chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at site, arm, shoulder and back under the arm on right side became sore and remains this way. Limited range of motion. Has become a chronic condition. Thought it was like bursitis. Got to thinking what could have cause it! No injury to area. Ice helps temporarly but I have limited range of motion. Symptoms are like an impingment or torn rotator cuff..pain and muscle spasms going from the right side of the neck clear under the right arm. I have not sought tx for this yet..but after reading about this adverse effect..I may have to IF there is a tx for it. Some of my co-workers have been affected the same way.
1 of 2 pts who devel inject site react; pt devel severe erythema & tenderness @ inject site-size of reaction unk; tx included APAP & alcohol compresses; not seen by MD;
approx 10 minutes p/receiving vax fainted & jerked arms few times; pt was given adrenalin; BP was 168/70 ER MD dx vasal vagal syncopal episode; pt unresponsive;
This spontaneous report was received from a pharmacist and refers to a 31-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-AUG-2011, the patient was vaccinated with the first dose of VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). On 07-JUL-2017, reported also as "6 years later, the patient was vaccinated with the second dose of VARIVAX (dose, frequency and route of administration were not reported) lot # N014368 and expiration date: 09-MAY-2019. Both two vaccines were reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. No causality assessment was provided by the reporter.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt was adminstered vaccine in store, remained inside store for about 6 minutes and then left. Upon leaving pantient reported to have fainted while driving.
COVID-19 Vaccine  headache, chills, fever, body aches particularly along the spine, fatigue  Advil taken to help relieve symptoms. Lasted two days.
esophagus ulcer; Initial information regarding this unsolicited valid courtesy non serious case received from Regulatory Authority from Other Health Care Professional via Pfizer (US-SA-SAC20211126000608) and transmitted to Sanofi on 23-NOV-2021.  This case involved 75 years old male patient who experienced esophagus ulcer while receiving vaccines COVID-19 VACCINE and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and while treated with clopidogrel bisulfate.  The patient's past medical history included Eyelid ptosis on 03-JAN-2020.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Hypertension on 03-JAN-2020.  Concomitant medications included atenolol (tenormin) for hypertension; famotidine (pepcid ac); and atorvastatin calcium (lipitor).  In August 2020, the patient started taking clopidogrel bisulfate unknown 25 mg daily via unknown route unknown (with an unknown batch number and expiry date not reported) for Prophylaxis. On an unknown date, the patient received dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported and expiry date not reported) for prophylactic vaccination.  On 06-Oct-2021, the patient received dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot 30155BA via unknown route in the left deltoid for prophylactic vaccination.  On an unknown date the patient experienced serious esophagus ulcer (oesophageal ulcer) following the first dose intake and following the last dose intake of clopidogrel bisulfate. This event was assessed as medically significant. The patient was hospitalized for this event. On an unknown date the patient developed a serious esophagus ulcer (oesophageal ulcer) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and (unknown latency) following the administration of COVID-19 VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Relevant laboratory test results included: Endoscopy - On 23-Oct-2021:  [Unknown]  clopidogrel bisulfate was discontinued in October 2020.  It was not reported if the patient received any corrective treatment for the event  At time of reporting, the patient recovered from the event.  No further information was provided; Sender's Comments: Sanofi company comment dated 03-Dec-2021: Considering the positive temporal relationship between the unlisted event and the suspect drug, the contributory role of the drug cannot be excluded. However, contributory role of underlying medical conditions from past medical history and concomitant medications cannot be denied either.
Patient had 2 doses of Moderna COVID vaccine on 5/4/21 and 3/31/21.  Patient admitted to the hospital for COVID resp failure on 2/17/22
Information has been received from a registered nurse referring to two patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot# H021861 and expiration date 09-OCT-2015, strength, dose and route unknown). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
outbreaks that presented at alternating parts of her bodies, more often at the join; Itchy; nauseous; Rash; Injection site erythema; Heat below the injection site; Swelling (approximately a 4-5 inch width); This case was reported by a consumer via call center representative and described the occurrence of rash in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Benadryl for antihistamine therapy.   Previously administered products included BENADRYL with an associated reaction of nausea (She described that she has a known problem with taking Bendaryl her whole life - it has caused her to be nauseous when she as used it before prior to receiving vaccine.).   On 4th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th October 2019, the patient started Benadryl at an unknown dose and frequency. On 6th October 2019, 2 days after receiving Shingrix, the patient experienced rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb, vesicular rash and itchy. In October 2019, the patient experienced nausea. The patient was treated with hydrocortisone. On an unknown date, the outcome of the rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb and vesicular rash were resolved with sequelae and the outcome of the itchy and nausea were recovered/resolved.   It was unknown if the reporter considered the rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb, vesicular rash, itchy and nausea to be related to Shingrix.  Additional details were received as follows: The patient two days after receiving the first dose of the Shingrix vaccine developed a rash, swellling, redness, and heat below the injection site. The area affected had approximately a 4-5 inch width.   The patient went to her physician the next day and was prescribed an antihistamine and hydrocortisone. The patient stated that she took Benadrayl as the antihistamine and it causes her to get nauseous and she threw up once. The patient also began to experience outbreaks that presented at alternating parts of her bodies, more often at the joints (ankles, knees, wrists, and elbows) but also on the tops of her hands, and her buttocks, too. The outbreaks was presenting as a red area with a pox in the middle and it is itchy. The have decreased in frequency and severity and she has not had any outbreaks. The patient consented to follow up. The patient gave permission for her physician to be contacted. The patient did not have the lot number for the Benadryl and indicated that it could have been the generic, diphenhydramine. The patient said that she only took one capsule daily when she took it.
Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/23/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-9 and she will consider getting revaccinated.
THE PATIENT CAME WITH COVID SYMPTOS AND TESTED FOR COVID ON 7/30/2021 THE RESULT CAME POSITIVE COVID
Administration of the Rotarix Diluent Alone; inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the Rotarix Diluent Alone) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152363:Different patient US-GSK-US2023152368:Different patient US-GSK-US2023152371:Different patient US-GSK-US2023152370:Different patient US-GSK-US2023152365:Different patient
Symptoms began between shoulder and neck. High sensitivity to noise in the left ear.  Discomfort behind left ear for 2 days. 3rd day, tongue and lips were numb. 4th day left facial paralysis. Went to Urgent Care. Diagnosed with Bells Palsy.
Received KINRIX on right thigh during nurse visit on 4/28/17. Patient developed swelling, redness and itching near injection site. Erythema noted as 10 cm x 10.5 cm.
Rolled over while sleeping and the room was spinning. Happened 2 more times and when I woke up & sat upright again. It?s been happening every night, but rarely during the day.
9/22/02 Patient had low grade fever, left arm weakness, muscle spasms, uncontrollable movement, numbness in left arm, hand and fingers. Also had muscle contraction in left jaw.
COVID-19; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 05-OCT-2022. The patient's weight, height, and medical history were not reported. On an unspecified date in 2021, the patient was previously treated with elasomeran (Moderna covid-19 vaccine) (Dose number in series 1) (Form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered for covid-19 prophylaxis.  On an unspecified date in 2021, the patient experienced pericarditis with the following vaccination elasomeran (Moderna covid-19 vaccine) (Dose number in series 1). The patient had pericarditis twice but did not specify the timing of the two incidences. The patient had received first booster with covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received second booster with covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. The drug was associated with Off label dosing frequency (Dose number in series 3). No concomitant medications were reported.  On an unspecified date in MAY-2022, after receiving second booster with covid-19 vaccine ad26.cov2.s, the patient had Covid-19 and also experienced symptoms phlegm and tiredness (Dose number in series 3). Laboratory data included: three confirmatory tests that the patient had were all negative (2 negative at home tests and 1 negative PCR test) (Covid-19) (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and off label dosing frequency was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000254110. The suspected product quality complaint has been confirmed to be voided (this report describes adverse events for the patient. Based on information obtained during outreach, the reporter stated they did not have any positive covid test/diagnosis. Since there is no positive confirmatory test for covid, there is no product quality issue reported) based on the PQC evaluation/investigation performed.
Muscular and joint pain in shoulders and upper arms (bilateral). First observed about 36 hours after injection. Persists as of 1543 EST, 15 JAN 2021
extreme muscle pain for 24 hrs . started immediately as minimal and increase to extreme within 3 hrs. face felt numb for about 20 minutes after receiving shot that lasted 15-20minutes. there was a tingling sensation present during the numbness in the center of my forehead. possibly related: experienced light nosebleed day after shot. three days after shot experienced a heavy nosebleed with very large clotting.
received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's comment: The pharmacist reported that the patient received expired dose of Boostrix by error. The lot number was not available.  No other information was available now of the call.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered an expired dose of Boostrix by error, which led to expired vaccine used. This case is 1 out of 4 cases reported by the same reorter.; Sender's Comments:  US-GSK-US2022146819:same reporter US-GSK-US2022AMR147251:same reporter US-GSK-US2022AMR147250:same reporter
At approximately minute 13 in the 15 minutes of observation after receiving the vaccine my face started to swell around my mouth. Blood pressure was elevated (150/100) and I was observed for about 40 minutes until blood pressure was within normal limits and facial swelling subsided.  No treatment was given other than the observation and several blood pressure readings.
Heavy nosebleeds. I thought due to dryness of cpap air. Dr said he thought due to Nasonex spray. Told meto reduce dose fr 2 sprays each nostil to 1 spray each daily. I did and two days later had another bleed. So I quit using Nasonex altogether w/o Dr. Order. Had used Nasonex for 20 yrs. Dr. Also told me to use saline mist spray several times daily and I have been doing so. And he suggested increasing humidity level on cpap and using a sleeve to prevent condensation build up in tubing. I complied.  I have not had a nosebleed in 2 weeks, after have 5 over approximately a 2 week period.
Legs ache, very fatigued, swollen lymph nodes in back of neck on both sides.
Patient received vaccine at 5:29pm. She immediately reported a funny taste in her mouth. She was monitored for 15 minutes. At 5:44PM the patient still had a funny taste in mouth, but no other symptoms. When pressed further she said she had some numbness in her tongue, but no swelling or tingling. The patient was given 50mg Benedryl by mouth and then monitored for 15 additional minutes. At 6pm the patient stated that she felt better and wanted to go get something to eat. At that point I let her leave the immunization area.
I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, exhaustion for 4 days. shot given on Wednesday and not able to shower or get up till Sunday Second shot symptoms more severe. Headache, sick to my stomach vomited, and exhaustion same thing shot given on Wednesday and not able to get up till Sunday. First 24 hours of the second shot I was so weak I good not get up even to get a drink.
Initial medication error report received on 12 November 2013 from a pharmacist. A patients whose, gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (route, lot and site of vaccination was not reported) on an unspecified date. She thinks they gave 1 of 2 patients 4 months old liquids in the same syringe as 1 injection and no Acthib. List of documents held by sender: none.
This spontaneous report was received from a physician via a company representative referring to a 12 month old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 03-MAY-2018, the patient was vaccinated with VARIVAX for prophylaxis (dose, route of administration, lot # and expiration date were not reported).  On 16-MAY-2018, the patient developed chickenpox (varicella). The patient went to the physician's office on the same date. It was unknown if any treatment was given for the event. No laboratory/diagnostic test was performed. At the time of reporting, the outcome of the event was reported as not recovered. The causality assessment between the event and VARIVAX was not provided.
It was as high as 210/105 but always high; Realized loss of certain smells Felt like I was jumping out of my skin; My inflammation number was 29 and should be under 2; Stress test bad; Realized loss of certain smells; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 15Mar2021 10:00 (at the age of 67 years) as single for covid-19 immunization along with patient also received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 23Feb2021 13:00 (at the age of 67 years) as single for covid-19 immunization. Medical history included autoimmune issues from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 10Apr2021 the patient experienced blood pressure during third week of April. It was as high as 210/105 but always high but Generally 185/92 and realized loss of certain smells felt like patient was jumping out of my skin and patient stated that my inflammation number was 29 and should be under 2 and stress test bad. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. On unspecified date the patient underwent lab tests and procedures which included blood pressure measurement found to be 210/105, blood test was 1.5 on inflammation numbers down dramatically to 1.5, cardiac stress test which was found to be bad, and echocardiogram found to be good, and electrocardiogram was fine as per report. Patient treatment received Various heart related tests and blood work for the adverse event. The outcome of the events was not recovered.    The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
11Dec90 pt vax w/ hepta B; 12Dec90 exp rt arm going asleep for aprox. 2 sec, twice a day.  Continued until 18Dec90.  Rt side of face went to sleep for 1 sec.  No tx.
Shortness of breath, dry cough, pleural chest pain progressively worse. Developed tachypnea over course of 4 hours refractory to Xopenex and O2 support palliated only with BiPAP. ARDS type picture on chest x-ray.  7/24/2008 D/C summary received for DOS 7/17-20/2008 with D/C DX: Acute Respiratory Distress Syndrome. Pt presented with worsening shortness of breath, dry cough and pleural chest pain which began that am along with sleepiness and upset stomach. Upon arrival in ED O2 sats were in the 80s and pt was in respiratory distress with tachycardia. No improvement with Xopenex nebs and supplemental O2. Transferred to higher level of care. Fever noted on admission. RR in the 50s. PE (+) for accessory mucle use, decreased breath sounds and tachycardia. Pt put on BIPAP with improvement in WOB and RR. Lasix given for pulmonary edema with good effect.  Slowly weaned to RA and d/c for outpt f/u.