chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm around the part of the arm that is itching; left arm started itching; red around the vaccination area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Sep2021 10:30 (Lot number: EW0175) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 02Feb2021, for COVID-19 Immunization; Bnt162b2 (2nd dose), administration date: 23Feb2021, for COVID-19 Immunization.  The following information was reported: PRURITUS (non-serious) with onset 26Sep2021, outcome "not recovered", described as "left arm started itching"; INJECTION SITE ERYTHEMA (non-serious) with onset 26Sep2021, outcome "unknown", described as "red around the vaccination area"; VACCINATION SITE WARMTH (non-serious), outcome "not recovered", described as "warm around the part of the arm that is itching". Relevant laboratory tests and procedures are available in the appropriate section.  Follow up (12Oct2021): This is a follow up spontaneous report from a contactable consumer. This consumer (Receptionist) reported in response to HCP telephonic follow up activity which included that:   Phone Out 2:02 PM, 1St attempt by phone to HCP to obtain mailing information. Phone out to HCP. Phone answered by receptionist (name not provided) who provided physician's mailing address and full name.  Follow-Up (18Oct2021): Follow-up attempts are completed. No further information is expected.
Patient began to complain about secretions on 2/1 and phlegm for days post vaccine. Following that she complained of upset stomach upset and large mucus. Loose stool followed on day 6 post vaccine, with continued large amounts of mucus.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
6 minutes after receiving the injection the patient became dizzy complaining of rotatory vertigo and complained of increased thirst.  She was placed on a stretcher in the observation area and given 3 glasses of water 09:45.  She complained of light sensitivity and a cloth was placed over her eyes.  SaO2 98% HR 63 BP 150/82 RR 18 CBG 95.  when after a few minutes she did not feel better. IV access was obtained and she was given a 1 L bolus of LR. after an hour   she felt better, and was sent home with family for the rest of the day
Upper lip, left cheek, part of right cheek swelled up.  We have pictures with times pictures were taken from different angles.  Ice was applied and generic Benadryl  was given, 2 tables.  Swelling started at 5 pm, continued to increase until approx 8:30 pm.  Upon waking face was still swollen the next day.  Swelling started to decrease noticeably approximately noon on the 9th.  By 7pm on the 9th most swelling had decreased, except for left lower cheek and upper lip still had noticeable swelling.  This report is being filled out at 7:10pmon January 9, 2021.
Received Covid  vaccine on 01/12/21. Late that afternoon, developed fever, chills, headache, body aches, and fatigue, lasted throughout the day on 01/13/21.
8-6-15 - Cut top of rt foot on rusty pipe. Went to Dr. 8-11-15. She gave me 7 days script for KEFLEX and booster for my 4-1-09 tetanus shot of a Tdap on 8-11-15 which caused muscle aches, tiredness, headaches and fatigue - still exhausted.
(Day 1) - Headache,  (Day 2)- Headache,  fatigue, muscle pain, pain in right eye, slight chest pain (Day 3) - Headache, fatigue, muscle pain, pain in right eye, tingling in left arm/hand, slight chest pain(Day 4)- Headache, fatigue, muscle pain, tingling in left arm/hand/leg, tingling in right arm, slight chest pain.  Have not been to Dr. for a follow up, I have been taking Ibuprofen which seems to improve  symptoms.
1/22/23 I noticed there were a few tiny, almost invisible, bumps on the top of one of his feet and ankle, can't remember which one. The next day, I noticed there was also similar bumps on his hands. We were at the Pulmonologist for another issue, and I asked the Pulmonologist to look at it. He said to keep an eye on it. Over the next few days, it got progressively worsened where the skin on his fingertips peeled off. It was very painful because it peeled down to the last layer of skin. We tried to prevent it from bleeding. We put AQUAPHOR on it for a couple of days. Eventually we went to his pediatrician on 2/13/23. By that point, it was not going away after a few weeks of washing his laundry in different detergents, wearing gloves, and applying different lotions. It was healing over by the time we went to the Pediatrician. He referred us to another physician because he was having another symptom that was neurological. He was falling down; his leg would buckle underneath him. He would regain his ability to walk right after he fell down. We were instructed to wait several days to see if there was improvement. Since he was improving, we did not feel the need to go. The falls have not happened in a few weeks. The bumps eventually went away after the peeling went away. His hands are almost back to normal. The hands were worse than the feet. Mom was diagnosed a week before with COVID. He tested negative for COVID with several home tests.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment drug as Paxlovid for COVID-19 from 22Jun2022 to 26Jun2022. Patient did not received any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After inserting the FLUARIX QUAD syringe in the patient's arm, and while injecting the vaccine, some of the vaccine liquid came out of the syringe and ran down the patient's arm. When I pulled out the syringe, the needle and screw top from the syringe remained in the patient's arm. Due to a product defect, the syringe and screw top separated, and the patient did not receive the full dose of FLUARIX QUAD.
The patient stated that she felt dizzy and lightheaded. The staff attended to her. They took her vitals. She stated that she felt ok after a few minutes. The patient stayed at the center eating and speaking to the director of the center after her observation time was up.
Pain and tense at injection site. Now a days lump at shoulder and armpit and I am feeling very severe dizzy. I can't lift my hand because of pain and very severe tense at injection site.
Pt received shot - called back in 20 min to say he was having violent shivering & felt that his B.P. was dropping. He did not want to contact PCP, so I did call his MD & notify them. Pt's phone number not working next day.
On 08/23/2005 father brought his daughter age 4 into clinic for IMM. On 08/25/2005 mother brought daughter back for PPD reading and to report clients reaction to vaccine, redness, pain, swelling. On left upper arm which client mention on the 08/24/2005 complains of hardness, itching in left arm. 08/26/2005 mother reports itching on left arm, redness almost gone. Child OK.
passed out; hit her head...head still hurts; slept the entire day; joints were achy; did not sleep well...woke up multiiple times; feet were cramped so she could not stand up very well; abdomen was painful to the touch; extremely thirsty; shaking so bad; very nauseous; low grade fever; A spontaneous report was received from a consumer concerning a 63 year old, female patient who experienced sore and tight red arm that was very hot, nausea, pain in abdomen, extreme thirst, woke up multiple times during the night, severe tremor, fever, achy joints, foot cramps, loss of consciousness, head injury, fatigue and headache.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number 029L20Ar) on 14-JAN-2021.  On 11-FEB-2021 prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:016M20A) intramuscularly for prophylaxis of COVID-19 infection.    After the second dose, she had a low-grade fever 6-7 hours post vaccination. She did not sleep well. She woke up at 10:30PM and was very nauseous, abdomen was painful to the touch, and extremely thirsty. She woke up multiple times in the night. Patient was shaking so bad she couldn't put a thermometer in her mouth as her teeth would not unclench. She had a temperature of 101F. Her joints were achy, and her feet were cramped so she could not stand up very well. At 6AM, she went to get another drink of water, she stood up then passed out. She hit her head on the floor. She was bleeding a little but there was no bump. She consulted her MD friend who recommended an Advil and to ice her head so she did. After the fall, her ankle, feet, hands, and joints were very achy. Her temperature was in the 100s and she slept the entire day. Her head still hurts. Treatment for the event included Advil.     The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event(s) was/were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
This spontaneous report as received from a pharmacist refers to a 77 years old male patient with allergy to penicillin and none pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) in "late 2011". No other co-suspects were reported. Concomitant medications included BENICAR and TOPROL XL tablets. In June 2012 ("3 months ago"), the patient experienced tingling sensation in the lumbar region of the back spine and insomnolence. The patient saw the pharmacist. Unknown treatment was given for the adverse events. The outcome of tingling sensation in the lumbar region of the back spine and insomnolence was reported as not recovered/not resolved. The relatedness for insomnolence and tingling sensation in the lumbar region of the back spine was unknown for ZOSTAVAX. Additional information has been requested.
I have continually bled with large clots since receiving the vaccine. My endometriosis was well managed x 3 years before the vaccine and has returned with a vengeance. I'm going on 3 months of constant menstruation which has effected my energy and work negatively.
Pt rec the appropriate 3rd dose  of Pfizer Covid vaccine in this Right arm and an additional 0.5 mL of Pfizer covid vaccine in his left arm during the same appointment. The nurse/administrator thought the second vaccine was an influenza vaccination.,
Vaccinated 4/1/21. Asymptomatic positive during hospitalization 11/27/21.
Whole body hurting me; Didn't wanna do anything; Itchiness between shoulder and elbowbetween , "Popey muscle"; Redness between shoulder and elbowbetween , "Popey muscle"; Tiny pink-ish spot; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Whole body hurting me), FEELING ABNORMAL (Didn't wanna do anything), PRURITUS (Itchiness between shoulder and elbowbetween , "Popey muscle"), ERYTHEMA (Redness between shoulder and elbowbetween , "Popey muscle") and RASH (Tiny pink-ish spot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031-A21A) for COVID-19 vaccination.     The patient's past medical history included Broken bones in 2013. Concomitant products included METFORMIN, ENALAPRIL, OMEPRAZOLE, FENOFIBRATE, THEOPHYLLINE, GABAPENTIN, COLECALCIFEROL (VITAMIN D3), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), Proair and latanoprost eye drops.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (Whole body hurting me), FEELING ABNORMAL (Didn't wanna do anything), PRURITUS (Itchiness between shoulder and elbowbetween , "Popey muscle"), ERYTHEMA (Redness between shoulder and elbowbetween , "Popey muscle") and RASH (Tiny pink-ish spot). On 24-Apr-2021, PAIN (Whole body hurting me) and FEELING ABNORMAL (Didn't wanna do anything) had resolved. At the time of the report, PRURITUS (Itchiness between shoulder and elbowbetween , "Popey muscle"), ERYTHEMA (Redness between shoulder and elbowbetween , "Popey muscle") and RASH (Tiny pink-ish spot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Tyleno
Started having nerve pain 3 hours after the second vaccine. It only got worse over time.; the pain has greatly interfered with my daily activities; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications on unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 07Apr2021 at 17:00, 3 hours after the second vaccine, the patient started having nerve pain. It only got worse over time. The patient was now being treated by her doctor because the pain had greatly interfered with the daily activities. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain that only got worse overtime and had greatly interfered with the daily activities was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/16/2023 ATRIAL FLUTTER, UNSPECIFIED
PT BROKE OUT IN HIVES ON ARM AND NECK MD ORDERED PREDNISONE.
7MAY pt recv vax & 9MAY t100.4; 13MAY t103.4-104 mom called clinic advised to given APAP & pt slept;upon awakening pt was confused & hallucinating;taken to hosp ER, t97.6, improved p/1hr;kept in ER 2hr & sent home w/instructions to monitor;
Urticaria and shortness of breath from 7pm to 1:30am; required antihistamines and steroids, no epi
weakness; chills; severe headache; body aches; nausea; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced general body pain, nausea, weakness, headache and chills. On an unknown date, the outcome of the general body pain, nausea, weakness, headache and chills were recovered/resolved.   It was unknown if the reporter considered the general body pain, nausea, weakness, headache and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the vaccine at the same location and time where her friend received the vaccine. Within few hours of vaccination, the patient developed body aches, nausea, weakness, chills and severe headache. Body aches, nausea, and headache resolved after 4 days. Chills resolved after 2.5 days. Weakness resolved after 6.5 days. The reporter consented to follow-up. This case had been linked to US2019123836, reported by the same reporter. The reporter consented to health care professional (HCP) follow up.
strong reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strong reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 029L20A and 038C21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2008.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (strong reaction). At the time of the report, VACCINATION COMPLICATION (strong reaction) outcome was unknown.            In 2008 patient had breast cancer for which she was performed a Mastectomy, though didn't receive Radiation nor Chemo   This case was linked to MOD-2021-318449 (Patient Link).
Woke up at 1:30 AM with sudden severe panic attack with heart rate at 160+, acute panic symtpoms including elevated heart rate & blood pressure lasted about 6 hours, ongoing anxiety throughout the next 24 hours treated with proscribed benzodiazepines. 102 degree fever without medication, 99 with steady usage of over the counter ibuprofen. Violent shaking and chills, severe muscle aches, extreme fatigue, couldn't walk up stairs without assistance. Sporadic dizzy spells, similar to the "Brain zaps" of SSRI withdrawal. Began to subside 36 hours post injection, with lingering symptoms still present 52 hours post injection.
Initially, 0.1 mL was administered. A second staff recognized the dose was too small. The patient received the other 0.1 mL for a total 0.2 mL dose before leaving clinic.
About 4 - 5 hours after the vaccine, I felt my feet was burning and itching. In the night it was itching all over but severely on the feet. I have had 4-5 serious episodes of Benign recurrent intrahepatic cholestasis starting from age 19 - 20 till 32 (ages not accurate) During those times, I had constant severe itching leading to bruises, jaundiced eyes, unable to fall asleep thus very fatigued overall. I had similar symptoms after the vaccine along with fever and shivering in the night. I was mortified to think that BRIC has set in again but luckily the symptoms subsided after a few days though milder itching lasted some more time.
Sharp intermittent pain up and down left arm; painful blister clusters above and below elbow and between finger;  sharp pain in fingertips. All outcomes on left arm
This spontaneous report as received from a physicians assistant via a company representative refers to a 15 year old female patient who was not pregnant. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot #, dose, and route not provided). On an unknown date, the patient developed hives "all over her body" "immediately" after receiving the dose of GARDASIL. The patient was given BENADRYL, in the physicians assistant office after the hives developed. No laboratory tests were performed. After the BENADRYL was given to the patient, the hives subsided "a little bit". The outcome of hives all over her body was recovered. The physicians assistant was not planning to give the patient a second or third dose of GARDASIL. Additional information is not expected.
Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 13:15 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included guillain barre syndrome (GBS) and aortic valve replacement (ON-X aortic valve replacement), on an unknown date and unknown if ongoing. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and warfarin (MANUFACTURER UNKNOWN) all for an unspecified indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not 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 vaccination. On 05Mar2021, the patient experienced arm soreness. The patient did not receive any treatment for the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event arm soreness was recovered on an unknown date in 2021. The patient later received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the right arm on 09Apr2021 at 09:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
fingers on both hands had little bumps and were sore and swollen; fingers were sore; fingers swollen; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (fingers on both hands had little bumps and were sore and swollen), PAIN IN EXTREMITY (fingers were sore) and PERIPHERAL SWELLING (fingers swollen) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced NODULE (fingers on both hands had little bumps and were sore and swollen), PAIN IN EXTREMITY (fingers were sore) and PERIPHERAL SWELLING (fingers swollen). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, NODULE (fingers on both hands had little bumps and were sore and swollen), PAIN IN EXTREMITY (fingers were sore) and PERIPHERAL SWELLING (fingers swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications included acetaminophen.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI. Patient declined follow-up