacturer and batch number: unknown) on 18 Apr 2014. On the same day, post vaccination, the patient experienced localized pain. By 20 Apr 2014, the patient started experiencing little bit of redness and swelling at the injection site and felt a lump under the skin. The following day the patient went to the primary provider who determined it was just a localized reaction (however, they are unable to determine which vaccine caused the reaction as they administered at the same site) and symptoms were improving at that point. Primary provider advised that patient be revaccinated. The patient stated that she was planning to revaccinate. No additional information was available.
NO ADVERSE REACTKION WHATSOEVER...  JUST REPORTING THAT ;PATIENT GOT A BIT EXPIRED VACCINE
Pt. wanted 2 vaccines, BOOSTRIX and meningitis. After administering BOOSTRIX, I went back pharmacy to draw up 2nd vaccination about 90 seconds. When returning to pt, he was unresponsive, wheezing, and fixed pupils. We called 911, and he returned to normal state and was nauseated. Upon talking to wife discovered he had hx of fainting. Pt. did not tell me prior.
My son suffered a sudden fever, sweating, felt nauseous and wanted to vomit. I also reported that he felt pain on the left side of his body and felt short of breath.
Sore arm right after shot and throughout the next day. Woke up in the middle of the night (around 11:45pm)with very bad chills, nausea, and headache. Temperature at the time was 99.7. Several hours later (around 3:45am) woke up again with less chills and temperature 101.6-101.8 with headache continuing. Woke up again at 5:45am with continued fever 101.7 and headache. Took ibuprofen around 6:30am and fever dissipated around 9am. Headache still continuing but not as severe.
Pain at injection site treated with ibuprofen. Intermittent itching on hands and face. Throat feels slightly swollen (not restricting breathing at this time). Itching feels similar to previous allergic reactions, although less severe.
Woke up with bad headache in back of head. Throat was hurting & swollen.  Chills, achy muscles all over.  Knee joint hurting bad.  Not hungry. Slept a lot after taking Tylenol. Next day by 12:00 pm, I felt better.