chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tinnitus which was pretty loud and severe, still occasions when she experiences it and it can be maddening sometimes.; itching; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus which was pretty loud and severe, still occasions when she experiences it and it can be maddening sometimes.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21C and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced TINNITUS (tinnitus which was pretty loud and severe, still occasions when she experiences it and it can be maddening sometimes.) (seriousness criterion medically significant), PRURITUS (itching) and PAIN (Soreness). At the time of the report, TINNITUS (tinnitus which was pretty loud and severe, still occasions when she experiences it and it can be maddening sometimes.) had not resolved and PRURITUS (itching) and PAIN (Soreness) had resolved.            No concomitant medications were provided. Treatment for the events were not provided. It was reported that, the most disturbing is the tinnitus which was pretty loud and severe. She states that it has gone for a bit but there are still occasions when she experiences it and it can be maddening sometimes.  Company comment: This is a spontaneous case concerning a 56 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition, as reported by the patient) unexpected, according RA, event of tinnitus. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-403774 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 56 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition, as reported by the patient) unexpected, according RA, event of tinnitus. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Breakthrough COVID case: When I woke up in the morning I had body aches, sore throat, I was sneezing and I was congested. I was also experiencing a lot of coughing. I took an off brand of Nyquil. I did lose my appetite. I stayed home for two weeks. My symptoms lasted from 01/01/2022 until 01/06/2022. I decided to go to urgent care and to get tested, but I wasn't able to get in to get tested so I called the nurse practitioner and they set an appoint for me to get tested for COVID. My appointment was on 01/14/2022. I received my results a couple days later and they came back positive. They told me to quarantine for 2 more weeks and take over the counter cold medicine.
Irritable bowels and stomach upset. Diarrhea in which anti-diarrhea medications do not seem to help. I have had this going on from 2/27 until now. I keep thinking it will go away, but so far it has not.  Also, back in March of 2020, I had all the symptoms of Covid19, but was unable to get tested. Is there a way to find out if I ever had it, going that far back?  If this keeps up, I will need to see a doctor.
Pain, color change, tenderness, swelling and edema. TX: KEFLEX, NEOSPORIN, CLARITIN.
Pt described as "urgent evacuation of total bowel" about 15 hours after vaccine, also experienced chills and left work early.
Booster given greater than 12 hours post puncture of vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours post puncture of vial) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours post puncture of vial). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours post puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-416295 (Patient Link).
Preterm Labor; Pregnancy; Initial Report Received on 02-DEC-2022  This is a spontaneous report received from a Chief Officer from a Hospital in the regarding a pregnant female patient who received HEPLISAV-B for hepatitis B immunisation .   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 17-NOV-2022, dose 1 of HEPLISAV-B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.    When the nurse called the patient to schedule the second dose, the patient stated she was in preterm labor.   No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the events as non-serious.
One week after the vaccination my blood pressure spiked to very high levels and especially in the evening. When going to bed I felt like I can?t breath right. The adverse side effects (blood pressure spikes) came back three evenings in a row. I was close to going to the ER being afraid of a stroke or heart attack.
My normal menstrual period of 5-6 days lasted over 22 days.  16 days longer than normal.  This has never happened before.  I contacted my doctor but did not have any in person appointments.
Pain in arm x 7 days; Had to go to hosp x 5 days;
The day after my 1st dose I had a change in vision in my right eye.  I went to a retina specialist who diagnosed cotton wool spot.  The evening after my 2nd dose I ran a low fever, was nauseas, sore all over (especially in my arm, back, neck & head),lost sense of taste & smell and was exhausted.
chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medications were provided  Action taken with mRNA-1273 in response to the events was unknown
Severe muscle aches, extreme weakness, headache, upset stomach, cellulitis at injection site.
Received 2/1 - by 2/10 dvp 2-3 cm hard lump/induration at site of vaccine, pain 4 out of 10, also had rash 4 d post shot.
Pt recvd Engerix-B vax 17-20 days later exp cutaneous eruption; MD indicated eruption was difficult to classify; it may reflect sweets synd; eruption was not uticarial, not erythema nodosum; was not a morbilliform; Rash was not serum sick
Patient was administered Pfizer vaccine LOT FX5095 EXP 01/31/2023 for third dose in primary series as medication error for patient. As of 12/08/2022, Pfizer 6MO-4YO monovalent vaccine was not authorized to administer for third dose in primary series. Patient was administered Pfizer dose at approximately 3:45PM in office by registered nurse. Patient was monitored for fifteen minutes. Left office with mother feeling well, alert and oriented, and in good spirits.
Patient received pfizer covid vaccine that was past its BUD.  BUD was 11/12/21 @ 1738. Patient received vaccine on 11/13/21 @ 1706.
Chills; Nausea; Fever of 101; Body aches; Headache.
very bad itching sensation starting in my back and then moving all over my body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very bad itching sensation starting in my back and then moving all over my body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very bad itching sensation starting in my back and then moving all over my body). At the time of the report, PRURITUS (very bad itching sensation starting in my back and then moving all over my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the first dose of the vaccine on 28-Jun-2021. After a day or so patient developed a very bad itching sensation starting in back and then moving all over body
Pt recvd 3 doses of Engerix-B 6MAY91; 6JUN91; 12NOV91 & 12NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
patient's husband came in this morning explaining that she had gotten prevnar yesterday and was experiencing swelling in the arm and lots of pain such that she could not sleep all night. Office was called and husband was told to make an appointment for patient to be seen by primary doctor to assess.  1pm- husband told me he would take her to urgent care. he was told to call us back with results
At 2030 last night (7/26/16) he felt dizzy, nausea, fever 103, increased heart rate, face was red, and she had bloodshot eyes and pain in her arm. Today (7/27/16) temp is 99, but she is still having pain in her left arm.
Itchy rash on body and extremities. Occurred the next day after vaccine was administered.
Symptoms began next day-initially aching and stiffness in neck and shoulders.  Following day began feeling weakness and unsteadiness in legs, and tingling and numbness in hands.  Worsened over 3-4 week period.  12/7/05 app't with internist.  He set up spinal MRI, blood tests, and appointment with neurologist.  1/2/06 app't with neurologist.  Diagnosis post vaccinial transverse myelitis.  He set up brain MRI and lumbar puncture procedure, as well as a 12 day program of interveinous and oral steroids. Information from medical records state abnormal gait.msv Follow-up: Transverse myelitis. No improvement.
cough; hoarseness; right ankle is sore; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPHONIA (hoarseness) and MYALGIA (right ankle is sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20 and 029SLOA) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and HYDROCHLOROTHIAZIDE for Hypertension.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced COUGH (cough), DYSPHONIA (hoarseness) and MYALGIA (right ankle is sore). The patient was treated with GUAIFENESIN (MUCINEX) at a dose of 1 dosage form. At the time of the report, COUGH (cough), DYSPHONIA (hoarseness) and MYALGIA (right ankle is sore) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was treated with  cough drops and tea with lemon.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Followup received on 13-Jun-2021 contains no new Information.
Fever as high as 103.5, tachycardia (170s), rapid breathing, mild to moderate facial swelling, extensive rash all over face and body, hives on shoulders and face. All occurred 11 days after vaccines given, and after last dose of 10 day course of amoxicillin. Ear infection also worse by then.
Headache; Throbbing pain in my left arm near injection site.; I felt a fever coming on and when measured had a 99.8 degree fever; Body chills; Sweats; Nauseous stomach; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 08:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. No known relevant medical history was reported. Concomitant medications included birth control. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 03Mar2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 13:00, the patient experienced throbbing pain in the left arm near injection site within a few hours. By the evening the patient experienced fever and when measured it was observed to be a 99.8-degree fever (unspecified unit), body chills, sweats, and a nauseous stomach. On 25Mar2021, the patient had a splitting headache and no fever. The patient did not receive any treatment for the events. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events throbbing pain in the left arm near injection site, fever, body chills, sweats, nauseous stomach and splitting headache were resolving. No follow-up attempts are needed. No further information is expected.
Clinic NP answers call (08JAN14 at 1047EST) re 24 y/o patient who was leaving on 22JAN14. Patient c/o severe HA's, blurry vision and UTI s/p AVA #1 (04DEC13)- does not want any more AVA's. Patient recently granted exemption from SPV (17DEC13), as patient endorsed h/o "eczema/dermatitis" treated with desonide steroid cream and KENOLOG 40 mg steroid shot. Also has taken VALTREX. Endorses "Yes" on SPV screening form questions #9, 10, 10a, 10b, 10c and 10d.
Starting the day after the second dose of Pfizer mRNA, he developed prodrome with fever/chills, N/V/D, systemic macular rash, and fatigue that persisted until presenting to the ED 9 days later.  He was noted to be tachycardic and hypotensive with a severe leukocytosis, elevated inflammatory markers and + troponin, and an LVEF 35-40%. He was referred to tertiary care center, had a cardiac MRI that showed little inflammation but LVEF now 12%.  On 5/21/21 he was started on high dose steroids and placed on mechanical circulatory support with VA ECMO.  Cardiac function quickly improved and he is ready to come off VA ECMO 5/29 with an LVEF improved to > 40% during weaning trials.
1 hour after vaccine sore arm, fatigued, 3 days after vaccine tachycardia ongoing to present day. Heart beats 130 per minute at rest with no anxiety or excersise. Chest pain, short of breath, dizzy. PoTs.
pt recv vax & devel a head cold that moved to chest, fits of coughing & was coughing up phlegm;pt visited MD twice & was dx w/bronchial infect;MD prescribed 3 courses of ATB & cough syrup;blood work was negative x/high uric acid;CXR negativ
Patient presented today (07/30/2021) with a bruise and rash on her arm. She was advised to apply ice and take an antihistamine.
The pharmacist injected the vaccine high up on my arm. It feels like I have a frozen shoulder. It's causing a lot of pain and ibuprofen doesn't help. It's difficult to move my shoulder, especially in the morning.
Redness, in a circular pattern around injection site, measuring 3 inches by 2.5 inches.; Swelling, in a circular pattern around injection site, measuring 3 inches by 2.5 inches.; Itching, in a circular pattern around injection site, measuring 3 inches by 2.5 inches.; Indurated, in a circular pattern around injection site, measuring 3 inches by 2.5 inches.; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Nov2021 at 14:00 (Lot number: 33026BD) at the age of 42 years as dose 1, single for COVID-19 immunisation and the patient also received bnt162b2 (BNT162B2), administered in right arm, administration date 28Nov2021 at 14:00 (Lot number: FH8027) at the age of 42 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) and VACCINATION SITE INDURATION (non-serious), all with onset unknown date in Nov2021, outcome "unknown" and all described as "redness, swelling, itching and indurated in a circular pattern around the injection site, measuring 3 inches by 2.5 inches". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pruritus and vaccination site induration.  Additional Information: Reaction began 72 post injection. There was no drainage and no streaking with pain even with light pressure. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
In February, 1991, the pt experienced hair loss and there has been little improvement. It is still thin. No treatment. She also experienced chronic fatigue (variously dx'd) which began at the end of 2/91, became more severe over time (1994-1997), slight improvement and reached a plateau until began treatment with doxycycline 100mg X 2 daily. After 6 weeks, there was some improvement to the extent that there were no days when I was unable to do anything. I also had nerve and muscle damage and blackouts. It was diffuse at first and seemed to be joint or bone pain. Over time it became more concentrated and wasn't in the joints but in the area of both elbows and both buttocks and hit all 4 places every time. The pain is very severe, hot and burning. My HMO doctor finally received authorization to repeat the EMG test which I did and which showed nerve and muscle damage. The blackouts lasted about 2 hours each time and were preceded by a fist-like pain in my head about 5-10 minutes before. After regaining consciousness, I would be too weak to climb 7 short steps to my bedroom or to eat. I had to sleep on the couch. This stopped within 4 days of self treatment taking 2000mcg of Vitamin B-12/day. I reported this to a doctor and he simply told me to stop taking it. I have tried stopping perhaps 3 times when I was feeling better, but started to feel pain in my head and went back to it. I am still taking it daily.
My period came 2 days early and quite heavy, next period came 3 days early and heavy.  One week after the last period described I have started spotting quite heavily but not a period.  Spotting now for 4 days.
received her second Pfizer covid-19 Vaccine on 5/6/2021 to her left shoulder.  This is what reported. ? I felt a sharp pain at the time of injection, which I did not have with the first dose. The pain in my shoulder increased as the evening went on and woke me up in the night when I tried to lay on my arm. The following day I could not lift and/or move my arm at all without severe pain. The pain was very different than the dead arm feeling I had with the first dose, it was a sharp pain near my shoulder joint (the injection site) and numbness down my arm. I went to the Doctor on May 17, 2021. I had limited range of motion for 2-3 weeks after the injection. I was prescribed an anti-inflammatory that I took for 10 days, regularly iced to control the internal swelling, limited exercise, and had acupuncture around the area to increase blood flow. I have not had any prior shoulder injuries.?
Achiness at site of injection within 30 minutes, muscle aches all over within a couple hours, muscle spasms in all extremities by 11pm, sweats, shaking chills, did not take temperature, headache, felt like eyes going to pop out head. Lasted thru the night and next day. 30 hours before resolved.
My diagnosed essential tremor greatly increased when I received the vaccination and has not diminished or returned to the same state before vaccination.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm , administration date 06Mar2021 at 12:45 (Lot number: EN6202) at the age of 52 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes and "Essential tremor" (unspecified if ongoing), notes: My diagnosed essential tremor greatly increased when I received the vaccination. Concomitant medications were not reported. Past drug history included: Scopolamine, reactions: "Drug allergy", notes: known allergies: Scopolamine.  The following information was reported: TREMOR (non-serious) with onset 06Mar2021, outcome "recovered with sequelae" (an unknown date in 2021), described as "My diagnosed essential tremor greatly increased when I received the vaccination and has not diminished or returned to the same state before vaccination". The event "My diagnosed essential tremor greatly increased when I received the vaccination and has not diminished or returned to the same state before vaccination." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor.  Additional Information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Treatment as a result of reported event included medications (unspecified) to decrease tremor. Since the vaccination, the patient had been tested for COVID-19.
Chills and fever as high as 101 started at 10:30 pm along with skin sensitivity and then deep pain in muscles, joints, & tissue throughout my body & very bad headache. Had mild nausea. Took Aleve for pain, was unable to sleep through the night.  Pain better by next morning, mild fever continued until approx  5 pm the following day. Some headache pain lasted about 20 hours.