chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After her first shot of the vaccine, she had taken Advil for her arm because it hurt; This is a spontaneous report from a contactable consumer(patient). An unspecified age female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a  first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after her first shot of the vaccine, she had taken Advil for her arm because it hurt. The next morning, it already didn't hurt. She wanted to know if the rumor was true or not. Patient had received the second shot of the Pfizer BioNTechCOVID-19 vaccine on Thursday (04Feb2021) and she had heard a rumor to not take Advil or Tylenol if you have discomfort. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Headache, Myalgia, Fever, fatigue Narrative: Employee reported moderate fever 1/25/2021, severe fever 1/26/2021, moderate fever 1/27/2021. Reported moderate headache 1/25/2021, mild muscle pain 1/25/2021, severe muscle pain 1/26/2021, moderate muscle pain 1/27/2021. Moderate fatigue both 1/26/2021 and 1/27/2021. Resulted in unable to work one day and did not seek medical attention for the symptoms.
The pt experienced a typical varicella rash with vesicles, papules and crusts. The pt also experienced a fever.
Patient arrived at ED 17 Jul 2009 @ 2300 with left sided facial swelling. Onset was 3 hours prior to arrival. She was given Benadryl 25 mg orally @ 0252 18 Jul 2009. She was prescribed Prednisone 5 mg/5 ml, 3 tsp a day x5 days. She was discharged that same day.
Information has been received from a nurse practitioner concerning her 18 month old grandson with no known relevant medical history who on 28-MAY-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported), and a dose of PREVNAR and DTAP. On approximately 04-JUN-2008 the patient developed a fever of 105F. On approximately 09-JUN-2008, also reported as 12 days after receiving the vaccine, the patient developed varicella like rash. The patient went to the doctor's office and sought unspecified medical attention. Lab diagnostic studied included unspecified blood work and lab cultures (results not reported). Subsequently, the patient's fever resolved and the patient is recovering from the rash. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. The pharmacist reported that on 29-MAY-2015, the patient missed a dose of ZOSTAVAX via dry SD 19.4 m unit, subcutaneous due to not having enough diluent. The patient would received ZOSTAVAX when the replacement arrived. The patient did not experienced any adverse effects. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to 13-year-old female patient. There was no information about the patient's concurrent conditions, concomitant medications or medical history provided. On 24-MAR-2022, the patient was vaccinated with the second dose (previous dose reported as 1) of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T036812, expiration date 28-APR-2023, intramuscular, left deltoid  (dose and route of administration were not reported) for prophylaxis, which were involved in a temperature excursion of 0.39 degrees Celsius for 80 hours and 11.2 degrees Celsius for 80 hours (product storage error). This temperature excursion was from 17-JAN-2022 to 31-MAR-2022. The medication error occurred in the process of storage in clinical practice. The operator of vaccine/vaccine-device was healthcare professional who was trained. The vaccine/vaccine-device was used according to the instruction leaflet. The patient wanted to repeat dose on September 2022. There was no additional adverse event or product quality complaint reported. No information about previous excursions reported.  This is one of cases from same reporter. ; Sender's Comments:  US-009507513-2204USA005218: US-009507513-2207USA000782: US-009507513-2207USA000783: US-009507513-2207USA000785:
existing tinnitus ringing has become higher in volume and consistency, was wondering if side effect normal and how long it usually lasts if it is??
Report 2000034782-1 describes red papules (annular ring) at the injection site in a 15 year old female who received Engerix-B for prophylaxis of hepatitis-B.  The reporter denied allergies and medical history of the vaccinee. The vaccinee was started on an antibiotics (NOS) on 15-NOV-2000, the day when she received her second dose of Engerix-B.  On 09-OCT-00, the vaccinee received her first deltoid dose of Engerix-B without adverse event.  On 15-Nov-00, the vaccinee received her second right deltoid dose of Engerix-B.  On 16-Nov-00, she experienced red papules (annular ring) at the injection site.  No treatment was given.  As of 30-NOV-00, the outcome of the event is unresolved.
This is being typed by patient's son. Here is what has been happening since side effects began appearing 1 week after he received his second dose of the Moderna Vaccine:  "Closer to one week after receiving my second dose of the Moderna Covid-19 vaccine, I began having trouble breathing, high blood pressure, and severe chest pains. I soon had to check myself into the ER of the hospital nearby, the cardiologist on call there ran tests and showed that my heart was working at 25% and my Oxygen levels were dangerously low. I was kept there for 2-3 days because they stated there was water retention occurring within my heart and that it enlarged. After they were able to get the water out, they put me on medication to keep my blood pressure low and I was to come back in for a check-up over the next couple of months. After going in for my checkups (MAY 2021 - JAN 2022), my cardiologist saw that my heart was not getting better, that it was still only working at a 25% efficiency. The biggest and best guess the doctors have is Myocarditis because my heart is severely inflamed and not working anywhere near where it should be for a 50-year-old man. I have not stopped taking my medications and I have done everything my doctors have asked of me. I have been dealing with symptoms: chest pains, difficulty breathing, shortness of breath, coughing, high blood pressure, heart palpitations. Yesterday (01/09/2022), my chest pains and labored breathing were so severe, my wife had to call an ambulance to come and get me. This is the third time that I have had to come to the ER since receiving my second dose of the Moderna Vaccine. Before this, I have never been sick, never had the flu, and never went to the hospital. This is the first time this has ever happened to me and I now have a permanently damaged heart, and cardiovascular system. Every year before this, I would get a checkup and my cholesterol, blood pressure, etc. have all always been very healthy. Now, I am in the hospital for a third time this year for myocarditis."
Mother reported "glazed" stare after a spit up episode lasting several seconds. Noted 2 additional episodes w/o spit lasting couple of seconds. At approx 9:30AM, she noted "glazed" stare and extremity shaking. Taken to ED and was admitted to pediatric ward.  Head CT, CBC, CMP, blood and urine cultures all negative. Discharged the next day.
Persistent pain for more than 6 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Persistent pain for more than 6 weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Persistent pain for more than 6 weeks). At the time of the report, PAIN (Persistent pain for more than 6 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient came to pharmacy on 10/8/2017 to report redness and swelling in his upper right arm and he suspected it may be due to the FLUZONE HD and PNEUMOVAX 23 vaccines he got in his arm on 10/6/2017. Patient stated his arm did hurt to move. When asked when the symptoms started, patient said he noticed it the morning of 10/7/2017. Upon inspection, the pharmacist noticed that patient had localized redness and swelling in the right arm from the shoulder area to the elbow area and patient was advised by pharmacist to visit to local emergency room as soon as possible.
Feelings of severve depression and dread. No energy, weakness, very tired, and cant get enough sleep.  Symptoms lasted 6-7 days.
3/4/21 Covid Pfizer 3/25/21 Covid Pfizer 8/9 ill 8/12 Covid + 8/20/2021 Potential to RTW
Headache, chills, low grade fever which started the evening after vaccination and continued the next day. Symptoms subsided the second morning after vaccination.
Pt had fever, dizziness, syncope, hypomagnesemia, hypophosphatemia, elevated LFTs and eosinophilia 24 hours after second dose of pfizer vaccine.  Admitted to hospital.  Treated with abx for possible pneumonia (although clinically pt did not have pneumonia - no cough, no shortness of breath, no hypoxia).
The patient has a 28 day menstrual  cycle (sometimes 27 days). This time the menstrual cycle lasted 42 days.
Developed Shingles two weeks after the first pfizer vaccine dose.; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 12May2021 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 24May2021, the patient developed shingles two weeks after the first vaccine dose. The patient never had shingles before. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with VALTREX. The clinical outcome of the event shingles two weeks after the first vaccine dose was resolving, at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The adverse reaction began 10/04/2021. Red, swollen, and itchy neck. Very painful and extremely painful to touch. No internal pain, all external.
Felt like full blown flu symptoms after second shot; First dose taken on 21-Jan-2021 and second dose taken on 8-Feb-2021; A little sore arm after the second shot; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-127079   ) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like full blown flu symptoms after second shot), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 21-Jan-2021 and second dose taken on 8-Feb-2021) and ARTHRALGIA (A little sore arm after the second shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 020L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like full blown flu symptoms after second shot) and ARTHRALGIA (A little sore arm after the second shot). 08-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 21-Jan-2021 and second dose taken on 8-Feb-2021). On 08-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 21-Jan-2021 and second dose taken on 8-Feb-2021) had resolved. On 11-Feb-2021, INFLUENZA LIKE ILLNESS (Felt like full blown flu symptoms after second shot) and ARTHRALGIA (A little sore arm after the second shot) had resolved.            No concomitant medications were provided.  No Treatment medications were provided.  The action taken with mRNA with the events was considered as not applicable.   This case was linked to MOD-2021-278770 (Patient Link).
pt recv vax 26SEP97 & 2 to 3hr p/vax pt exp n/v & diarrhea;it was reported that the pt recovered w/in 24hr;3MAR98 pt recv 3rd dose of vax;
Difficulty waking and increased irritability with long bouts of intense crying that slowly resolves. Comfort measures advised. Continues to improve.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and CDC. As per recommendation from CDC, affected dose should be repeated. Pt was notified and all questions answered. Pt repeated dose on 10/1/21
Within 30 minutes of receiving vaccine, developed dripping sweat, no fever. This continued for whole day. Shot site became red, Swollen, warm to touch,  and painful. Took Tylenol/Benadryl. By next morning 0930 ( 24 hours later) increased redness, swelling, warmth, and pain. Seen in the ER since worsting. The redness on right upper arm measured 4 1/2 inches by 8 inches. Took Tylenol/ Benadryl, and iced that evening after work. Redness remains. Same on day three which is today. Now the area that is red now itches.,slight reduction in redness and warmth. Arm aches from shoulder joint to 1/2 way down right upper arm. Will continue to monitor over this weekend and follow up with PMD hopefully on Monday or Tuesday.
severe allergic contact dermatitis; type iv hypersensitivity reaction; Allergy to aluminum; This case was reported by a consumer and described the occurrence of allergic contact dermatitis in a patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, 1 day after receiving Hepatitis B vaccine, the patient experienced allergic contact dermatitis, type iv hypersensitivity reaction and allergy to aluminum. On an unknown date, the outcome of the allergic contact dermatitis, type iv hypersensitivity reaction and allergy to aluminum were unknown.   It was unknown if the reporter considered the allergic contact dermatitis, type iv hypersensitivity reaction and allergy to aluminum to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. In 2014 the patient had severe allergic contact dermatitis the day after the hepatitis B vaccine.  The reporter found out this was type iv hypersensitivity reaction and reporter thought it was the aluminum.
After vaccination, just soreness at the site and lasted about 1.5 to 2 days.  Nothing after that, then I noticed two day agos, which would be 9 or 10days after vaccination, a quarter size red area at the site.  It looked like the aftermath of a mosquito bite so didn't think much of it.  Then tonight, I noticed that the rash got bigger...a slight tingling sensation, not severe and slightly itchy.  Definitely not a bug bite.  I did some research and read it could be "covid arm" or "vaccine arm." I'll monitor it for next few days since I read it'll go away and is harmless.  I'll call my doctor if no improvement by end of the week.
2-4-30 hours     Sore arm; Chills;  body ache; extreme headache; more passing gas than I have ever experienced, HUGE  amount at a time
patient developed a patch of red skin rash that shifted from the outer shoulder area to inner area. Patient described it was slightly painful.
Sitting on exam table , received vaccines Gardasil and Menactra. Got down from exam table, stood up and fell forward, hitting forehead on the wall. Nurse pivoted her onto a chair, sitting position. "Patient's eyes were open, back arched, arms straight and posturing" x approximately 3 seconds. Relaxed - still staring, not alert. Nurse and medical student placed her on exam table reclining.
Administered vaccination to a patient that was 17 years old; A spontaneous report () was received from a healthcare professional concerning a 17-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) (Product administered to patient of inappropriate age) .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The nurse was aware that the patient was recommended to be 18 years of age (Product administered to patient of inappropriate age).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 014M20A) with no associated AEs reported.
Numbness and tingling in left leg; Numbness and tingling in left leg; burning sensation all over leg; unable to walk; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date not provided), via an unspecified route of administration (right arm) second dose on 09Jan2021 17:15 at single dose for covid-19 immunisation. The patient medical history was not reported.  There were no concomitant medications.  Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) via an unspecified route of administration (left arm) first dose on 21Dec2020. On 09Jan2021 22:30, the patient experienced Numbness and tingling in left leg, burning sensation all over leg, unable to walk. The patient did not received treatment for the events.  The outcome of the events was not recovered.
Information has been received from a health professional concerning a 27 month old male with no known drug allergies who on 12/01/1999 was vaccinated with varicella vaccine. There was no concomitant medication. On 03/16/2001 the pt presented to the office with 20-50 vesicular lesions mostly on the chest and back. It was reported that no other symptoms were noted. Unspecified medical attention was sought. Follow-up info has been received from a health professional that reports the child was not hospitalized and there was no treatment. On an unknown date, the pt recovered. No further info is expected.
Approximately three to four minutes after the second dose, he reported feeling dizzy. A few seconds later he lost consciousness with eyes rolled to the back of his head. He was unresponsive to verbal communication or attempts to shake him awake. He then began grunting and struggling for breath. His body began to shake/convulse and he lost control of his bladder. This lasted about five to ten seconds. He regained consciousness and reported that he felt as if he was "dreaming". He also reported feeling very hot, and had sweat dripping down his face. Paramedics were called to the scene where his vital signs were checked. All signs including temperature were normal. His first dose on /26/21 had an almost exact reaction, minus losing control of bladder, although that time nobody was around to assist him.
Received Hep A and HPV vaccine on 08/14/07. On 8/15 she began c/o pain (R) side. Saw doctor. Pts LFT's were elevated. Pain continued. Saw doctor again in Dec 2007 and LFT's were still elevated. Ultrasound showed sluggish gall bladder. Gall bladder removed on March 14, 2008. Still has pain. Surgeon told pt it could be the shots.  8/26/08 Reviewed PCP medical records of 8/13/07-7/29/2008. FINAL DX: none provided Records reveal patient experienced sore throat, rhinorrhea, irregular menses & on 8/13 BCP changed. RTC on 10/16/07 w/dizziness, HA, sore throat, left chest pain, wheezing, nonproductive cough, fever x 1 wk. Dx w/asthma, bronchitis & left lateral chest pain. Tx w/antibiotics.RTC next day w/increased left chest wall pain which increased w/inspiration.  Dx w/bronchitis & pleurisy.  Tx w/meds.  Developed gastroenteritis.  RTC 7/29/08 w/diffuse abdominal pain x 1 mo.  Had gallbladder removed 3/2008 & been seen in ER for abdominal pain.  Tx w/meds.
105 fever , fatigue , N&V ,  headache , dizzyness , bodyaches
fever; chills; sore arm; Booster (0.5 ml) 6oct2021 lot number 020F21A (not immunocompromised); This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and OVERDOSE (Booster (0.5 ml) 6oct2021 lot number 020F21A (not immunocompromised)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 031L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Pityriasis rosea. Concomitant products included NAPROXEN, LORATADINE, FISH OIL, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA, MULTIVITAMINS [VITAMINS NOS] and CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2021, the patient experienced OVERDOSE (Booster (0.5 ml) 6oct2021 lot number 020F21A (not immunocompromised)). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm). At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and OVERDOSE (Booster (0.5 ml) 6oct2021 lot number 020F21A (not immunocompromised)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first booster dose on 06-Oct-2021. No treatment medication information provided
chills, feverish, body aches, headache, SOB, abdominal pain
Patient was sitting down, he said he felt lightheaded and tried to get up to tell the pharmacy staff, and he dropped on the floor as soon as he got up . He was conscious most of the time but didn't remember if he hit his head or not, he  didn't have trouble breathing and was able to talk. The EMS came few minutes later and checked on him. He was fine and didn't opt for medical treatment.
This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 29-DEC-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 49 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.