chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a tingling sensation in her bottom lip; like as if it's coming off of being numb; just feels weird; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Aug2021 16:00 (Lot number: FC3182) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 17Aug2021, outcome "recovering", described as "had a tingling sensation in her bottom lip"; HYPOAESTHESIA ORAL (non-serious) with onset 17Aug2021, outcome "recovering", described as "like as if it's coming off of being numb"; FEELING ABNORMAL (non-serious) with onset 17Aug2021, outcome "recovering", described as "just feels weird". Therapeutic measures were not taken as a result of paraesthesia oral, hypoaesthesia oral, feeling abnormal.  Additional information: It was stated that, patient had her first dose on 16Aug2021 of the vaccine and this morning (17Aug2021) she had like tingling in her bottom left side of her lip. She did get the vaccine in her left arm and the best way she could describe it was like when you went to the dentist and they numb your mouth for getting a cavity and the Novocain starts to wear off and theirs tingling in your lips, that was what the feeling was like for most of the day and it was now subsided but it still felt like it was struck, like as if it was coming off of being numb but for majority of day, She felt actual tingling where like almost if it was her lip was fathoming and tingling at the same time and she just, she tried to call and they said that was not a known side effect and she was not sure if she should take like Benadryl or something or what to do regarding this side effect. It was not like it was not tingling as bad it just felt weird, She did not know. She would say like less intense. They had improved throughout the day. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Follow-up attempts are completed. No further information is expected.
Fever/Headache/flu like symptoms/muscle pain-weakness/difficulty walking/cough
pain in the chest that moves towards the lung on the left side; shortness of breath; strong head ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain in the chest that moves towards the lung on the left side), DYSPNOEA (shortness of breath), HEADACHE (strong head ache) and NAUSEA (nausea) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (pain in the chest that moves towards the lung on the left side), DYSPNOEA (shortness of breath), HEADACHE (strong head ache) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (pain in the chest that moves towards the lung on the left side), DYSPNOEA (shortness of breath), HEADACHE (strong head ache) and NAUSEA (nausea) outcome was unknown.            No concomitant medications information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
1 week after shot, injection site presented with red hard bump. Next day, this had turned into an itchy lesion the size of a quarter, with another lesion of the same size directly beneath it.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (lot # L034370 with expiry date 08-SEP-2017) (dosage and route not reported) and RECOMBIVAX HB (lot # L027733 with expire date 13-SEP-2017) (dosage and route not reported). The patients received improperly stored (Oka/Merck) VARIVAX which was reconstituted with improperly stored RECOMBIVAX  HB. The conditions storage of (Oka/Merck) VARIVAX was 40 F for 100 hours then was back in range. The conditions storage of RECOMBIVAX HB was: maximum temperature 47 F for 21  hours and minimum temperature 29 F for 273 hours (multiple cycles, more than 3). There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter.  Additional information has been requested.
severe itching, red hands and feet, coughing, wheeze in less than an hour after Varivax booster. Albuterol neb tx, 2x Orapred, Epi pen given. Pulse ox 98-99%. Solumedrol 31.25 mg im x 1 Transported to ER via EMS
Extreme, extreme repeating  ice pick stabbing pain behind ri.ght ear.  Pain repeats every 30 seconds.  Pain is dibilatating and does not abate Continuous  extreme pain in neck and top of  and neck Blistering hives on top right side of chest
I was so sick on 03Jun2021; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; sweating; migraine; Headache; nausea; hair still falling; shaking; I was aching worse on 2nd shot; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0172), via intramuscular route of administration on 03Jun2021 at 09:10 AM (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from 18Feb2021 to an unknown date (my hairs still falling out after had covid by hands full as of 18Feb2021. I had Covid & so sick. I could not get out of bed). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP753), via intramuscular route of administration on 12May2021 at 09:00 AM (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and experienced shaking, I was aching all over. The patient experienced shaking, I was aching worse on 2nd shot, hair still falling on an unspecified date in 2021, sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed on an unspecified date in Jun2021, I was so sick on 03Jun2021. Pertinent Details: shaking, I was aching worse on 2nd shot & had to go to bed when got up at 10 AM and sweating, migraine, headache & nausea. Could not eat, had to stay in bed & whole Day & Night. My hairs still falling out after had covid by hands full as of 18Feb2021. Family medical History: Patient husband (withheld) took Moderna & no symptoms at all. But patient was so sick on 03Jun2021. Patient never want to take that shot again because patient felt like I did when I had Covid & so sick. Patient could not get out of bed. The patient underwent lab tests and procedures which included COVID test: had covid (my hairs still falling out after had covid by hands full as of 18Feb2021) on 18Feb2021, blood test was kidney, liver, heart all good and thyroid good (everything good & doctor still don't know why my hair is falling out in hands full) on 01Jun2020. The patient received Tylenol, Chicken soup as a treatment for the event shaking. Outcome of the events I was aching worse on 2nd shot, hair still falling was not recovered; sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed was unknown; shaking was recovered on an unspecified date in 2021, I was so sick was recovered on 03Jun2021.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Elevated BPM every now and again after vaccine. Not all the time but when resting, heart BPM has increased to 90 bpm or higher. This has never occurred prior to the first dose.; This is a spontaneous report from a non-contactable consumer. This 30-year-old Female Consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection, Batch/Lot Number: EW0177), dose 1 via an unspecified route of administration, administered in Arm Right on Jul2021 at 18:00 PM (at 30-years age) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Elevated bpm every now and again after vaccine. Not all the time but when resting, heart bpm has increased to 90 bpm or higher. this has never occurred prior to the first dose on an unspecified date. The patient underwent lab tests and procedures which included heart rate: >90 or higher on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the event. The outcome of event was not resolved.  No follow-up attempts are possible. No further information is expected.
Thursday, April 8: 1st dose of Pfizer vaccine. Friday & Saturday: No symptoms Sunday, April 11: Severely sleepy and fatigued Monday, April 12: Began congestion and a slight cough. Tuesday & Wednesday: Noticing things aren't tasting right.  Total loss of smell & no taste with most foods. Sweeter food items taste horrible like bad breath
Pt is experiencing pain in the arm, chest, neck and head. Still having problems month later. Pt advised to seek medical attention.
Patient reported feeling dizziness and disorientation to the point of being unable to walk steadily alone essentially for the duration of the day after the vaccine was given. He says he has had similar symptoms before from severe dehydration and is unsure if this was related only to the vaccine. Symptoms cleared up after 1 day and patient is feeling better, did not seek medical care other than pharmacist consultation after symptoms resolved.
Resident received the vaccine on 1-22-21 and she was diagnosed with COVID-19 during routine testing on 1-28-21.  She didn't have any symptoms except feeling weak and she had a decrease in her appetite.  She already had a poor appetite prior.  She died on 2-2-21.
A pulsing movement near our thumb; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (A pulsing movement near our thumb) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (A pulsing movement near our thumb). At the time of the report, MUSCLE TWITCHING (A pulsing movement near our thumb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
bad itching; Redness; rash; circle of rash 3 or 4 inches below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site). At the time of the report, PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
headache; Joint pain; Knee pain; Fatigue; Arm hurt; Pain on the injection site; Pain all the way down to her wrist; chills; fever; Breaks out sweat; Sick; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm hurt) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sjogren's syndrome. Concurrent medical conditions included Arthritis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE PAIN (Pain on the injection site), PAIN IN EXTREMITY (Pain all the way down to her wrist), CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (Breaks out sweat), ILLNESS (Sick) and NAUSEA (Nauseated). At the time of the report, HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE PAIN (Pain on the injection site), PAIN IN EXTREMITY (Pain all the way down to her wrist), CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (Breaks out sweat), ILLNESS (Sick) and NAUSEA (Nauseated) outcome was unknown.        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.   This case was linked to MOD21-072106, US-MODERNATX, INC.-MOD-2021-071096 (E2B Linked Report).; Sender's Comments:  MOD21-072106: US-MODERNATX, INC.-MOD-2021-071096:
School Nurse called after flu clinic mid am today and student, (who received 2nd dose of Flumist about 30 minutes ago) came into clinic with red raised bumps to right face, neck, and back. He also complained that it hurt to take a deep breath. VS were normal and lungs clear no SOB. Student is in only 6yo and speaks very little English. (He had received his first dose of Flumist on 11/30/11 with no known problem or difficulties reported.) Gave Benadryl and called parent to pick up. RN (flu laison) returned to clinic and notified me at this point.  I called and Dr. was notified - she did not think it was from vaccine but student had not had any breakfast or bites etc. and had "no known Allergies" on his Emergency card at the school. Followed protocol for allergic reaction. Parent took student straight to MD. Parent called back after MD visit and said student was doing well and for parents to bring back if has any further problems. MD further recommended for student to receive flu vaccine next year somewhere he can be monitored for 24 hours. Completed incident report in HO (health office) checking off risk management. She is also adding possible allergy to H.O. Alerts and emergency card. I am also calling risk management. RN spoke with parent later that afternoon and child was "doing fine".
Reported itching and hives at 11:45 am. Gave 25 mg diphenhydramine. Breathing became more distressed and gave 0.3 mg epinephrine in upper left thigh at 12:00 pm. Breathing and itching improved. Paramedics arrived at 12:05 pm and took over.
48 hrs local swelling at injection site 2.5x2cm and limitation of motion on internal rotation of left upper arm at shoulder joint.
pt recvd vax 15JUN95 & 6 hrs later pt devel fever of 104 presented to MD who noted no abn physical findings other than temp;pt tx APAP & Ibuprofen (Advil); fever ranged from 99 to 105.4;exp dec appetite
lt upper arm w/large red swollen area, warm to touch, no hardness;reported by phone @ 10AM 18JUL97 pt assessed 1145AM;Keflex given & DPH;
No energy; Hand started shaking; Facial flushing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), TREMOR (Hand started shaking) and FLUSHING (Facial flushing) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE for Shoulder injury and Hip injury, CLOPIDOGREL BISULFATE (PLAVIX), PRAVASTATIN, METOPROLOL and OMEPRAZOLE for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ASTHENIA (No energy), TREMOR (Hand started shaking) and FLUSHING (Facial flushing). The patient was treated with PARACETAMOL (TYLENOL) on 25-Jan-2021 at an unspecified dose and frequency. At the time of the report, ASTHENIA (No energy), TREMOR (Hand started shaking) and FLUSHING (Facial flushing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Patient email reply received, confirming events resolved but did not provide an end date(s). significant follow up-event outcome appended; Sender's Comments: 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.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose, route of administration: default as oral, lot# and expiry date were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On 17-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX (lot # reported as M027117, expiration date 26-JUL-2017, dose and route not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
1113 Patient reports to Nurse compliant of right arm numbness, intense headache, "feeling funny, feels like body is floating." Nurse obtained assistance and vitals: 144/82, HR 74, SpO2 99. 1118 Neuro assessment by Nurse shows sluggish response, diaphoresis, clammy, bilateral extremity response weak. Benadryl 25mg PO given. NO swallowing diffliculty.  1120 This nurse arrives, vitals 178/82. Diaphoresis worsening, neuro decline  verbal response unable to identify companion, headache worsening, upper respiratory stridor upon ausculation, pulse increased. 1125 0.3 mg Epi given IM LVL Vitals 192/63, 84, RR22 99%  phoned EMS  1127 Ems arrived, report given including medications administered and vitals Patient taken to closest Emergency Center where the following notes were dictated: Chief Complaint Patient presents with ? Dizziness     pt brought from urgent care after receiving her second vaccine, reported dyspnea and dizziness at clinic.  pt was given 0.3 of epi and 25mg of benadryl prior to arrival.  pt arrives in no distress.  ? Shortness of Breath       Chief complaint: Reaction to Covid vaccine       History of chief complaint: This 74-year-old female presents to ER stating that she had her second Covid vaccine this morning in the urgent care when she began to have some lightheadedness shortness of breath and headache.  She said she also felt quite cold.  The squad was called and the patient had been given subcu epi and Benadryl.  She has also a diabetic and her blood sugar was found to be 176 prior to transport.
Rash on neck,metallic taste,ears ringing,severe chest and abdominal pain,leg and back pain severe headache,fatigue and joint pain. Hospitalized 2 days, left eye blurred vision
red, hot, hard area around injection site approx. 4 inchs by 4 inches. Child complained about pain and itching day 2 post injection. Went to ER day 2 started motrin, benadryl with intermittent ice.  Day three the redness grew larger continued motrin, benadryl, and intermittent ice.
pt recvd vax; reddened area w/ lots of tenderness & warm to elbow inject site;
Dry eyes and throat got painful in August 2022 after being dry and itchy and light pain for a few months.  Went to rheumatology and ophthalmologist for eyes and blood work up.  Sjogrens diagnosed   Corneas painful very dry eyes not producing tears .  On Xiidra twice a day from Sept 8, 2022 and artificial tears 10 times a day at least.   Starting Vital Tears biological on Tuesday.   Squinting  eyes tightly which has caused facial and neck pain from  tightening so much with no moisture .    Eyes are bone dry on tear test, (schirmers test) corneas very dry painful .  Outdoor activities are zero as this affects my eyes greatly causing much corneal pain with facial contortions due to the lack of tears and pain in eyes.  Affecting glands.
6/26 67y.o. female with history of breast cancer, fibroids status post hysterectomy, presented with complaints of rib pain, left hip pain after a fall.
On the morning of April 19, I awoke with with my bottom lip swollen.  Took a Claritin and it improved.  The next morning, I awoke with both lips swollen and facial puffiness.   I took another Claritin.  I contacted a nurse at the Health Dept, wondering if it could be related to the vaccine and was told that some reactions are being seen 2 weeks out; but of course, cannot be sure the symptoms are related.  Advised to take Benadryl and if problems worsened to go to ER.  I improved.  Three days later,  my left facial cheek and left ear became red and hot, again improved with Benadryl.  Same reaction the next day during the morning and again in the late afternoon, improving with Benadryl. Not knowing if these issues were related to the vaccine, I am hesitant to receive the second dose.  I did report this incident to my PCP.