chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus after each dose; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus after each dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (breaks into pinkish rash). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TINNITUS (Tinnitus after each dose). At the time of the report, TINNITUS (Tinnitus after each dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Carbohydrate antigen 125: Normal. In November 2020, Carbohydrate antigen 19-9: normal. In November 2020, Carcinoembryonic antigen: normal. In November 2020, Computerised tomogram: normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient did not had any COVID-19 test or diagnosis previously. Tinnitus after each dose, it was so loud, took 3-4 months. Reporter reported that patient had went to the acupuncturist for Tinnitus.   This case was linked to MOD-2022-613185 (Patient Link).
Atypical chicken pox disease after receiving Varicella vaccine on 5/22/02.
Patient reported feeling "quievering" on right side of face a few minutes after receiving 2nd dose of Moderna. Patient said symptoms lasted about 10 minutes then went away. She was monitored for a full 30 minutes before leaving with her companion without further incident.
Presents @1730 With temp 100.4 after taking 2 8hr tylenol @ 1640 C/o chills, fever body aches, headache.  No redness or edema at site of injection.  Spoke with Pt on 11/10/04 stated had temp of 103 night before with total body hives, nausea,and chest flutters. Pt instructed to take Benadryl 50mg and Tylenol 1000mg every 6 hours. Inst if difficulty breathing occured go to emergency room.
Today my arm has a knot; Arm itches; Soft, tender area near collar bone; Swollen area near my collar bone; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jul-2021 and was forwarded to Moderna on 25-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Today my arm has a knot), PRURITUS (Arm itches), TENDERNESS (Soft, tender area near collar bone) and SWELLING (Swollen area near my collar bone) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB MASS (Today my arm has a knot), PRURITUS (Arm itches), TENDERNESS (Soft, tender area near collar bone) and SWELLING (Swollen area near my collar bone). At the time of the report, LIMB MASS (Today my arm has a knot), PRURITUS (Arm itches), TENDERNESS (Soft, tender area near collar bone) and SWELLING (Swollen area near my collar bone) outcome was unknown.            No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
My next menstrual cycle after the shot was 14 days and the last two days were clots. I had large blood clots coming out. I also have low blood pressure, I got up in the middle of the night and ended up fainting and hit my head on the wall and concussed myself. I ended up with a mild concussion.
pounding, fast heart rate/heart got up to 125-130s not just in the low 100s; tightness in her throat and chest; tightness in her throat and chest; pounding, fast heart rate/heart got up to 125-130s not just in the low 100s; This is a spontaneous report from a contactable nurse.  A 36-year-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated on behalf of her niece inquiring about receiving the second dose of the Pfizer Covid-19 vaccine following a side effect from the first dose. Caller reported that her niece received her first dose of the vaccine and experienced a pounding, fast heart rate. Caller states "she actually had multiple symptoms. Her heart got up to 125-130s not just in the low 100s, she had tightness in her throat and chest." Caller asked should she get the second dose?. At the time of this report event outcome was unknown.   The lot number for the vaccine, was not provided and will be requested during follow up.
Flushing, hives, and facial swelling starting about 7-10 days after injection that lasted 6+ weeks. Triggers include touch, pressure, heat, and stress. PCP appointment 11/15/21 with recommendations of oral Benedryl, topical cortisone cream, and unscented laundry detergent. Consult with allergist 12/9/21 for persistent symptoms. Unable to complete skin testing 2/2 too reactive.  Prescribed Allegra 2-3x/day and Famotidine 1x/day, as well as further reduction of environmental allergies, including avoiding high histamine foods.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021 at 9:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.83 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of cognitive impairment in a 58-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 3rd July 2018, the patient received the 1st dose of SHINGRIX. On 5th July 2018, 2 days after receiving SHINGRIX, the patient experienced cognitive impairment. On an unknown date, the outcome of the cognitive impairment was recovered/resolved. It was unknown if the reporter considered the cognitive impairment to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient was unable to remember numbers or do math in his head. He could normally calculate tips in his head, but he was unable to do so for about a week then his memory and math ability returned. His physician did not know if he should get the 2nd dose of SHINGRIX or not.
Initial and follow up information ahs been received from a Registered Nurse concerning a 26 year old female patient who on 06-NOV-2006 was vaccinated IM in the left deltoid with her first dose of Gardasil, lot #653735-0688F. Concomitant therapy included FLOVENT, albuterol, omeprazole, clindamycin, and DIFFERIN. The patient experienced severe pain and significant discomfort from her neck to her fingers on her left arm after the vaccination. Her symptoms lasted approximately two weeks. medical attention was sought. The patient stated "I ... cut back a little on what I did", however she was able to maintain her normal activities of daily living. She did not take any treatment medications even though it was painful to lift her arm. Due to the severity of her symptoms, the patient was apprehensive in receiving her second dose of Gardasil. She has not yet received her second dose. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a Registered Nurse concerning a 26 year old female patient who on 06-NOV-2006, at 8:15 AM, was vaccinated IM in left deltoid with her first dose of GARDASIL, (lot #653735/0688F). Concomitant therapy included FLOVENT, albuterol, omeprazole (MSD), clindamycin, and DIFFERIN. The patient experienced severe pain and significant discomfort from her neck to her fingers on her left arm after the vaccination. Medical attention was sought. The patient stated "I ... cut back a little on what I did"; however she was able to maintain her normal activities of daily living. She did not take any treatment medications even though it was painful to lift her arm. As of 20-NOV-2006 her symptoms resolved. Due to the severity of her symptoms, the patient was apprehensive in receiving her second dose of GARDASIL. At the time of this report, she has not yet received her second dose. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on an unknown date, see case US2019GSK027110). Concurrent medical conditions included degenerative disc disease (discs in neck slightly compromised). On 29th January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, shoulder pain and injection site bruising. The patient was treated with paracetamol (Tylenol) and trolamine salicylate (Aspercreme). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, injection site pain, shoulder pain and injection site bruising were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, shoulder pain and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX in the left deltoid. The patient had the typical symptoms she had the first time also, soreness and redness at injection site. This time however, she was getting worse on day 6. The patient was experiencing a sharp pain around her left scapula radiating up to her neck. The patient reported some discs were compromised already before SHINGRIX. The bruise at the injection site still had not gone away. The patient could not get comfortable in bed a night before the date of reporting and so she took one Tylenol which was unusual for her to do. Her husband rubbed some Aspercreme on the affected area. The patient mentioned she had some blood work done recently and would see her primary doctor on 6th February 2019. The patient declined to provide pharmacist's name and did not think there was an issue with technique. This was all the information the patient wished to provide and she would callback to provide additional information after seeing her physician. The patient declined the prescriber's information.
Left arm began to get sore less than 5 min after the injection it continued to be sore for the next 2 days.   3 hours after the shot I had a headache, became very tired and irritable.   6 hours after the shot I started to experience body aches.  Whole body was achy through the night and until about 7 pm the following day.   Waking up the following day I was still very tired. I experienced chills from 9 am to 5 pm.  No fever. The second day following the vaccine I became itchy all over my body.  No noticeable rash.  This lasted just that one day.
Rec'd pneumonia vaccine on 8/20/15. Started having pain and swelling within 24 hrs. Now on 8/23/15 pain is 9/10 and (R) deltoid with erythema & swelling. Painful to touch.
36 hours of fever, chills, rigors, sweats. Generalized pain and malaise. But this is not the adverse event I wish to report. There was hyperacusis with tinnitus.  The tinnitus has continued for 3 months. Also the vaccine has caused my wife to mumble. I can hear her speaking, but have to ask her to repeat herself - this is a daily occurrence.  Previously I had mild tinnitus that was only audible in quiet situations when I was inactive (laying in bed before falling asleep. It is now constant.
Left arm soreness onset 2 hours post injection. Chills and fatigue onset 3 hours post injection. Fever 4 hours post injection. 24 hours post injection still feeling fatigue, sore arm, and chills.
Cellulitis around DTaP site - 8cmx4cm indurated, warm, tender, swelling at left deltoid, noted 2 days after immunization in office. No fever. Patient was admitted to hospital for IV antibiotics. 2/10/06 Review of d/c summary confirms diagnosis of cellulitis of left upper arm treated with Clindamycin. Patient was discharged one day following admission.
"Yesterday, April 3, I noticed a large rash on my left arm where I received the vaccination. It is itchy, warm, and annoying, but nothing more severe than that. "
A hive type rash on her neck, both legs, both arms, elbow about 24 hours. Treatment: 50mg Benadryl Q6 PRN after 3rd HPV, urticaria type rash.
Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited; Felt I wanted to vomit and then I vomited; Chills; Had a bowel movement, it felt soft; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes, and acid reflux from an unknown date. Concomitant medication included hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) for hypertension, labetalol for hypertension, metformin for type 2 diabetes, and pantoprazole for acid reflux. It was reported that the patient took the shot on Friday, 22Jan2021 and everything was fine, felt fine. Today, 24Jan2021 the patient was requested to call because on Saturday, 23Jan2021, the patient woke up, and got herself something to eat. The patient took her medication as normal and may be about, after she ate a meal, took the medicine (unspecified medication), the patient felt she wanted to vomit and then she vomited, she felt chills. She immediately had a bowel movement, it was like soft. She just wanted to just lay down and she went on and she just went to work because she was thinking it is just a shot and it will subside but she did want to get to work and felt she cannot do it. She came home and this morning (24Jan2021) and just felt a lot of tightness under her breast. She did not know if it had anything to do with it? Her heart rate is elevated a little it is like 104 because she is hypertensive. The patient reported that she did not have treatment and was going to go and get an X-ray as to why she is feeling this tightness under her breast. The patient underwent lab tests and procedures which included heart rate: 104 (elevated) on 24Jan2021. The outcome of the events was unknown.   Information on Lot/batch number has been requested.
PT fainted after observation time on her way out.  PT became alert immediately and was in no physical difficulty.  No pain reported, PT stated she had not eaten since early morning.  Vitals taken BP 122/74 O2 100% on RA HR 71  PT offered snacks and water then observed for another 15 minutes.  No difficulty reported.  PT stated she usually faints after receiving a shot.  PT was released after instructed to call for medical attention in case of any further distress.
a few sore arms for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms for a day or two".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300149591 same reporter/drug/event, different patient;
1 of 2 pts vaxed from the same vial exp a 15cm area of swelling, redness & induration (size of half dollar); swelling extended from deltoid to elbow; resolved w/in 72 hrs; tx included warm soaks; afebrile; no culture taken; pt recovered;
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: ears clogged
hives, resp problems treat w/hydroxyzine HCL albuterol;pneumonia: treat w/erythrityl 400;
Not Feeling Well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not Feeling Well".  Additional information: The first one did make me feel bad for a day or two but the second wasn't bad at all. Patient's Other medications, Past Medical History, Family History, Social History, Other relevant information were unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patchy rash with wheal and flare hive reactions in several places appeared on the torso bilaterally. Other areas appeared the same itchy rash on the inner biceps, forearms, waist band and inner thighs.  Antihistamine of Chlorpheniramine maleate 4mg resolved the rash in 30 minutes. This re-occured weekly side July 23, 1 day after testing positive for COVID-19. 5-7 days later, the rash would re-appear in smaller areas but on the torso, inner bicep, waist band but would resolve within 1-2 hours without an antihistamine.  Rash now re-appears in smaller patches but still on the inner bicep and torso.   No other symptoms were associated other than (during COVID-19) headache and fatigue. Treatment was only self-treatment with antihistamine and hydrocortisone 1% cream
moderate sized erythema to left thigh . 8 cm raised wheal, old compress was applied for 30 minutes and Benadryl 1tsp given po .
Higher than authorised dose volume administered of the correct formulation Pharmacist gave patient 0.5ml of vaccine instead of 0.25ml The booster dose of Moderna COVID vaccine is 0.25ml. But the pharmacist gave her 0.5ml as if the first dose No adverse sign/symptom reported to the pharmacy
a little itchy; body rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a little itchy) and RASH (body rash) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (a little itchy) and RASH (body rash). At the time of the report, PRURITUS (a little itchy) and RASH (body rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   This case was linked to MOD21-034959, MOD21-029945 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-jun-2021 , contain No new information
Admitted for treatment of hematuria and altered mental status on 4/21/21 When we were preparing to discharge patient to nursing facility, he had a COVID-19 test that returned positive (PCR) even though he was vaccinated (3/5/21; 4/2/21) and had COVID-19 in January.  The patient only stayed in the hospital because of the positive COVID test. Patient was placed on isolation however he never displayed any symptoms of COVID infection.  Repeat COVID swab on 5/7 was negative.
LEFT ACHILLES  PAIN - PATIENT DID NOT COME INTO OFFICE  HE WORE HIS WALKING BOOT FOR 2 DAYS UNTIL PAIN STOPPED
Moderna COVID?19 Vaccine EUA sharp sudden menstrual cramping, swollen breast and swollen nipples.