chrisvoncsefalvay/vaers-outcomes huggingface dataset:
as a person with severe cough variant asthma, he/she immediately noticed a change in his/her breathing/ breathing so much better; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization.  Medical history included ongoing severe cough variant asthma. The patient's concomitant medications were not reported.  The patient reported he/she just received the covid vaccine the day before reporting date and wanted to let company know that as a person with severe cough variant asthma, he/she immediately noticed a change in his/her breathing. It was very noticeable all of the day 28Dec2020 and even this morning (29Dec2020). He/she was breathing so much better. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
dry cough, diarrhea. dx with covid pneumonia, bilat cavitary infiltrates. IV abx,  zinc, O2 @ 2L. no other treatments. pulmonologist thinks lesions are old. DC with home O2.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 02-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
hive in the middle of her chest, it is swollen and raised; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9231), via an unspecified route of administration (left upper arm) on 14Jan2021 (15:30) at single dose for Covid-19 immunization. The patient's medical history included blood cholesterol abnormal, anxiety, high blood pressure, sleep disorder, and obesity. Concomitant medication included amlodipine besilate (NORVASC) for high blood pressure been on it for years and ongoing, hydroxyzine for anxiety been on this medication for 10 years and ongoing, trazodone for sleep taking for 10 years and ongoing, pravastatin sodium (PRAVACHOL) for cholesterol taking for 12 years and ongoing, and colecalciferol (VITAMIN D) from 2019 and ongoing. In November, she received her shingle shot and croup shot. The patient reported that got she the vaccine yesterday (14Jan2021S). She woke up with a hive on 15Jan2021 (8:30 am). She has a hive in the middle of her chest, it is in between her boobs. She added that it is swollen. There is nothing else anywhere. She is going to take Benadryl. She didn't have a prescribing doctor. Her boss set up the appointment for them. The hive has stayed, it is swollen and raised. Her second dose is scheduled on 04Feb2021. The outcome of event was not recovered.
I developed some flu symptoms (chills and aches) around 11 pm the day of the shot, and these symptoms lasted about 36 hours.
VOMITING, DIZZINESS, LACK OF FOCUS, FEVER, CHILLS, HARD RED LUMP ON ARM, STOMACH PAINS, LETHARGY, LACK OF APPETITE
This spontaneous report as received from a healthcare professional refers to 4 unspecified patients of unknown demographics. No concurrent condition, concomitant therapy or medical history were reported. On unspecified dates, these patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (dose and route of administration were unknown, lot # K010338, expiration date: 22-JUL-2016). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Left arm numbness, itching. Rx Benadryl 50mg IM and Decadron 10mg IM. Then his symptoms improved.
Currently a nursing mother and experienced a tint of green to breast milk after pumping. Noticed this only the day after the second dose was given. Still currently experiencing this symptom.
Check out"feeling dizzy", blurring vision, blood pressure systolic=80 (Pre Vaccine B/P 142/92). Slight chest pressure. Epinephrine ADM, 911 notified, transported to RWJ, evaluated and discharged.
patient started with numbness and muscle aches within two weeks of vaccine.  Now with increased myalgias and CK elevation.
Two weeks after vacination patient reported swelling in her arm. She stated that the swelling started after she was vaccinated. Visual swelling was evident. I recommended that she try cold compress. Today, Nov 11, patient reports that her arm is still a little swollen (info given to me over the phone) and that the cold compresses helped.
Immediately after the shot, I saw stars, went completely red, felt dizzy, and experienced shortness of breath. All of the symptoms subsided within 5 or so minutes.
Severe pain in left deltoid causing difficulty with abducting arm (without erythema/swelling/fever) lasting >2 wks.
the vaccine leaked / unknown how much medication was /administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) (batch number 7354R, expiry date 15th November 2022) for prophylaxis.   On 2nd August 2021, the patient received the 1st dose of Shingrix. On 2nd August 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that while injecting the 1st dose of Shingrix into a patient the vaccine leaked out between the syringe and the needle and it was unknown how much medication was actually administered to the patient, which led to incomplete dose administered. The reporter consented to follow up. The Pharmacist was warm transferred to GRC for reporting of potential PQC. No further details provided.
Hair started falling out; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Hair started falling out".  Additional Information: Caller reported she received all three Pfizer BioNTech Covid19 Vaccine doses, but after the first dose she noticed her hair started falling out. After second dose, her hair started falling out more. Then it stopped and everything seemed ok. Then she got the booster and her hair started falling out again. She had questions. This report was for caller's friend. She had a dear friend at work that has also reported the same thing. They both got Pfizer and got boosters together, 10 days ago. Caller noticed the hair failing about within a month of first dose. She noticed hair everywhere. Certainly after second dose it was like woah. Her friend at work said she had the same thing and she is caller's age too.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101595915 same reporter/drug/AE, different patients.
Sweats; Experienced 100.8 fever; Chills; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), PYREXIA (Experienced 100.8 fever), CHILLS (Chills) and FATIGUE (Extreme fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Environmental allergy. Concomitant products included IRBESARTAN and HYDROCHLOROTHIAZIDE for Blood pressure, LOVASTATIN for Cholesterol, DIPHENHYDRAMINE HCL and FLUTICASONE for Environmental allergy.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 9:12 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced HYPERHIDROSIS (Sweats), PYREXIA (Experienced 100.8 fever), CHILLS (Chills) and FATIGUE (Extreme fatigue). On 10-Apr-2021, PYREXIA (Experienced 100.8 fever), CHILLS (Chills) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 100.8 (High) 100.8 (degrees F).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up received, Patient demographics added, Relevant history added, concomitant medication added, events out come added.
Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 04-OCT-2016, a healthcare provider at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2016, the patient was treated by the patient's healthcare provider at a medical group immediate care for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Information has been received from a nurse concerning a 75 year old female with no known allergies who on 03-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). In October 2007, the patient called the office and stated she one itchy blister behind her knee. The patient's itchy blister behind her knee persisted. Additional information has been been requested. 03/26/2008 Information has been received from a nurse concerning a 75 year old female with allergies to codeine and DEMEROL who on 03-OCT-2007 was vaccinated SC with a first dose of ZOSTAVAX (Oka/Merck) (lot # 657767/0740U). There was no illness at the time of vaccination. In October 2007, the patient called the office and stated she one itchy blister behind her knee. The patient's itchy blister behind her knee persisted. Additional information from a registered nurse indicated that the patient called the office on 08-OCT-2007 complaining of a blister on the back of her knee. On 29-OCT-2007 the nurse spoke with the patient again and she indicated that she had no further complaints, the blister lasted a couple of days then went away without treatment. It was reported that the patient recovered on 12-OCT-2007. No further information was provided. Additional information is not expected.
Developed a 101 fever along with body/joint aches on 12/19/2020
Worsening menstraul cycles - heavier bleeding and associated dizziness, fatigue, intermittent nausea through cycle and unbearable prior to menstraul bleeding.
Chest pain, general body fatigue, fever, swelling of tongue (airway remained open) and severe headache. Awaiting follow-up in 3-5 days. ASA-steroid burst.
Information regarding Flumist nasal solution was received from a consumer regarding a 13 year old female patient who experienced a headache and body aches. At 13 years of age, the patient received a dose on 12/15/03. The patient had no relevant medical history. Indication for Flumost was immunization. Product was administered on 12/15/03. Dose regimen was one dose (IN). Patient was not taking concomitant therapy. The patient experienced headache and body aches on 12/15/03. The patient's sister developed a headache and body aches following receipt of Flumist on 12/15/03, at 15 years of age. No additional information was available at the time of this report.
Post flu shot felt dizziness, chest pain, flushing. Epinephrine administered 911 called - she refused transport - was feeling better.
I was super tired and achy; I was super tired and achy; Sweaty; Nauseated; Dizzy; The site pain was about half what I had before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 11:30 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; CRESTOR; SYNTHROID; LITHIUM; PRISTIQ. Vaccination history included: Bnt162b2 (Dose number=1,, Administration time=11:00 AM,, Vaccine location=Left arm), administration date: 25Jul2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "I rubbed my arm a few hrs after injection to ease the pain I had with the 1st shot & that seemed to work". The following information was reported: HYPERHIDROSIS (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Sweaty"; NAUSEA (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Nauseated"; DIZZINESS (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "Dizzy"; VACCINATION SITE PAIN (non-serious) with onset 15Aug2021 11:45, outcome "recovered" (15Aug2021), described as "The site pain was about half what I had before"; FATIGUE (non-serious), PAIN (non-serious) all with onset 16Aug2021, outcome "recovered" (17Aug2021) and all described as "I was super tired and achy". Therapeutic measures were not taken as a result of hyperhidrosis, nausea, dizziness, vaccination site pain, fatigue, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination were atenolol, crestor, synthroid, lithium, Pristiq. Reported that, for 2nd shot, patient rubbed arm a few hrs after injection to ease the pain had with the 1st shot & that seemed to work - the site pain was about half what she had before; in the first 15 mins after injection, Patient was dizzy, sweaty and nauseated, but that passed pretty quick; after that, patient was super tired and achy the next day but that only lasted the one day. Patient has been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Follow-up attempts completed. No further information is expected.
Diffuse swelling of entire thigh area at day 2-4 post vaccine administration- frontal mid thigh area. Focal swelling and minor irritation (puritis) prior to this time at site of vaccination.
Fever (48+ hours), Joint clicking (48+ hours), severe headache (10 hours), low blood pressure (5 hours), back pain (48 hours), depressive episode (48+ hours)
Tingling and numbering on the face, mainly nose and sinus region. First noticed 1h after the shot. Then, it went away and came back next day, but it was stronger and with a sensation of itching throat. The last not present the day before.
23/F received second dose of Moderna vaccine and had vasovagal response. Pt has a hx of this response with needle injections. Pt reports being dizzy and nauseous. Pt given emesis basin just in case she needed it. Pt vomited, ice was applied to the back of her neck. PT stated she immediately felt better after vomiting.  Pts vitals taken. Pts condition and symptoms dissipated. Pt monitored additional 15 minutes. When her observation time was up she was accompanied to the exit sign.
Was awoken w bad headache/eye ache in middle of night follow vaccination (2nd Covid) previous morning.  Over the next few hours, experienced bad muscle pains throughout body, cd barely move.  Chills, cd not get warm, even wearing thermal underwear top & bottom, fleece jacket, in bed w flannel sheets, one quilt, one thick heavy woolen blanket & a woolen throw blanket.  Cd not get out of bed for many hours.  Eventually, Saturday 3/27 took temp--100.5, v high for me as normal morning temp is 96.7-97.1.  Oxygen saturation 94% (normal for me--89-99%).  Most scary, pulse rate of 92 (normal resting pulse for me--68-72) while I was inert, in bed.
Pt complains of nausea and lethargy beginning day after shot. Also developed rash and pain below site of injection. Patient was better by Monday.
Very painful area where injection was given, painful without even touching area.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 13Apr2021 at 10:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 infection, post-traumatic stress disorder (PTSD) and cardiac disorder (the patient was stabbed 14x on 24Aug2019 nicked heart, jugular, etc. The patient was survived and was ok at the time of this report). The patient had known allergies to amphetamine (MANUFACTURER UNKNOWN), dextroamphetamine (MANUFACTURER UNKNOWN), cephalosporins, sucralose (MANUFACTURER UNKNOWN). The patient received unspecified concomitant medication on an unknown date, for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced very painful area where injection was given, painful without even touching area. It was still continued at the time of this report. No therapeutic measures were taken as a result of the event. The clinical outcome of the event very painful area where injection was given, painful without even touching area was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Meniere's disease; off balance; vertigo; memory loss; dizzy; feels brain fog; This case was reported by a consumer via call center representative and described the occurrence of meniere's disease in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 2 days after receiving Shingrix, the patient experienced meniere's disease (serious criteria GSK medically significant), balance disorder, vertigo, memory loss, dizziness and foggy feeling in head. On an unknown date, the outcome of the meniere's disease, vertigo, memory loss, dizziness and foggy feeling in head were resolved with sequelae and the outcome of the balance disorder was recovering/resolving.   It was unknown if the reporter considered the meniere's disease, balance disorder, vertigo, memory loss, dizziness and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated in early October 2019. Two days after vaccination, the patient felt off balance, vertigo, dizzy, brain fog, and memory loss.  The patient was seen by an ear, nose throat physician and had a brain scan, which was normal.   The physician diagnosed meniere's disease.   The symptoms were becoming worse. In December 2019, the patient received 2nd dose of Shingrix. The events were still present at the time of 2nd vaccination.  The reporter did not consent to follow up.
rash, little bumps, some are red & itchy; has already had chickenpox;
pt states just started feeling bad right p/shot;29OCT PM devel aching uncomfortable feeling, fever, redness, swelling, hot to touch rt arm from shoulder to 2" above elbow;
cluster of ulcers on her tongue and under her tongue; could not walk because her right knee was hurting; fatigue; achy; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hepatitis c.   On 14th October 2019, the patient received the 1st dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced fatigue and pain. On 15th October 2019, the patient experienced tongue ulceration and knee pain. On an unknown date, the outcome of the fatigue, pain, tongue ulceration and knee pain were unknown.   It was unknown if the reporter considered the fatigue, pain, tongue ulceration and knee pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that many years ago she had a diagnosis of hepatitis C for which she was treated. The patient stated that she received the first dose of the Shingrix vaccine from the doctor's office and started to feel fatigue and achy. The patient not walk because her right knee was hurting. The patient to see cluster of ulcers on her tongue and under her tongue.