chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right facial numbness; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020, 18:00 at single dose (dose 1, reported as right arm, and also reported as left arm) for COVID-19 immunization. Medical history included DM, hypothyroid, and HTN from an unspecified date. The patient's concomitant medications were not reported. No other vaccines were given in four weeks. Patient has no COVID prior vaccination and did not undergo COVID testing post vaccination. The patient has no known allergies. The patient experienced right facial numbness on 16Dec2020 19:00, also reported as 50 minutes after receiving the vaccine. She was instructed to take one dose of BENADRYL as treatment. It was reported that numbness last for about 2.5 hours. Outcome of the event was recovered on 16Dec2020. The event was reported as non-serious.
She has SHINGRIX injection with pain at injection site (expected) Left deltoid however within two hours significant soft tissue edema left axilla with pain 10/10. Pain was to degree she consider ER visit. She applied ice, then heat. On examination no lymphadenopathy and now mild soft tissue swelling with pain 6/10. This is her second injection.
pt. recvd. booster vax 04JAN91. Pt. had 2 prior doses of vac in 1965 & 1980.
01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and throbbing excruriating pain in the left arm (10/10). I was barely able to move the left arm, and I could not bend it due to severe pain in the elbow joint. At approximately 0800, I started having diarrhea that lasted for no more than an hour. By noon the soreness and aching had reduced to a moderate pain (5/10). I was able to bend my left arm, but the arm remained sore at the elbow joint until 01/10/2021. By the morning of 01/10/2021, all the symptoms were gone.
Shivers and shakes starting 9 hours after 2nd dose (Fri). Fever of 99.9 the next morning (Day 2 - Sat) with cold sweats and shakes all day. On day 3 (Sun), no fever but still extreme exhaustion and tiredness. Throwing up also started on Day 2 around 2pm and could not keep anything down. On day 4 (Mon), still extreme exhaustion that lasted until about noon. Was finally able to eat something at noon and felt back to normal by 2pm on Monday.
Rapid heart palpitations; Headache; Dizziness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Rapid heart palpitations) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced PALPITATIONS (Rapid heart palpitations). On 12-Mar-2021, DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved and PALPITATIONS (Rapid heart palpitations) outcome was unknown.            Treatment medication was not provided.
Terrible headache; Little bit nauseated; Just close to achiness; fever; Very sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Terrible headache), NAUSEA (Little bit nauseated), PAIN (Just close to achiness), PYREXIA (fever) and ILLNESS (Very sick) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HEADACHE (Terrible headache), NAUSEA (Little bit nauseated), PAIN (Just close to achiness), PYREXIA (fever) and ILLNESS (Very sick). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Terrible headache), NAUSEA (Little bit nauseated), PAIN (Just close to achiness), PYREXIA (fever) and ILLNESS (Very sick) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other medication reported.
Swollen, Itchy Lips, Nostrils, and Spot on Cheek whenever immune system is down. (cold, period, etc._
Report 2000033914-1 describes chest tightness in a 49-year-old female who received an injection of hepatitis B vaccine. Concurrent medical history included hypersensitivity to "many drugs", "too many to mention". No concurrent medications were taken at the time of immunization. The patient received her first dose of the hepatits-B vaccine on 04-August 2000. Within minutes of immunization, she developed chest tightness and a rash across her chest. She recovered within a 24 hours.
Severe lower back pain and stiffness.  Could not play golf for over a week.  Difficulty and pain standing and sitting.  As bad as 8 of 10 pain.  Seemed to be located around spine at belt level.  Lateral stretch most painful/difficult.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date in 1979 the patient was vaccinated with a dose of ZOSTAVAX dose and route unspecified (lot# was not provided). On an unknown dates the patient has developed shingles six times since receiving ZOSTAVAX in 1979. The outcome of the event was unknown. Relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Chills; Hot flashes; Dizziness; Headache; Fatigue; Stomach pains; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; DIZZINESS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pains".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
POTS; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001190 (Novavax). A female patient received bnt162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "recovered" (2023), described as "POTS". Additional information: On 16Sep2023, it was reported that a patient started treatment on unreported dates with 4 doses of Pfizer BioNTech COVID-19 vaccine for COVID-19 immunisation. It was reported the patient had POTS for a year and a half. The patient never knew when the episodes would turn up, and so she only had 4 of the shots. At the time of reporting, the patient did not have a POTS episode for 6 months.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician regarding a female patient of unknown age. Medical history and concurrent conditions were not reported. On 25-JUN-2015, the patient received improperly stored VARIVAX (Merck) (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reprots received from the same reproter. Additional information has been requested.
SMILE (stratified mucin producing intraepithelial lesions).; diagnosed with Human Papillomavirus; pap smear abnormal; This spontaneous report was received from a doctor of pharmacy, via a company representative, and refers to a 27-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-NOV-2006, the patient was vaccinated with first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) 0.5 milliliter, intramuscular injection (anatomical location, lot # and expiration date were not provided). On 09-JAN-2007, she was vaccinated with second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) 0.5 milliliter, intramuscular injection (anatomical location, lot # and expiration date were not provided). On 30-APR-2007, the patient was administered third dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) 0.5 milliliter, intramuscular injection (anatomical location, lot # and expiration date were not provided). All vaccines were administered for human papillomavirus (HPV) prevention. On 28-SEP-2020, the patient had a pap test performed. On 07-OCT-2020, she was notified that her pap was abnormal. On 23-NOV-2020, the patient had further testing and was told she had HPV and stratified mucin producing intraepithelial lesions (SMILE). The HPV result was as follows: HPV high risk type 16 was negative, HPV high risk type 18 was negative, "other high risk types that were positive: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 66." On 18-FEB-2021, the patient had the loop electrosurgical excision procedure (LEEP) performed as a treatment for the events. It was reported that, the patient sought medical attention. The outcome of the events was reported as recovering.   The causal relationship between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and the events was not provided.
Pt is a 89 y.o. female  with ovarian cancer and HFrEF, HTN, and atrial fibrillation who presents with significant weakness after being diagnosed with COVID on 9/1. She came in today because as she states it she "didn't think she was going to make it". This is a lady that at baseline does aerobics for 50 minutes three times per week.  She lives alone and due to her weakness and fatigue felt like she could fall. She has not fallen and denies feeling light headed, she just feels weak.   Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Positive for palpitations. Negative for chest pain.   COVID-19 pneumonia - on 2L this morning, saturating 98% - CXR 9/6 with bibasilar airspace disease - She has had 2 doses of moderna vaccine Plan: - hold off lasix today, seems euvolemic, likely can get off oxygen - wean off oxygen - remdesivir,  dexamethasone   On discharge:  COVID-19 pneumonia - was requiring 2L oxygen, successfully weaned down - ambulatory pulse ox was 97% on room air - She has had 2 doses of moderna vaccine - s/p 5 days of remdesivir and 7 days of dexamethasone - to continue 3 more days of dexamethasone at rehab - not received antibiotic  Discharge Disposition/Condition  Condition: Stable (s/sx potential problems absent or manageable)
Morbilliform rash developed after 10 days. Also diagnosed with viral URI and acute right OM.
legs that were pink and red/ both leg was red; experienced swollen legs/ Both legs were swollen; This serious case was reported by a consumer via call center representative and described the occurrence of redness of legs in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 11-SEP-2023, the patient received Arexvy (unknown arm) and Flu vaccine (unknown arm). In SEP-2023, an unknown time after receiving Arexvy and Flu vaccine, the patient experienced redness of legs (Verbatim: legs that were pink and red/ both leg was red) (serious criteria hospitalization) and swelling of legs (Verbatim: experienced swollen legs/ Both legs were swollen) (serious criteria hospitalization).  The patient was treated with antibiotics nos (Iv Antibiotics (Nos)). The outcome of the redness of legs and swelling of legs were unknown.   It was unknown if the reporter considered the redness of legs and swelling of legs to be related to Arexvy and Flu vaccine.     It was unknown if the company considered the redness of legs and swelling of legs to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 22-SEP-2023 The consumer reported received the Arexvy in one arm and flu shot in the other arm (did not remember flu vccine name or which arm). Afterwards experienced swollen in both legs that were pink and red, was referred to emergency room who admitted her for 2 days with Intravenous antibiotics and they wanted to make sure it was not a blood clot. The patient's husband also received the same vaccine on the same day with no adverse event. Consumer stated would provide additional details to reporting Agent. Consumer declined to provide any further  details or self details. The reporter did not consent to follow-up.
6:00pm, 4 hours later my arm starting hurting. 7:00pm it itches asome. At 9:45pm I started shivering and feeling bad and took my temp which was 99.6. at 12:30 am I woke up and felt worse and took my temp and it was 101.6 it ran in the 100.6-100.8 range all day on 5/26/2021 after my vaccine. My fever finally stopped around 11:30pm on 5/26/2021. I also developed a slight cough with some congestion on 5/26/2021 as well. I still have a slight cough today 5/27/2021.
Soreness at site of injection and when my left arm is moved (elbow raised); leg muscle ache during first night after second shot; temperature of 100.4 upon waking the next morning (now).
Chills/ sweating, fever (103) with Tylenol, muscle and joint pain/ burning, difficulty standing, difficulty walking, difficulty bending limbs, nausea, fatigue, headache, loss of appetite, lower abdominal pain, sensitivity to light, weakness
This case meets criteria for vaccine breakthrough review. SxS include decreased PO intake, weakness, no respiratory complaints.
Patient received vaccinations and felt lightheaded he explained. Patient laid down on exam table BP 102/62. Patient had to lay down for 15-20 minutes and he felt good enough to sit up BP 106/52. Patient stated he felt he could stand up BP 102/55. Someone walked patient to car.
Swelling and pain for 3 days. Used ice packs on left deltoid and acetaminophen for pain. Most painful vaccine I ever had.
Healthy fetus until 9 days after vaccine.  The fetus became non-viable without a heart beat at 11W 0D.
Mini Stroke. Could not talk for 2 minutes then jumbled sentences. next day tired but improved. Following day just tired. No long term symptoms
he has eaten almost nothing; Hot to the touch (Maybe had a fever); started shaking again; has neuropathy and felt extreme pain in his feet; A little bit of delirium; Shaking violently from chills and felt very, very cold/ Could not stop the shakes; has neuropathy and felt extreme pain in his feet; Nausea; A Spontaneous report was received from a consumer concerning her husband, a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced extreme pain in his feet (increased neuropathy), a little bit of delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, hot to the touch (maybe had a fever), started shaking again, and he has eaten almost nothing.  The patient's medical history included neuropathy. Concomitant medications included fish oil, blood thinner, blood pressure medication, atorvastatin, Lyrica and baby aspirin.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the patient started to experience side effects: nausea, shaking from chills, felt very cold and couldn't not stop the shakes. The patient has neuropathy and felt extreme pain in his feet which continued until 01 Feb 2021, when it got somewhat better.   On 02 Feb 2021, the patient was good at first but then started shaking again. During the night, the patient shook violently from chills again and he was hot to the touch (maybe he had a fever but we didn't have a thermometer). The patient also had increased neuropathy and nausea and had eaten almost nothing. He also experienced a little bit of delirium. The patient's wife gave him acetaminophen that seemed to bring down the chills.  Action taken with mRNA-1273 in response to the events was not reported.   The events of has neuropathy and felt extreme pain in his feet, shaking violently from chills and felt very, very cold/couldn't not stop the shakes, and started shaking again were recovering/resolving on 01 Feb 2021. The outcome of the events of a little bit of delirium, nausea, hot to touch (maybe had a fever), has neuropathy and felt extreme pain in his feet, increased neuropathy and he has eaten almost nothing  was considered unknown.; Reporter's Comments: This report concerns a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced non-serious events of extreme pain in his feet (increased neuropathy), delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, fever, and he has eaten almost nothing. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
periorbital edema, lip swelling Narrative: ED note: This is a 29 year old employee who got her COVID vaccine yesterday. This morning she noticed facial puffiness, mostly around her eyes. No swelling of lips, toungue, no trouble swallowing or speaking, no swelling of throat, no SOB, no n/v or dizziness. Here she had some mild periorbital puffiness that I would not be aware of if she did not point it out to me. There is no swelling of her lips, airway and no SOB or problems with her voice. Her symptoms are improving in the ER. I think it is unlikely that this delayed symptom is related to the vaccine, however, she also states she had some swelling of the right side of her lip yesterday (none today), so I'm going to prescribe her an epi-pen.
Pt has a history of diabetes and osteomyelitis of the right foot. Arrives status post syncopal episode. Has been experiencing weakness and chills for the past few days. Was positive for COVID-19. Admitted due to acute worsening of the right foot osteomyelitis and COVID which could cause cardiac or respiratory failure.
One week following the first dose of Pfizer, my Mom was not able to say her words on the morning of 3/22/2021 and was admitted to Hospital with the admitting diagnosis of a cerebral vascular accident.  My mother was treated with TPA and spent 3 nights hospitalized in the ICU for a stroke. An MRI confirmed she had a left frontal lobe CVA.  She was discharged to home on 3/25/2021.
Injection site pain, muscle aches , Headache , body ache ,  Muscle ached lasted through the rest of the week
Swollen painful lymph node in neck/jaw, ear ache, dizziness, nausea, ringing in ears
same day pain at injection  site. next day headache, extreme fatigue, body aches including top of my feet with tingling sensation. I felt miserable and very sick manage with Ibuprofen
generalized pruritic rash and redness, patient describes symptoms as "red and blotchy" Patient taking Benadryl to relieve symptoms. Recommended to see primary provider if symptoms worsen.
Pt states drove to parents home-town (90min) and went to fair, started feeling feverish et malaise, went home.  Fri morning fever et malaise continued with arm becoming puffy with hot, itchy rash et painful to touch. Sat rash continues with pain et malaise increasing.  Ibuprofen et Benadryl taken Sat, pt states slept afterwards, unknown if ibuprofen helped fever. Sun pt starts to feel "a little" better, swelling from rash starts to decrease, no longer red in color, now pink. Monday pt continues to recover. Tuesday pt states site looks bruised, half-dollar size, no longer red, itchy, or raised.  Pt feels a small lump under skin and is tender to the touch. Highest recorded temperature was 102.4.  (Pt agrees to summary)
Received DTAP on 2/2/11. Was seen 2/4/11 with c/o "hard, red & swollen area" where shot given. Physician assessment indicated moderately erythematous skin, mildly indurated under left deltoid injection site. No open lesions/drainage treatment - area marked to observe, cold compresses recheck prn.
After second dose, experienced rapid heart beat, feelings of unbalance, lightheaded ness, feelings of anxiety . Brain fog as well.
This spontaneous non valid report was received from a medical assistant, and refers to three patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was provided. On three separate dates after 07-NOV-2017, three separate patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # N012615 with an expiration date in 16-MAR-2018), for prophylaxis, that underwent a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 1 hour. Furthermore, it was also reported that an additional previous temperature excursion was registered from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 14 hours and 30 minutes. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT). It was unknown if sterile diluent (MERCK STERILE DILUENT) was properly stored. Digital data logger was involved. No adverse effects reported. This is a non-valid case due to lack of patients' identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient's identifiers were provided. Follow up information has been received from the medical assistant on 17-JUL-2018. The patient, who was 70 years old, received the improperly stored dose of ZOSTAVAX on 22-NOV-2017. No adverse events had been reported to date. This is one of three cases received from the same source.; Sender's Comments: US-009507513-1807USA010667: US-009507513-1807USA010666: