chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; This is a spontaneous report from a contactable physician. A 37-year-old female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 29Dec2020 17:50 (5:50 pm) at a single dose as Covid vaccine. Medical history included hypertension and depression. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); olmesartan medoxomil (BENICAR); and unspecified medications for depression and blood pressure medication (hypertension). It was reported that the reporter's nurse got her vaccine last night, about 6'o clock at night, and woke up with Bell's Palsy on Dec2020. She woke up in midnight to go to the bathroom and when she looked in the mirror, she noticed that there was discrepancy. The physician examined her this morning, so it was in several hours getting the vaccine that she noticed it. She got the vaccination last night at 5:50 pm. When she went to bed it wasn't a problem. She woke up at midnight and noticed it. The patient was started on Medrol dose pack but she hasn't taken it yet because she's at work so she would start it today (unknown if the treatment was already received); it's steroid, Methylprednisolone, at 24 mg on day one and then decreases 4 mg a day over the next five days until it's done. The doctor inquired what should the patient do about her second dose and also asked if she should not get her second dose. The outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a nurse and refers to a 24 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-DEC-2017, the patient was inadvertently vaccinated with a dose of PROQUAD lot # N019251, expiry date 20-DEC-2020 (exact dose and route of administration were not reported) for prophylaxis and a dose of M-M-R II (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The lot# of the sterile diluent used was N014365 with an expiry date of 11-OCT-2019. No adverse effects were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 50-year-old patient who received SHINGRIX for prophylaxis. Concomitant products included Herpes zoster SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, headache and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills, headache and general body pain were recovered/resolved. It was unknown if the reporter considered the fever, chills, headache and general body pain to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient itself, who is a pharmacist. The patient said that SHINGRIX had been the worst immunization the patient had received as far as it related to side effects. The patient experienced fever, chills, headache and body pain, after vaccination. The patient was in excellent medical and physical condition and being a pharmacist he or she would be very reluctant to offer and administered SHINGRIX to other patient population because of the severe side effects that experienced self by the patient. Most of their population were older than 50 years and in worse physical health than the patient with underlying comorbidities. This case has been linked to the case US2018GSK102941, reported for the same patient.
Information has been received from a nurse concerning a female patient (age not reported) who on 23-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot # 651356/0089F).  Later the same day the patient's arm in which the vaccine was administered swelled and became red and was swollen from the elbow to the shoulder.  The patient was seen in an urgent care clinic and diagnosed with cellulitis and released.  On 24-OCT-2006, "the next day", the patient was re-evaluated and diagnosed with cellulitis.  The nurse stated that he was unaware that the patient missed any work because of the reaction.  At the time of this report, the current status of the patient was unknown.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Rash, red, no blisters. On and off started 2 days after vaccine. Will continue for 3 to 4 days than go away for about a day than return. Does not hurt. Itches but not bad. Worse on opposite arm from vaccine arm. Patient reported to me 8-19-16.
This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient did not have any concurrent conditions, medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with either one or two doses of the series of RECOMBIVAX HB intramuscularly, (lot number, dose and frequency were not reported). Concomitant therapies were not provided. In early March 2016, after the patient had started the RECOMBIVAX HB series, she was diagnosed with protein C deficiency. It was reported that the patient visited a different unspecified provider and then she received an unspecified treatment. No laboratory studies were performed. No product quality complain (PQC) was involved. At the time of reporting, the outcome of protein C deficiency was reported as not recovered. The reporter did not provide a causality assessment between the reported event and the RECOMBIVAX HB. This is one of two reports from the same source. Additional information has been requested.
round red raised area(silver dollar sized)below the injection site; started itching; sore skin; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (round red raised area(silver dollar sized)below the injection site), PRURITUS (started itching) and PAIN OF SKIN (sore skin) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN OF SKIN (sore skin). On 25-May-2021, the patient experienced ERYTHEMA (round red raised area(silver dollar sized)below the injection site) and PRURITUS (started itching). At the time of the report, ERYTHEMA (round red raised area(silver dollar sized)below the injection site), PRURITUS (started itching) and PAIN OF SKIN (sore skin) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported. No treatment was reported.
"floater showers" on both eye ,could read the 1st 3 letters of the word but not the last 2 letters; mild headache; tiredness; low back pain; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS ("floater showers" on both eye ,could read the 1st 3 letters of the word but not the last 2 letters), FATIGUE (tiredness), MYALGIA (low back pain) and HEADACHE (mild headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 044B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 18-Apr-2021, the patient experienced FATIGUE (tiredness) and MYALGIA (low back pain). On 27-Apr-2021, the patient experienced VITREOUS FLOATERS ("floater showers" on both eye ,could read the 1st 3 letters of the word but not the last 2 letters) and HEADACHE (mild headache). On 20-Apr-2021, FATIGUE (tiredness) and MYALGIA (low back pain) outcome was unknown. On 27-Apr-2021, VITREOUS FLOATERS ("floater showers" on both eye ,could read the 1st 3 letters of the word but not the last 2 letters) outcome was unknown. At the time of the report, HEADACHE (mild headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
At around the 24 hr of receipt pt describes bilateral abdominal/trunkal "splotchy, red, itchy, elongated hives" that lasted 7 days. Symptoms would ebb and flow and improve with Benadryl. No other s/sx reported. No meds, no reported allergies or health conditions, no new products or environmental exposures reported.
Since Nov 2022, I?ve experienced heat intolerance. I get sharp shocking sensations in my middle/ upper back when I get hot.. When I tried to exercise I would feel tingling pins and needles which started in my entire front of left leg. These symptoms have progressed to feeling pins and needles shocking sensations in my feet, both legs, back, neck, arms, hands, and my face. I have gotten so much worse since Nov. Exercise makes my symptoms so much worse. I?ll feel bad for at least 3 days if I decide to do a small workout. I?m seeing a neurologist that performed all kinds of tests on me. He said he doesn?t think it is a neurological issue. He was thinking it?s possibly autoimmune. I?ve seen one rheumatologist that straight up said it wasn?t autoimmune (our visit didn?t even last 5 mins). I will be getting a second opinion from another rheumatologist but I just don?t know what it is. I?m wondering if it could be that vaccines i received. I have very high sensitivity at times that even the slightest touch is so painful. All these symptoms come and go. It?s never in the same spot all the time.
7/21/18 patient complained of sore throat head congestion, stomach upset and coughing. Rash at injection site. 7/23/18 not feeling well patient complained of coughing. From previous dose patient developed cough and went to physician assistant and diagnosed with virus. No stomach upset with first dose.
after about two weeks after second dose developed systemic body inflammation. C- reactive protein (149). I have been struggling since then. Dr. diagnosed as "polymyalgia rheumatica" treated with prednisone and  meloxicam. I never have any arthritis or problems like this before the vaccine.
pt recv vax in ofc 11AM no rxn x 20mins; mom took pt home 220 called back stating pt was having rxn; called paramedic pt was transported to ER per amb; spinal tap done; APAP given; dx prob febrile sz;
Patient report swelling and redness at the administration site. The spot was also warm to the touch. She started experiencing this on 1/5/19. Pharmacist recommended the patient apply a cold compress and taking NSAIDs if tolerable. If it doesn't improve, patient is to follow up with her PCP.
Hives at site of varivax injection within 24 hours of injection. Otherwise well.
Information has been received from a 94 years old female patient referring to herself. The patient had cancer in spleen. She had no drug reaction or allergies. Concomitant therapy included levothyroxine sodium (manufacturer unknown). On an unspecified date in approximately September 2012 (about 4 or 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (strength and dose unknown, route reported as vaccine). Some years later, on an unknown date, the patient got cancer and then since she had a weak "immune system", she believed this triggered her body to get shingles. She stated she had the shingles for a year since 18-SEP-2015. She went to a clinic and they gave her some strong pills that she believed contain opium. After that she still had the shingles, so someone prescribed her the gabapentin, but then she broke out with psoriasis. Now she took TYLENOL maybe once a week. She woke up with the shingles in the morning and went to sleep with it. She was able to sleep even though she has the shingles. No lab was performed. The outcome of the events were unknown. The causal relationship between the events and ZOSTAVAX was unknown. Upon internal review, cancer was considered to be medically significant. Additional information is not expected as there is no consent to contact the physician.
Reactivation of HSV2 virus, outbreak on left buttock/flank and related lymphnode tenderness, flank pain, body aches, malaise.
(L) thigh Local redness at site-developed "hives" warm to the touch itchiness reaction to DTaP "large area of thigh"
I had the Prevnar 20 injection. I was fine until late afternoon except for pain at I jection site. I became very lethargic so I went to bed. My husband had to check my pulse when he came to bed, because there was no response. I could not get up for work the next morning, I slept until noon. My arm was swollen, red, and very painful to touch. It itched, but could not scratch because it was painful to the touch. It is five days later and my arm is still tender and I'm now having dizziness and nausea and just want to sleep. I will take notes of new or existing symptoms.
Muscle soreness at injection site; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site muscle pain and tiredness. On an unknown date, the outcome of the injection site muscle pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: After getting the first dose of Shingrix vaccine, the patient experienced muscle soreness at injection site and tiredness.  This lasted for a week then he recovered.  For tolerance after 2nd dose refer case US2020087455. This case is 1 out of 3 cases reported by the same reporter
really bad smell coming out of my pores; Sense of smell; cough drops called "breath", to open up nasal passage; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (really bad smell coming out of my pores), HYPOSMIA (Sense of smell) and DYSPNOEA (cough drops called "breath", to open up nasal passage) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 28-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAROSMIA (really bad smell coming out of my pores), HYPOSMIA (Sense of smell) and DYSPNOEA (cough drops called "breath", to open up nasal passage). At the time of the report, PAROSMIA (really bad smell coming out of my pores), HYPOSMIA (Sense of smell) and DYSPNOEA (cough drops called "breath", to open up nasal passage) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was using Eye drops as concomitant. Treatment medication was not provided.    Patient was treated with Cough drops called Breath.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Significant follow-up appended as outcome of event and patient demographics are updated
Instead of receiving the pediatric dose of the Hepatitis A vaccine (0.5 ml), patient was given the adult dose (1 ml). Patient had no reaction to receiving the adult dosage of Hepatitis A vaccine.
JANUARY 16-18, 2021:  headache, fatigue, sore arm.  JANUARY  27, 2021: extremely fatigued.   FEBRUARY 5-15, 2021:  difficulty breathing, extreme fatigue,  heavy chest; collar, neck and head pain;  weak; chronic headache; accelerated heart rate (100-115 bpm), low blood pressure (approx. 80 systolic), and  mild fever (99-100.9 degrees), especially in evenings. FEBRUARY 9, 2021:  1st visit to Hospital ER diagnosed as arrhythmia due to accelerated HR and sent home with metoprolol to lower blood pressure and eluquus  to thin blood. FEBRUARY 10-14: above symptoms persist.  FEBRUARY 15, 2021: Symptoms worsen, return to ER. FEBRUARY 17-19, 2021: admitted to hospital; diagnosed with and treated for fluid on heart sac (pericarditis) and left lung (drained on 2/18/21). FEBRUARY 19, 2021: Released
Neuropathic pain to 2-3 toes on left foot, starting approx 4 weeks after 2nd Moderna vaccine.  8 weeks post 2nd shot, develop right sided facial pain.
No adverse event; Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available).    No concomitant medication information was provided. No treatment medication were provided.
sore throat 6 days p/shot x 2 days; fever 101.3 x 3 days; URI x 2 days;
Patient vaccinated on 5/1/06 with Menactra (lot U2004AA).  Culture confirmed meningococcal disease on 6/5/08.  Blood culture was positive for Neisseria meningitidis serogroup C. 3/4/09-death certificate received-COD Sepsis. Acute Meningococcemia. 3/8/09-office note received for DOS 5/1/06-well visit-mild scoliosis. 3/19/09-records received for DOS 6/3/08-life flight tranferred in hypotensive state intubated. Lifting weights day before, developed diffuse abdominal painlast evening worsened overnight, this morning developed fever and sweats with vomiting. Mottled, hypotensive and tachycardic. PE: cold, tachycardic febrile and mottled. Bleeding from both eyes. Unresponsive. Purpura, petechiae in eyes. At receiving facility in cardiac arrest resuscitation efforts failed. Pronounced dead.
Had 1st vaccine on 3/30/21started feeling ill on 4/2 on 4/5 went to hospital for fever, aches & pains, loss appetite  shortness of breath, etc. Was back in hospital 4/9 ? 4/14  for weight loss, fever, aches & pains, headache high white count
Vaccine received 7/5/22 @ 1:15 PM, symptoms of fever   (101.6 at highest) and vomiting began @ 7:45 AM on 7/6/22.  Symptoms resolved around 10:30 AM and were not present throughout the day but both fever and vomiting returned around 9:30 PM.
Dizziness started a couple of days after 1st vaccine.  It was so severe that by Sept 25th I went to urgent care and nothing showed up in my urine.  UC dr recommended that I go to my PCP On Monday and I had blood drawn.   Thyroid levels were off and my thyroid medication had to be decreased. 2nd shot on 10/14/21- symptoms started the next day  with my glucose staying above 300 for a few days. Also a month later developed vertigo and and remained dizzy until my prescribed me medicine for the dizziness.
This case was reported by a consumer via sales rep and described the occurrence of shingles in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less  than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported to the reporter's friend from a friend of hers (patient). The patient experienced outbreak of SHINGRIX after vaccination. The event resolved in 3 days after receiving VALTREX. The reporter did not agree to be contacted for follow up.
Information has been received from a health professional concerning an 18 year old female who was vaccinated on an unspecified date with zoster vaccine live (Oka/Merck) (Lot # 57559/0462U) (Dose and route not specified). The patient was given ZOSTAVAX (Oka/Merck) instead of GARDASIL vaccine. The reporter noted that this was a case of product confusion because both of the products looked the same. It was reported that both vaccines were in the freezer and were the only medications in the freezer. It was reported that the medications were not next to each other but close and the colors "similar." The nurse picked up the wrong medication. There were no adverse reactions reported. Additional information has been requested.