chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/4/2022- Patient reported numbness, tingling and discomfort at injection site. When RN returned call it was discovered that the patient started experiencing pain, numbness, and tingling in her arm at injection site on Tuesday, 8/2/2022 (24 hours after injection) that continues to radiate down her arm. She's tried Tylenol and ice, but nothing is helping. She was not able to sleep due to this. Provider gave order for Medrol Dose Pack which was sent to the pharmacy.  8/12/22- Patient phone call. Still complaining of pain at injection site, discomfort with lifting arm, and reports her arm throbs at night and wakes her up. Provider recommended office visit. Patient notified; OV scheduled for 8/15/22. Patient was currently taking OTC Ibuprofen 4 tabs (200 mg each) every 6 hours having only some pain relief. Provider sent in Medrol dose pack and see if responds to this    alternate ice /heat to area 15 minutes three times daily. Use OTC lidocaine gel to help with pain at night.  8/15/22- Physician saw patient following complaints of shoulder pain affecting ability to work. Gabapentin prescribed.  8/19/22- Patient phone call. No improvement in pain or ability to sleep from Gabapentin, called provider. Provider recommended increase in dose and referral to Ortho for possible should injection. Appt scheduled for 9/19/22.   9/16/22- Pt called in to state she was discontinuing Gabapentin because it was no longer helping her symptoms.
14 hours after injection I had normal reactions of headache, nauseous, fever, body ache, but I also had every joint hurt even my knuckles I couldn't bend my fingers neck was stiff I couldn't turn my head and I had the heart palpitations like a racing heart.
8/20/21: Admitted to hospital c/o generalized weakness over the last week. found to be COVID positive on 8/19/21. Diagnosed with: sepsis, hypoxia, acute COVID-19.   Note: patient vaccinated with Pfizer COVID-19 vaccine on 3/11/21 and 4/1/21.  8/24/21: Discharged
Developed swelling, redness and warth of the arm and and face. No difficulty breathing, no swelling of the eyes, lips or tongue.
ringing in my left ear; This spontaneous case was reported by a health care professional and describes the occurrence of TINNITUS (ringing in my left ear) 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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced TINNITUS (ringing in my left ear). At the time of the report, TINNITUS (ringing in my left ear) 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.   No concomitant medications were reported. No treatment details were provided.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.  Moderna vaccine was  pulled from the freezer on 13-Oct-2021 with a 'use by date' of 12-Nov-2021(30 days storage viability in the fridge).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received contains no new information
Pt presented to pharmacy 9/26/18 and said she thought she might be having an allergic reaction to the flu shot recieved on 9/20/18. She said she started feeling very itchy over the weekend (around 9/22/18) and the only thing she could contribute it to was the flu shot. I advised for the patient to take some BENADRYL and counseled on signs and symptoms should the allergy progress (wheezing, trouble breathing, swelling, chest tightness) and told her to seek immediate attention should a reaction occur.
Information has been received from a pharmacist referring to herself, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose and route unknown). On an unknown date, the patient developed a rash on her (unspecified if left or right) arm. The rash became itchy. The outcome of the events was unknown. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Thursday and Friday had a sore arm. Saturday, muscles ached and arm was red and hot from shoulder to elbow. States allergic to eggs, but eats baked products with eggs and eats 1 egg a week.
Palpitations, anxiety, and dizziness. BP 144/76 (pulse 66), and stabilized after receiving albuterol.
Mom reports that pt recently received his MMR and within about 10 minutes he started coughing and the coughing progressed, mom then noted he had developed hives and they returned to the clinic where upon arrival he was noted to be wheezing, he was given Benadryl and a nebulizer treatment containing Albuterol, but it continued so they decided to administer Epinephrine, 0.2mg IM in thigh.  Mom states that from the time the presented until all was stable was approx 30 minutes or less. Mom states they typically do not vaccinate but due to his heart problems he has received several of his vaccines and never had a problem. Mom states he has even had a flu shot and no problems. Mom states they are vegan but on occasion he will eat products that contain eggs without any problems. Pt has not had any problem with any of his other vaccines that he has received:  DTaP, Pneumovax, Flu Shot.
Patient was vaccinated in the upper left thigh.  It took a long time for the vaccine "bump" to go away. No illness at the time of vaccine on 06/27/2011, though there was redness/swelling at injection site, and he was tired all day and didn't want to eat.  Those are all things that we're told are "normal" so I wasn't too worried.  06/28/2011 patient awoke in the night screaming that his leg and foot were hurting! I didn't think it had anything to do with the vaccine at that time.  After his pain returned randomly, for a while (almost a year I believe) I took him in for x-rays of his feet and ankles, and I spoke with his pediatrician about possible deficiencies, and arthritic issues, that might have been causing the pain.  Patient had labs done, which came back normal, and there was nothing abnormal on his x-rays.  Dr. suggested shoes with arches.  That did not fix the issue.  Not until patient had his second Hepatitis A vaccine on 06/28/2012 did we (his parents) realize the cause of the pain.  It has been almost 6 months since that final Hepatitis A vaccine was administered, and random occurrences of the injection site swelling correlate to the pain in his leg and foot.  The pain is almost exclusively in the left leg and foot.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with MMR II (lot # K010319, dose and route of administration not provided) that may have been improperly stored for the month of June 2015. No adverse symptoms was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from same reporter link (1507USA004579). Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 14th May 2018, refer case US2018190915). On 24th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms (serious criteria other: serious as per reporter). On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported but it could be 76 years or 77 years. The patient experienced flu like symptoms. The first two days the patient stayed in the house resting. Less than a month after receiving vaccination, the patient's arm was sore at the injection point. The patient was back to normal after two weeks. The patient was otherwise in good health. The side effects were much more serious with the 2nd vaccine. The reporter reported that initial reason he called GlaxoSmithKline was the lack of availability for the vaccine. The case has been linked to the cases US2018GSK229696 and US2018GSK229702, reporter by the same reporter for patient's wife.
pain on the arm that she got the PNEUMOVAX vaccine in; This spontaneous report has been received from a pharmacist referring to a female patient of unknown age. Information about medical history, concurrent conditions and drug allergies was not provided. Concomitant therapies included influenza virus vaccine (reported as flu vaccine).      On an unknown date in October 2019 (reported as last year), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date and dose details were unknown) intramuscularly for prophylaxis (reported as prevention of pneumococcal disease).      On an unknown date in October 2019 (reported as one year ago), the patient experienced pain on the arm that she got the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine in. It was unknown that if any treatment was given.      The outcome of the event was unknown. The causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Infant asymptomatic and resumed breastfeeding 2.5 hours after vaccination; This spontaneous case was reported by a physician and describes the occurrence of EXPOSURE VIA BREAST MILK (Infant asymptomatic and resumed breastfeeding 2.5 hours after vaccination) in an 8-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE VIA BREAST MILK (Infant asymptomatic and resumed breastfeeding 2.5 hours after vaccination). On 26-Jan-2021, EXPOSURE VIA BREAST MILK (Infant asymptomatic and resumed breastfeeding 2.5 hours after vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medication were reported. Infant (8.5 months old) exposed to the reporter's breastmilk remained asymptomatic.   This case was linked to MOD-2021-029952 (Patient Link).; Sender's Comments: This is a case of product exposure via breast mikl with no associated adverse events. Patient will continue to be contacted for further monitoring of adverse events.
4" diameter rash on the arm centered around the site of the site of the shot, with moderate pain.
Presented to the ED on 4/18/21 with tachycardia and shortness of breath.  Found to have bilateral DVTs and bilateral pulmonary emboli - confirmed with imaging. As a result, was found to have obstructive shock with presumed right heart failure.  She received 50mg of systemic TPA along with catheter directed thrombolysis.   Remains critically ill in the ICU.
Parents heard baby moaning, went into room and found baby seizing and febrile, seizure last appx 5 min with 20 min post ictal period, did not call 911, grandfather who is a doctor examined baby in the morning.
Patient had a positive COVID test on 2/3/2022 and expired on 2/20/2022.
Tinnitus, ringing in ears, full feeling sound like noise outside of ears started shortly after the booster, and is continuing into week 4 post booster. Gets better with neti pot treatment but still there.
The patient stated with a rash a week later after reciving the small pox vaccine on the 3rd of June 2016. Clobetasol and Atarax were prescribed by PCM. Pruritic rash continued to spread on the patients arms and legs. The PCM prescribed Prednisone and a follow up within 48 hours.
rash seems to be coming back; rash 9 days later, went away in 3 days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash 9 days later, went away in 3 days) and RASH (rash seems to be coming back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced RASH (rash 9 days later, went away in 3 days). On 02-Feb-2021, the patient experienced RASH (rash seems to be coming back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Jan-2021 for Rash, at an unspecified dose and frequency. On 29-Jan-2021, RASH (rash 9 days later, went away in 3 days) had resolved. At the time of the report, RASH (rash seems to be coming back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded. Location of rash not reported and as appeared 9 days after vaccination the event conservatively kept as "rash" rather than coding to vaccination site rash
Information has been received from a physician concerning a 5 year old male patient who on 13-OCT-2005 was vaccinated with the first dose of VARIVAX (Merck). On 12-AUG-2010 the patient was vaccinated with the second dose of VARIVAX (Merck). Secondary suspect therapy included: MMR. In approximately September 2010 after receiving two doses of VARIVAX (Merck), the patient developed severe chickenpox. He also developed "strep" throat along with chickenpox lesions all over his scalp. The patient had no fever. The patient sought unspecified medical attention. There was no lab diagnostic test performed. The patient was prescribed with AUGMENTIN and BACTROBAN. At the time of report the patient's status was recovering. Additional information has been requested.
Headache, Sedation, Arthralgia, eyes burning, chills, sore arm Narrative:
2.5 weeks after first shot developed Shingles.; cellulitis; This is a spontaneous report from a contactable other-health care professional (Patient). A 45-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0162 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 21Apr2021 15:45 (at the age of 45 years) as single for covid-19 immunisation. Medical history included HTN and asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included candesartan taken for an unspecified indication, start and stop date were not reported. Patient had known allergies. 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 08May2021 the patient experienced shingles 2.5 weeks after first shot and cellulitis. The adverse event result in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. Patient received Valtrex and antibiotics for cellulitis. The outcome of the events was recovered on unspecified date of 2021.   Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
SOB, numbness and rash in arm where vaccine was administered. Referral to allergist for allergy testing.
approximately 26 hours after immunization, patient had first of 3 seizures lasting 15-25 seconds. patient normally has not had seizure for 34 days (since taking doxycycline).  Husband and wife reported to pharmacy 5/30 approximately 3 pm.
couldn't lift my arm over my head; excruciating pain.; very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night; dehydration; fever; chills; extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.) and INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), CALCIUM, ASCORBIC ACID (VIT C) and ZINC for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.), INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night) and DEHYDRATION (dehydration). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow) had not resolved and INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.), INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night), DEHYDRATION (dehydration), PYREXIA (fever) and CHILLS (chills) outcome was unknown.
Covid19 breakthrough.  1st vaccine received on 01/02/2021.  80 y/o with PMH Hypothyroid, CHF, HTN, Type 1 DM, DVT, DJD, osteoporosis, Hypo-pituitary, HLD, anxiety, spinal stenosis, Hydrocephalus, VP shunt, melanoma presents to ED with c/o worsening SOB.  Pt was recently discharged from hospital Covid +, received Regeneron and 2 days of Remdesivir.  Now requiring O2 at 4L nc.  CXR with bibasilar patchy opacities.  Treated with IV ABX and steroids.
bad arm pain; Pain at injection site; This is a spontaneous report from a contactable consumer or other non HCP (patient reported for herself) Pfizer sponsored program.  A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2; Solution for an injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on 23Feb2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2; Solution for an injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on 02Feb2021 for covid-19 immunisation. Patient reported that she received first dose of the COVID-19 vaccination 02Feb2021 and then her 2nd dose 23Feb2021. After the 1st dose she did experience sick like symptoms with a fever and headaches that resolved. On 23Feb2021, patient experienced bad arm pain was intermittent although it continued to persist and affect her ability to raise her arm after the 2nd dose of the vaccine. Patient also had pain at injection site and its not going away post second vaccine on unspecified date in Feb2021. Patient wanted to know what she could do for the pain. At the time of this report, outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Pain at injection site the day of injection, but the pain lingered on and continues now. It is affecting the patient's activities of daily living. She has been using rest, ice, and ibuprofen without much relief. It is difficult for her to actively raise arm above shoulder height. To note, the patient and I work in the same clinic so we discussed her symptoms over the course of a few days. Her husband has been encouraging her to seek an evaluation for the pain, but she did not since she works in a clinic.
Roughly 10 minutes after the injection, the patient stated that she felt funny. We had her sit on the bench while we brought her a cup of water. She stated she felt dizzy and nauseous. We provided her with a small garbage can while standing over her. She had a seizure, we held her so she wouldn't slump and fall. Another associate in the pharmacy called 911 so the patient was not left unattended. Patient again stated she felt dizzy, knew the name of the pharmacist, but did not recall having the seizure (shaking, etc.). After another 5 minutes she had another seizure (each approximately 20-30 seconds). After this she desperately wanted to go to the bathroom. We escorted her to the pharmacy bathroom while waiting for the ambulance to arrive. She was able to go on her own and walk with assistance.