chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US024265, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 91 year old female patient. Her medical history and concomitant medication were not reported. Her previous vaccinations (unspecified) were well tolerated. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscular in left deltoid at a dose of 0.5 ml on 14 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history and recent vaccination site.
Administered vaccine to patient, after administration realized patient had already received a Moderna bivalent. Patient was unaware of vaccines received prior and only one vaccine card was visible prior to vaccination. Patient has now had two Moderna bivalent vaccines. Patient was not having any symptoms and is aware of situation.
Per patient's report, he was shaking so hard that he had to sit on his hands.  The next day his chest hurt due to all the shaking. Fever of 103 evening of the vaccine.  Felt unsteady and "terrible" for 2 weeks post vaccine administration.
SYMPTOMS OF HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, Laboratory data included: Blood test (not provided) Not Reported, CAT scan (not provided) Not Reported, and Lab test (not provided) Not Reported. On 01-SEP-2021, the patient experienced symptoms of headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms of headache. This report was non-serious.
Pt recvd vax & exp pruritus; next day exp a lunar-shaped fluid filled blister (half moon shape);
Fever of over 99 throughout the night and 100.5 early next morning. Muscle weakness overall body, mainly arms and legs. Very tired for next 24 hours.
My normal menstrual cycle was about 3 days. First day was heavy. After the vaccine, my cycle lasts about 7 days. It's heavy for several days and very clotty. It was not clotty before. Since the vaccine (after my period), I am having a thick clear discharge for at least a week.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Keeps her up at night), CHEST PAIN (Chest pain under left breast), PAIN (Pain is pretty intense) and MYALGIA (Aching and muscle pain in her legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse (Patient had a history of mitral valve prolapse which she has had for several years.). Concomitant products included IBUPROFEN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Keeps her up at night), PAIN (Pain is pretty intense) and MYALGIA (Aching and muscle pain in her legs). On 13-Mar-2021, the patient experienced CHEST PAIN (Chest pain under left breast). At the time of the report, FEELING ABNORMAL (Keeps her up at night), CHEST PAIN (Chest pain under left breast), PAIN (Pain is pretty intense) and MYALGIA (Aching and muscle pain in her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Pt given adult dose of vaccine versus peds dosing. No issues with 15 minutes of vaccine. Per Father patient did have fever at home, was whiney and did more hand holding than normal, was "unlike himself".  Per Mother patient was feverish and lethargic, disinterested in stuff similar to past vaccinations, no reaction at injection site.  Per Father and Mother fever controlled with Tylenol.
Narrative:  Patient received Moderna COVID vaccine #1 on 1/6/21 and #2 on 2/3/21. There are no further scanned records or notes in medical records since 2/3/21. Date of death is recorded as 3/7/21. No autopsy reports. Time from second vaccine to date of death is 32 days.
ataxia, irritable, mood swing, hand got bluish intermittantly; was hospitalized for 2-3 days; CAT scan, MRI, blood work= all WNL; no neuro consult; no work dx;
Sore arm; Light lower back pain; Muscles aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BACK PAIN (Light lower back pain) and MYALGIA (Muscles aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included FLECAINIDE for an unknown indication.    On 09-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 PAIN IN EXTREMITY (Sore arm), BACK PAIN (Light lower back pain) and MYALGIA (Muscles aches). At the time of the report, PAIN IN EXTREMITY (Sore arm), BACK PAIN (Light lower back pain) and MYALGIA (Muscles aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medication was not reported.   This case was linked to MOD-2021-024726 (Patient Link).
She noted a flare in her urticaria and also onset of dermatographic urticaria 11 days after she received her third dose of Moderna mRNA COVID-19 vaccine which led her to present to the ER where she received treatment with H1 and H2 antihistamines and prednisone.
Seen in ED for COVID 19 symptoms and positive test. Fully vaccinated April 2021.
Patient developed an infection at the injection site, accompanied by redness, swelling, pain, and cellulitis.  She was treated with Keflex starting within five days of developing the infection.
The patient received dose #2 of shingrix vaccine on Wednesday June 12th. She woke the next morning not feeling herself and having bad headaches and weakness. Upon getting up, she passed out and lost consciousness. She was taken to the emergency room where she was admitted to the hospital and kept overnight for observation. She was discharged on Friday and returned home.   On Monday, she was still not feeling herself, having weakness and headaches. She went back to the emergency room where she was re-admitted on Monday and an MRI was performed. She stayed hospitalized overnight and was discharged on either Tuesday or Wednesday with a final diagnosis of a concussion likely due to side effects from dose # 2 of Shingrix. She is still experiencing symptoms of headaches without other explanation and is taking 2 Tylenol every 4 hours to help the pain.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 21-MAR-2014, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degree C from 15-MAY-2013 to 21-MAR-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. A follow ups requested to complete the case were received.
tooth ache; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced a tooth ache on unspecified date and after he got the shot they told him not to take paracetamol (TYLENOL) or anything, but didn't say for how long. He need to know if he can take paracetamol. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
11/24 - reported pain/hurt through out arm since shot given on 10-22-08. Has not taken anything as of yet. Saw doctor within last few days - MD said it could take up to 3 months to get better.
migratory arthralgia in right foot; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (migratory arthralgia in right foot) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ammoniacal dermatitis (Allergic to ammonia in Hair dye), Myasthenia gravis on 01-Jan-2012 and Lymphoma.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ARTHRALGIA (migratory arthralgia in right foot). At the time of the report, ARTHRALGIA (migratory arthralgia in right foot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's relevant concomitant medications weren't reported Treatment medication include Benadryl before and after vaccination.
Pt was given TIV fku vaccine 10-3-08.That night she had chest pain, dyspnea,dysphagia.  Went to ER and was given breathing treatment,IV's and injections.In ER again with heart pounding dysphagia and dyspnea on 10-06-08.  Okay after breathing treatment.  Sent home with epi pen and albuterol inhaler.  Office visit 10-17-08 pt doing well.  She was instructed to continue with prednisone tapering dose.  Also given Rx for benadryl and cimetidine.  She is instructed to not have the flu vaccine again and to follow in office prn.
Initial unsolicited report received from a consumer on 17-Mar-2015. A male patient (age not reported), whose medical history and concomitant medications were not provided had received a dose of INFLUENZA VACCINE (batch number, dose details, expiry date, route and site of administration was not provided) on an unspecified date. On an unspecified date after vaccination, the patient developed cold. It was reported that the patient felt like he was on fire when he took Tecfidera. He also had diarrhea. He had taken Copaxone for a year and the number of lesions he had increased. He was "feeling like pin cushion" when he was on Rebif. He also took AUBAGIO for multiple sclerosis. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event: cold was reported as unknown. Documents held by sender: none.
7/19/18 RN accidently gave a single antigen HIB vaccine in addition to a PENTACEL vaccine today. TC to MOC and informed of vaccination error, to have MOC monitor child for any increased side effects, and call clinic if she has any concerns. RN to contact MOC next week to check on status of child. 7/24/18 TC to MOC. MOC stated child is "fine" and experienced no significant side effects from the vaccinations given on 7/19/18. Advised MOC to call clinic if child develops any concerning side effects. No further follow-up needed.
nausea, headache, and my arm hurt really bad, I've gotten dizzy, my feet and ankles were swollen, tired, my hands hurt, my eyelids were swollen and interfered with my vision. I still have a bit of a headache.
Fever, sweating, nauseous, headache, joint pain, stomach pain, upset stools
Subsequent to receiving one dose of varicella virus vaccine live the pt developed 50 - 100 skin lesions on the arms, feet, hands, legs and face that were described as not being vesicular; they look like a hive with a head and is questionable if they are fluid filled. The lesions have erythema at the border and are the size of a dime to a quarter. The lesions are not located in the typical areas of chickenpox such as the groin. The pt was treated with Atarax.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included rheumatoid arthritis (patient takes prednisone for this). Concomitant products included prednisone. On 28th July 2018, the patient received the 1st dose of SHINGRIX. On 2nd August 2018, 5 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the erythematous rash was unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the pain in arm and chills to be related to SHINGRIX. The reporter considered the erythematous rash to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who herself was patient. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced sore arm and chills. On 2nd August 2018 in morning, the patient woke up and found four or five red bumps on her abdomen that look similar to bug bites but did not itch and on the same day she was seen by her gastroenterologist for a regular appointment, and the physician noted it appeared to be a reaction to the SHINGRIX. The patient declined to provide physician and noted she was willing to answer any follow up questions or details needed for the report. The patient had denied permission to contact their physician.
tested positive; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 27Apr2021, as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 09May2021, patient was tested positive. Patient was schedule for the second dose of the vaccine on 18May2021. Patient wanted to know if she needs to go to the facility on that schedule. The outcome of the event of tested positive was unknown.  No follow-up attempts were needed. Information about lot/batch number could not be required. No further information was expected.
chills; pain; heaches; This case was reported by a physician via sales rep and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced chills, pain and headache. On an unknown date, the outcome of the chills, pain and headache were recovered/resolved.   It was unknown if the reporter considered the chills, pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had chills, pain and headache for 2days. The reporter did consent to follow up.
Patient deals with intense anxiety and stated he does have a fear of needles. After giving him a few moments to calm down until he was ready, the vaccine was administered and the patient seemed fine and was even joking with his girlfriend in the clinical services room. Had the patient take a seat and moments after his girlfriend told us he fell off the bench. I ensured his airways were clear and the patient was starting to sit up and was responding. No Epipen or Benadryl needed. He was pale and sweating profusely. I gave the patient some cold water to help cool him down. He did not want us to call the ambulance because he knew he would get better. I determined the patient had not yet eaten today so his blood sugar was already low and his fear of needles only intensified the situation. I gave him a bag of fruit snacks to get some sugar into his system. He was perking up just fine and normal breathing . After about 5 to 10 more minutes of observation the patient left feeling fine. Recommended some Tylenol and Advil.
25 Mom phoned said patient "broke out in hives and blotches" while driving home from PCP office. Resolved by the time arrived home. 27 Mom phoned said temp. 101.7 on 3/26/14. Afebrile today. (L) arm red at top of arm (i.e. at DTaP-IPV injection site). Advised MOTRIN and cold compresses. Picture sent by mom. Dr reviewed pictures 3/27/14.
administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 37-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 24th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 24-FEB-2023 Reporter's comment: The reporter asked how to proceed with the patient and requested safety information of two doses of Twinrix given the same day. The reporter consented to follow up. The HCP did not confirmed if the patient would receive the non-expired Twinrix dose on the same day. Additional Supportive Information: The nurse reported that an expired Twinrix dose was administered to the patient, which led to expired vaccine used.
We found the first Moderna primary shot was given on 10/22/22 while it was 4 days passed after Beyond Use Date 10/18/22 by a pharmacist. I checked the patient if he had any adverse effect but he only had usual side effects of headache, body aches, tiredness, sore arm. After taking Ibuprofen he felt fine next day. I reported to Moderna and they performed activity test on the very lot (083B22A) and concluded the activity has been maintained to protect the patient from Covid 19. We concluded this patient doesn't need any additional vaccination and just need to complete the 2nd shot for the primary series.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2014, the patient was treated by a Physician assistant for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Painful L arm; Pain at injection site (L arm); Itchiness at injection site (L arm); Swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful L arm), VACCINATION SITE PAIN (Pain at injection site (L arm)), VACCINATION SITE PRURITUS (Itchiness at injection site (L arm)) and VACCINATION SITE SWELLING (Swollen at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management. Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and PARACETAMOL (TYLENOL) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful L arm), VACCINATION SITE PAIN (Pain at injection site (L arm)), VACCINATION SITE PRURITUS (Itchiness at injection site (L arm)) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, PAIN IN EXTREMITY (Painful L arm) and VACCINATION SITE PRURITUS (Itchiness at injection site (L arm)) outcome was unknown and VACCINATION SITE PAIN (Pain at injection site (L arm)) and VACCINATION SITE SWELLING (Swollen at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication includes compound of water pill and blood pressure pill.   This case was linked to MOD-2021-048256 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported potential local injection site reactions with SHINGRIX which described as redness, pain, and swelling. The reporter was unable to clarify if the patient was involved or not and was unsure of any patient or product information.