chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Called over to see a patient with C/O of feeling lightheaded. He reports an episode of a vasovagal response > 10 yrs ago.  After responsing and while waiting for wheelchair transfer from the observation floor, the patient became diaphoretic and pale and soon experienced and episode of syncope. The patient regained consciousness after sternal rubs and after about 30 seconds started  responding to verbal instructions and was abnle to self transfer to a wheelchair.  Patient was placed in a  supine position and vitals taken. Which was WNL.. BP 117/78 HR. 73 O2sat 97%.    He was hydrated and later regained his baseline and was DC'd home with instructions to F/U as needed with PCP .
Both eyes blew up swollen; Slight Swelling at the injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Both eyes blew up swollen), INJECTION SITE SWELLING (Slight Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Allergy to nuts (Patient is allergic to peanuts,), Drug allergy (Patient is allergic to sulfite.) and Latex allergy (Patient is allergic to latex.). Concomitant products included AMLODIPINE, METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA), CLOPIDOGREL, ROSUVASTATIN and RANOLAZINE (RANOLAZINE EXTENDED RELEASE) for an unknown indication.   On 08-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 10:30 AM, 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 EYE SWELLING (Both eyes blew up swollen), INJECTION SITE SWELLING (Slight Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). The patient was treated with OMEPRAZOLE ongoing since an unknown date at a dose of 40 mg; NITROGLYCERIN ongoing since an unknown date at a dose of 0.4 mg and OLOPATADINE ongoing since an unknown date at a dose of 0.2 %. At the time of the report, EYE SWELLING (Both eyes blew up swollen) had resolved and INJECTION SITE SWELLING (Slight Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown.            Concomitant medicines include Amlodipine, Metoprolol, Clopidogrel, Ranolazadine, Rosuvastatin.  Treatment information were olopatadine 0.2 %  provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: ADR Form- Updated contact information , moderna vaccine information , treatment medication , event tab changes was done .
Hair loss on top of head; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss on top of head) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced ALOPECIA (Hair loss on top of head). At the time of the report, ALOPECIA (Hair loss on top of head) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Wrong Moderna was given. Pt received Moderna 6-11 years Moderna instead of 6mths to 5 years.
Client  presented to the vaccination site on 11/06/2021. The client notified that he received the complete series of AstraZeneca COVID vaccine in a specific country on 03/10/2021.  A medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Moderna booster. Per CDC guidance, approval to proceed with COVID vaccine Moderna booster was obtained from medical consult team via text message. Vaccine Operations Lead. Client received COVID vaccine Moderna Booster. The client did not report any symptoms during observation. vaccinator educated client on possible adverse reactions and when to seek medical care.
corneal ulcer outbreak/two ulcers on her eye; A spontaneous report was received from a consumer concerning a 73-year-old female patient of who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced corneal ulcer outbreak/two ulcers on her eye.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included aciclovir sodium, atenolol, and lisinopril.  The patient received the first of two planned doses of mRNA-1273 (batch number: 030L20A) on 25 Jan 2021. On 22 Feb 2021, 3 hours prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Feb 2021, 3 hours after administration of the second dose, the patient had a corneal ulcer outbreak which she explained as two ulcers on her eye. The event corneal ulcer outbreak/two ulcers on her eye was assessed as medically significant.  Treatment for the event included, acyclovir, 5 times a day and ganciclovir (zirgan) ointment.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of event, corneal ulcer outbreak/two ulcers on her eye was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
17-year-old male with no medical history, no allergies and no surgeries presented to the ER on 5/22 at 11 PM with concern for chest pain.   The patient received his 2nd COVID-19 Pfizer vaccine on Thursday, 05/20/2021 in his left arm.  The patient developed a temperature of a 102.5° with aches, chill, and pain overnight.  The symptoms subsequently dissipated.  Around noon on 5/22 he began to experience an achiness and pressure beneath the sternum and it has been constant since.  The pain does not radiate into the back.  No associated ripping or tearing sensation.  No shortness of breath or difficulty breathing. In ED, EKG showed normal intervals, no ST changes and no STEMI. The patient underwent a CT angio of the chest and abdomen and did not show any dissection of the aorta.   The left and right proximal coronaries are visible, however their path could not be seen on the studies performed.  No pneumomediastinum both pneumothorax was observed. He had an elevated troponin of 3.1 and it increased to 7.3 prior to transfer to the ICU.  VS were stable with HR 80 - 90 and normal BP. Repeat ECG was normal but his troponin increased x 2 with maximum of 16. His CRP was mildly elevated and BPN upper limits of normal. Echo was normal.  Cardiologist consulted and pt diagnosed with myocarditis.  As of 5/24/21, patient remains hospitalized as troponin was 13.1 at 9:00 am.
No adverse effects were reported; were inadvertently administered one dose each of expired VAQTA (lot R013858 exp 6/12/2019); Information has been received from a nurse referring to a 2 years old patient of unknown gender. There was no information about the patient's concomitant therapies, concurrent conditions, medical history drug reactions/allergies provided.  On 12-JUL-2019, the patient was inadvertently administered one dose of expired of hepatitis a vaccine, inactivated (VAQTA) (strength 25/0.5 (unit was not provided), lot # R013858, expiration date 12-JUN-2019) for prophylaxis (expired product administered). No adverse effects were reported.  This is one of two reports received from the same reporter (linked case # 1907USA010605).; Sender's Comments:  US-009507513-1907USA010605:
Information has been received from a licensed practical nurse (L.N.P.) concerning an approximately 30 day old patient (reported as "one month of age"), who on 20-DEC-2010 was inadvertently vaccinated with a 0.5 ml dose of VAQTA (Lot # not reported) IM instead of hepatitis B virus vaccine. No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Covid monitoring documentation. PT admitted 1/6/22 documented to have positive covid. PT received Moderna 3/6/21 Lot 030A21A for dose 1. Dose 2 was Moderna given on 4/5/21 Lot 025B21A. PT received Moderna Booster on 11/29/21 Lot RXPCGC2. PT did die on 1/6/22.
Patient was given PROQUAD instead of VARIVAX. Patient developed redness, tenderness and edematous arm 5/16/08 - Patient went to school nurse, FR; On 5/17/08 - mother called PMD 3P - he recommended warm compresses - Patient went to bed at 8P.
pt stated he was having chest pains, high pulse...111, high blood pressure, and felt winded
Employee developed generalized hives/rash along the neck and chest shortly after vaccine administration. Employee also had dizziness, "head fog", and nausea. Blood pressure and pulse were also elevated during reaction.
Patient had redness around vaccination site for first 24hrs, this self-resolved w/o intervention. 40-48 hrs after vaccination he erupted in flares of atopic dermatitis in various locations on lower extremities. Rashes have continued erupting and are now on abdomen, pelvis, groin, face/neck, wrists. BENADRYL, ALLEGRA, CLARITIN, Prednisone. Allergy testing to be done. Rash still present on 5/30/17.
Summary:  neurological/motor problems, movement disorder, significant decrease in receptive and expressive language, muscle seizures, aggression, screaming, crying, mood swings. Details: Loss of appetite for 2 days after the vaccination and constipation for approximately a week.  Within 30 hours of the vaccination, she began having motor problems and some type of movement disorder.  She would "pause" while walking (from seconds to minutes).  She would get "stuck" in one spot.  She would often walk backwards several steps before proceeding forward.  She could walk but it was if her brain was having trouble telling her limbs what to do.  She would writhe or squirm with her waist and shoulders, making slow contortions with her hips and upper body.  She has spells where she lays on the ground and writhes uncontrollably.  She began asking us to get things for her, as she didn't want to move as much.  Her pediatrician wondered if it was Dystonia.  This behavior has never subsided, and over the past few months she has continued to decline.  Her pre-existing autism has made the diagnosis more difficult to determine.  Prior to the vaccine, her general state of interaction with others was about 60-80% of the time, with 20-40% of the time she enjoyed time alone playing games and listening to music, but was happy to include us if we joined her.  After the vaccination, she became more difficult to reach, with her interaction level decreasing to about 30-50% of the time, with 50-70% of the time in her own world.  Previously she was a cheerful and happy child, but since the vaccine she is often unhappy and sad, with sudden outbursts of crying.  She has indicated that she does not want to make these movements and that she needs to go to the hospital.  We have seen neurologists.  We have also seen a doctor at the neurology clinic.  Currently there is no clear diagnosis.  In November and December, her movement episodes have been accompanied with increased behavioral problems.  Over the last six weeks she has hit her teacher, hit a student, and hit her parents.  She had never done this before.  At other times she becomes destructive, and has broken or attempted to break various things in the house. She has difficulty sleeping through the night, and sometimes wakes up screaming and runs through the house.  She has also gained about 15 pounds since the vaccine.  We believe the tetanus vaccine adversely affected her nervous system.  She is not the same.  It has drastically decreased her ability to think, speak, and move like she had been able to prior to the vaccine.  She now needs almost constant supervision.  She began taking medication (Clonidine, began 12/25/2012) to try to help calm her.
MIGRAINE; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines.  Manufacturer Receipt Date: 07-OCT-2021  A clinical investigator reported that subject of unspecified age and sex (subject number and site number were not reported) experienced non-serious grade 1 migraine. The event occurred unknown days after COVID-19 vaccine Ad26.COV2.S was administered intramuscularly for prophylactic vaccination. The action taken with study vaccine was not applicable. The outcome was recovered.  The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported.  On an unknown date, the subject was treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported.   On 19-JUL-2021, the subject experienced migraine.  The subject recovered from migraine on 19-JUL-2021.  Investigator's causality assessment:  The event of migraine was related to the study vaccine.  Company causality assessment: The event of migraine was related to the study vaccine.
w/in 24hr pt recv vax & had 3hr period of non-consolability
Vaccine given at 10:00 AM, Motrin given at 10:30AM and again at 4:00 PM for muscle pain at injection site in L. thigh.  Fever of 103.5 noted at 6:00 PM that broke after Tylenol dose at 8:00 PM.  Fever (104.0) came back at 2:30 AM and reponded well to Tylenol administration.  No return of fever after that.
Arm was extremely painful and swollen for 3-4 days  Extreme fatigue continuing for 2+ weeks, still not resolved All-over muscle aches for 24+ hours
The next morning after vaccine, I woke up with horrible headache, intense pressure behind my eyes, and extremely high bp (198/114).; The next morning after vaccine, I woke up with horrible headache, intense pressure behind my eyes, and extremely high bp (198/114).; The next morning after vaccine, I woke up with horrible headache, intense pressure behind my eyes, and extremely high bp (198/114).; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 16Mar2021 at 10:00 AM (age at vaccination: 61 Years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included high bp, diabetes 2, high cholesterol, low thyroid, and drug allergy to meloxicam, Norvasc. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 17Mar2021 at 07:00 AM, the next morning after vaccine, I woke up with horrible headache, intense pressure behind my eyes, and extremely high bp (198/114). The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment which included doubled blood pressure Rx until dr follow up. There was not a product complaint to report. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Shortness of breath, rapid heart, nervous,  oxygen dropped I had to rush her to Emergency Room at hospital.  She was placed on oxygen, giving multiple breathing treatments, rocephine, and steriods.
Patient stated that she started with cough, runny nose and no fever, she has a hx of alleriges and normally takes Claritin
pt recv vax & pt devel a rash of 150 lesions; No further details were provided;
Body aches - moderate chills - moderate headache - very tired - several swollen, painful lymph nodes on left side of neck - swollen, pain pressure points behind right knee - pain/tenderness at injection site. Body aches, chills, headache and moderate tiredness lasted until about 36 hours post vaccine administration. Swollen, painful lymph nodes were ongoing until 2.5 days post vaccine then decreased gradually through day 4.
Burning in throat, worse with deep inspiration and lying down; no dyspnea, but limiting exercise; resolved in 4-5 days
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis.  On 27th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and myalgia. The patient was treated with analgesic, NOS. On an unknown date, the outcome of the injection site pain and myalgia were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient reported pain at injection site and on the same day the patient reported pain in right arm (injection arm) as her arm hurts bad and myalgia. The reporter wanted to know the side effects of SHINGRIX vaccine. The reporter confirmed she had taken an analgesic for the pain and referred her to the health care professional for additional medical advice and questions.
Gave Pfizer BioNTech vaccine as second dose to complete series instead of Moderna.
Moderate headache immediately following the vaccine. 4/6 feeling nauseous, moderately fatigued, and sore arm where injection was placed. Symptoms lasted 3 consecutive days following the vaccine. On 4/13, the soreness of the injection site came back as a mild symptom. By 8:00am 4/14 a reaction due to the vaccine appeared with no other symptoms. As of 9:00pm 4/15, size of the reaction has increased and a mild headache is present. No other symptoms such as fever, chills, or affecting shortness of breath has been present.
3 days after Moderna C19 vaccination on 4/23/21 Patient suffered a massive stroke on 04/26/21.  He is now a hemi-plegic with severe apraxia and aphasia, unable to work, communicate or care for himself. He had no health issues prior to the vaccination. He was in ICU, Intensive care and hospital for 2 months and rehab continues.
she got the RSV vaccine last 10Nov and yesterday it started itching and red on the site of the injection; she got the RSV vaccine last 10Nov and yesterday it started itching and red on the site of the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 14Nov2023, outcome "unknown" and all described as "she got the RSV vaccine last 10Nov and yesterday it started itching and red on the site of the injection". Additional information: Caller calling in because she got the RSV vaccine last 10Nov2023 and yesterday it started itching and red on the site of the injection, she wanted to know what to expect regarding the reaction  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
patient came into pharmacy stating her shingrix shot gave her a red warm swollen area on her right arm (even though reported it was given in her left). The red area was warm and located down her upper arm near her elbow area. She claims it was given to her in the right arm yet our documentation states left arm. I referred the patient to alert her pcp on this reaction.
Local erythema and induration at injection site involving 2/3 of right lateral thigh around DTAP injection. Treated on 4/26/01 by Family NP with Augmentin. No fever or other systemic symptoms.
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the patient experienced administration of vaccine from the vial affected from temperature excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from the vial affected from temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916312, 20210916455, 20210916228, 20210916498, 20210916553, 20210915661, 20210916658, 20210916910, 20210915719 and 20210916697.
Hematoma and pain to injection site, light headed, fatigue, rash to trunk of body
Patient states she had fatigue, fever and chills for 3 days following her Zostavax and Prevnar 13 vaccinations.  She states she was "sick as a dog".
received the vaccine and is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (received the vaccine and is breastfeeding) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (received the vaccine and is breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (received the vaccine and is breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: TCR form is received on 23-MAR-2021 and does not contain any new information; Sender's Comments: This is a case of product exposure during breastfeeding with no associated adverse events. Patient will continue to be contacted for further monitoring of adverse events.