chrisvoncsefalvay/vaers-outcomes huggingface dataset:
full body rash; covid arm; itchy at rash area; This spontaneous case was reported by a consumer and describes the occurrence of RASH (full body rash), VACCINATION SITE REACTION (covid arm) and RASH PRURITIC (itchy at rash area) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Psoriasis has been under control until the vaccine) and Autoimmune disorder. Concomitant products included AMITRIPTYLINE for Sleep disorder NOS, LORATADINE, FUROSEMIDE, SPIRONOLACTONE, VITAMINS NOS, COLLAGEN, MAGNESIUM, POTASSIUM, VITAMIN D3, ZINC, CRAMP BARK and MELATONIN for an unknown indication, BIOTIN.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-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 RASH (full body rash), VACCINATION SITE REACTION (covid arm) and RASH PRURITIC (itchy at rash area). The patient was treated with PREDNISONE at a dose of two rounds of Prednisone. At the time of the report, RASH (full body rash), VACCINATION SITE REACTION (covid arm) and RASH PRURITIC (itchy at rash area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication includes Antihistamines was provided.   This case was linked to MOD-2021-242114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant : patient Gender and event related information.
Around 8pm on the day I was given the vaccine,  my heart began to race and lasted for about 1 minute. I was able to breathe deeply and eventually my heart rate slowed down. I had 2 more episodes the next morning. Around 9am. Again I was able to breathe through them.  I received the vaccine when I was 18 weeks, 4 days pregnant.  I called my OBGYN's office and was told to monitor and register my reaction.
not yet received their second dose of Shingrix / more than a year since the first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than a year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient did not provide a specific date for when the first dose was received; they simply stated it had been more than a year. After call catch; limited demographics were obtained. The reporter did not consent to follow up.
tongue felt thick, speed slurred on weekend;On 25MAY96 contacted MD;21MAY96 went for CT scan rt arm started to feel numb/tingling;dec in appetite;
This spontaneous report was received from a female patient of unknown age, regarding herself. The patient's medical history and concurrent conditions were not reported. On 26-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX on her right arm (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. On 27-FEB-2015, the patient experienced pain and soreness on her right arm and also on her chest. The outcome of the patient's pain and soreness on her arm and chest was unknown at the time of the report. Additional information is not expected, as there is no contact information to follow up.
pt recv Td inadvertently as intradermal inj when mistaken for PPD tuberculin vial;resulting in 5x8 induration & erythema w/resolution starting on day 3;
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Treatment information provided as "used pills for vertigo"
Swelling; Scratcky tongue; Scratchy mouth; This spontaneous case was received on 21-Dec-2020 from nurse via Agency (reference number: SEQW20-05868) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration and anatomical location: not reported) for flu prevention. The batch number was not reported.   On an unspecified date in 2019, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed scratchy tongue, swelling and scratchy mouth.   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  This case as assessed as non-serious.  Company comment: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed scratchy tongue, swelling and scratchy mouth. Causal role of the suspect vaccine is unassessable, due to lack of information regarding temporal relationship, diagnostic findings and corrective treatment.; Sender's Comments: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed scratchy tongue, swelling and scratchy mouth. Causal role of the suspect vaccine is unassessable, due to lack of information regarding temporal relationship, diagnostic findings and corrective treatment.
No Adverse event, reporting age differential from approved. During a covid vaccine clinic vaccinated. While processing the vaccine, the vaccine was given to the patient and it wasn't until later they saw the rejection for the patient that she was not 16. Patient had no adverse reaction and patient and facility are aware she cannot get second dose until she is 16.
This spontaneous report was received from a pharmacist and refers to a 74 year old female patient with penicillin allergy. No information about the patient's medical history was provided. On 04-OCT-2017, the patient was vaccinated with the first dose of ZOSTAVAX 19400 PFU injection, subcutaneously, lot # N020939 with expiration date: 26-OCT-2018 (dose was not reported) to prevent shingles reconstituted with sterile diluent (manufacturer unknown) lot# M016886 with expiration date: 07-DEC-2018 and with the first dose of FLUAD intramuscularly, lot# 178901 (expiration date and dose were not reported). Concomitant therapies included Carvedilol (unspecified) orally, 50 mg daily, atorvastatin, SINGULAIR, ramipril and PRILOSEC. The patient had no illness at the vaccination time. On 04-OCT-2017, the patient experienced "red circle" at injection site which were still there, 5 days later on 09-OCT-2017. Injection site also itched on the same date as 04-OCT-2017, but had since dissipated. The events lasted longer than usually. No treatment was commenced for the events. The outcome of the events was reported as recovering/resolving. The patient did not seek medical attention. Product quality complaint was not involved. The causality between the event and suspect therapies was not reported.
Lethargy/joint pain at gaut sites/body ache/increased pain at injection site/  all of these symptoms lasted till 10/15/2021 night.  On 10/16/2021 had a full gaut attack in my left big toe site...can't be 100% sure if this is related to the vaccine or not ...odd coincidence...
With embryo in the womb received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (With embryo in the womb received vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (With embryo in the womb received vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (With embryo in the womb received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.; Sender's Comments: This is a case of product exposure during pregnancy with  associated no AE of   female (age not provided). Very limited information regarding this event has been provided at this time.  Further information has been requested.
pt recv vax 16JAN97 & 18JAN97 pt devel fluid-filled chickenpox blisters & fever of 102 degrees;
flu like symptoms; runny nose; cough; Initial information received on 10-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer Non-Healthcare Professional (under reference number: US-SA-SAC20211012001046).  This case involves Adult female patient who was experienced flu like symptoms, runny nose and cough (influenza like illness and rhinorrhoea) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported.  On an unknown date the patient developed a non-serious events flu like symptoms, runny nose and cough (influenza like illness and rhinorrhoea) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/ event.  It is unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment from the events.  At time of reporting, the patient outcome was Unknown for the events.
PSYCHOTIC EPISODES; MINIMAL SLEEP FOR AT LEAST 50 HOURS; TIREDNESS; This spontaneous report received from a consumer concerned a 29-year-old white  female. The patient's height, and weight were not reported. The patient's concurrent conditions included cognitive disability, but she was not on medication for anything.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 10805031 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 in left arm around 4:40 pm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient exhibited bizarre behaviors that raised eyebrows but not red flags, as her father thought she was goofing around, she was talking loudly and laughing to herself with nobody around. She seemed very tired, taking a long time in the bathroom (about an hour/an hour and a half). On 03-APR-2021, she was saying things that did not make sense and people could not make sense of what she was talking about. On 04-APR-2021, she started experiencing really bizarre behavior. She was hearing voices, talking to herself and seeing people that were not there, insisting that people were coming over to the house and she had to go there. By the evening, she experienced hallucinations and delusions. She was taken to emergency hospital. She had been awake for about 12 hours, possibly longer. She was tested for a urinary tract infection, but the result was negative. In the emergency room, she had a blood test and computed tomography (CT) scan that did not show anything. In the night on same day, her condition was bad. She was trying to get out of the house. On 05-APR-2021, at 6am, she went back to the hospital room and was admitted to the psych ward for psychotic behaviors. She had been there for 7 days. She had been on unspecified medications, which was helping the symptoms. She was examined by a doctor and admitted to the psychiatric ward. In the evening on same day, her behavior became more severe, showed signs of aggression, flipping furniture, throwing things, saying a light on the wall was watching her. On 06-APR-2021, the psychiatrist stated that she was experiencing psychotic episodes and she was put on antipsychotic medication and examined her. She did not sleep for almost 3 days, started 04-APR-2021 morning at 7:00 am until 06-APR-2021 night (about 50 hours with minimal sleep). Then she was sedated, and she finally slept.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minimal sleep for at least 50 hours on 06-APR-2021, was recovering from psychotic episodes, and the outcome of tiredness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210420207- Covid-19 vaccine ad26.cov2.s-psychotic episodes. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient was seen 8/12/2020 for a well child check up and vaccines. Patient was late for her period so pregnancy test was done in the office and was negative. The two vaccines listed above were administered. On 9/10/2020 patient was seen in urgent care and pregnancy test was positive at that time. Patient not currently experiencing any adverse effects.
I had 40 minutes of generalized body itch.  In addition, within 5 minutes of the injection, my hands became very red and hot.  This disappeared within about a minute.
Information has been received from a certified medical assistant concerning a 72-year-old female who on 26-Jul-2007 was vaccinated with a 0.6 ml dose of Zostavax (lot #657558/0461U).  Concomitant therapy included levothyroxine Na (Synthroid), estrogens, conjugated (Premarin), hydrochlorothiazide (manufacturer unknown) and amlodipine besylate (Norvasc).  On approximately 22-Aug-2007, (the exact date was unknown, but was documented as occurring several weeks before the patient notified the physician's office which was on 05-Sep-2007) the patient experienced pain and a "knot" at the injection site.  There were no other symptoms or complaints.  Medical treatment was sought by a phone call to the office on 05-Sep-2007.  No laboratory tests or diagnostic procedures were performed.  As of 12-Sep-2007 the injection site pain persisted.  It was unknown if the "knot" persisted.  No product quality complaint was involved.  Additional information has been requested.
The usual, sore arm, mild fever, fatigue for 24 hours starting the next day. Somewhere between Saturday and Sunday, I started to feel a heaviness in the center of my chest, a type of deep ticklish pain. It made me a bit short of breath and would catch me off guard and make me cough. It reminded me of the residual effects of bronchitis. I had it quite a bit in my 20's.
Awoke with shivers, fever 101.2' intense left chest wall pain and left breast tenderness, followed by left breast swelling over next 2 days; had MMR and TB tine admin. In left arm; no symptoms to right breast or right chest wall; no redness or bruising to injection sites or elsewhere.
Pt has left upper arm soreness, redness 4 inches x 3 inches of swelling nausea, headache, fever 102.5 tympanic.
Per ED 9/18/2021 note: The patient is an 81-year-old male with history of prostate cancer in remission as well as recently diagnosed spinal stenosis who presents to the emergency department with worsening bilateral lower extremity weakness. The patient was seen in the emergency department on Wednesday 9/15/2021 for new onset bilateral lower extremity weakness. At that time an MRI was done that shows bulging disc at L4-L5 with compression of the spinal canal. Also performed her CT angiogram of the chest and ultrasound bilateral lower extremities as well as MRI brain. The patient was discharged to home with plan to follow-up with Dr. for likely surgery. However, since Wednesday the patient has had worsened lower extremity weakness including a fall today at home. The patient has begun using a walker and was able to get around yesterday. However, today while in the bathroom he lost his balance and did have a fall resulting in no injuries, no head trauma, however he did have difficulty getting up with his wife's help. He denies any bowel or bladder incontinence. He does have numbness and tingling bilateral lower extremities to his knees. He denies any back pain or pain going down his legs. Repeat MRI lumbar spine done today is unchanged from 3 days ago. Neurologist has recommended admission for surgery early this week. The patient is uncomfortable going home due to weakness and falls.  Neuro 9/21/2021 Note: This patient is an 81-year-old male who presented with acute decompensation and paraparesis.  He was evaluated in the emergency room and at that point in his clinical course it was thought not to be Guillain-Barré syndrome.  MRI demonstrated critical spinal stenosis at L4-5.  The patient underwent urgent decompression following optimization on September 20, 2021.  On postoperative day 1 the patient has an ascending paralysis that now involves his hands.  His lower extremity weakness is now much more profound with 2 out of 5 strength proximally and distally.  The patient's clinical picture is now more consistent with an acute demyelinating syndrome.  Patient does have a history of immunization approximately 4 weeks ago however denies watery or bloody diarrhea.
Site of injection got swollen, red, warm and very painful. Sx lasted 5 day. Pt took Tylenol for comfort, no other tx needed.
Developed redness, pain, swelling at vaccination site. Similar reaction occurred after the first dose of Moderna vaccine 3 weeks prior.
This spontaneous report as received from a other health professional via a company representative refers to an unspecified article which stated that the types of GARDASIL protects against are not a prevalent in a certain population and thus GARDASIL may not be as effective in said population. The outcome of lack of efficacy of GARDASIL in a certain population was unknown. The causality between GARDASIL and the events was unknown. Additional information has been requested.
Fever; Chills; extreme weakness; so weak he couldn't stand up out of a chair; extreme weakness; so weak he couldn't stand up out of a chair; felt really bad; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; EL3247), via an unspecified route of administration in the left arm near the shoulder on 16Jan2021 at about 2-3:00 PM as a single dose for COVID-19 immunization (also reported as to protect himself; hopefully). The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines on the same day as BNT162B2 or even four weeks prior and had no problems with vaccines in the past. The patient experienced fever, chills, extreme weakness; so weak he couldn't stand up out of a chair, and felt really bad on 26Jan2021. He had a fever a little over 100 degrees, extreme weakness. He was so week he couldn't stand up out of a chair. He also had chills and just felt really bad. The patient thinks he was over it, he hoped. The events did not require any visit to the Emergency Room or Physician's office. Outcome of the events was recovering.
tingling sensation; lightheadedness; This is a spontaneous report from a contactable consumer via a Pfizer Sales Representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced tingling sensation and light-headedness post vaccination. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
I generally did not feel well after my vaccination and my arm was sore for about a week. Mast Cell activation disorder has been flaring up more frequently since receiving the shot. I was receiving an IV infusion on 06/24/2022, where I then had a terrible mast cell reaction during my IV infusion. I was given steroids in my IV to counteract the reaction as quickly as possible. I was then just placed on observation and on Tuesday, I saw my primary care and they said I should have went to the ER. My blood pressure dropped very low and I was in an altered state of mind during the recovery period. I started to feel better on 06/29/2022 and am still recovering.
Fluid in lungs, persistent rattling cough, excess mucous, headache, fever, dizziness, ....
Swelling tenderness (LA) clavicle area several hrs after flu shot. Swelling, pain has improved. Assessment: adenopathy ->improving.
Fever, chills, headache, body aches.  Took  Advil dual action. Was better the next day
Within about 24 hours I experienced flu like symptoms for about 48 hours I was bed ridden.  Feverish, exhausted, dizzy, chills and sweats.  This went away and then after about 10 days then injection site swelled up and became increasingly painful.  Now one month later the injection site continues to be painful, and I am suspecting an allergic reaction.  I have felt "off" ever since the first shot and am very fearful to get shot number 2 and need some guidance please.  I just cannot believe that my left arm still hurts.  I am unable to teach yoga which is what I "do", because I cannot use my arm in this manner.
I had no symptoms other than a sore arm the day of shot that faded quickly. One week after shot with no symptoms, my arm began to itch while sleeping. When I woke up, I had whelps on my arm that grew in size throughout the day. It was hot, itchy, and red. I used benedryl cream and latter that night alcohol topically.  10 days after shot redness is fading with little to no itch nor swelling.