chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has all over body rash, small raised bumps that itch. Symptoms occurred 1 day after vaccination. I recommend the patient use BENADRYL as well as hydrocortisone cream if needed. Also recommend the patient follow up with PCP to discuss this event. I counseled on signs/symptoms of serious allergic rxn and to go to ER if any trouble breathing occurs.
"We had an error in administration with ROTARIX which should be given orally after reconstitution, but it was given IM. No harm to patient, except that an injection was given when it shouldn't have been. Attached pictures depict differences in syringes...the one with the diluent is a small glass syringe, very similar to many syringes for IM/SC injections, i.e. flu shot. The oral syringe for medications is substantially bigger. Reconstitution of the ROTARIX is cumbersome. The process of mixing up the diluent, adding it to the vial of virus via an adapter to reconstitute the solution is very similar to reconstituting a parenteral medication. Even one of our Pharmacists said that they would have "put a needle on it" to complete the reconstitution instead of using the adapter enclosed in the packaging. Since this occurred, we have labeled the ROTARIX supply "For Oral administration."
A pediatrician reported that a male child received his second dose of Prevnar. On 07-JAN-02, at 29-months of age, he developed meningistis due to Streptococcus pneumoniae. No further information was available at the date of the report. Cancelled: Duplicate of HQ0190228JAN2002 which will remain the cse of record.
On the week of 07/15/2022 I volunteered at a local election site. On the evening of 07/14/2022, my husband was up coughing all night so we decided to test for COVID-19 and were both positive. That day of the 15th, I began to feel a bit fatigued and sounded very congested. After testing positive, I had a telehealth visit with my doctor where they advised that I continue to treat my symptoms with over the counter medications like Mucinex but also prescribed Paxlovid and told me to take it if my symptoms got worse but it was never needed. It took about 5 days for my energy to return and I tested negative for COVID-19 on the 7th day.
Patient experienced: pain, redness, or swelling at the injection site fatigue headache muscle pain chills fever vomiting Patient was advised to use cool compress for swelling, increase fluid intake, and rest. Patient stated side affects ended after two days.
Pfizer-BioNTech COVID-19 Vaccine EUA"  There was a rash that popped up in patches all over my body.
On 2/26 morning, I couldn't really use my arm due to arm weakness on top of pain. Around new I began experiencing nausea and diarrhea. That afternoon I began experiencing dizziness and shortness of breath and went to the ER. They gave me Zofran and Tylenol. They told me that I have COVID arm and a stomach virus which they said I probably had it before the vaccine. I went to my PcP on 2/28, and she determined that it was an adverse reaction and prescribed a prednisone inhaler.
Approximately around 10:30 too 11 PM, patient experianced shortness of breath and cough and change in colors (expressed as purple), patient called 911 and EMS arrived in 3 minutes. According to the patient, oxygen saturation was low around 82 and blood bressure was up and down, at times the systolic was 220. EMS gave her oxygen and took patient to hospital where she was treated with oxygen and discharged around 3 am.
Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had muscle pain the day after Shingrix vaccination.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He mentioned he was vaccinated with the Pfizer and Moderna vaccines and now he has Covid) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. Concurrent medical conditions included Blood pressure high. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (He mentioned he was vaccinated with the Pfizer and Moderna vaccines and now he has Covid). At the time of the report, COVID-19 (He mentioned he was vaccinated with the Pfizer and Moderna vaccines and now he has Covid) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. The patient had rebound and the second case was much worse than the first. The patient had not started Paxlovid and had been prescribed. The patient talked to doctor and stated he did not have all the herbal supplements he was taking and the biggest thing was the rebound. The patient would like to double check if herbal supplements would have any reaction to Paxlovid. No treatment medications were reported. Company comment: This is a spontaneous case concerning a 69-year-old, male patient with no reported medical history and with no relevant concurrent medical condition. Patient has vaccination history of receiving unknown dose number of co-suspect product BioNTech. Patient experienced the unexpected non-serious AESI event of Covid-19. The event Covid-19 occurred after the unknown dose number of mRNA-1273 and BioNTech. Patient was prescribed with Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Non-significant live follow up: QE number was added. Sender's Comments: This is a spontaneous case concerning a 69-year-old, male patient with no reported medical history and with no relevant concurrent medical condition. Patient has vaccination history of receiving unknown dose number of co-suspect product BioNTech. Patient experienced the unexpected non-serious AESI event of Covid-19. The event Covid-19 occurred after the unknown dose number of mRNA-1273 and BioNTech. Patient was prescribed with Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Contracted symptomatic Covid-19 on 17May2022; Contracted symptomatic Covid-19 on 17May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old adult female received COVID-19 immunization at a workplace clinic with the first dose of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot EN5318 and expiry information not provided) as a single dose on 27Jan2021 (at 50-years-old); a second dose of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot EN5318 and expiry information not provided) as a single dose on 17Feb2021 (at 50-years-old); and a third (booster) dose of intramuscular  BNT162B2 (COMIRNATY, solution for injection; Lot ED6955 and expiry information not provided) as a single dose in the right arm on 30Sep2021 (at 51-years-old). The patient had no medical history, denied any known allergies and also denied receiving any other medications within two weeks of the vaccinations. The patient also denied receiving any other vaccination within four weeks of these vaccinations. The patient reported that she contracted symptomatic COVID-19 on 17May2022 confirmed with a positive nasal swab test on 18May2022. Treatment details included PAXLOVID. The outcome of the event Contracted symptomatic Covid-19 was recovered on an unspecified date in 2022.
Large pruritic, burning subcutaneous nodule. Possibly migrating from deltoid to elbow. Resolved at time of medical doctor evaluation (onset after immunization).
8/6/15 pt came in stating she started having pain and numbness in her left arm at 7pm on 8/03/15. This continued 8/4/15, 8/5/15 and 8/6/15. She can raise her arm only 20% and then there is pain in joint. She's been using BIOFREEZE on her own, along with TYLENOL. She's avoided Ibuprofen as she said it causes drowsiness.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: After 15 minutes patient began to sweat profusely and began to come in and out of consiousness, blood pressure was very, pulse was elevated
Redness, swelling around injection site, and pain in arm for one week after administration of vaccine.
Moderna COVID 19 Vaccine EUA Arm sore at inoculation site for over a week.  Not a terrible pain, just continually sore and hard to ignore.
Had a flu shot around 8:30 AM, then was acting totally normal and went to the park and played. Mom states that he went down for a nap around 10:30-12:30 PM. He woke up screaming, red and had a runny nose. Dad states that when he woke up he was having a hard time breathing. House is being painted right now. Now very lethargic. Came to pediatricians offc around 5:00 PM. On the way to the office his eyes rolled back and he fell asleep and was hard to wake up. Mom was shaking him to try and wake him up and that didn't work. Woke up when they took him out of his car seat. Was diagnosed with Altered Mental Status, as well as change in sensorium following a vaccine.
Headache, sores top of head down to the eye (right side only). Sore all over and blur vision. Medicine acyclovir and Neo-poly-dexa ophth susp.
PATIENT WAS IN WAITING PHASE AFTER  VACCINE GIVEN , SITTING IN CHAIR AND FAINTED , HIT HEAD ON FLOOR CAUSING A 1 INCH GASH  ABOVE RIGHT EYE BROW . EMT CAME  AND TRANSPORTED TO ER , BECAUSE OF GASH IN HEAD, PATIENT WAS ALERT AND SAID SHE HAD FAINTED BEFORE TAKING SHOTS, BUT ON RTELEASE FORM CHECKED NO , PROBABLY JUST AN OVERSIGHT FOR PATIENT, TEXT HER MOTHER AND TRYED TO CALL WITH NO RESULTS.
Started with fever 102 the evening of shots. Fussy, crying, not eating, sleeping the next four days. Mom called office on 9/29/10 to report this. Pt. was seen on 9/29/10. Called on 9/30. Doing better, no fever, slept 6 hours during the night.
Received a full dose of 0.5 mL and not a half dose; She received the vaccine at took 1 syringe at a time, filled it up, threw away the bottle, and had prefilled syringes; Fever of 99-100 F 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99-100 F 2-3 days), ACCIDENTAL OVERDOSE (Received a full dose of 0.5 mL and not a half dose) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (She received the vaccine at took 1 syringe at a time, filled it up, threw away the bottle, and had prefilled syringes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PYREXIA (Fever of 99-100 F 2-3 days). On 22-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received a full dose of 0.5 mL and not a half dose) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (She received the vaccine at took 1 syringe at a time, filled it up, threw away the bottle, and had prefilled syringes). At the time of the report, PYREXIA (Fever of 99-100 F 2-3 days) had resolved and ACCIDENTAL OVERDOSE (Received a full dose of 0.5 mL and not a half dose) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (She received the vaccine at took 1 syringe at a time, filled it up, threw away the bottle, and had prefilled syringes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Body temperature: 99-100 f (High) 99-100 F.         No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-207751 (Patient Link).
Tennitis. Non stop ringing in Ear, have never had anything like this for this long.
Very fatigued on 6/14/2012 and 6/15/2012, Dizzy and re-injured joints and one year old incision, were hurting on 06/16/2012, Dizzy and sinus drainage on 06/17/2012, Headache on 06/18/2012, Sore throat on 06/19/2012, Headache and cough wheezing on 06/20/2012 (went to Multi Care Doctor, my doctor was on vacation, Dr said there was a nasty cold going around and prescribed 500MG Amoxicillin daily and told me to take Advil, by 7AM 06/21/2012 I was so sick and dehydrated my husband took me to Hospital, I was diagnosed with pneumonia, was given Levaquin intravenously and four tablets, 750MG each daily at home, and an Albuterol inhaler.
After receiving vaccination - next day patient experience redness, swelling, itching at vaccination site. Also the vaccination site had fever & a small nodule as well. Patient still has itching/redness as of date 4/25/12.
Pt recvd vax & 4 days later ex shaking & tremors which lasted 5 mins; noted a dime-sized area of redness @ inject site w/subsequent sloughing of the sking;
Redness to injection site, parent informed to monitor site and call nurse line if it worsens.
Red. Itching. Swelling. Rash. Small Bumps around injection area. Red spotting
She states that after the first shot, she started having pain in the left arm. After the 2nd shot the other arm started hurting. The arm was sore./ pain in both arms, and shoulders. /arm started hurting.; headaches / The pain shoots up to her neck and head from both sides of her body.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (She states that after the first shot, she started having pain in the left arm. After the 2nd shot the other arm started hurting. The arm was sore./ pain in both arms, and shoulders. /arm started hurting.) and HEADACHE (headaches / The pain shoots up to her neck and head from both sides of her body.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 017B21A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL SUCCINATE for Blood pressure high.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (She states that after the first shot, she started having pain in the left arm. After the 2nd shot the other arm started hurting. The arm was sore./ pain in both arms, and shoulders. /arm started hurting.) and HEADACHE (headaches / The pain shoots up to her neck and head from both sides of her body.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (She states that after the first shot, she started having pain in the left arm. After the 2nd shot the other arm started hurting. The arm was sore./ pain in both arms, and shoulders. /arm started hurting.) and HEADACHE (headaches / The pain shoots up to her neck and head from both sides of her body.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. On 20-Jul-2023 patient had pain in both arms and shoulders. It was reported that since the COVID-19 vaccination, patient had not received a flu shot or any other shots. Patient stated that even Tylenol does not help and she can not sleep at nights because of the pain.
Extreme pain all over body. Patient received dose with 650mg APAP in system. Redosed APAP 8 hours after original AM dose. Arthritic pain flare, fibromyalgia pain flared, extreme headache pain as well. Even tried using tramadol she had on hand and that did not even touch the pain level she was experiencing. Nausea occurred but no vomiting. Chills occurred but no temperature taken to determine if she had a fever. Extreme fatigue as well. Patient had to call a family member to care for her elderly and ill husband because she could not perform any activities of daily living. The symptoms started about 8 hours after administration and lasted for about 24 hours. Patient treated symptoms with rest and 650mg Tylenol. Patient was counseled on the likelihood of these adverse events prior to vaccination but feels the reaction was so severe it needed to be reported.
pt recv vax  1 1/2 wk ago;pt recently discovered is 4 wk pregnant,& has been experiencing cramping since receiving the vax & subsequent dx of pregnancy
pt recv vax 18JAN96 & 6hr later pt devel an inj site rxn, characterized by swelling, redness, & tenderness;pt recovered;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild
Vaccine reconstituted incorrectly. 0.8mL instead of 1.8mL of diluent used. 3 patients received the higher concentrated doses. Patients notified. No adverse reactions reported.
cough that will not go away; pain in her heart; she lost her voice for 3 weeks; pain in her lung; feels dizzy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough that will not go away), CHEST PAIN (pain in her heart), APHASIA (she lost her voice for 3 weeks), PULMONARY PAIN (pain in her lung) and DIZZINESS (feels dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068(H or 4)21(7)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced COUGH (cough that will not go away), CHEST PAIN (pain in her heart), APHASIA (she lost her voice for 3 weeks), PULMONARY PAIN (pain in her lung) and DIZZINESS (feels dizzy). At the time of the report, COUGH (cough that will not go away), CHEST PAIN (pain in her heart), APHASIA (she lost her voice for 3 weeks), PULMONARY PAIN (pain in her lung) and DIZZINESS (feels dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not overweight. Patient do exercises and was taking care of herself. No concomitant medications were reported.  Treatment information was not provided. Symptoms started the next day of vaccination and had not resolved.   Reporter did not allow further contact
the patient received VARIVAX in 1995 when the patient was 9 years old and received a second dose at age 18.; No adverse effects are being reported; This spontaneous report as received from a consumer (patient's mother) refers to her 9 years old child (gender was not reported). The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date in 1995 and subsequently in 2004, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) first dose at the age of 9 years and second dose at the age of 18 years (lot # and expiry date was not reported) for prophylaxis (inappropriate schedule of product administration). The patient had no adverse events.
Patient did not experience any adverse events. The vaccine that the patient received had gone through one freeze thaw excursion. After speaking with Pfizer and reviewing information provided by them, we were able to determine that the safety and efficacy of the vaccine was not compromized.
Fatigue; Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. 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 COVID-19 vaccination. On 05Apr2021 at 19:45, the patient experienced fatigue and loss of taste. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events fatigue and loss of taste was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Extreme area of redness-5 inch oval.  Fever-101. Very bad temper, shouting, slamming doors, for 2 days after shot. Swelling of site, 1 1/2 inches bigger than other arm.  Unable to raise arm to shoulder height for 10 days. No range of motion for 5 days.  Severe pain-needed 4 ibuprofen (200mg. ea) and 3 extra strength Tylenol every 6 hours for 4 days following shot.  Arm is still red and blotchy in an oval about 4 inches by 2 inches.  In the center is still a hard lump. The site has been very itchy for the past 7 days.
77yo 69kg F received dose #2 COVID-19 vaccine. PMH significant only for basal cell carcinoma. Allrgy hisotry includes adhesive, ciprofloxacin, ibuprofen (swelling), meloxicam (swelling) . Approx 10 min after vaccination pt reported feeling flushed, hot, and weak at approximately 1:30pm. She was able to walk into Triage under her own power. BP was 190s/90s upon arrival to traige. Pt pale and complained of feeling lightheaded and that she felt like she was going to pass out. 400ml of orange juice given since patient stated that she had not eaten since 8am. Blood sugar taken 15 minutes after resulted at 116. Multiple blood pressures taken resulted in consistent 190s/90s. 911 called by provider at 2:07pm. Fire Department arrived on scene at 2:13pm. EMS arrived on scene at 2:16pm. Vitals taken by EMS and it was determined that since her blood pressure continued to be elevated similar as prior and she felt unable to stand under her own power to take her to Emergency Department. EMS left the clinic at 2:30pm.  She remained conscious and able to answer questions throughout the event. BP in ED 162/89. Pt with no prior hx hypertension. Elevated BPS thought possibly due to "white coat hypertension". In ED pt received diazepam 2.5mg po x1. She returned to baseline and was able to be discharged a few hours later at 1742.