chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic anaphylaxis; A spontaneous report was received from a consumer, concerning herself a 77 years old female patient, who received Moderna's COVID-19 vaccine and experienced allergic anaphylaxis reaction in which the throat is swollen and could not eat and drink liquids.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 MAR 2021 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 030A21A) via Intramuscular route for COVID-19 infection prophylaxis.  On unknown date, she experienced allergic anaphylactic reactions which the throat was swollen and could not eat and drink liquids. She took Benadryl (diphenhydramine) as the treatment.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event was considered to be unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Approximately 2 hours post vaccination patient experienced sore throat, hoarseness, and her tongue felt slightly swollen.  In addition, she complained of bilatteral eye swelling and redness.
Pt received Moderna vaccine at pharmacy. States he developed rash all over body 2 weeks after receiving vaccine.
Vascular Dermititis on leg and blood in urine. Nurse follow up on 05/18/04: Itching.
I travel on 04Jun where the swelling got worst; My feet are swelling/ Then my right hand started having pain and swelling; My left arm and hand which was where I got the vaccine started to hurt/ Then my right hand started having pain and swelling/ pain in two hands; I started getting the pain in my hand, shoulder join, hip and knee joint and foot joint mainly the ankle; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, 2 days after vaccination, patient experienced left arm and hand which was where the vaccine was given started to hurt. Then his right hand started having pain and swelling. All this started in both hands. Last 2-3 weeks Patient started getting the pain in hand, shoulder joint, hip and knee joint and foot joint mainly the ankle. His feet were swelling. Patient stated that this could be a coincidence but very unlikely. Patient had pain in two hands. Patient did not had any issues and not was on any medications. His cholesterol level was good. patient got so many blood tests but they found nothing. Patient stated that his  blood pressure was normal. Patient went to the clinic and they said it was all normal. Patient travelled on 04Jun where the swelling got worst. It would not get better even after 1-2 weeks. Patient heard that he can have symptoms but don't last this long. Doctor's told me it's most likely a reaction to the Pfizer vaccine. They gave me steroids which helped with swelling. He finished the treatment end of June. Although the swelling decrease but pain didn't go away. Patient pain scale is 3-10 9-10  5-6 and sometimes 2-3. Last 2-3 weeks patient started getting the pain in his hand, shoulder join, hip and knee joint and foot joint mainly the ankle. His feet are swelling. The pain and swelling is so bad patient considered going to the emergency. he chose however to go to the clinic in hopes they would give me steroids. It's not good to take too many steroids.  His swelling has decreased by 30%-40%. He stopped using pain killers. He was not sure if it's an underlying condition or not. The patient underwent lab tests and procedures which included blood cholesterol: good on 2021, blood pressure measurement: normal on 2021, blood test: they found nothing, on 2021. I got so many blood tests but they found nothing, pain assessment: 3-10 on 2021, pain assessment: 9-10 on 2021, pain assessment: 5-6 on 2021, pain assessment: 2-3 on 2021. Therapeutic measures taken as a result of events included steroids. The outcome of the event My feet are swelling/ Then my right hand started having pain and swelling, I travel on 04Jun where the swelling got worst were recovering and rest of the events were not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Vomiting-Medium
Tinnitus left ear Hearing loss left ear  Previously never had tinnitus or hearing problems. After about 1 week of 2nd Moderna dose I developed Tinnitus and loss of hearing
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 15-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
In October of 2021 I went in for my routine visit for my bloodwork to monitor my ALT. My doctor noticed that my levels were slightly elevated and said that we needed to keep an eye on this. In January the same thing happened, I went in for my routine visit for my bloodwork, as my ALT was even higher than before. In April and again in July my numbers continued to climb higher, my doctor order an ultrasound of my liver. I went in for the ultrasound in January 2023. It was confirmed, my liver was enlarged, I have a fatty liver. I was advised to take alpha lipoic acid, exercise, clean up my diet. I will be going back for more bloodwork in two weeks.
n/v/headache and presented to UC @ 8pm on 4/11/2021
Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2010, Ocular hypertension (Pressure on eyes), Penicillin allergy and Drug allergy (Darvon allergy). Concomitant products included LEVOTHYROXINE for Hypothyroidism, BIMATOPROST (LUMIGAN) for Ocular hypertension.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) had not resolved.            Patient took her booster shot on 26-Oct-2021 with the batch number 939905 and patient received probably Flu vaccine on Sep-2021.  Patient's dermatologist stated that the hair loss could be due to her immune system was attacking her hair and the that had been worsened and also stated that she would go to take some lab analyses and patient did not had ever COVID positive test or diagnosis.  No treatment had been given for hair loss.
pt recvd vax & in JAN93 pt devel pain & swelling @ inject site w/nausea & vomiting; sx persisted for 2 1/2 to 3 days; also devel dizziness, depressed & overly tired; constantly fell asleep during the day; unable to sleep @ noc; pt recovered
Nurse also reported that two patients received expired vaccine for their booster shots, past 30; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse also reported that two patients received expired vaccine for their booster shots, past 30) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse also reported that two patients received expired vaccine for their booster shots, past 30). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Nurse also reported that two patients received expired vaccine for their booster shots, past 30) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Ding ding ding noise in the head; Very painful headache, Feeling of being cut by something sharp, Banging feeling between his brain and his skull; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ding ding ding noise in the head) and HEADACHE (Very painful headache, Feeling of being cut by something sharp, Banging feeling between his brain and his skull) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TINNITUS (Ding ding ding noise in the head) and HEADACHE (Very painful headache, Feeling of being cut by something sharp, Banging feeling between his brain and his skull). At the time of the report, TINNITUS (Ding ding ding noise in the head) and HEADACHE (Very painful headache, Feeling of being cut by something sharp, Banging feeling between his brain and his skull) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
1st and 2nd dose of Shingrix at less than recommended interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult patient who received Herpes zoster (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, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided but selected as adult as per vaccine indication. The patient received 1st and 2nd dose of Shingrix at less than recommended interval, which led to shortening of vaccination schedule.  The reporter wanted to know how to proceed further. The reporter consented to follow up. No details from patient or vaccination and no further details were provided.
I started to feel flu like symptoms 1 day after shot which never went away and progressively got worse for 3 weeks.  I exsperienced increase flushing, night see rats and fatige. During the 3rd week, I developed chest pain, shortness of breath and flushing.  I was diagnosed with pericarditis as a result of getting a 3rd moderna full dose 3rd booster shot
Patient admitted for worsening COVID 19 symptoms (fever, hypoxia, generalized weakness, chest tightness, dyspnea, nausea, and cough). Patient tested positive for COVID 19 in 4/15/. He received courses of remdesivir and dexamthasone,  Noted by attending physician, suspected patient may not have mounted sufficient immune response with vaccine due to Cellcept.
Moderate to severe pain at injection site. Right shoulder pain is getting worse after 5 weeks. Called doctor and told to try ice. Doesn't help.
Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea 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.
POSITIVE COVID TEST (7/20/21) WITH HOSPITALIZATION (7/22/21)
Patient began excessively clearing throat and coughing within 10 minutes of booster. RN administered 50mg of diphenhydramine. Symptoms briefly worsened to include difficulty swallowing before rapidly improving. No further action required.
This spontaneous report was received from a female patient of unknown age. The patient has penicillin allergy. The patients medical history included hip replacement and back surgery which resulted in the residual pain the back. On an unknown date about 2-3 years ago, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route was not reported). Concomitant medications included medication for high blood pressure, thyroid and Detrol. On an unknown date, the patient developed itchy rash and pain about a week ago. The rash appeared on her arms and legs. Her skin was sensitive and painful to the touch especially on the hip. She saw a dermatologist and the dermatologist could not diagnose the symptoms. The patient mentioned that she just recovered from pneumonia. As a treatment the patient was given Benadryl. The outcome of the other reported events were not recovered. The patient sought medical attention. The causality was not provided. Additional information has been requested.
hypertension, dizziness - occurred ~15 minutes after her first dose; first BP was 166/81, second dose was 158/84;  Taken to ED; outcome unknown
Itching, swelling, and fever. Emp. received shot in employee health office 1/27/10. On 1/31/10, he noticed a red, inflamed, itchy rash all over body. Cream applied at home, rash slightly improved 2/1/10, but still itchy. Hydrocortisone lotion applied, employee will try BENADRYL. Improving, but not yet fully healed.
Evening of vaccination chills, whole body aches, inability to sleep, uncontrolled tremors. Next morning loss of balance, left sided hemiparesis, dysarthria, tremors, and whole body aches, fatigue.
Fever (up to 38.5) for 24 hours, headache, dizziness, joint and muscle pain, strong pain in the left arm where the shot was done, heart palpitations. The only medication taken was Ibuprofen (for the fever and pain).
She's come down with what looks like a bad cold. She's coughing constantly but says she doesn't really feel bad.v
Pt.'s Wife states that after receiving the 2nd dose of Moderna 04/11/2021, started experiencing symptoms 04/17/2021 of right knee pain with difficulty walking, hand numbness in the left hand, and a "twitch" in the mouth. No noted Primary visit/communications.
High temp for two days after shot and then low grade temp for three days Headache  Nausea  Chills Body aches Joints hurt Left eye became bloodshot and hurt Cold sores inside and outside of mout
Retinal Detachments Right eye, treated by emergency laser procedure/laser photocoagulation, outcome - good. Symptoms - visual impairment from retinal detachment, affecting job performance until treatment recovery for months.
On 1/12 pt had pain at the injection site, radiating to bicep and rotator area wtih constant pain 5 on a scale of 10.  On 1/13 pain increased to a 7 out of 10 and on 1/14 pt could not lift arm.  On 1/15 pt packed shoulder in ice and took Advil with relief. On 1/16 pain decreased to a 6 out of 10 and kept decreasing until 1/22 on which day there was no pain noted just tenderness at the site.
The client reported that the next day she developed dizziness. The client states she had experienced approximately 4 episodes of dizziness that last about three minutes each. The client states the episodes of dizziness happen almost daily. The client also stated she felt nausea the day after the vaccine. The client also reported "ringing in her right ear" about one week after she received the vaccine which resolved after about 40 seconds. The client denied any injuries related to the dizziness. The client stated there have been episodes of dizziness where she had to sit down. The client described the episodes of dizziness "like I'm floating." Vitals obtained  were as follows BP 120/70, HR 81, and O299%. The client did not report shortness of breath after the first dose of COVID vaccine Pfizer.
My son had severe regression in his language skills.  He lost the ability to read words that he had been able to read prior to vaccination
Patient felt dizzy and unsteady shortly after receiving the vaccine.  Starting later that evening and in days following patient lost much of her bodily fluid.
Patient stood up and felt lightheaded; She experience pain in the throat and the stomach. Gave 2 (25 mg ) Benadryl to the patient immediately. She also took 1 (500 mg) acetaminophen to help with the pain. Told the patient to sit down and take a deep breathe in and out. Observe her for >30 minutes to make sure that she was okay. Symptoms improved after 15 minutes
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FDO809) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE. Past drug history included: Kenalog, reaction(s): "Known allergies: kenalog". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: rebound COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. as Paxlovid from 14Jun202 to 19Jun2022.
Patient came to get his 2nd dose on 11/29 and he stated that he started to have headache, breathing problem, chest pain, chest congestion with slight cough few hours after his 1st dose on 11/08. He brought an ER visit from 11/10/21 and the ER discharge report shows he had complete blood cell count, covid test, EKG, and x-ray done. Per patient he was told that everything came back normal. Pt stated that his symptoms resolved after 5 days
Liver seems to hurt more; Sharp, intermittent pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC PAIN (Liver seems to hurt more) and VACCINATION SITE PAIN (Sharp, intermittent pain at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Fatty liver.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sharp, intermittent pain at the injection site). On an unknown date, the patient experienced HEPATIC PAIN (Liver seems to hurt more). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Jan-2021, VACCINATION SITE PAIN (Sharp, intermittent pain at the injection site) had resolved. At the time of the report, HEPATIC PAIN (Liver seems to hurt more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old male patient who experienced extreme flushing in the limb where the vaccine was administered. At 3 months of age, the patient received the second dose on 6/21/2005 Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 6/21/2005. Dose regimen was 1 dose intramuscular. Concomitant therapy included Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection). On 6/21/2005, five minutes after the administration of the Prevnar vaccine, the patient experienced extreme flushing of the limb. This event occurred in the same limb as where the Prevnar was administered. The child was taken to the ER. Outcome was unknown. No additional information was available at the time of this report.