chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12-year-old white male with a history of osteochondrosis and "ADND" who was vaccinated subcutaneous in the left arm at 11:58 with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658594/1330U). Concomitant vaccines administered on 26-NOV-2007 included a first intramuscular dose of MENACTRA (dip toxoid) administered at 11:58 in the left arm as well as an intramuscular dose of hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B) administered at 11:58 in the right arm. On 28-NOV-2008 at 13:54 the patient experienced redness and swelling at the injection site (previously reported as a large injection site reaction). The area was also reported as firm and tender. The patient did not receive any treatment and was advised to take ibuprofen. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Felt sleepy; "mouth movement"; Headache; Fatigue; Soreness arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt sleepy), MOVEMENT DISORDER ("mouth movement"), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SOMNOLENCE (Felt sleepy), MOVEMENT DISORDER ("mouth movement"), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness arm). On 16-Mar-2021, SOMNOLENCE (Felt sleepy), MOVEMENT DISORDER ("mouth movement"), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.  Reportedly, the patient experienced the symptoms all weekend and felt all right on 16-Mar-2021.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Upon follow receipt: Contains and no new information.
This case was reported by a physician via sales rep and described the occurrence of general malaise in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX.5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general malaise. On an unknown date, the outcome of the general malaise was recovered/resolved. It was unknown if the reporter considered the general malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called medical science liaison (MSL) to ask about 1 dose efficacy of the vaccine. He had the patient who got her first dose of SHINGRIX and reported general malaise and feeling down for about a month. He was not sure if the malaise was due to vaccine and did not want to report the adverse event. He did not have information on patient's initials, date of birth, age, vaccine lot number and expiration, date administered or any additional details on the adverse event reported. The healthcare professional stated if he thought that it was due to the vaccine, he would call MSL back. The reporter did not agree for follow up contact.
She got the vaccine, and they asked her to stay for the 15 minutes and she was fine, but when she went out onto the street she started to have a few seconds of feeling faint but did not.  That feeling passed and was able to walk home and was getting vertigo.  She had a sore arm the next day, very fatigued and exhaustion.  Three days later had redness appear on the arm and then had headaches, and insomnia that night.  Her eyes were burning as well.  A day later had irregular heart beat and then six days later had the red line, raised in a circle that lasted one day.  She then continued to have the itching and then became a rash which was traveling under arm and onto her chest.  She then went to the city UC and was spreading to her breast, and started to subside.  Since then she has been having on and off headaches, on and off itching of both of her arms, as well as her scalp and other parts of her body.   As  a child had a history of hives.  When she went to the UC they did an EKG due to the irregular heart beat and did not want to go to the ER during the pandemic.  He gave her one Benadryl and 3 Ibuprofen which she only took one of, as she has a lot of allergies.  She has been taking Zyrtec 5 mg for the itching when she has it, which works for her.  The symptoms are subsiding, and has transient rashes on the vaccine arm, and on the right arm still have a few areas and still itching on and off.
Rapid onset of a fever of 103.7 degrees Fahrenheit and severe weakness in the arms and legs. Nauseated and drowsiness occurred and swelling of the throat. Severely confused and tired slept from 4:30 pm on 11/19/2014 until the following day at 6:00 pm.  Fever broke around that time as well.
Within 8 hours of vaccine developed fever, achiness, pain at site area, large blackened area with swelling and warmness at injection site and body aches all over. Saw primary medical doctor 12/8 and was given prescription for antibiotics.
6/21/12 Pt called stating recv'd HPV and VARIVAX (Lt) arm on 6/19/12 - pt states arm was itching with rash next day - took BENADRYL PO. Now (Lt) arm red, hard/swollen and painful. Pt came to office on nurses instruction. (Lt) upper arm painful with 8cm by 4cm redness/induration. Dr observed. Pt f/up instructions: BENADRYL, Ibuprofen q 8 hrs (po), Cool compress PRN, off work today, RTC PRN.
2/22/22 pt to ED with increasing SOB; pt tested positive 2/21/22 for COVID with a home test; wife with COVID; pt tested positive in ED for COVID; c/o fever, cough, chills, fatigue; given Remdesivir, Baricitinib, Decadron, ABX; during hospital stay pt's condition worsened; required intubation with mechanical ventilation; pt had sudden bradycardia event; medication administered; family decided on no CPR; cardiac arrest; pt expired in the hospital
Aching joints; sore throat; swollen glands; ear ache; fever 103; headache. F/U 20FEB91:  SEEN BY MD 18FEB91 DX=MUMPS, LATER THAT NITE TO ER, DX=PHARYNGITIS & SEVERE RXN TO VAX. 20FEB91 - PT STATES FEELING MUCH BETTER.
Pain in the left calf that goes to the knee. Pt described it as a muscle pain saw physician 4/19/21; advised to use heat and rest. taking advil which is helping. no pain with rest. only pain with movement. no trauma. no birth control use. no SOB/no CP. +smoker.  PMD recommended getting a venous doppler ultrasound if symptoms do not resolve by Friday. Will call next week to follow up on symptom resolution/outcome. Advised patient to monitor symptoms and if she develops CP/SOB then to go to the emergency room. -DG
Patient got the flu shot on 9/28/10. The next day, she said she woke up to swollen left arm from elbow to shoulder. The area was red and hot, the glands underneath the armpit swollen quite large. She put ASPERCREAM on the red area around injection site to get the pain out. On 09/30/10, she came to the pharmacy to show it to me. I told her not to use ASPERCREAM, and recommended cold compresses and BENADRYL capsules. She took the BENADRYL twice, and the swelling of the arm has come down, but not the swollen glands. On 10/11/10, she called the pharmacy and reported the swollen glands still there. I was not working on that day, but the pharmacy manager on duty called me and relayed the message. On 10/12/10, I called the patient, and she said the swelling came down, and the glands were reduced in size now, and she feels a lot better. When asked if she wanted to seek medical attention from her doctor, she said it was not necessary, but wanted the adverse event reported to the CDC.
Began with discoloration the size of a dime on abdomen  and spread larger to right leg and right arm. Developed right arm inflammation and thickened skin. 2 biopsies done to confirm diagnosis of generalized deep linear morphea scleroderma. Receiving treatment of weekly injection of methotrexate 25mg.
He got PREVNAR shot on 7/10/18 at 7:30 pm and went to bed. Said he woke up around 11:00 am on 7/11/18 and went to another pharmacy to pick up his medications and he said he was slurring his speech and looked disoriented. He was off also balance and keep on laughing. Said he was like that til 5:00 pm 7/11/18. He said as of 7/12/18 those symptoms are gone except arm pain and some body ache.
Per nurse, pt. presented with large, swollen red mass, shot given 8/1/11.
Severe pain in muscles, bones, stomach and intestines.  Severe chills, to the point that the chattering chipped a tooth.  Diarrhea, vomiting, to the point that I was unable to keep even water down for about the first 36 hours.  The shaking subsided, but the chills and severe muscle pain continued for three days. My bowels are still painful after three full days, but skin and muscle pain has subsided.  During the three days of pain, I slept about 20 out of 24 hours.  When awake, I tried to read but was unable to concentrate.  Same for TV.
Patient reports that the next morning after receiving  his second dose his legs and feet were swollen. This condition has worsened over the last 2 days and I advised him to contact his PCP.  His right calf is extremely swollen and both feet as well.
11/8/06 - Right side back of neck, swollen lymph. On or around 11/16, shins started hurting after walk. Left foot around toes hurting. Then noticed swelling of feet then knees, then right foot and ankles. Now notices feet and hands swollen in AM and can no longer wear rings. No fever; just ache.
Dose was administered beyonf 30 days of use; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Dose was administered beyonf 30 days of use) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was administered beyonf 30 days of use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Dose was administered beyonf 30 days of use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with booster 2. No concomitant medications information was reported.  HCP stated they administered expired doses of the Moderna COVID-19 Vaccine to 27 patients. Number of doses/vials: 27 doses Vials were thawed on the same day of administration Date(s) of administration of vaccine- since 06-Apr-2022 until 25-May-2022 The vial did not undergo any temperature excursions. There were no known reactions in office.  No treatment medications were provided.
Head cold; cannot smell or taste anything; cannot smell or taste anything; This is a spontaneous report from a contactable nurse (patient herself, ICU nurse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After receiving the vaccine on 18Dec2020, she had a head cold, she cannot smell or taste anything. Clinical outcome of the events was unknown.  Information about Lot/Batch number has been requested.
temperature of 101.2; hurts all over; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 101.2) and MYALGIA (hurts all over) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Mar-2021, the patient experienced PYREXIA (temperature of 101.2) and MYALGIA (hurts all over). At the time of the report, PYREXIA (temperature of 101.2) and MYALGIA (hurts all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Upon callback, patient confirmed information provided in voicemail. She got the vaccine in her left arm. LOT# not available as she could not find it on the vaccination card. Patient notes that she already had coronavirus back in September. Questioning if she should have not gotten the vaccine since she did have coronavirus back then. She is also wondering what she should do about the second vaccine as she does not want to experience these side effects again.
congestive heart failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "congestive heart failure". Clinical course: Reporter mentioned that she believes the Pfizer covid shots her parents got, caused her mother to get congestive heart failure.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
1815: pt complained mild dizziness, O2:97 %, BP: 115/83, HR: 86, pt given 50 mg Benadryl orally, ate some almonds and chips, not redness or swelling at site 1830: pt stated she was feeling better, requested to go home
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Apr2021 13:15 (Lot number: EW0162) at the age of 45 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, administration time:10:45 AM, lot number: ER8730, Anatomical Location: Arm Right), administration date: 27Mar2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 19Apr2021 17:00, outcome "not recovered", described as "Extreme tiredness"; SOMNOLENCE (non-serious) with onset 19Apr2021 17:00, outcome "not recovered", described as "very sleepy". Therapeutic measures were not taken as a result of fatigue, somnolence. Additional information: Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. No treatment received for the adverse event. No allergies to medications, food, or other products. No follow-up attempts are possible. No further information is expected.
Fever, body aches, dizziness. Right breast mildly tender, red and warm to touch 2 days after vaccination.
Following morning extreme pain in raising R arm. Either mediated or got used to it, but continues to present. Pain is extending from original site down arm to fingers. Feels like an active process
Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.; No Adverse Event; Given expired vaccine. 9APR2023 was expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine. 9APR2023 was expiration date.), WRONG PRODUCT ADMINISTERED (Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.) and NO ADVERSE EVENT (No Adverse Event) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine on 08-Mar-2021, Moderna COVID-19 Vaccine on 05-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE on 03-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE.    On 24-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine. 9APR2023 was expiration date.). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine. 9APR2023 was expiration date.), WRONG PRODUCT ADMINISTERED (Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Given expired vaccine. 9APR2023 was expiration date.) and WRONG PRODUCT ADMINISTERED (Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.).    No concomitant medications were reported. It was reported that patient received 2nd booster dose and no symptoms were reported. The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2023: Live follow up received: suspect product coding and additional event verbatim was updated
Staff member received 2nd Hep B vaccine 3/20 - on 3/21 reported to ICN pain in neck, bilat wrists, bilat ankles, numb tingle of hand and feet, difficulty ambulatory due to pain to ER for eval Dx "myalgia",
My periods have all been very heavy, short in length, and my cycle has been shorter. It used to be about 32-35 days average now it's been 28-31 days and about 4 days in length when previously it was 6-7 days.
changes in breathing; it just feels different; a little nauseous; a little achy/body aches; headache in the top of her neck; tiredness/extremely tired; chills; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 05May2021 at 15:45 (Batch/Lot Number: EW0167) as, single dose for covid-19 immunization. Medical history included ongoing hyperthyroidism, seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 25May2021, morning she woke up, 20 days after receiving her first vaccine and patient was extremely tired, she had to lay back down. She was a little nauseous, a little achy, had a headache in the top of her neck and changes in her breathing stated that it just felt different. She does think it was related to the Covid 19 vaccine because her husband woke up with the same symptoms last week on 19May2021. She took a powernap this morning and she felt better. She also had chills, not shivering, just kind of like a chill and then she was fine. That was this morning also. She had a sweatshirt on. She started blaming her symptoms on seasonal allergies. She still had a little headache at the top of her neck. She was still tired, she could lay down and go to sleep. She has hyperthyroidism so being tired is not normal for her. She was leery over getting the second Covid 19 vaccine because she was heard that people get sicker after the second dose. The outcome of the events nausea, changes in breathing was unknown and other events was not recovered.
2 days after receiving the Johnson and Johnson COVID vaccine I developed a lump on my arm about 1/2 inch from my elbow.  Nobody said anything about it being related to the vaccine  ..this has never happened before..I have gotten the flu shot pneumonia shot never had a problem. But I felt that someone should know just in case.
This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with ROTATEQ (lot #, expiration date, dose, route of administration and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
Patient was seen in the ER on 11/06/2020 for 102 fevers and febrile seizure.  Patient had a 99.1 -temporal temp in ER and diagnosed with fever and febrile seizure.
Woke up during the night after the booster from a very, very bad headache Took ibuprofen  Was mostly but not entirely gone by morning  Gone by the end of the day
Patient seen in office 01/08/2005 by Dr.  Diagnosed with atypical varicella.  Had scattered papules and pustules on torso with low-grade fever and itching.  Patient was previously vaccinated on 03/20/1998 for varicella.
10-25-09-Wife noticed red rash on R side of neck, flat, occasionally itchy. Pt uses over the counter cortisone cream. No trouble breathing. No new detergent or soap used. No different foods. No allergies. Advised to check with PMD.
LMP 8/5/2021 first trimester miscarriage patient states vaginal bleeding consistent with miscarriage
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unspecified dates during the time period of 06-DEC-2016 to 13-DEC-2016, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L035882, expiration date: 19-APR-2017; lot # M026317, expiration date: 11-JAN-2018; lot # L014458, expiration date: 11-FEB-2017; dose and route were unknown) for prophylaxis. The detail of the storage was a temperature excursion of 53.4 Fahrenheit for 2 hours 24 minutes for the refrigerated vaccine PNEUMOVAX 23. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as follow up with the reporter is not permitted. Sender's Comments: US-009507513-1701USA001925: US-009507513-1701USA001927: US-009507513-1612USA007495.
The following day plus 2 more days (3total) I had severe muscle pain in my left lower back/hip area, only when I would sit or lay down. It was very faint if I would walk around. The next 4 days I only had the muscle pain morning and evening, and very faint. Not at all throughout the day.