chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with no drug reactions/allergies. On 24-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # were not reported), subcutaneous. The patient experienced an unspecified allergic reaction to an unspecified substance ZOSTAVAX (could not be ruled out) on an unspecified date following the ZOSTAVAX administration and was prescribed MEDROL dose pak for treatment. The patient sought unspecified medical attention. The outcome of event was unknown. Additional information has been requested.
She developed pain a week after date of injection, this seemed to get better but then returned again about 2 weeks later. Her L arm pain got progressively worse. She then received the 2nd dose of pfeizer vaccine on 4/19/2021 this time she got it in her R arm because of the pain  in her L arm. Her L arm pain got worse to the point she was not able to feel her entire L arm. So she decided to go the ER
Severe chest pain, swelling in the chest closing the airway, lower heart rate, severe headache, and nausea. We went to the ER the day after and it got severe she could barley breathe, she said it felt as she was slowly dyeing,  she was given a high nebulizer in the ER and then she was given an injection of dexamethasone. X-rays were taken of the chest and the swelling had been noticed.   She slowly came out of it but not completely she was on high nebulizers for at least 3/4 month and then she moved to the lower dose, she is now off of them completely. She then carried around an inhaler for quite some time, she still runs into complication sometimes after going on long runs, but is overall healthy.  She started taking TB4- frag which has seem to help her run longer distances. The nausea has gone away 6 weeks ago and was prescribed Prilosec  and Zofran. Under propofol her heart was then noticed to go down to 30 for a short period, she's always had a very good heart rate but was never that low. She has and been directed not to get the second dose by Dr., and if needed a note would be written.
The patient received the 2 vaccines and then walked to the waiting area and sat down.  Within 5 minutes he lost consciousness and slid to the floor.  I did not witness this directly, but the patient's father did. The father told me that the patient slowly lay down on the empty seat next to him and then slid to the floor.  By the time we reached him (about 15 feet) he had started to regain consciousness and push himself into a sitting position.  He was confused for a moment, but it passed.  We kept him on the floor with his father supporting him. A quick look revealed no obvious injury from the fall, and he denied any pain.  After one to two minutes he said that he was nauseous, and then he vomited intermittently over the next three to four minutes.  It was not a large volume overall. He asked for some water and he slowly drank most of a 16 oz bottle over the next 5 minutes. We kept him seated on the floor for about ten minutes, and then back in the chair for about another five. He left with his parents and under their care.
Client received Zostavax vaccine at our clinic on 12/11/07.  States within 20 minutes a blister appeared on her R eyelid.  It was accompanied by redness & pruritus.  She saw Dr. who prescribed (R/13) Valtrex.  She saw an ophthalmologist who prescribed Bacitracin ointment.  She showed PHN the eyelid on 12/15.  Still has swelled scabbed areas to R eyelid.
experienced trouble in walking for 2 days and she is still limping; Limping; Feels pain sometimes; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (experienced trouble in walking for 2 days and she is still limping), GAIT DISTURBANCE (Limping) and PAIN (Feels pain sometimes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced GAIT DISTURBANCE (experienced trouble in walking for 2 days and she is still limping), GAIT DISTURBANCE (Limping) and PAIN (Feels pain sometimes). At the time of the report, GAIT DISTURBANCE (experienced trouble in walking for 2 days and she is still limping) had not resolved and GAIT DISTURBANCE (Limping) and PAIN (Feels pain sometimes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In concomitant medications thyroid medicines was reported. Treatment information was not provided.
lightheadedness Narrative:  Developed mild lightheadedness after ~20 minutes post-vaccination. Ambulated w/o assistance from waiting area to examination room (~200 feet). No  other s/sx of immediate allergic reaction or concerns for anaphylaxis. Exam WNL,  including vitals (T98.2F, BP 131/88, HR 75, SpO2 100% on RA). Observed for  another 10 minutes with some improvement in sx, preference to return to area of  work - where there would be LIPs present. Provided water, which was consumed w/o any difficulty.
Dizziness and fatigue on the day of the injection. Next morning woke at 4 AM to vomiting diarrhea fever of 100° delusional soreness and terrible headache. Also suffered irregular heartbeat and breathlessness
PATIENT HAVING FEVER, DIARRHEA, SWELLING AND REDNESS AT INJECTION SITE.
Approx 10 hrs after IM in left arm developed hives on entire body. Not allergic to latex. Took BENADRYL & hives resolved in 2 days.
Incorrect product storage; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Incorrect product storage) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). On 06-Oct-2021, PRODUCT STORAGE ERROR (Incorrect product storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
even at 70° F and a small walk, she starts sweating "like a little piglet"; serious side effect to something; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (even at 70° F and a small walk, she starts sweating "like a little piglet") and VACCINATION COMPLICATION (serious side effect to something) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (even at 70° F and a small walk, she starts sweating "like a little piglet") and VACCINATION COMPLICATION (serious side effect to something). At the time of the report, HYPERHIDROSIS (even at 70° F and a small walk, she starts sweating "like a little piglet") and VACCINATION COMPLICATION (serious side effect to something) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Small dose of thyroid medication as concomitant drug.  No treatment drug information was provided by reporter.
Left eye began seeing flashes, almost like sparks, in peripheral vision (outer-side of vision). Occurs in both low and bright lighting conditions. Occurs periodically, once every few hours. Have never experienced this before. Is still occurring as of 5/7/21. Incidentally, day after 2nd dose, I was very tired with flu-like symptoms. I slept almost all day.
Around 08/02/2021 The reaction I was having, I just had a very similar set of reactions with the 1st Dose, cycling fever, body aches, and chills, and then the fever will break for a few hours and come back.  My temperature went as high as 103. Each fever that came the temperature kept getting higher each time.  There was concern for me and baby and I sought care from my doctor. I was admitted to labor and delivery and monitored. I was found to be extremely dehydrated. The baby was not considered in distress. I was given IV fluids and sent home. The fever broke while I was there and did not return after that. The baby was born at 39 weeks via normal, scheduled induction. I had signs of preeclampsia, I had that with my previous child as well. The baby was born at 6 lbs. 8 oz. The baby is healthy and good. The baby was born 08/20/2021.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 09/28/2021. PATIENT WAS FULLY VACCINATED ON 09/24/2021
Narrative: Pt with history of hypothyroid, HL, HTN, BPH. Pt c/o "stabbing" chest pain, palpitations, fluttering of the chest, and fatigue after receiving vaccines. No sob or other symptoms. Pt stated "I did not have anything to eat today." Pt's initial vitals were b/p 189/82, p-55, O2 sat 97% on RA. Upon reassessment BP is 160/101 and pt stated that his chest pain is resolved. With pt's permission, EMS was called and pt was transferred to ED for further evaluation. In ED patient reports pain resolved in about 1 minute. No shortness of breath, nausea, sweating, dizziness or weakness. Has not had any significant cardiac history nor any symptoms previously. EKG was negative; not thought to be cardiac in nature given is history of no symptoms and normal stress in 2019 at age of 85
Immediately after receiving vaccine, patient began to experience skin and throat itchiness. Given 25mg oral Benadryl and sent to Urgent Care clinic. At clinic, patient received 50mg Bendryl IM and 125mg Solu-Medrol IM. No anaphylaxis. Patient refused to wait 30 minutes for observation following injections. Patient educated about risks and signed AMA. Patient stated understanding of strict ER precautions and of Epi-pen prescription. Patient returned as advised to clinic following day for follow-up appointment. Symptoms improved but not resolved. Patient received another 50mg injection of Benadryl IM; again declined 30 min wait. Patient agreed to start oral Bendaryl and prednisone burst tomorrow. Aware of Ep-pen prescription and use.
This prospective pregnancy case was reported by a consumer (the subject) and a healthcare professional, via a GSK representative, and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline) during pregnancy. The subject's medical history included miscarriages. Concurrent medical conditions included allergy to ibuprofen. Concurrent vaccination included tetanus toxoid vaccine; manufacturer unspecified;unknown;unknown given on 13 July 2010. On 13 July 2010 the subject received unspecified dose of HAVRIX (unknown route, unknown arm), and possibly experienced vaccine exposure during pregnancy. At the time of reporting the subject had just discovered that she was pregnant and was not sure if she had been pregnant at the time of vaccination. She had not yet consulted a physician and did not know the estimated date of delivery. The pregnancy was ongoing at the time of reporting. Follow-up received from the consumer on 17 August 2010: The estimated delivery date was 22 March 2011. On 09 August 2010, 27 days after vaccination with HAVRIX, the subject experienced miscarriage.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with ROTATEQ (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. ROTATEQ was administered to a 7 month old patient. ROTATEQ lot number J008725. This is case 1 of 4 patients. This case was linked to cases: 1403USA007267, 1404USA014642, 1404USA014643. Additional information has been requested, all scheduled correspondence was scheduled.
Case number PHEH2014US025313, is an initial spontaneous from a medical assistant received on 16 Dec 2014. This report refers to a 60 year old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015) 0.5 ml intramuscular into right deltoid that was stored at minus 0.6 degrees Celsius for 2  hours and 50 minutes. No adverse event was reported. No further information was provided.
Patient seen for right arm pain and a small 2-3 mm area of induration on right deltoid 3 days following HPV vaccination. No numbness/weakness. No signs of infection. Full strength.
5:30 aches and chills and headache , day after 4/20 - lethargy , extreme headache, chills, fever, incredible arm pain, 4/21 continued aches in arm, headaches, 4/22 headaches continue, 4/23 headaches continue, 4/24 headaches continue, 4/25 headaches continue
Rt upper back of arm injection site red rash from injection site covering back of arm. Warm to touch.
Rotarix - Administration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number KX5XM, expiry date 01-JUL-2023) for prophylaxis.   On 03-JUL-2023, the patient received Rotarix lyophilized formulation. On 03-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: Rotarix - Administration of expired dose). 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: 3-Jul-2023 The vaccine coordinator asked if the patient had to be revaccinated. The reporter consented to follow-up. The patient received an expired dose of Rotarix, which led to expired vaccine used.
Information has been received from a health professional concerning a 23 year old female with a history of mitral valve prolapse who on 09-AUG-2007 was intramuscularly vaccinated with her first dose of Gardasil (lot # 658219/0680U).  On 09-Oct-2007 the patient was intramuscularly vaccinated with her second dose of Gardasil (lot # 657872/0515U).  On 11-Feb-2008 the patient was intramuscularly vaccinated with her third dose of Gardasil (lot # 658219/0755U).  On 11-Feb-2008 the patient experienced raised, red area the size of a dime at the injection site, dry skin at injection site which lasted about a week but then the patient started experiencing a sore arm and discomfort in her arm.  Subsequently, the patient recovered from dry skin at injection site.  the patient's raised, red area at injection and sore arm and discomfort in arm persisted.  The patient sought unspecified medical treatment.  No further information is available.  Additional information has been requested.
9 days after my booster I had hives/ rash with itchiness all over my whole body. It?s was the worst on my arms/ legs/ ears/ hands/ feet, but it was on my whole body. I was itchy for about 6 days. On the third day of symptoms I got put on prednisone which lessened the symptoms. It has now been 12 days and I still have reactionary hives on my body and red splotches randomly. The steroids got rid of the constant itchiness and hives but they come back when I touch or itch my skin.
This spontaneous case, initially received on 18-Oct-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Drug history includes AFLURIA received in 2014 (reaction: no side effects) and Shingles vaccine (reaction: arm blew up, went to urgent care, outcome: resolved within 48 hours, start date: occurred 2 years ago). Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date at least 4 years ago, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drug. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient had vision floaters in her eyes (outcome: recovered / resolved). The patient saw the eye doctor.
Intense soreness at injection site, red mark approx. 3" around at injection site, warmness at injection site. Extremely mild itching, but I didn't notice any detectable rash, swelling nor did I ever feel any tightness of breath, wheezing or anything else related to injection. It was at least a week that I experienced these above symptoms.
At time of vaccination the pharmacist was told patient had only received two doses previous (1/6/21 and 1/27/21) and was due for their booster dose.  According to the database patient also had received doses on 2/3/21 and 2/24/21.  So patient received 5 doses total.  Our pharmacy only administered one of them.
Please NOTE: I am unaware of what brand of shots I was given. Please contact my doctor for brand and Lot Number. Flu symptoms started approximately 24 hours after injection on 10/4/17. Experienced aches and chills. Took ADVIL which helped symptoms. That night had night sweats and site of Tdap booster was red and swollen. On 10/5/17 flu symptoms were still present with a 3 inch red and swollen mark at injection site. Site was burning and very hot to the touch. Administered KEFLEX 500mg at 2pm on 10/5/17. Swollen lymph nodes in neck that evening. Morning of 10/6/17 experiencing improvement, but still feeling stiff neck.
Pt tolerated well, then few minutes after injections reported dizziness, feeling faint. Pt emesis x1. Vital signs were taken, BP/temp/heart rate all stable. Pt laid down x15 mins and RN and charge RN assessed. Pt provided juice to drink. Pt stable to leave office. No previous rxs to vaccines.
A little soreness after receiving the second dose of Moderna COVID-19 vaccine; Rash at the injection site after receiving the first dose of moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (A little soreness after receiving the second dose of Moderna COVID-19 vaccine) and INJECTION SITE RASH (Rash at the injection site after receiving the first dose of moderna COVID-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (A little soreness after receiving the second dose of Moderna COVID-19 vaccine). 26-Feb-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site after receiving the first dose of moderna COVID-19 vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, INJECTION SITE PAIN (A little soreness after receiving the second dose of Moderna COVID-19 vaccine) and INJECTION SITE RASH (Rash at the injection site after receiving the first dose of moderna COVID-19 vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.
A 10 year old patient was vaccinated with Flublok, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via The Agency (Reference number- 00333429) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 10 year old female patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2053, expiry: 30-Jun-2021) once via unknown route in the right arm for prophylactic vaccination on 27-Oct-2020 (product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccinations or medications   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
I experienced pain in my left wrist and hand, and then numbing and tingling in left ring finger and pinky finger.
pain; tired; his arm started feeling stiff and heavy in the area where he had the injection and back towards his shoulder; his arm started feeling stiff and heavy in the area where he had the injection and back towards his shoulder; This is a spontaneous report from a contactable consumer (Patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on 21May2021 as 1st dose single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tired the next day of vaccination (on 22May2021) and his arm was stiff, but then he felt fine. A 6-7 days later (in May2021), his arm started feeling stiff and heavy in the area where he had the injection and back towards his shoulder. The pain and stiffness were light but continued. He wanted to know if this was normal and if he should get his second vaccination in a few days. As a response he was suggested to discuss with his vaccinator. The outcome of the event tired and heaviness in arm was unknown, stiffness and pain was not resolved.  Information about lot/batch number is requested.
Patient presented to the emergency room with chills and generalized weakness. Found to have severe sepsis with septic shock due to UTI - started to feel much better after IV fluid resuscitation and  antibiotics. He remained afebrile and WBC improved.  He continued on IV Vancomycin and Rocephin until sensitivities returned on day of discharge. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.