chrisvoncsefalvay/vaers-outcomes huggingface dataset:
short of breath; Total fatigue; This is a spontaneous report from a contactable consumer. An 89-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 12:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergies to penicillin, codeine, vicodin, sulfur, erythromycin, oxybutalin and oxycodone. Concomitant medications included losartan potassium 50mg (MANUFACTURER UNKNOWN), amlodipine 10mg (MANUFACTURER UNKNOWN), sertraline HCL100mg (MANUFACTURER UNKNOWN), apixaban 2.5mg (ELIQUIS), cetirizine HCL 5mg (MANUFACTURER UNKNOWN), donepezil HCL 10mg (MANUFACTURER UNKNOWN), mirabegron ER 25mg (MYRBETRIG ER), atorvastatin 10 mg (MANUFACTURER UNKNOWN), sodium bicarbonate 650 mg (MANUFACTURER UNKNOWN), paracetamol 650 mg (TYLENOL), riboflavin 100mg (MANUFACTURER UNKNOWN) and cyanocobalamin 5000 mcg (B-12). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 16:00, the patient had experienced short period of short of breath which was about for 03 hours and total fatigue which was started 4 days ago and was continuing at the time of report. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events short of breath was resolved on 25Mar2021 at 19:00; while that of the total fatigue was not resolved at the time of this report.  No follow-up attempts are needed. No further information expected
site of inject pink & swollen approx 2 hrs p/inject; @ about 4 hrs later had fever of 104? was seen @ hosp; stayed there 4-5 hrs; treated w/APAP & cold packs then released; lab work done; s/s resolved by 2 days;
Patient reported hives all over her body and swelling in her face and arms beginning approximately 5 PM on 06/05/2020, and lasting until the morning  of 06/06/2020. She reports taking two Claritin pills of unknown dosage the morning of 06/06/2020.
5/26/22 10;00 PM FEVER T103, SWEATS 5/27/22 RIGHT ARM PAIN, ACHING EVERYWHERE JOINTS, SKIN SENSITIVITY, H/A, SORE THROAT, MILD ATAXIA X 3 DAYS
pt devel marble size lump under la pit on 5/13 @ m.d. ofc. taking tylenol. 5/14 la swollen, red & lump under arm c/o itches.
Just as I was going to get into bed to sleep on the night of 06-04-2021, I experienced vertigo. I found one position I could be in that gave me relief, but any movement of my head beyond that one position resulted in severe vertigo. It was severe all day on 6-5-2021. My doctor on call advised me to take Claritin and Dramamine during the day and Benadryl at night. I did not take the Benadryl and did not seem to get any relief from the Claritin and Dramamine. Late in the day, I tried an exercise for vertigo and could not complete the exercise because it exacerbated the vertigo to a point I thought I would pass out had I continued. On 6-6-2021, symptoms were lessening and I was able to get back on my feet but could not fully function without vertigo. On 6-7-2021 I felt fairly normal and resumed all my regular activities without incident..
The thing is the caller got hurt and can't drive safely now for a few days; The thing is the caller got hurt and can't drive safely now for a few days; Unable to go to scheduled second dose Vaccine appointment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EW0173) at the age of 78 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "The thing is the caller got hurt and can't drive safely now for a few days"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 2021, outcome "unknown", described as "Unable to go to scheduled second dose Vaccine appointment".  Follow-up attempts completed. No further information is expected.
Report described possible vasovagal reaction in a 7 year old female who received hep A vacccine. Allergies, medical history, and concomitant medications were not specified. On 06/15/2001, the vaccinee received her first left arm dose of Havrix. The vaccinee fainted within three minutes of receiving the immunization. The reporter stated that "they suspect vasovagal." Emergency care was administered at the ER. As of 06/20/2001, the pt was "improved."
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Aug2021 03:30 (Lot number: 42 8969406564) at the age of 81 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Bronchitis asthmatic" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "known Allergy: penicillin", notes: known allergies: Penicillin.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Aug2021 21:00, outcome "recovered" (2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No covid prior and post vaccination. No other vaccines in fours week.  Follow-up attempts are completed. No further information is expected.
ALS.  My mother was perfectly healthy for her age which can be attested to by her Internist noted here in.  Within 10 days of the vaccine the symptoms of Bulbar onset ALS started appearing.  However, no one in the family knew what it was.
14:11-vaccine 14:20- passed out, myself and family eased her to the ground, placed her head on a pillow, called for help.  She had a pulse and was breathing.  Warm, diaphoretic.  After propping her legs up, verbally stimulation, she came to quickly, knew her name, where she was.  She quickly was alert and oriented x4. 14:25  120/70, HR 80, 20 RR, we had her drink some juice.  By 1430 she was describing "throat tightness, coughing and had inspiratory wheezing. 14:33, she took 25 mg of PO benadryl from her own E-kit (her SO had it)  Myself , another RN and the PA were watching her closely. 14:36: she still coughing and wheezing, her anxiety was increased, we called EMS and help administer her EPI pen from her E-kit., continued to monitor closely. 14:40- 118/74, HR 80, RR 22, Lungs CTA , anxiety, wheezing , coughing and throat tightness eased up. 14:46:  EMS arrived, patient was talking and answering questions.  Requested to be called "they".   Patient was loaded onto a stretcher by EMS and they transported her to the hospital. SO and Dad were involved in the decision making.
Cramps in head/cramps in all over her body; fatigue in all over her body; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in head/cramps in all over her body) and FATIGUE (fatigue in all over her body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Thyroid disorder. Concomitant products included METFORMIN for Diabetes, TELMISARTAN for Hypertension.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps in head/cramps in all over her body) and FATIGUE (fatigue in all over her body). At the time of the report, MUSCLE SPASMS (Cramps in head/cramps in all over her body) and FATIGUE (fatigue in all over her body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Platelet count: low Low. On 05-Apr-2021, Platelet count: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Leboxetoril for thyroids. Treatment medication included Ibuprofen. Platelets were low before the vaccine, and 5 days after the vaccine platelets were normal
Erectile Dysfunction; This is a spontaneous report from a contactable Other HCP.  A 47-year-old male Other HCP reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the right arm on 05Jan2021 09:30 AM for COVID-19 immunization. Medical history included kidney stones. Concomitant drugs were unknown. The patient reported that on 20Jan2021 he experienced erectile dysfunction. No treatment was received. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt reports having intense pain and inflammation at injection site. This has resolved, however there is a dime sized discoloration at injection site. Looks like and 'age spot'.
Pt received both Influenza & Pneumonia vaccine. State Tues AM (next day) arm was sore & looked at it. It was all red with a lump. The underside of arm was swollen & red. She had a rash that developed over body. Went to MD & was given antibiotics for red/swollen arm. It is getting better but not fully resolved.
Pt experienced possible side from vaccines.  Redness, pain in her R arm.  Headaches, fatigue diarrhea, chills.  Pt was monitored for about 30 minutes.  Blood pressure and SpO2 were normal when she left clinic.  No other treatment given.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, as the reporting pharmacist was administering a dose of PNEUVMOVAX 23 injection, lot # L035687, expiration date: 16-FEB-2017, (dose and dose number were not provided), the medication leaked out onto the patient's skin. Another dose was administered successfully. No adverse effect was reported. Product quality complaint (PQC) had been filed for leaking PNEUMOVAX 23 syringe. Additional information is noted expected because the reporter did not wish to be contacted.
pronounced swelling under left arm - lymph node. achiness. some discoloration. slight swelling under right arm (site of 2010 lumpectomy, with sentinal lymph node removed, so less swelling). swelling and achiness reduced but still present 1 week later.
his heart rate was 131. States he took some additional medication and it went back down to 82, then up to 128, down to 48, up to 115; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 15:30 (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (AFib) on 10Mar2021 (had A-Fib while hospitalized from 10Mar2021 to 22Mar2021. Did a cardioversion) and Guillain Barre syndrome on an unspecified date. Concomitant medication included metoprolol taken for heart (disorder). It was reported that on 10Apr2021 15:30, the patient got his first vaccine. The next morning (11Apr2021 08:30) when he did his vital check, that he does every morning, his heart rate was 131. Stated that he took some additional medication and it went back down to 82, then up to 128, down to 48, up to 115. Stated he was reading where fast heart rate can be one of the side effects. Stated today (12Apr2021) the highest his heart rate has been is 109 and lowest at 42. The patient stated that his heart rate goes from high to low. The patient stated that he normally takes Metoprolol 25 mg a day but he upped it to 100 mg on 11Apr2021 because that's what they did when he had AFib. The outcome of the event was recovering.
Headache, sensation of feverish, low back pain started day after administration, lasted 3-4 days, followed by sore throat.
10 mins after receiving the vaccine, my right hand started to swell a bit and had pain in the wrist and I got the injection in my left arm. Them I went to urinate and it was painful that continued until this morning. My body became itchy all over my blood pressure was 184/107. I was having heart palpitations. I got queasy and didn't feel well. I was given benadryl and zolfran. My blood pressure went down to 151/92 after a bit then after an hour I was still itchy, blood pressure was 133/ 84 but then my throat left side tried to hurt and I Felt like something was stuck in my throat. I waited another 30 thirty mins and left. My left side of throat hurts a little and my left hand still hurts and a little itchy
Pt received flu shot here and per mom within 15 minutes had 7 focal seizures in a row.  Mom took pt to our local pediatric minor care and per them pt was hospitalized.  Pt does have a history of convulsions but has received a flu vaccine every year per our records, did receive Flumist last year.
diarrhea; vomiting; Coughing; nose running; flu-like symptoms; shaking chills; headache; aches; feverish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (nose running), DIARRHOEA (diarrhea), COUGH (Coughing) and CHILLS (shaking chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, 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 INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (headache) and MYALGIA (aches). 08-Apr-2021, the patient experienced CHILLS (shaking chills) and PYREXIA (feverish). On 09-Apr-2021, the patient experienced RHINORRHOEA (nose running) and COUGH (Coughing). On 12-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and VOMITING (vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (nose running), DIARRHOEA (diarrhea), COUGH (Coughing), CHILLS (shaking chills), VOMITING (vomiting), HEADACHE (headache), MYALGIA (aches) and PYREXIA (feverish) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 99.5 (Inconclusive) low-grade fever of 99.5 degrees F. On 10-Apr-2021, Carbon dioxide:. On 24-Apr-2021, Carbon dioxide: 93 (Inconclusive) CO2 93.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On 4th December 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain. On 5th December 2018, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the erythema of extremities and skin warm were unknown. It was unknown if the reporter considered the injection site pain, erythema of extremities and skin warm to be related to SHINGRIX. Additional details were provided as follows: A few hours after the injection, the patient experienced pain at the injection site. On 5th December 2018 at night, the patient noted that a red circle appeared about 3 inches below the injection site. It was dime sized, painful, red and hot to the touch. The reporter did not consent to follow-up.
Tingling in the left leg; Tingling in the right leg and; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the right leg) and PARAESTHESIA (Tingling in the left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included MULTIVITAMINS [VITAMINS NOS] from 24-Apr-2021 to an unknown date for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PARAESTHESIA (Tingling in the right leg). On 18-Apr-2021, the patient experienced PARAESTHESIA (Tingling in the left leg). On 18-Apr-2021, PARAESTHESIA (Tingling in the right leg) outcome was unknown. On 26-Apr-2021, PARAESTHESIA (Tingling in the left leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drugs were reported.   Reporter did not allow further contact
lips and cheek were numb and swollen; lips and cheek were numb and swollen; lips and cheek were numb and swollen; left sided swelling of her face; lips tingling and it was like numb; feeling sick; Fever; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2021 (Lot number: EL3248, Expiration Date: Apr2021) at the age of 34 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: SWELLING FACE (non-serious) with onset 09Jan2021, outcome "recovered" (2021), described as "left sided swelling of her face"; PARAESTHESIA ORAL (non-serious) with onset 09Jan2021, outcome "recovered" (2021), described as "lips tingling and it was like numb"; PYREXIA (non-serious) with onset Jan2021, outcome "unknown", described as "Fever"; HYPOAESTHESIA ORAL (non-serious), LIP SWELLING (non-serious), HYPOAESTHESIA (non-serious) all with onset 09Jan2021, outcome "recovered" (12Jan2021) and all described as "lips and cheek were numb and swollen"; MALAISE (non-serious) with onset 08Jan2021, outcome "unknown", described as "feeling sick".  Additional information: Caller initially says she got her first dose on 06Jan, then says she thinks the date she got it was the 08Jan2021, she can't tell because of how it was written, but she thinks it was the 08Jan2021 She says that the dose was injected in her left arm, because that was the side where she got the reaction to. She says she had left sided swelling of her face, with lips tingling and it was like numb. AE Treatment: Caller says she drank water for treatment. AE Outcome: Caller says it went away on its own. She says she also had a fever, but she felt like that was a normal reaction to the vaccine. No further details provided about her fever. Caller says half of her face was swollen which didn't seem normal, and it looked like Bell's palsy, kind of similar, with tingling and numbing on one side and swelling. She says this started the next day after she got her first dose, so 12-14 hours after getting it, she had got it that morning. Captured as provided by the caller. She says she was feeling sick that night, then the next morning she noticed that her lips and cheek were numb and swollen, and it took about 3 days to go away.  No follow-up attempts are possible. No further information is expected.
Symptoms began at work and I felt off. My throat was extremely sore. Since having the vaccines and COVID-19 began having cardiac issues (tachycardia, chest tightness)
approx 3 mins p/vax batting eyelids pt went limp-fell backwards; striking head & elbow elbow on back wall; back was arched up stiff; total LOC=10sec; pt then c/o h/a, dizziness, weakness & was not self until 1 1/2 hr later;
rash formed under injection site with burning/itching; rash formed under injection site with burning/itching; rash formed under injection site with burning/itching; dizziness; nausea; migraine; fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21May2021 10:00 (at the age of 46-year-old) (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included known allergies to Septra, Cipro, Erthamycin, Lexipro, protonix, strawberries and house dust. The patient had no other medical history. Concomitant medications included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) and multivitamin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0123) on 30Apr2021 at 10:00 AM (at the age of 46-year-old) for COVID-19 immunisation. On 21May2021, the patient experienced fever, chills, and body aches 8 hours after 2nd shot. On 23May2021 at 10:00 AM, the patient experienced rash formed under injection site with burning/itching, dizziness, nausea, and migraine began 48 hours after the injection. The events required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all events which included Benadryl, Tylenol, and ice. The patient was recovering from all events.  Follow-up attempts are needed. Further information is expected.