chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna covid vaccine found to be out of date after administration on 8/APR/2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021). On 08-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021) had resolved.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.   Concomitant product use was not provided by the reporter. No treatment information was provided. The patient was notified and opted not to repeat the vaccine.  No adverse events were reported as a result of the event.
severe headache with 'excruciating left foot pain shooting up her leg.  no swelling : reported at approximately 12pm called patient back at 4pm and she reported the headache feeling much better, eating and zero foot and leg pain at this point.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 16-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
[PFIZDER BIONTECH COVID VACCINE] use for COVID-19 under Emergency Use Authorization (EUA):Pfizer Biotech Vaccine \ I am concerned the doctor may have directed someone to give me the vaccine booster without my consent even though I had adverse reaction to the first and second dose of the Pfizer BIONTECH COVID Vaccine. He the refused to diagnose myocarditis and then prescribed medications claiming the hypertension and high lipids were naturally occurring and not the result of vaccine reaction. I now believe that Dr. enrolled me in a myocarditis study without my consent, and directed others to take actions, which made my symptoms persist. It has been ongoing since last year. He refused to diagnose and prescribed relevant medication for another purpose.
Patient was administered vaccine at 11:00 AM in the left deltoid muscle IM. Patient reported feeling chest tightness, heaviness as if someone was sitting on her chest, pressure on her chest, and found it a little hard to breath at 11:10 am. Patient had a history of congestive heart failure and suffers from anxiety, but wasn't sure if the chest pain was due to her past medical history or the vaccine. At 11:17 am the chest pain remained the same. At 11:30 she was still feeling chest pressure and her right arm was feeling weak. At 11:30  Heart rate was 56,  Blood Pressure was 138/72, and respiratory rate was 12. EMS was called at 11:35. Patient was taken to the hospital once EMS arrived.
LIGHTHEADED, METALLIC TASTE IN MOUTH, MILD ITCHING ON LEFT SIDE, HEAVINESS IN CHEST AND GUT. NO SHORTNESS OF BREATH. TWO SYNCOPAL EPISODES, NO IMPROVEMENT IN SYMPTOMS AFTER 10 MINUTES, TRANSPORTED TO HOSPITAL.
Dizzy, fast heart rate , pain in arm for weeks not days, sweaty all the time , blurred vision , Short moments of confusion randomly for no reason
Site Pain beginning evening of April 27 Swelling and soreness in left supraclavicular nodes beginning upon waking the morning of April 28th and reducing in size to date. Swelling still present today, May 8th. Postmenopausal  spotting, hot flashes, nigh sweats.  Fatigue
Fever, with rash developing over the next 3 days.  Started on the head, covered the body over 3 days. Some crusted.
mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     no medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE for Parathyroid tumour.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       treatment medication: tylenol   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Caller returning call from Safety, concomitant  medication was updated
DTAP given instead of TDAP. PC to mother to inform - will need Tdap - in 6 months ok for school till then. Public Health Nurse informed.
vaccine vial was not diluted and patient was administered 0.3 ml of undiluted product.
Noticed Swelling and redness of left arm below shoulder and in the inside of arm very warm to the touch
My iWatch was showing that my heart rate was over the suggested number.  I was experiencing edema in the leg and ankle right afterward.  I thought this might be due to my Femara as it can do it.  I stopped the Femara for a couple weeks but did not see a difference in the edema.  Then my iWatch started to set off alarms of elevated heart rates, starting 8/1/2022 on a daily basis.  I then purchased a blood pressure cuff.  With my first reading I was 200/120.   I then set up a virtual appointment with my doctor on 8/16/2022.  She then placed me on HCTZ to see if that would help.   It did help to some extent but have changed the medicine to Lisinopril/HCTZ and now seems to help keep under control.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted for few seconds few minutes after getting the shot , and had dizziness for few minutes afterwards, pt also stated that he has mild nausea
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 15F for cold temperature and in 51F for warm temperature) doses of GARDASIL 9 (dose, route of administration, lot # an expiration date were not reported. The call was made because of the data logger. No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient reporting pressure behind both of her eyes and some mild eye pain with extraocular movements. Patient also had generalized myalgias, arm soreness where vaccine was administered along with some chills.
24 hours post shot, muscle aches, fever, chills, nausea, vomiting, headache. 48 hours post shot still mild muscle aches and headache.
Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremors
Gardasil #1 (1423X) given in right arm on 4/23/09. Adverse reactions symptoms began 4/24/09 exhibited by: dizziness, headache, stomach pain, nausea, chest pains, shortness of breath, pins/needle sensations to feet, burning of skin, nerve pain to right elbow, fatigue, muscle weakness to legs, nausea, swollen lymph nodes to neck.  Physician contacted 4/28/09 because this was felt to be in direct relation to the vaccine. She felt it was viral.  6/03/09  Same physician seen due to symptoms becoming more severe.  Lab work drawn to rule out Mono due to swollen lymph nodes. 6/08/09  Pediatric Neurologist seen who confirmed that the symptoms were directly related to the Gardasil injection. Diagnosed peripheral neuropathy.  6/17/09 Medical and immunization records received DOS 4/23/09 to 6/3/09. Assessment: Pain & tingling, fatigue, lymphadenopathy.  Patient presented with fatigue, headache, dizzy, chest pain, tingly feeling in arms and legs, pale, tender cervical lymph nodes. Referral to neurologist.  LABS and DIAGNOSTICS: Planned CBC, ESR, CRP, Electrolytes, EBV, IgG, IgM.  8/3/09 Consultant medical records received DOS 12/12/08 to 6/29/09. Assessment: New onset symptoms after Gardasil. Patient presents with dizziness and waves of nausea. Chest pain, shortness of breath, and intermittent bifrontal headaches. Tingling of feet and hands with associated pain. Burning sensation in hands and quadraceps muscles. Off balance. Back pain. EB Virus pending. Neuropathic type pain - ulnar region. Allodynic pain. Tender in C2 to C6. Heart rate 74 and standing heart rate 100. Flat affect and dysphoric mood.
Dizziness, Headache, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, chills Narrative:
Narrative: Patient with very complex medical history. First Covid 19 vaccine administered 2/16/2021, Second vaccine administered 3/10/2021. PHM involves: Stem Cell transplant Feb 2016, with mild AGVHD. ALL Relapse Oct 2017. CAR-T cell treatment Jan 2018. MDS diagnosis 8/2019. Patient had stopped Acyclovir and Bactrim Prophylaxis therapy March 2021. Hospitalization May 2021 for Herpes Zoster Ophthalmicus affecting right face above eyebrown. ADR entered for Covid-19 vaccine after patient refusal for additional vaccine. Administration dates of Covid 19 vaccine unlikely related to shingles occurrence
The right arm where my daughter received the unknown 2 of the 3 vaccines started to form a red lump and swell around 6:30pm, 4 hours after the vaccines were applied. After we got home around 5pm she went to lay down in her bed with immense pain on her right shoulder which was swelling and hot. She developed a small fever around 7:00pm and could not move or lightly touch the right arm without feeling immense pain. Around 8:00pm she developed a swelling and bruised feeling in her top right shoulder socket and right clavicle and side of the neck. It has been almost 48 hours and her right arm is still swollen. The fever and swelling clavicle has gone down but she still feels a bruised feeling in her clavicle.
within 2 hours  of vaccine got  nauseous, vomiting, dizzy and not able to walk.  Had to call 911 adn hospitalized for 2 days
PNEUMOVAX23 was indicated for prevention of pneumococcal disease by the 23 serotypes contained in the vaccine. Despite its extensive use, relatively few cases of severe hypersensitivity reactions have been reported. This literature marketed report as received from a health care professional refers to a 24 year old female patient with a history of persistent asthma, allergic rhinitis. It was assumed that patient had been vaccinated with PREVENAR previously. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, dose number, lot no and route of administration unknown). Concomitant therapies included Tdap. The patient had been vaccinated with both vaccines for school enrollment. One day after the immunizations she developed a 10 cm induration and erythema at the PNEUMOVAX injection site and a fever of 104.3 F, fatigue, dizziness, headache and nausea. She was admitted to the hospital for presumed erysipelas versus a vaccine allergic reaction. Relevant laboratory values on admission were leukocytosis (19,100/uL) with 86% granulocytes. There was no eosinophilia. She was treated with intravenous antibiotics for two days with improvement and was discharged on antibiotics. Two months later, an allergy clinic follow up visit revealed very high titers against Streptococcus pneumoniae (serotype 14- 223.0 mcg/ml; serotype 5 > 100 mcg/ml; and elevated but normal range protective titers for all other serotypes). Anti Tdap antigen titers were only moderately elevated (tetanus toxoid-5.34 IU/ml; diphtheria-2.67 IU/ml; and pertussis-12 IU/ml). Total serum IgE was elevated (317.6 IU/ml), but quantitative serum immunoglobulin levels were normal. She had a history of gelatin intolerance which caused nausea. None of the two vaccines she received contained gelatin but porcine gelatin-specific serum IgE levels were minimally elevated. It was concluded that the severe delayed systemic reaction associated with very high anti-pneumococcal antibody levels, suggested a type 3 (immune complex mediated) hypersensitivity (hospitalization). Highest antibody titers after the PNEUMOVAX were against two serotypes (5 and 14) that were contained in the 13 serotype PREVENAR. The outcome of Type 3 immune complex mediated reaction was reported as recovering. The event Type 3 immune complex mediated reaction was reported to be related to the suspect product. This case suggested that caution should be used when immunizing younger individuals with PNEUMOVAX, especially if they have previously been immunized with PREVENAR. Additional information has been requested.
A report was received from a health care professional on 11/07/03, concerning a vaccinee of unknown demography who experienced pain at the injection site for more than 2 days after receiving Fluvirin vaccine on 11/03/03. The outcome of the event was not reported. There was insufficient information to determine the reporters causality assessment. Follow up pending.
Post menopausal bleeding (54 at last period, no issues like this since) started a couple of weeks after vaccination. Symptoms started with very painful abdominal cramping. Used an electric hot pad to ease pain. The bleeding  started the day after the cramping. One sanitary pad was used per day for 5 days. At the time of report patient says that the bleeding has reduced significantly and "almost ended."
After injection (flu) - arm swelled some and rash appeared - (slight red, raised rash). Throat sore and became sweaty and glands on neck swelled. Took vitals and had pt sit down and relax for a while. Felt better.
Pt received Td booster on 7/30/02. On 8/5/02 pt contacted health dept to report pain on left arm since receiving vaccine. Seemed OK on 7/631/02; then has had pain since 8/1/02. Has tried OTC pain relievers, ice packs, without relief.
It was reported that a 15 y.o. female PT received a Rabies Imovax IM series starting in July 00. Reportedly after the 2nd dose on day 3, the PT developed systemic immune-complex like side effect such as headache, nausea, flu-like symptoms with joint discomfort in back and shoulders. It is now 6 months since the series and she still has nausea and fatigue and problems with her back and joints. This event was classified as medically significant by AVP US on 4/25/01. From follow-up #1 mailed correspondence received on 7/2/01 additional PT, vaccine and vaccine administrator info. was provided.
5 hrs post DTP dose the baby ran a fever to 103 - turned limp and pale - eyes rolled back episode lasted approx l min.
stroke; She had blood clots in her heart up until her brain; hand went numb and tingling; hand went numb and tingling; she has not had energy/she feels weak/dizzy; she has not had energy/she feels weak; Dizzy; This is a spontaneous report from a contactable consumer. This consumer reported for a 91-Year-old female patient that patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from unknown date in Mar2021(at the age of 91-Years) on unknown location for COVID-19 immunization. No prior Vaccinations (within 4 weeks). No AEs following prior vaccinations. Patient's Medical History (including any illness at time of vaccination) was reported as None. Patient's family medical history was not reported. Concomitant medications were not reported. It was reported that patient experienced stroke (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), she had blood clots in her heart up until her brain (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), hand went numb and tingling (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days). Her mother's first shot was in March, her second shot was in April. She has been perfectly healthy up until this point. Ever since she got the shot in April, she has not had energy, she feels weak, and she has been dizzy worsened, no treatment received, and the same doctor tells her to rest. She has not had energy, no treatment received, and she has went to doctor she has been resting more. A week ago, yesterday she was standing at the pantry and her right hand went numb and tingling so she rushed over and took her to the urgent care and the doctor said he thinks she is having a stroke and she took her to hospital, and they found out on the second day they did an MRI and cat scan and an ultrasound of the heart. The MRI showed she had two strokes. So, they kept her in the hospital she had blood clots in her heart up until her brain. She got the covid vaccine and now she has two blood clots. The outcome of the events for stroke, she had blood clots in her heart up until her brain, hand went numb and tingling was unknown, and for she has not had energy/she feels weak, Dizzy was not recovered.  Information on the lot/ batch number has been requested.
My left upper arm was itchy and swollen; My left upper arm was itchy and swollen; lethargic; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLUOXETINE; PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE]. Vaccination history included: Covid-19 vaccine (Dose:1, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:2, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:3, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:4, unknown manufacture), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 14Oct2023, outcome "recovered" (17Oct2023) and all described as "My left upper arm was itchy and swollen"; LETHARGY (non-serious) with onset 14Oct2023, outcome "recovered" (Oct2023), described as "lethargic". Therapeutic measures were not taken as a result of pruritus, peripheral swelling, lethargy. Additional information: Patient reported, "My left upper arm was itchy and swollen starting the day after I received the vaccine and the swelling and itching lasted for four days. I also felt very lethargic the day after receiving the vaccine, which happened with the other doses but the arm swelling and itching was new this time".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
a little harder to breathe afterwards (dyspnoea); Information has been received from an other company on 14-SEP-2023.  This spontaneous report was received from a consumer referring to a 75 years old female patient. The patient's concurrent condition included primary pulmonary arterial hypertension. The patient's medical history and concomitant therapy were not reported.  On an unknown date in 2023 (reported as "a couple weeks ago"), the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for immunization (strength, dose and route of administration were unknown; lot number and expiration date were not reported).  After the vaccination, the patient found a little harder to breathe (dyspnoea). At the reporting time, the outcome of the event was unknown.  The causal relationship between zoster vaccine live (ZOSTAVAX) and the event of dyspnoea was reported as possibly related.
Fever that peaked at 107 °F, body aches, stuffy nose, headache.
This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional stated, the patient was given Shingrix and developed a few isolated spot two days later that resembled chicken pox. The healthcare professional did not have vaccine information.
Headache, extreme body aches, chills, slight fever, slight nausea all began approximately 9 hours after receiving the vaccine. and lasted approximately 72 hours. Within 48 hours site became sore and red. this lasted 5 days after receiving the vaccine.
Received MMR 3/19/03 and on 3/22/03 developed 101 deg fever which continued thru 3/25/03. Also c/o joint pain, developing rash on arms, leg, torso that is itching and large welts with blisters (hives). ER staff told client she probably had allergic reaction to hives. Went to ER on 3/25/03 - given Tylenol & Benadryl.
Narrative:  77yo M patient w/ALS and was declining. He was hospitalized x2 07/2021 for respiratory distress/failure and it was decided during hospitalization the pt/family wanted home hospice care. PMH includes ALS, respiratory failure, untreat OSA, COPD, HTN, dyspnea, spasms BLE, constipation, seasonal allergies, increased oral secretions. Pt admitted to home hospice on 8/17/2021. Pt died at home with home hospice on 9/11/21. Pt had received covid vaccines on 4/1/21 & 4/30/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Pt. reported redness, swelling, tenderness and heat to injection site (left subcutaneous tissue). Pt. arrived to clinic to report symptoms x 2 days. Pt. denies fevers. Pt. given at home care instructions.