chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the dose was administered "too low, and into the fatty part of my arm".; dose 1st dose on 20Apr2021 and 2nd dose on 23Apr2021; have redness and swelling near the injection site, which traveled down her arm, and around to her back; have redness and swelling near the injection site, which traveled down her arm, and around to her back; the area is "very warm to the touch"; brusing; Spread past injection site from back of arm to back side of torso; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0162, Expiry date: unknown) (age at the time of vaccination was 55 years, patient was non-pregnant at the time of vaccination), administered in Arm Right on 23Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history included seizure, asthma, drug allergy to phenergan. The patient's concomitant medication included Lamotrigin, montelukast, cetrizine and losartan. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and tested negative with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER975), via an unspecified route of administration, administered in Arm Right on 20Apr2021 at 12:00 as dose 1, single for COVID-19 immunization. On 24Apr2021, the patient started to have redness and swelling near the injection site, which traveled down her arm and around her back. The patient reported that the area was warm to touch. The patient has been seen by primary care and visited the emergency room and they told to take an antihistamine treatment. The patient believe that the dose may have been given incorrectly. The patient stated that the person who administered the dose was joking around, walking too much and not paying attention to what she was doing, and thinks that the dose was administered too low and into the fatty part of her arm. On 20Apr2021 the patient took first dose and on 23Apr2021 the patient took the second dose. The patient's treatment included antibiotic. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
slurred speech; Nausea; unable to eat; painful arm; couldn't walk; Chills; Shakes; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes) and VOMITING (Throwing up) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes) and VOMITING (Throwing up). On 12-Jan-2021, the patient experienced NAUSEA (Nausea) and FEEDING DISORDER (unable to eat). On 13-Jan-2021, the patient experienced DYSARTHRIA (slurred speech). On 13-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes), FEEDING DISORDER (unable to eat) and DYSARTHRIA (slurred speech) outcome was unknown and VOMITING (Throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol and Advil. No concomitant medications were provided by reporter.; 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.
Received COVID-19 vaccine within  2 hours of non-OB transvaginal radiology appointment, follow-up appt related to finding from prior hospitalization for sepsis and pyelonephritis in late November 2020.  Later in the evening after receiving vaccine, noticed bleeding that resembled normal menstrual bleeding. Bleeding ended within 24 hours.  Menstrual period did not formally begin/return(?) until April 12. Experienced heavy flow going into the 5th day now, expect period to end soon as cycle normally lasts no more than 5-7 days. Suspect radiology and/or vaccine could be cause for delayed period.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years 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 included: "Known allergies- Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE. Past drug history included: Cephelexin, reaction(s): "known allergies: Cefalexin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.Ae treatment Diphenhydramine  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events. Linked Report(s) : US-PFIZER INC-202200821473 Same patient, different product and event;
Fever, sore throat, shakes, body aches, headache, fatigue for three days.
Mild chills one day after with some muscle aches. 2 days of alot of soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for 4 days after injection --everything was better after a week.
Initial report was received from a healthcare professional on 05 January 2012. A female patient (age and date of birth not reported) had received an injection in the left upper arm of FLUZONE Intradermal, sanofi pasteur Inc. lot number UT426AA (lot number UT426AA correspond with FLUZONE , not FLUZONE Intradermal) (route not reported) on 12 November 2011. On 25 November 2011, the patient developed a site reaction of redness and swelling and went to the emergency department (ED). The patient was prescribed analgesics and instructed to apply local heat to the site. The patient returned to the ED on 28 November 2011 and was administered BENADRYL and prednisone. The reporter informed the patient that this was not an allergic reaction. The patient also complained of left hip pain and facial numbness. The patient was evaluated by a neurologist and found nothing wrong. The patient denied any illness  at the time of vaccination. The patient had a medical history of hypertension (HTN) and claimed an allergy to latex and thimerosol. The patient's concomitant medications included LOPRESSOR and NORVASC. The patient had no other vaccinations within four weeks of FLUZONE. The patient had no previous doses of influenza vaccine. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
pt recvd vax 18NOV93 & evening of of same day devel itching on chest & back-welts; seen by MD treated w/Vistaril;
After the 2nd shot, I couldn't lift my arm above my head for about 2.5 days.  Then, it seemed to go back to normal.   About a month later, I started getting a pain or stiffness in my neck that ran down to my shoulder on the side I got the shot. It's been constant; it hasn't gone away.  It has lasted for about 4 months. It hasn't gotten worse, and it hasn't gotten better.
Pt. came to pharmacy complaining about redness around 2 inches, swelling and itching at the site. Got better by the time pt came in.
Chills and sweating, general soreness throughout the body, difficulty catching breath, migraines, lethargy.
Fever of 101.5 (taken with tympanic thermometer) lasting for about 3-4 hours, with fatigue and chills  Diffuse pain in left arm (arm that received injection) with gradual onset after injection, worsening overnight, and resolving within 24 hours of receiving vaccination
Confirmed Breakthrough   COVID-19 (Janssen) 1 04/09/2021 Health Dept Janssen 042A21A
This case was considered medically important. Information regarding PREVNAR was received from consumer regarding a 15-month-old male patient who experienced asthma, bacterial pneumonia, ear infection, vomiting and febrile seizure. The patient received the third dose on 09-Apr-2008. Within 48 hours of being administered the PREVNAR vaccine, the patient experienced a fever, shortness of breath with wheezing, vomiting, and a febrile seizure after being administered the third dose of the PREVNAR in April-2008. He was also diagnosed with an ear infection, bacterial pneumonia and asthma in 2008. The patient was not hospitalized. The patient was treated with oral and injectable antibiotics. No additional information was available at the time of this report. No additional information was available at the time of this report.
shingles; itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th July 2019, 7 days after receiving Shingrix, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination, the patient experienced shingles on her right side and left side of body. On an unknown date, the patient planned to continue follow up with her physician.  The reporter consented to follow up.
Patient received influenza vaccine (FLULAVAL) on left deltoid. Right away I noticed swelling at the injection site. Patient developed quarter size induration without pain or tenderness. No redness. Patient was observed for 30 minutes in the office and no further symptoms reported.
severely sick/sickness after the second shot was very weird, different and severe than normal flu symptoms; developed swollen and bruised injection site; not move and it  took 2 days to get out of her bed; body was on fire.; soreness with red and hot muscle; rash down the arm/covid arm; soreness in whole body- including joints, muscle; Chills/chills made them stay under the cover at all the time.; still have a little fatigue; developed swollen and bruised injection site; nauseous due to the sickness; fever with 100.9 F; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (severely sick/sickness after the second shot was very weird, different and severe than normal flu symptoms), VACCINATION SITE BRUISING (developed swollen and bruised injection site), MOBILITY DECREASED (not move and it  took 2 days to get out of her bed), BURNING SENSATION (body was on fire.) and ERYTHEMA (soreness with red and hot muscle) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (severely sick/sickness after the second shot was very weird, different and severe than normal flu symptoms), VACCINATION SITE BRUISING (developed swollen and bruised injection site), MOBILITY DECREASED (not move and it  took 2 days to get out of her bed), BURNING SENSATION (body was on fire.), ERYTHEMA (soreness with red and hot muscle), INJECTION SITE RASH (rash down the arm/covid arm), ARTHRALGIA (soreness in whole body- including joints, muscle), CHILLS (Chills/chills made them stay under the cover at all the time.), FATIGUE (still have a little fatigue), VACCINATION SITE SWELLING (developed swollen and bruised injection site), NAUSEA (nauseous due to the sickness) and PYREXIA (fever with 100.9 F). At the time of the report, ILLNESS (severely sick/sickness after the second shot was very weird, different and severe than normal flu symptoms), VACCINATION SITE BRUISING (developed swollen and bruised injection site), MOBILITY DECREASED (not move and it  took 2 days to get out of her bed), BURNING SENSATION (body was on fire.), ERYTHEMA (soreness with red and hot muscle), INJECTION SITE RASH (rash down the arm/covid arm), ARTHRALGIA (soreness in whole body- including joints, muscle), CHILLS (Chills/chills made them stay under the cover at all the time.), FATIGUE (still have a little fatigue), VACCINATION SITE SWELLING (developed swollen and bruised injection site), NAUSEA (nauseous due to the sickness) and PYREXIA (fever with 100.9 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.9 (Low) low.         No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.   This case was linked to MOD-2021-301986 (Patient Link).
The patient developed redness, swelling at the injection site. The patient had aches and fever and the site was warm to the touch.
hard screaming p/2mos vax lasted 1 wk; pt also would not sleep more than 2 hrs & wake up screaming; no listless; pt stiffened up most of time; mom called MD;
Patient stated that he began falling multiple times daily. His wife took him to hospital and the patient stated the staff said that the vaccine might have caused the adverse reaction
scared to receive the 2nd vaccine; diarrhea; chills; nausea; fever; Can't sleep at night; no appetite; shortness of breath; throat was hurting; trembling; shaking; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't sleep at night), DECREASED APPETITE (no appetite), DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat was hurting) and TREMOR (trembling) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Palpitation and Kidney transplant. Concurrent medical conditions included Blood pressure high. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), NIFEDIPINE, PREDNISONE, ROSUVASTATIN, VALSARTAN and TACROLIMUS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INSOMNIA (Can't sleep at night), DECREASED APPETITE (no appetite), DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat was hurting), TREMOR (trembling), TREMOR (shaking), ANXIETY (anxiety), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). On 24-Mar-2021, the patient experienced FEAR (scared to receive the 2nd vaccine). At the time of the report, INSOMNIA (Can't sleep at night), DECREASED APPETITE (no appetite), DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (throat was hurting), TREMOR (trembling), TREMOR (shaking), ANXIETY (anxiety), FEAR (scared to receive the 2nd vaccine), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient treatment information was not provided.
woke with chills during the night; has a bad headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced headache. On 22nd April 2020, the patient experienced chills. On an unknown date, the outcome of the headache and chills were unknown.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had his booster dose the day before reporting and woke with chills during the night. The patient now had a bad headache and wants to know if he could take Advil or Tylenol.
Patient developed purpura on lower extremities and buttocks 1 week after immunization with Hepatitis A vaccine from Merck.
Headache, Arthralgia, Fever, Fatigue, chills, injection site pain and swelling, tenderness and swelling of the local lymph nodes onthe injection side. 6.7.2021 RTD. Narrative:
Hands like purplish; This is a spontaneous report from a contactable consumer (patient's father).  A 15-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0187), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, patient experienced hands like purplish. The outcome was unknown.  No follow-up attempts are completed. No further information is expected.
Adult dose of PF Flu vaccine (0.5ml) was given instead of 0.25ml.  No adverse event followed.
The patient was admitted to the ER with a reaction to a tetanus shot that was given 2 days prior the the ER visit. The patient had right arm pain, redness and swelling and nausea. The patient was treated with Compazine and Tylenol. The patient improved and was discharged home. 3/9/06 REceived medical records which revealed patient experienced erythema, arm pain & rash, nausea & arm edema/ss
Firm pressure on skin anywhere on body causes raised red marks that last approximately 30 minutes to 1 hour.  No change to diet, life style, pets, home, work, etc.
No adverse effects reported.; approximately 125 unspecified patients were vaccinated with improperly stored ROTATEQ and approximately 50 unspecified patients were vaccinated with improperly stored VAQTA on multiple unspecified dates; This spontaneous report was received from a medical assistant, concerning 175 patients of unknown age and gender. Information about the patients' medical history, concurrent conditions and concomitant medications was not provided.  It was reported that on multiple unspecified dates between 09-SEP-2019 and 25-OCT-2019, approximately 125 unidentified patients were vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (strength, dose number, route of administration and anatomical location of vaccination were not provided; lot numbers S010702, S010045, 1660932, R035369 and R035371 has been verified to be valid; expiration dates 16-JAN-2021, 24-NOV-2020, 25-OCT-2020, 10-OCT-2020 and 07-OCT-2020, respectively); and approximately 50 unidentified patients were vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (strength, dose number, route of administration and anatomical location of vaccination were not provided; lot number S010727 and expiration date 26-JUL-2020; lot number S005725 has been verified to be valid; expiration date 10-JUL-2020) (product storage error).  The temperature of the vaccines administered was reported as above 9 degree Celsius (C) (10 C) and cumulative; there were multiple excursions, during a time frame of 4 hours and 16 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report.  No adverse effects were reported.  This is a non-valid case due to lack of patient identifiers.  Lot # S010727 has been verified to be a valid lot # for hepatitis A vaccine, inactivated.  As of 06-MAY-2020, all telephone attempts trying to obtain additional information has been unsuccessful.  As of 07-MAY-2020, the medical assistant reported that due to office moving to a new location, the administration dates and patient's identifiers would not be provided.
L thigh with red, slightly swollen area 5cm x 8cm surrounding injection site.  Symptoms started at night no fever.  Treated with Keflex, follow up in 2 weeks.
The patient believes the 2nd dose was not the real COVID 19 vaccine; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and believes that the second dose was not the real Covid-19 Vaccine (Counterfeit drug administered).   The patient's medical history, as provided by the reporter included cardiomyopathy, hypertension and diabetes. Concomitant medication was not provided by the reporter.  On 18 Jan 2021, the patient received their first of the planned doses of mRNA-1273 (Lot number: 025L20A) in the left arm for prophylaxis of COVID-19 infection. The patient had a mild reaction after the 1st Dose.  On 19 Feb 2021, prior to the onset of the events, the patient received their second of the planned doses of mRNA-1273 (Lot number: 11M20A) in the left arm for prophylaxis of COVID-19 infection. The patient had absolutely no reaction after the 2nd Dose. The patient believes the second Dose was not the real COVID-19 Vaccine.  The patient has reported 2nd dose vial had a red label COVID-19 Vaccine with (#15110911) stamped onto the vial and no Moderna label on the vial. The Patient has pictures of the vial. The Patient thinks the same counterfeit vaccine was administered to at least nine other patients. Patient wanted to receive a real 2nd Dose, so that the patient was protected.  Treatment information for the events was not provided by the reporter.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, second dose was not the real COVID-19 Vaccine was considered resolved on 19 Feb 2021.  Follow-up received on 23 Feb 2021 included, anatomical location, lot# of both the vaccines, expiry Date of the product.; Reporter's Comments: This report refers to a case of Counterfeit product administered for the second dose of mRNA-1273 (Lot number:11M20A) with no associated adverse events.
Unknown. It was reported to us 2 days later that patient went to the hospital and died 9/29/2016.
Vial of BOOSTRIX Vaccine only contained 0.25ml instead of 0.5ml. Lot AC52B088AA exp 6/14/14.
4 days after shot blood glucose elevated up to 400 and higher. Memories decreased.. at first thought maybe I forgot to give my injection. Had a friend help me with it. No, nothing ,I was doing. Had forgotten I had  The vaccine until my friend told me we had it together .  Then was told needed to report issues, just Incase. Increase memory loss and elevated Blood sugar.  Returning on migraines .
localized redness of rt upper arm-began around 9PM 3NOV96;soreness cont 5NOV96 swollen lymph node;
Developed chronic urticaria starting shortly after second dose. Demonstrates ongoing elevation of inflammatory markers and elevated d-dimer approx 2 months after 2nd dose of vaccine.