chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right arm was aching; lymph node maybe swollen; left arm really hurting after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm really hurting after getting vaccine), PAIN IN EXTREMITY (right arm was aching) and LYMPHADENOPATHY (lymph node maybe swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), IBUPROFEN, AMLODIPINE BESILATE (NORVASC), OMEPRAZOLE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ), POTASSIUM, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), TOPIRAMATE (TOPAMAX), SIMVASTATIN and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm really hurting after getting vaccine). On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (right arm was aching) and LYMPHADENOPATHY (lymph node maybe swollen). At the time of the report, PAIN IN EXTREMITY (left arm really hurting after getting vaccine), PAIN IN EXTREMITY (right arm was aching) and LYMPHADENOPATHY (lymph node maybe swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No treatment medications were reported.  Patient stated she does not want to get her second dose of vaccine which is scheduled for 20-APR-2021.
Pt recvd 3 doses of Engerix-B in 1991 & it was determined that pt was a non-responder; an addtl dose was given & titers are non-reactive;
Day after taking the vaccine he experienced blurred vision. He went to see an opthamologist on June 11th and was diag with Viscus Degeneration.
Member reports going home the night of the vaccine and having a fever of 103, with chills,  and fatigue. The next day the individual noticed swelling in the face, hands were itchy and tingly, and also skin welts in the back and shoulder area. Member went to urgent care and was advised to buy Zyrtec which he stated helped. Member has since recovered and is doing fine.
Dose #3  given too early. Dose #1 was given on 7/28/2022.  Dose #2 was given on 8/25/2022.  Parent aware. No adverse effects reported.
Information has been received from a mother concerning her 19 year old daughter with no known pertinent medical history or known drug reaction/allergies, who on 04-SEP-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included birth control pills. The mother reported that on 02-OCT-2008, the patient experienced strange lumps on her one leg after getting GARDASIL. On an unknown date an MRI was preformed. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 36.39. No concomitant medications were reported. Batch number 044B21A administered on 15-Apr-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. On 15-Apr-2021, 18 vials were moved to the clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
Sore arm; COVID arm; Hives on arms, hands, and back of achilleas tendon; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (COVID arm) and URTICARIA (Hives on arms, hands, and back of achilleas tendon) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (COVID arm) and URTICARIA (Hives on arms, hands, and back of achilleas tendon). On 01-Apr-2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (COVID arm) and URTICARIA (Hives on arms, hands, and back of achilleas tendon) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information provided.   This case was linked to MOD21-087942 (E2B Linked Report). This case was linked to MOD-2021-114519 (Patient Link).; Sender's Comments:  MOD21-087942:First dose case
Headache, Fever, Palpitations & Tachycardia Narrative:
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant (MA). The age at vaccination was not reported. The patient experienced redness and swelling at injection site for almost 1 month. The physician was unsure if this was an adverse reaction. The patient's initials and date of birth were unknown.
Information has been received from a 26 year old female who in 2006 was diagnosed with an "auto immune disease with her eyes."  The consumer reported that she received the first dose of Gardasil (lot not reported) in June 2007.  The patient received the second dose of Gardasil (lot not reported) on an unspecified date.  In August 2007, the patient reported she started unspecified immunosuppressive therapy for her auto immune disease with her eyes.  The patient's status was not reported.  No further information is available.
This spontaneous report as received from a pharmacist refers to a 84 year old female patient. No drug reactions or allergies were reported. On 21-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and route of administration not reported) lot # J004269, expiration date 12-JUL-2015. Concomitant therapies included calcitriol, losartan potassium (manufacturer unknown), LASIX and lovastatin (manufacturer unknown). On approximately 27-APR-2014 (about two days ago), the patient experienced rash around her tailbone (Coccyx) area and was diagnosed with shingles by the patient's physician on 29-APR-2014 (today). No lab diagnostics studies were performed. The patient was treated with acyclovir. The patient sought medical attention by visiting physician's office. The outcome of adverse event was reported as not recovered/not resolved. Relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Progressive weakness in both legs starting approximately 2 days after vaccination. Symptoms progressed to lower body paralysis. Patient was hospitalized about 6 weeks. Other symptoms: constipation, incontinence, peripheral neuropathy.
Patient received Influenza, Quad PF in right arm on 9/7/23.  Reaction noted numb tongue and lips and soon after rash all over.  Was seen at ER 9/7/23.  Patient had taken Benadryl at recommendation of her NP.  Patient is now going to see an allergy Dr.
Optic neuritis with loss of vision in left eye treated with IV steroids during five day hospitalization at Hospital and two rounds of tapering oral steroids with some improvement.  CT scans, MRI's, lumbar punctures, blood work, follow up with three specialists to date, resulting in multiple sclerosis diagnosis.  Eye sight in left eye not fully restored to date.
Mom states gradual increase in swelling in left upper arm - getting as large as a grapefruit - 24 hours post vaccination. 48 hr post vaccination - arm still enlarged but decreasing in size. Client has been taking MOTRIN for pain - per mom via phone.
Headache; aching; felt like she had a ton of bricks on her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm (Lot number: EL9266) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; PAIN (non-serious), outcome "recovered", described as "aching"; DISCOMFORT (non-serious), outcome "recovered", described as "felt like she had a ton of bricks on her".  Additional information: It was reported that patient had a terrible headache, aching, and that she felt like she had a ton of bricks on her. She says it took two days almost for her to feel back to normal.  No follow-up attempts are possible. No further information is expected.
This case was reported in a literature article and described the occurrence of febrile seizure in a subject of unspecified gender born between 1974 and 2008 who was vaccinated with Hib vaccine (manufacturer unspecified), Dtap vaccine, MMR vaccine (non-gsk) and varicella virus vaccine (non-gsk). Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Hib vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Dtap vaccine (administration site and route unknown, batch number not provided), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of Varicella virus vaccine (Non-GSK) (unknown). 5 days after vaccination with Dtap vaccine, Hib vaccine, MMR vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced febrile seizure. 5 days later, the subject had otitis media and fever. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immunosuppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
This case was reported by a nurse via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced fever, shivering, fatigue, pain and myalgia. On an unknown date, the outcome of the fever, shivering, fatigue, pain and myalgia were recovered/resolved. It was unknown if the reporter considered the fever, shivering, fatigue, pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The Healthcare professional did not have any patient demographics for the patient at the time of call. The patient experienced fever, pain, myalgia, chills, shivering, fatigue and felt like they had no energy shortly after receiving SHINGRIX. The patient stated these symptoms lasted about 24 hours, but symptoms had all since resolved. No further information was provided.
Pt recvd hep B vax,1st 2 doses were Recombivax;3rd dose on 21MAR90 was Energix-B.04MAY90 test results were neg for HBSAB.Addt'l Engerix-B dose given;test results again neg for HBSAB.
No additional AE reported; Customer called and reported that VARIVAX was inadvertently administered concomitantly with PROQUAD to a 4 year old patient. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from Medical assistant and refers to a 4-year-old of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-APR-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (dose, units, strength, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, units, strength, lot #, expiry date, and route of administration were not provided).  Customer called and reported, that on 25-APR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was inadvertently administered concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) to a 4-year-old patient (Accidental ovedose). No additional AE reported. No PQC reported. No additional information provided.
(First 72 hours after 2nd shot) Severe Chills, and then over heating.  Temperature as high as 103.5   Severe fatigue and brain fog Severe Low Back Pain (48 hours after 2nd shot) Puking and Diahrea  (After 72 hours) Fatigue Can't regulate body temp in regards to feeling very hot and sweating Rash on forehead on left side from eye brow to hair line Insomnia  Low Back Pain Stomach Issues
Had the shots, have shingles/Suspected vaccination failure; Shingles/ sitting here with painful shingles; Painful shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shots and was sitting here with painful shingles. The reporter denied for the follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose back on 1st February 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 1-Jun-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt has large reddish purple area with rashed rash at injection site, didnt show up until 11 days after injection.
Pfizer vaccine was administered outside of facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------------- I24.8 DEMAND ISCHEMIA 4/24/2023 CHRONIC OR UNS GASTRIC ULCER W/HEMORRHAGE
At first I thought I was getting a pimple on my left shoulder, but it soon turned into a nasty patch of Shingles.  I have had Shingles before, so I was certain that's what it was!  PCP prescribed Acyclovir, which took care of it!
It started with my nerves being hyper sensitive, where anything brushed against my arm needle like pain would shoot through my arm.  Also whenever I turned my head I got dizzy. That lasted about an hour and half, then turned to full body aches and a slight headache. Over the next few hours the headache grew worse and worse. Then about noon I got the chills and my face became super flush and my eye lids felt like they were on fire.  When I arrived home from work at 1pm I took a warm/hot bath to try help with my body aches. Then I went to bed to help my body fight it. I was also drinking lots and lots of water and a few gatorades throughout the whole day. When I woke up at 11pm all of my symptoms were gone.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated they "felt weird, like really heavy" immediately after receiving shot. Patient was observed to have hives/redness on the entire upper arm and shoulder where the vaccine was administered and was flushed. Patient stated that there was no itching or difficulty breathing. Patient stayed on site after receiving the shot to be observed. The hives/redness faded after approximately 10 minutes and at 30 minutes after receiving the shot the patient went home with no further incident.
Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 29Dec2020 07:30 at single dose for Covid-19 immunisation. Medical history included rosacea, depression, asthma. The patient was not pregnant. No Covid prior vaccination. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), lisdexamfetamine mesilate (VYVANSE), spironolactone and multivitamin.  The patient previously took cefalexin (KEFLEX) and experienced allergies: Keflex, rash. The patient developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days on 02Jan2021 09:00 on 02Jan2021 09:00. No treatment received for the events. The events was reported as non-serious. No emergency room/physician office visit. The outcome of events was recovered on 04Jan2021.
Red Blotch 3 inches in diameter.  Swelling of entire thigh.  Hot to the touch and painful.
Later evening on 10/21/14 pt developed chills. Began vomiting at 11 pm and continued through the night. Next day, malaise and rash all over face x 36 hours. Rash has resolved and patient is beginning to get her energy back.
I got the shot on Thursday night, and I felt fine and then the next day I started to feel a little more tired. That night, I started to get chills and the normal affects you would get after a shot. Saturday, I woke up and felt a little bit worse with chills, tiredness and fatigue. Sunday night, I got a 100 fever, so I drank a lot of fluids. Then Monday I went to go get a COVID-19 test just in case, I didn't feel as bad but I had diarrhea and stomach pain from Monday to Wednesday and then I felt better on Thursday.
Parents took patient to the emergency room on 5/1/19 at 8:54 a.m. They stated that the child had developed a fever after receiving vaccines on 4/29/19 and that the morning of 5/1/19 the patient was sitting on his dad's lap and suddenly had a seizure. It lasted 1-1/2 minutes. Following the seizure he became active again but not quite back to normal.  His temperature in the emergency room was 100.1 degrees Fahrenheit. He was given 100 mg liquid ibuprofen and monitored for an hour with no recurrent seizure. He was then discharged.