chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of  unknown age. Information regarding the patient's pertinent medical history was not provided. On 08-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously. Lot number, strength and dose were not reported. Information regarding concomitant medication was not provided. On 09-OCT-2013, the patient developed blisters. The patient sought medical attention, she saw the pharmacist. No treatment was given for the event. At the time of report, the patient was recovering from blisters. Additional information has been requested.
Post vax, in approximately 2000, the patient developed shingles. Unspecified medical attention was sought. No additional information is expected.
No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding unspecified patients of unknown demographics. The patients' concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 12-SEP-2019 and 13-SEP-2019, the patients were inadvertently vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 and lot # R018931, expiration date: 02-JUL-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). All lots of varicella virus vaccine live (oka/merck) (VARIVAX) were reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccines underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  The case is considered non-valid, as no patient identifiers were provided.   Upon receipt of follow-up information on 24-MAR-2020 from medical assistant it was determined that this case is now valid because patient identifiers was reported. The case is regarding a 16-year-old male patient. On 12-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951 and expiration date: 16-APR-2021.  This is one of the several reports received from the same reporter.
Sudden head and shoulder jerks and head drops.  Lucid look for a couple of seconds after head drop.
Pt started to have low grade fever (101 F) post vax, then went up to 103 F one day post vax. Had shaking, rolled eyeballs, and foaming from mouth which lasted at least 4 minutes. Pt developed skin rash 4 days post vax.
elevated T- 17Jan @ 6pm T 100, 17Jan @ 9pm T 100, 18Jan @ 10am T 101, 18Jan @ 2pm T 103, 18Jan @ 3pm T 103-4, Tylenol @ 230 pm. F/U 22Jan91 Fever resolved over wkend, stated mom
Patient reports injection site soreness followed by severe burning pain in L arm from posterior L shoulder to fingertips immediately after receiving anthrax vaccine.  Pain lasted for six hours; pain severity 8 to 9/10.  Pain was less severe the following day, however, pain caused limited mobility.  Patient could not move L elbow above/superior to L deltoid.  Patient used Tylenol and Aleve PRN to control the pain.  During 28-29 July, patient reports a decrease in pain and increase in mobility.  30 July, patient states pain was 3/10, with full mobility.  Patient did not seek medical attention until today.  Reports minor soreness in the L deltoid at this time.
71-year-old male with chronic COPD and CHF presents to the emergency room with worsening shortness of breath.  This is his fifth admission to the hospital for similar issues this past year.  Has been having increasing shortness of breath and accessory muscle use.  Started to have some increased confusion and family brought him into the emergency room.  Noted to be hypoxic with hypercapnia.  Received bronchodilator in the emergency room and placed on NIPPV.  Had COVID back in March and incidentally tests positive again here today.  No fevers, chills or purulent sputum at home.  He has a history of mechanical aortic valve replacement.  He was treated with Decadron and Remdesivir during hospital admission in March 2022 for COVID-19.  He required thoracentesis for bilateral pleural effusions.
Approximately 5 minutes after receiving vaccine felt dizzy, did not feel well. Vomited multiple times and had diarrhea, developed hives on chest and face. I spoke with father at 1PM, no face or lip swelling, no drooling or wheezing, no difficulty breathing. Instructed them to go immediately to the ED. In the ED received Epinephrine, zofran, IVF and benadryl, observed for 5+ hours.
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. From an unspecified date in June 2015, the patients were administered an unspecified number of improperly stored doses of PNEUMOVAX 23 (lot # L014458, expiration date 11-FEB-2017; strength, route and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested
Feverm, irritability 8-10 hrs after shots. ER visit next day 05/24/02. Lab: see below #12. Dx. fever, leukocytosis. Rx: Rocephin IM 05/24 and 05/25.
pt. recvd 2nd dose of M-M-R II 19MAY89 & dx w/ mumps 14NOV90,hospitalized w/ pancreatitis.
Patient stated that he had felt dizzy after first vaccine (Jansen) and had not had anything to eat/drink before hand.   Instructed patient to get a bottle of water and take a few sips.   After immunization, patient stated that he was starting to feel dizzy.  Lowered his head, dropped water bottle and fainted.  Patient remained in seated position and came to in about a minute.  Disoriented for first few seconds.  EMS was called.  Patient was evaluated/ declined transfer.  Called family member to pick him up from Pharmacy.
T104 & gen malaise day p/vax;temp subsided w/OTC rx p/4hr approx;
Had routine reaction immediately post vaccine (pain, redness, nausea, muscle aches, fever, etc) that recovered. Then, on 7/12/21, she started to experience pain, redness, and some swelling again but this time there was some pain on the right side as well. Pain originating from deltoid and radiating through arms and shoulders. On 7/16/21 the pain was worsening and she was no longer able to perform daily activities as well as would cry if her arms were even slightly touched. she was referred to the Urgent Care who did testing for illness and muscle conditions which came back normal. She was screaming through trying to get bloodwork due to the pain which is atypical for her and they sent us to the ER for pain with unknown origin. ER physician said all neurological processes were normal and was concerned for Complex Regional Pain Syndrome so he wanted an urgent follow-up with Primary Care. on 7/19/21 Primary Care suggested delayed response to the vaccine and referred her to Neurology. On 7/22/21 Neurology decided it was a delayed immune response to the Covid vaccine and prescribed Prednisone to start today 7/23/21.
Feel kind of achy/some achiness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22-MAR-2023, the patient received the 2nd dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Feel kind of achy/some achiness). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient got second shot yesterday. The patient feel kind of achy but he/she would rather go through some achiness versus shingles. The patient stated that please get the shot. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information
Chronic pain in pelvis area. Pins and needles on left thigh . Fatigued but unable to sleep. Brain fog.
Email received in the mailbox on 23Jun2023 at 5:26 pm with possible AE from social media. Report verbatim: "message from social media "about to get @Merck 's MMRII vax for my 2 month old unless someone can convince me not to." See atta; This spontaneous report was received from a consumer referring to a 2-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age).
My left neck gland swelled up about an hour after receiving my vaccine. It went away quickly. I woke up at 2 am on 3/5/21 with a strange headache right over my neck. I took Tylenol for the headache but then I could not go back to sleep. The following day the headache was gone but I was very tired and lethargic (3/5/21 & 3/6/21). I also had a fever on the afternoon on 3/5/21, it was 99 degrees maybe 100 degrees. I took Tylenol for that. All symptoms were fine by 3/7/21.
Rash, hives, burning sensation starting at crown of head and ending up at feet 5 minutes later. Rash covers over 90% of my body. Reaction started almost exactly one hour after injection of seasonal flu shot. I have experienced the same reaction every 8 days since the initial reaction.
Patient's son who is a physician came in to report side effects to vaccination on 10/25/20 around 11AM.  He stated that a couple of hours after receiving the vaccination his mother began experiencing  shaking and chills that lasted a few hours.  Patient also experienced swelling around the eyes, tongue, and lips as well as sore throat.  Only patient allergy listed is to Codeine and no other medication or food allergies known.  She was evaluated my a physician and they are monitoring her at home.
Swollen, itchy, hot spot under my injection site.; Swollen, itchy, hot spot under my injection site.; body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 12:00 (Lot number: Ff2590) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos thyroiditis" (unspecified if ongoing), notes: Other medical history: Hashimotos thyroiditis; "Nickle Allergy" (unspecified if ongoing), notes: Known allergies: Nickle. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EW0158, prev dose lot unknown: False, prev dose administration date: 08Apr2021, prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 08Apr2021, when the patient was 39 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er8727, prev dose lot unknown: False, prev dose dose number: 1), for Covid-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 14Nov2021, outcome "not recovered" and all described as "Swollen, itchy, hot spot under my injection site."; PAIN (non-serious) with onset 14Nov2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 14Nov2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of injection site swelling, injection site pruritus, pain, fatigue.  Additional information: No other vaccine in four weeks and other medications in two weeks was levothyroxine. It was reported that, patient was swollen, itchy, hot spot under her injection site. 3 inches by 2 inches. She first noticed it about 36 hours after her booster shot. Its been about 20 hours since that and it was still there. She experienced body aches and fatigue before that. No covid prior vaccination and not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning an unspecified number of patients who on an unspecified date were vaccinated with a dose of VARIVAX (Oka/Merck) instead of a dose of ZOSTAVAX (MSD). No AE was reported. Upon follow-up, the nurse reported that she could not recall the specific number of patients or patient identifiers
Hallucinations; This serious case was reported by a nurse via sales rep and described the occurrence of hallucination in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received Arexvy and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant). The outcome of the hallucination was resolved (duration 1 hr).   It was unknown if the reporter considered the hallucination to be related to Arexvy.     It was unknown if the company considered the hallucination to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter reported that the patient received Arexvy vaccine accompanied with an unspecified flu vaccine and experienced hallucinations. The reporter stated that she did not know when the hallucinations started after administration of Arexvy vaccine.   The reporter stated that the patient thought she was on fire for an hour and then hallucinations resolved. It was unknown if the reporter considered the hallucination to be related to Influenza vaccine. This case was 1 of 3 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023152424:Same reporter( 2 Of 3) US-GSK-US2023152427:same reporter( 3of 3)
6-7 days post vax, the pt developed a fever up to 104. She had vomiting for 2 days, was sore to touch all over. She developed a rash which started in chest area. Her throat and tongue was red. She was taken to ER and treated with an injection of antibiotic.
Moderna COVID?19 Vaccine EUA I have sciatic and have had a rhyzotomy on my right side. On 15 Jan, exactly one week after receiving the vaccine, I began to get back and leg aches from my sciatica, but on my left side.  I immediately began my routine (exercise) and back brace which usually stop the pain. Over the next two day, the symptoms got worse to the point of extreme pain in my back and all down my left leg.  This resulted in a trip to the emergency room on 17 January.  I have since had an appointment with my pain specialist, and an MRI.  We are awaiting results from the MRI.  The pain has not lessened, and pain medication are only mildly effective. The pain being in my left side make since as the Rhyzotomy had been done on my right side.  I am concerned the vaccine may have cause tissue or nerve swelling. Pain is still intense to the point of immobility and difficulty sleeping.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-FEB-2015 a dose of ZOSTAVAX (0.65 ml, lot # not reported) was administered in the area of patient's arm that was slightly different than was recommended in prescribing information and pharmacist suspected that dose might had been administered intramuscularly rather than subcutaneously due to location of administration. The pharmacist could not be certain if dose was administered intramuscularly but stated that area of the arm used for injection was slightly different than deltoid region of upper arm. The pharmacist did not specify the exact location of administration. No adverse effects were reported. Additional information has been requested.
Shivering (1/2 hour+) , extremely painful movement, headache, sore throat, fatigue, painful shoulders and neck,  body aches, low grade fever.  I have been experiencing a sore throat and headaches, dizziness, weakness, and breathing okay but chest hurt.  Ran through the most extreme of these within a 24-period.  Still lingering is headache, sore throat, body aches, very painful neck and shoulder area.
Arm swelling continued; Injection site red; Injection site Itchy; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling continued), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE ERYTHEMA (Injection site red) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swelling continued), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, PERIPHERAL SWELLING (Arm swelling continued), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE ERYTHEMA (Injection site red) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  Treatment in: Ice, and Benadryl for redness.
Information has been received from an immunization Officer concerning an unknown number of patients who, on unspecified dates might have received a dose of ROTATEQ, Oral (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports form the same source. The other linked reports are: 1211USA005919, 1211USA006714, 1211USA006715 and 1211USA006717. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
On 10/17/2001 the patient complained of her left arm being red and swollen after taking the flu and pneumonia vaccines. The patient states she also ran a fever. The patient's arm was painful and tender. The patient was diagnosed with cellulitis. The patient was treated with Keflex and Diflucan.
(L) thigh red, swollen, 4x6 cm, the injection site it is the middle region. Rash was first noticed the AM of 1/11/18. No fever, vomiting, diarrhea, difficulty breathing or swallowing. Given sample of ZYRTEC.
40 minutes after vaccine administration - throat began to close up , BP dropped , face flushed, diaphoretic  Emergency response called , oxygen via nasal cannula administered , Epi Pen 0.3 mg given to Right thigh Taken to Hospital in - Additional solumedrol and Famotidine given as throat began to swell again around 1505 and 1530.  Discharged on Prednisone and Epi pen - advised to follow up with allergist/PCP
Received Moderna booster on 12/14. Noticed that I felt itchy at the base of my scalp along my hairline and in my groin the afternoon of 12/24 after showering. Itching resolved on its own. After washing my face before bed I noticed that my eyelids were red and swollen. I went to bed and the itching returned. It began in my armpits and spread all over my back then to my groin. My hands felt like they were burning and my forearms began to ache. Didn't sleep well. Woke up the next morning slightly itchy but it wasn't until after I showered that morning that I developed intensely itchy hives. I noticed these in my armpits, along my neck, chest, and along the skin folds of my groin. I took a zyrtec and applied anti histamine cream which resolved the itching. The itching returned in the evening most significantly in my groin and armpits and the hives had turned into large angry red rashes in those areas. I also developed heartburn which was not responsive to tums, bicarbonate, apple cider vinegar or pepcid (all of which typically resolve these symptoms for me). I took 2 benadryl at bedtime and slept well. I awoke on 12/25 with continued heartburn and pain in my esophagus when swallowing. I took another zyrtec that morning. The rash in my armpits remained angry red. The itching returned in the afternoon. I also felt as if I had a fever/chills but temp was lower than usual at 96.9. The itching became a painful burning and along with heartburn, I developed 6/10 aching in both forearms. I took 2 ibuprofen and used a heat pack to relieve the symptoms. 12/27 I felt better. I have continued with zyrtec daily and protonix along with tums. The rash flares along my hairline/neck after I shower and tonight (1/4) I noticed my face was red and slightly swollen. My hands and forearms are itchy today as well. Heartburn has been present nightly since 12/25 but the pain in my esophagus is gone. I have managed the symptoms at home with otc medications but will be seeing my PCP if they persist. I have no known history of rash, skin, seasonal or food allergies, urticaria, dermatitis etc.
Gave patient expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included BUDESONIDE, LISINOPRIL and OMEPRAZOLE for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) had resolved.        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.   Treatment details were not provided.   This case was linked to MOD-2021-276704 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Patient's demographic details and Patient route of administration was added.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 05-SEP-2012, was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX23 (lot number 669579/0595AA) that was expired. The vaccine expired on 30-AUG-2012. The patient was not experiencing any known symptoms. Additional information has been requested.