chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seizure; Rash on Both legs; Headaches; Fever; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), RASH (Rash on Both legs), HEADACHE (Headaches), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, SEIZURE (seizure), RASH (Rash on Both legs), HEADACHE (Headaches), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.            Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pain, swelling, redness, warmth at injection site. Started day of vaccine and lasted 6 days.  Next day: abdominal cramping, lower back pain, hip pain (both sides). It felt like I was in labor (not pregnant) only with constant contractions. It was the worst the following day (2 days post-inoculation ) and lasted for a total of 4 days.
Patient's right arm red and swollen.  She said if touched it is does hurt a bit.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 21st February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain. The patient was treated with TYLENOL. On 23rd February 2019, the outcome of the injection site muscle pain was recovered/resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the pharmacist for himself. The patient received the SHINGRIX vaccine into the left deltoid. The patient experienced the expected muscular soreness at the injection site for 2 days in the left arm. The reporter provided the consent for follow up.
was pregnant during the first/second dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (was pregnant during the first/second dose of Moderna vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, VITAMIN D3 for Vitamin supplementation.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was in December 2020 and the estimated date of delivery was 08-Sep-2021. On 23-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (was pregnant during the first/second dose of Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 20-Jan-2021, EXPOSURE DURING PREGNANCY (was pregnant during the first/second dose of Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Ultrasound foetal: normal (normal) normal.         Date of positive pregnancy test: 31-DEC-2020. Estimated date of conception: 16-DEC-2021.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Internal review on 24-Jun-2021 resulted in updates to event coding and pregnancy details.
Received Bexsero in rt arm 2 days prior to onset of symptoms. Awakened morning of 9/22/22 with pain in Rt arm/elbow, pain worsened when tried to straiten arm. Mom gave ibuprofen, pain improved, now hesitant to move arm. No redness at injection site.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/14/2021, 1/31/2021 and 12/27/2021. Presented to ED 2/4/2022 c/o generalized weakness, fatigue, and high output from his ostomy. Admitted for septic shock, acute cycstitis, Covid19 requiring O2. Course c/b AKI w/azotemia, hperkalemia, metabolic acidosis and acute metabolic encephalopathy delirium. Tx'd w/decadron and Tylenol. Transitioned to comfort care instituted and expired 2/17/22.
On 7/14/17 patient developed sore throat, fever, and arthralgias. Parent took patient to Hospital. Rapid strep testing was negative. Diagnosis viral pharyngitis. Bilateral 1 mm sized petticheal lesions to distal legs [on shins] developed same day after ER visit. All symptoms except lesions have resolved. Lesions have not spread or worsened.
The adverse event was wrong vaccination. I did NOT request to receive the Pfizer COVID 19 shot, I requested the flucelvax shot. I was given the Pfizer COVID 19 shot without my knowledge or consent.
Developed 2 separate 1.5 cmn red hives on elbow/forearm area immediately after giving ROTATEQ vaccine. No difficulty breathing.
This spontaneous report was received from a pharmacist via a company representative referring to an elderly female patient of unknown age with hypertension. The patient's medical history was not reported. On 20-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, administered in an unspecified arm (dose, dose number, route, frequency, lot number and expiration date were not provided). Concomitant medication information was not provided. On 20-SEP-2016, the patient's arm became "red and hot" and it was diagnosed with cellulitis. As a result, the patient sought medical attention and cephalexin was prescribed as treatment with an unknown dose, 4 times daily for 4 weeks. However, the patient was not hospitalized, there was no significant disability or incapacity, the event was not a congenital anomaly, there was no life threatening situation and the patient did not die. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of cellulitis was reported as not recovered. The primary reporter did not provide the causal relationship between PNEUMOVAX 23 and cellulitis. Upon internal review, cellulitis was determined to be medically significant. Additional information has been requested.
When patient came in for her vaccine appointment, I asked her if this would be her first or second dose.  She replied that this would be her first dose.  I next asked her, if she ever received a dose from another manufacturer or any other dose from anywhere ever.  She replied that she did not and that this would be her first dose.  When I went to go enter her info into the system, I noticed that she did in fact receive 2 doses of Moderna from Health Department.  Next, I tried to call her to discuss this with her and the number she gave me did not work.
Itchy scalp/more itchy scalp; DID NOT FEEL GOOD; losing hair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 48-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Intramuscular), administration date: 31Jan2021, when the patient was 48-year-old, for COVID-19 immunization, reaction(s): "Psoriasis flare-up"; BNT162b2 (DOSE 2, SINGLE, Intramuscular), administration date: 21Feb2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovered", described as "losing hair"; MALAISE (non-serious) with onset Jul2022, outcome "unknown", described as "DID NOT FEEL GOOD"; PRURITUS (non-serious), outcome "recovered", described as "Itchy scalp/more itchy scalp".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had completed post vaccination and returned to the area stating the roof of her mouth feels funny. After questioning her about it feeling funny she stated it feels weird. I questioned her regarding difficulty swallowing or if she felt  any difficulty such as throat tightening, she stated no. I gave he a little water and was able to swallow without any difficulty. She stated her mouth felt dry. V/S taken B/P 118/78 P-72 R- 20.  Advised we would observe her for 30 minutes to make sure she was not having an allergic reaction.  She continued talking to family members without any difficulty noted or voiced. She requested another bottle of water no problems noted . After 30 minutes she stated she was feeling better and she did not have numbness or dry mouth . She was escorted to her car at 12:40 without any complaints or distress voiced or noted.
Tinnitus in both ears began the following morning after my first dose of the Pfizer vaccination.
Patient noticed blood blisters; Patient noticed a similar red patch on the opposite foot; Scarred areas; chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (Patient noticed blood blisters), ERYTHEMA (Patient noticed a similar red patch on the opposite foot), SCAR (Scarred areas) and CHILLS (chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Hay fever. Concurrent medical conditions included Sun sensitivity. Concomitant products included ALLOPURINOL for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced BLOOD BLISTER (Patient noticed blood blisters), ERYTHEMA (Patient noticed a similar red patch on the opposite foot), SCAR (Scarred areas) and CHILLS (chills). The patient was treated with MAGNESIUM SULFATE (EPSOM SALT) at a dose of UNK dosage form. On 19-Apr-2021, BLOOD BLISTER (Patient noticed blood blisters), ERYTHEMA (Patient noticed a similar red patch on the opposite foot), SCAR (Scarred areas) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Other concomitant medication included blood pressure pill     Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Added patient demographics (Race, Medical history), Added the event chills and updated the outcome of events from unknown to recovered. Added lab test.
when she was given a dose of the Pfizer vaccine for Covid-19, her throat closed.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "when she was given a dose of the Pfizer vaccine for Covid-19, her throat closed."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial misuse report received from a healthcare professional on 19 June 2013. A 17-year-old patient had received first dose of MENACTRA in 2007, a booster in 2012 and then received another dose again in 2013 due to record issue. No adverse event was reported. List of documents held by sender: none.
Tachycardia Chest pain; pleurisy Narrative:  Employee received the vaccine approx 11:45am on 1/5/2021.  Around 4am on 1/5/2021, the patient experienced stabbing chest pain which  awoke her from sleep. She states she had stabbing pain like a heart attack. She  stated her heart rate was 150 and it hurt to breathe. She went to her local ER. At the ER she had a cardiac work up. She was also treated with pepcid, toradol, and a GI cocktail which did not alleviate her symptoms. She states that her heart rate stayed above 100 the entire time and her blood pressure was 150/100 without any previous history. She also mentions she has a slight cough. She was diagnosed with pleurisy from the ER visit and given a prescription for ibuprofen 800mg. She stayed home from work yesterday. She states she has a history of asthma. Her  symptoms are improved today. (1/7/2021)
Patient called and complained that her arm hurt (She said arm hurts more that the first time and wondered if we had used a big needle instead). She complained of numbness, being tired and sleepy and muscle stiffness. Advised her to take tylenol and call her dr. I had called her twice today  to  follow up on her but had to leave a message.
I was working at my desk seeing patients via telehealth and had the sudden onset of extreme sweating, felt odd/dissociated. BP and P were normal sitting and standing. No other associated symptoms. I cancelled the rest of my day. Took about 3-4 hours to feel normal again. No recurrence.
Patient returned 5 days after flu shot with a lesion on his arm where the flu shot was given.
high fever less than 24hr p/vax;myalgia/arthralgia & h/a;severe neck stiffness noted on 3rd day p/vax;tx w/meds;
Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering.  Information on lot/ batch number has been requested.
Immediate pain in the Occipital area right after shot. The severity reduced slowly. Lingering pain all night.
This spontaneous report as received from a physician refers to a 58 year old male patient with aspirin allergy concerning her husband. On an unknown date, patient developed hives to aspirin. On 07-FEB-2014 the patient was vaccinated with ZOSTAVAX, (dose number unknown) with lot # J011882 and expiry date 04-JAN-2015, 0.65 ml, subcutaneously. Other suspect therapies included PNEUMOVAX23 0.5 ml (dose number, lot number and expiry date unknown) was administered on 12-FEB-2014. On 07-FEB-2014 within 24 hours, patient developed erythema and pain after receiving ZOSTAVAX. Approximately on 11-FEB-2014 (within 3-4 days), patient recovered from erythema and pain. The outcome of developed erythema and pain within 24 hours was reported as recovered/resolved. The outcome of received a dose of ZOSTAVAX on 07-FEB-2014 and a dose of PNEUMOVAX23 0.5ml on 12-FEB-2014 was unknown. This case # 1402USA007610 is linked to case # 1402USA007605 via same reporter link. Additional information is not expected.
Within 10 days pt describes intermittent severe burning type pain across the middle of her back lasting hours.
3PM on 10/20/2018 dizziness, weakness, nausea. 10/21/2018 severe headache at 2am, followed by loss of consciousness at 3am, followed by diaphoresis, vomiting, followed by dizziness, weakness, loss of appetite for 3 days. On 4th day on 10/24/2018 sore throat, cough, postnasal drip. On 8th day on 10/28/2018 bronchitis dx by M.D. at urgent care.
Patient began to feel lighththeaded and "woozy" about 20 minutes after injection.  No loss of consciousness, BP 118/78, HR regular, color pink, began to complain of "sore" on one side of throat, began clearing her throat frequently,
Information was received from an immunization program of a community nursing service concerning a patient (demographics not provided). On an unknown date, the patient was vaccinated with GARDASIL, lot # J003727 (exp. 07-NOV-2015) (dosage and route of administration not provided). The vaccine was reported to have been properly stored. Additional information has been requested.
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On 05-MAR-2014, the patient was vaccinated with GARDASIL dose 1, 0.5 ml Intramuscular. On 05-MAY-2014, the patient was vaccinated with GARDASIL dose 2, 0.5 ml Intramuscular. On 04-JUN-2014 the patient was vaccinated with GARDASIL dose 3, 0.5 ml intramuscular. No adverse effects reported. Additional information has been requested.
Chronic headaches turned into migraine headaches; developed a sinus infection that wouldn't clear for over a month and settled into the sinuses in the back of head/neck; these sinuses swelled and pushed on nerves causing severe migraines, vision disturbances, and blood pressure that reached stroke level as told by the urgent care doctor; all of this culminated in a Bell's Palsy diagnosis after being rushed to the hospital in an ambulance with a suspected stroke. Bell's Palsy is rectifying after nearly a month of no use of the right hand side of her face and having no taste or control inside the right hand side of her mouth.
No adverse effect reported.; patient received improperly stored PROQUAD; This spontaneous report has been received from a nurse referring to a 4-year-old patient of unknown gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.     On 27-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S002924, expiration date: 28-JUL-2020, dose, frequency, route were not reported) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent. No adverse effect was reported. No product quality complaint (PQC) was involved.  The administered doses experienced a temperature excursion at 6 Fahrenheit scale to 14 Fahrenheit scale (10.4 F) for 1 hour and 30 minutes. There was previous temperature excursion, total time in the range 6 Fahrenheit scale to 14 Fahrenheit scale (14 F) for 1 hour 56 minutes and total time in the range 15 Fahrenheit scale to 46 Fahrenheit scale (29 F) for 5 hours. Data logger was involved.  This is one of three linked cases received from the same reporter.; Sender's Comments:  US-009507513-1907USA002200: US-009507513-1907USA002134:
about 2 weeks after the shot he developed a lump and small bumps around the injection site. sore and itchy. a few other chicken pox like bumps on his body appeared in the following 3 days. since traveling we didn't see the doctor.
Client phoned to report that she experienced a seizure occuring on 4/11/21 in the early evening. She was riding in the back seat of a vehicle and became nauseus and began seeing flashing lights.  She was taken by her husband to the nearest ED where they stabilized her. She has never had seizure activity before. Does have occasional migraines which are accompanied by flashing lights. Client is scheduled for an MRI on 4/15/21. She has not had any seizure activity since the episode on 4/11/21    Vaccination Dates:  Dose 1 on 1/6/21                              Dose 2 on 2/3/21
Initial unsolicited case received from a Physician on 29-SEP-2017. This case involves a female patient (age not reported) who was vaccinated 0.5 ml single dose of FLUZONE QIV (batch number, expiry date and dose in series were not reported) via subcutaneously by mistake in the left arm on 28-SEP-2017 for Immunization. The patient medical history and concomitant medications were not reported. On unknown date, after vaccination, patient developed a warm raised red area to the back of her arm which was a size of a hand. It was reported that the physician will have the patient (nurse) evaluate the site for size it if it doesn't improve or becomes larger or more concerning, the physician will have her seek medical treatment immediately and will have the occupational health Doctor evaluate it. It was also a case of actual medication error due to vaccine administered at inappropriate site and inappropriate route of vaccination because the staff member mistakenly gave it subcutaneously with a 5/8th inch needle to the back of her left arm. Lab tests and corrective treatment were not reported. Outcome of the event was not recovered. 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 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. Documents held by sender: none.
Arm is swollen and red.  Looks like cellulitis but pt is going to go to ER to confirm.  Pt took benadryl but did not work.