chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got Moderna Booster.  Large golf ball size, swollen, red lump/rash on arm. Very itchy, painful, warm to the touch, and somewhat hard/firm.  This popped up about 12 hours after shot. About a half hour after shot, felt nauseous, tired, and developed a headache. Those symptoms came and went for about 24 hours. By the 48 hour mark, had developed sore throat, sore muscles, tired, lump had gotten bigger on arm, and had a horrible, constant headache. Ibuprofen and Zyrtec hasn't seemed to help much.
Parent states that patient developed rash approximately 4 hours after receiving the 2nd dose of vaccine. Rash itchy and described as hives. Resolved 2-4 hours with OTC Benadryl. Woke the following day with rash and again resolved 2-4 hours of Benadryl. Developed diarrhea 48 hours after vaccine. Has not sought medical evaluation at this time.
Rapid Heart beats; Dizzy; Wanted to sleep a lot; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid Heart beats), DIZZINESS (Dizzy) and SOMNOLENCE (Wanted to sleep a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Rapid Heart beats), DIZZINESS (Dizzy) and SOMNOLENCE (Wanted to sleep a lot). At the time of the report, TACHYCARDIA (Rapid Heart beats), DIZZINESS (Dizzy) and SOMNOLENCE (Wanted to sleep a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.
Swelling of arm, red hot, itching, fever, throwing up.  Given Ciprofloxacin 500mg. twice a day for one week.
Chest pain from GI Hernia discomfort . Flu referred to GI specialist next wed. Warm feeling dizziness in arm , chest. EKG results wnl.  Feeling OK @this and not going to hospital.
day 8 after shot-slight bump at site of shot with itching and slight soreness day 9-bump the size of a lemon with redness, itching, and HOT to touch and slight soreness day 10-bump the size of an orange with redness, itching and HOT to touch with slight soreness day 11-symptoms are shrinking with a little itchiness day 12-all symptoms appear to be gone Other than the symptoms described above, i would classify this as just an annoyance and on a scale of 1-10, would call this a zero.
Pt. husband reported pt started with headache 2 hours after administration then started vomiting went to ER that night and ER physician felt it was due to ZOSTAVAX. Pt received a RX for ZOFRAN 4mg OPT and was sent home. Pt went back to ER on 4-3-17 due to dehydration. Pt was not admitted and was given fluids and another ZOFRAN RX.
aneurysm; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender may received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Caller claimed that some guy she knows got an aneurysm and died but she was not sure if that person took the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: aneurysm
pt recv vax 8DEC97 & 14DEC97 pt devel full body rash (head to lower torso) w/high fever (104 & higher);pt did not exp itchiness, but was very uncomfortable;pt required two visits to MD;
Very hot to touch injection site exactly one month after injection. Caused me to leave work due to hot flashes, chills, dry sweats, tenderness, major swelling and very red and swollen arm.
Tachypnea/"heart racing" following HBV Reported on 5/27/11 during MD visit
diagnosed with an autoimmune condition called CIDP . It's the chronic of Guillaine-Barre; face was numb ,hands were numb, then my feet; tongue was tingly; no reflexes in my legs; little reflex in my arms; Initial information was received on 29-Sep-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced diagnosed with an autoimmune condition called CIDP. it's the chronic of Guillaine-Barre (chronic inflammatory demyelinating polyradiculoneuropathy), face was numb, hands were numb, then my feet (hypoaesthesia), tongue was tingly (paraesthesia), no reflexes in my legs (areflexia) and little reflex in my arms (hyporeflexia), after receiving INFLUENZA VACCINE (MONOVALENT).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (MONOVALENT) produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site.  On an unknown date, the patient developed serious event diagnosed with an autoimmune condition called CIDP. it's the chronic of Guillaine-Barre (chronic inflammatory demyelinating polyradiculoneuropathy) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT). This event was assessed as medically significant.  On an unknown date, the patient developed non-serious event face was numb, hands were numb, then my feet (hypoaesthesia), tongue was tingly (paraesthesia), no reflexes in my legs (areflexia) and little reflex in my arms (hyporeflexia) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT).  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns unknown demographic patient (unknown age and unknown gender) who had chronic inflammatory demyelinating polyradiculoneuropathy, hypoaesthesia, paraesthesia, areflexia and hyporeflexia after receiving INFLUENZA VACCINE (MONOVALENT) (unknown manufacturer). The time to onset is compatible with the role of the vaccine. Further information regarding medical history, condition at the time of vaccination, past medical treatment, vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Small raised dots around mouth. Not itchy/irritating, rechecked 1 hr later, without change. Msg left for mother. No difficulty breathing/no mouth involvement.
Large local reaction on left thigh. 12.5 x 16 cm wheal. Localized warmth.
ACTHIB was prepared using sterile water with no reported adverse event; Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who received HIB (PRP/T) VACCINE [ACT-HIB] which was prepared using sterile water instead of normal diluent.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product preparation error (latency same day).  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
had just sore arm x1hr;6hr later had very sore muscles in neck, arm, back & shoulder;went to MD 25OCT96 said rxn to flu vax & gave Pred;feels no better yet even eyes hurt on 4th day post vax;was told by MD to reconsider flu shot next
The patient was vaccinated on 12/17/20. Wife was diagnosis with COVID-19 on 12/18/20. He was diagnosis with COVID-19 on 12/21/20. Symptoms woresen on 12/26/20. And he had chest exam (x-ray's), pneumonia bi-lateral and he was hostipalized on 12/26/20.
Patient experienced soreness after injection, pain continued with limited use of arm. Dr diagnosed inflammation of bursa in shoulder.
TINGLING IN BODY; DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced tingling in body. On 07-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in body, and diarrhea. This report was non-serious.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 62-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADINE; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: positive test after multiple negative tests post-Paxlovid; (2022) Negative, notes: positive test after multiple negative tests post-Paxlovid. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Covid 19 treatment involved brand Paxlovid, treatment start date was 27May2022 and treatment stop date was 31May2022, administrator route was oral. Vaccine lot was unknown as not available provided to reporter at the time of report completion, patient was taking other medications products within 2 weeks of starting Covid-19 treatment. Patient previously received a Covid-19 vaccine. Reported event was rebound symptoms and positive test after multiple negative tests post Paxlovid. Adverse event start date was 08Jun2022. Patient was recovering. Device date was given as 17jun2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.
Patient received the Pfizer Vaccine around 11:35 AM.  Patient  proceeded to sit at the observation area for around 5 mins then patient flagged down staff with c/o nausea and dizziness.  Patient was noted sitting at the observation area with LVN next to her side. Patient was handed a vomiting bag/trash. Patient vomited once and stated she felt much better after vomiting. Ice pack was placed on the back of patients neck, patient drank some water and ate a couple saltine crackers and candy bar. VS were taken and noted to be stable. Patient was monitored for 30 mins before departure.  Nurse instructed patient  signs, Symptoms of Severe Adverse Reactions to report to health care provider or to go to the emergency room. patient verbalized understanding.
Red, warm, inflamed area around injection sight; Red, warm, inflamed area around injection sight; Red, warm, inflamed area around injection sight; Significantly tender to touch and movement; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 15:00 as dose 4 (booster), single (Lot number: Ek9895) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: theophylline, reaction(s): "Drug allergy", notes: Known allergies: Theophylline. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), INJECTION SITE INFLAMMATION (non-serious), INJECTION SITE ERYTHEMA (non-serious) all with onset 06Apr2022 at 16:00, outcome "not recovered" and all described as "Red, warm, inflamed area around injection sight"; TENDERNESS (non-serious) with onset 06Apr2022 at 16:00, outcome "not recovered", described as "Significantly tender to touch and movement". Therapeutic measures were not taken as a result of vaccination site warmth, injection site inflammation, injection site erythema, tenderness.  Additional Information: Adverse event: Red, warm, inflamed area around injection sight. Significantly tender to touch and movement. Now 5 days after injection, the red inflamed area is moving down his arm. Still significantly tender to touch and movement. Patient was infected with covid prior vaccination. Post vaccination patient was not tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Area around injection site is red, warm and swollen. About 1-2 inches in diameter.
30 minutes after vaccine developed chills, progressed to numbness, tingling of lips and palate, increased BP and heart rate.
Initial unsolicited report received from a healthcare professional (physician's assistant) on 25 August 2015. This case involves a two-month-old patient (gender not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiration date, dose, dose number and route were not reported) and a dose of IPOL (batch number, expiration date, dose, dose number and route were not reported) in left thigh on an unspecified date. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe tissue damage to entire upper left thigh where vaccines were administered, much more than dimpling. The dermis was adhering directly to the muscle. At the age of 10 weeks old, the patient was come back to physician for severe tissue damage to entire upper left thigh where vaccines were administered. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was not reported. Upon internal review, company assessed the event of severe tissue damage to entire upper left thigh where vaccines were administered, much more than dimpling, the dermis was adhering directly to the muscle as serious and important medical event. List of documents held by sender: None.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient with unknown age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 20-MAR-2009 the patient was prescribed and administered with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions by a healthcare provider. On an unspecified date (reported as subsequent to patient's inoculation), the patient was treated by a doctor for shingles. It was claimed that as a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered as not recovered. The causality was assessed as related by the lawyer.
Injection site redness; Itching; This is a spontaneous report from a contactable consumer. This consumer reported for a 60-year-old female patient (Reporter mother) that who received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration at arm right on 26Mar2021 as dose 1 single for covid-19 immunisation. Medical history included thyroid disorder from an unknown date and unknown if ongoing Verbatim: thyroid it was diagnosed many years ago, reporter said his mom takes medication for this, and it was diagnosed many years ago. No further details provided about this medication, blood pressure abnormal from an unknown date and unknown if ongoing Verbatim: Blood pressure reporter said his mom takes medication for this, and it was diagnosed many years ago. No further details provided about this medication. The patient's concomitant medications were not reported. Reason for no lot number: of Pfizer COVID-19 vaccine: Complainant does not have the product with them at the time of call. Consumer said he was called about his mom; she got the Pfizer COVID-19 vaccine shot Friday and she had one of the side effects called injection site redness. He said that she was also having itching a little bit, so he was wondering is there any cream or something she could take for that, reporter says his mom has her vaccine card with her and she was not there with him, they do not live together. He said his mom got her first dose Friday during the early morning around 08:00-08:30AM in her right arm. He said that her itching and injection site redness began yesterday (29Mar2021). He said he doesn't think his mom has done treatment yet, he doesn't think she used anything though he thinks she took a Cerlatin, NDC/LOT/EXP unknown, this medication was with his mom. Medication name spelling documented as provided by reporter. Outcome of the events was unknown    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right Lacunar Stroke causing loss of feeling on entire left side.  Most feeling has returned except in left forearm and hand which has only partially recovered.
The patient was feeling hot and dizzy. He was sweating and felt like passing out.  An ambulance was called. The patient was able to drink some water and by the time the ambulance arrived he felt better. He was checked out by the paramedics, they said he was fine and left.
Bright red gold ball size lump on left arm at injection site developed 24 hrs after injection - no heat from site. Recommended apply ice pack and watch - Followed up on 4/4/16: Lump resolving "going away".
patient's mother was asked if they were doing any trials for women that are nursing because she got her 1st and 2nd shot recently; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the parent (mother). A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transmammary (Batch/Lot number: unknown) as dose 2, single and transmammary (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "patient's mother was asked if they were doing any trials for women that are nursing because she got her 1st and 2nd shot recently".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021265330 mother case
sinus congestion; muscle aches; headaches; cough; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. A42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6200), via an unspecified route of administration in the left arm on 22Feb2021 at 09:00 at the age of 42-year-old as a dose 1, single for COVID-19 immunisation. The patient medical history included hypertension. Concomitant medications included benazepril hydrochlorothiazide, Pantoprazole (PROTONIX), loratadine (CLARITIN) all for unknown indication from unknown date. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The Patient had not tested positive for COVID-19 since the vaccination. The patient experienced cough on 14Mar2021 at 22:00 and sinus congestion, muscle aches and headaches on 15Mar2021. The patient underwent lab tests and procedures, which included COVID-19 Virus test on 15Mar2021 and resulted negative. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Pt receive Flu shot (Quad) on 11/5. Next day, on 12/11/13 in the morning saw a 2" round red puffy area at injection site. Hard when pressed in middle, itched a bit, warm. On 12/12 area had grown to a 4" circle. Stopped by pharmacist for feedback but went to the doctor. Also doctor recommended cortisone cream for itchiness. On 12/13 are larger and middle of it darker and hard.