chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer sponsored program. A contactable Health Care Professional reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age, gender, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient became ill and experienced pretty bad fatigue, fever and was feeling crummy. Clinical outcome of the adverse events was unknown at time of this report. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): PFIZER INC-2017503287 Same reporter/product/events, different patient; PFIZER INC-2017503280 Same reporter/product/events, different patient.
Delayed reaction (1 week) - Lump, Warm & Itchy at site of vaccination on upper right arm.  I have taken an antihistamine (1 Benadryl) and am awaiting further guidance from medical provider.
swelling in my left armpit; chills; chills and sharp upper back pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 13Feb2021 at 09:30 AM at single dose for COVID-19 immunisation. Medical history included allergies to penicillin and latex. The patient was not pregnant. Concomitant medications included metoprolol tartrate (METOPROLOL - 1 A PHARMA) at 25 mg and acetylsalicylic acid (ASPIRIN (E C) at 81 mg (medication in two weeks). No other vaccine received in four weeks. The patient previously took epinephrine sensitive and had allergies. Patient has not tested COVID prior vaccination. It was reported that exactly 1 week after vaccine, the patient suddenly experienced chills and sharp upper back pain lasting 23 hours on 20Feb2021 at 02:30 PM. Three days later (23Feb2021), the back pain returned for a few hours along with swelling in her left armpit, lasting several hours. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
4 days after first vaccine while jogging  I felt increased in mucous production in my airways.  since then I'm suffering from an increase in my asthma severity.  for 3 decades since my asthma began I had a mild intermittent course which means I use puffers for several days not more than two times a year. since the first COVID vaccine I changed to moderate asthma. at the first few months I was hoping for it to disappear, then when it didn't I started using puffers on a daily basis and for 4 months now I use moderate levels of inhaled CS with LABA . I tried to decrease the dose of my RELVAR 184/22 to 92/22 and it doesn't work. That's why I've decided to report now.
Soreness at injection site, low-grade fever, chills, and body aches over course of 2 days.
PATIENT RECEIVED MODERNA BOOSTER VACCINE MONDAY AFTERNOON, THEN STATED THAT SYMPTOMS STARTED THE FOLLOWING DAY. PATIENT'S INJECTION SITE BECAME SWOLLEN, RED, HARD AND PAINFUL TO TOUCH AND PATIENT IS STILL EXPERIENCING THESE SYMPTOMS AS OF TODAY (THURSDAY). PATIENT DID NOT REPORT ANY SYMPTOMS OF FEVER, CHILLS OR PUS AT THE SITE. PATIENT WAS ADVISED TO CONTACT DOCTOR TO DETERMINE IF IT IS A HYPERSENSITIVITY REACTION OR CELLULITIS AND ALSO ADVISED INTERIM MANAGEMENT OF SYMPTOMS WITH ICE PACK, ORAL ANTIHISTAMINE, ARM ELEVATION AND MONITORING OF REDNESS PERIMETERS.
Information has been received from a physician concerning her son, who 2 years ago (2005), was vaccinated with varicella virus vaccine live (Oka/Merck) and developed hives after the vaccination. Medical attention sought was not reported. On an unspecified date the patient had recovered. Additional information has been requested.
" c/o COVID onset 2 days ago. Associated symptoms include SOB, weakness, and fatigue.  -                                                       Zinc -Vitamin D-supplemental O2, supportive care; pt also with w afib (has hx of); rec'd cardizem and amiodarone for afib; Patient was discharged home with home health services in a stable condition."
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: Arm is red and swollen and warm to touch
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were administered doses of improperly stored Oral, ROTATEQ lot # K015816, expiration date reported as 29-MAY-2016, (dose was not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
flu like symptoms; slight body ache; slight fever; slight chills; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product included blood pressure medication and diabetic medication the patient chose not to disclose the names of the medications.  No treatment medication information was provided   This case was linked to MOD-2021-329305, MOD-2021-329306 (Patient Link).
Woke up very thirsty; Woke up very thirsty; Body felt very warm like it was radiating heat; it was cold and hot, hot, and then cold; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 48-year-old female patient received BNT162B2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP6955) at the age of 48 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL, start date: Dec2017. The following information was reported: MIDDLE INSOMNIA (non-serious), THIRST (non-serious) all with onset 29Mar2021 01:00, outcome "recovered" (29Mar2021) and all described as "Woke up very thirsty"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 29Mar2021 01:00, outcome "recovered" (29Mar2021), described as "Body felt very warm like it was radiating heat; it was cold and hot, hot, and then cold".  Additional Information: The patient wanted to report side effects from the vaccine. Overnight after the third night, the patient woke up very thirsty and her body felt very warm like it was radiating heat. It was a form of blinking light, it was cold and hot, hot, and then cold. It was overnight and the patient went to sleep, and she woke up and it was better.  No follow-up attempts are needed. No further information is expected.
burning sensation; metallic taste; Hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation ), DYSGEUSIA (metallic taste) and HOT FLUSH (Hot flashes) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced BURNING SENSATION (burning sensation ) and DYSGEUSIA (metallic taste). On an unknown date, the patient experienced HOT FLUSH (Hot flashes). At the time of the report, BURNING SENSATION (burning sensation ), DYSGEUSIA (metallic taste) and HOT FLUSH (Hot flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had my first Pfizer vaccine for COVID-19 within hours I stopped coughing all together; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "dry cough" (unspecified if ongoing), notes: Hello I have had a dry cough for about 18 years that no one has been able to find a cure for. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I had my first Pfizer vaccine for COVID-19 within hours I stopped coughing all together".  Additional Information: patient reported that, I have had a dry cough for about 18 years that no one has been able to find a cure for. When I had my first Pfizer vaccine for COVID-19 within hours I stopped coughing all together! A few months after the 2nd dose the coughing slowly started returning. I was disappointed after the booster that my coughing did not stop. What is in your dose that stopped my coughing and how can I get regular use of it? PQC present was reported as, no. AE present was reported as, yes. This case was reported as, non-serious.  Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
Breasts were severely sore; Under the arm very sore; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Breasts were severely sore) and AXILLARY PAIN (Under the arm very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Breasts were severely sore) and AXILLARY PAIN (Under the arm very sore). At the time of the report, BREAST PAIN (Breasts were severely sore) and AXILLARY PAIN (Under the arm very sore) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: other (Inconclusive) Patient had a mammogram after the first shot..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Client inadvertently given adult dose Hep A vaccine.  Mother notified - will follow-up in one week.  Corrective action taken: adult vials physically separated from pediatric vials.
Client reports she developed a rash and it reminded her of hives she had from a previous allergic reaction.  She noted the rash around her waist band and on her abdomen and no where else on her body. The rash or hives itched and she took generic Benadryl 1 tablet and used hydrocortisone ointment on it on the evening of 12/19/09 and the rash was resolved by 12/21/09.
I had no reaction to the 1st shot. About a week after the 2nd shot, I experienced occasional sharp tolerable burning pain at the back/bottom of my right arm's arm pit. About a week later, this experience subsided and is now gone.
Have not been able to sleep through the night since vaccine; Fatigued; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Sep2021 at 12:00 (Batch/Lot Number: FC3181) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization at age of 51 years old. Medical history included hashimotos disease, thrombocytosis, hemochromatosis, anxiety. Concomitant medications included escitalopram oxalate (LEXAPRO); levothyroxine sodium (SYNTHROID); bupropion hydrobromide (APLENZIN); liraglutide (SAXENDA). The patient experienced have not been able to sleep through the night since vaccine, fatigued, and heart palpitations on 08Sep2021. The report was non-serious. No treatment received for the events. The patient did not have covid prior vaccination, and did not test covid post vaccination. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Pt had a dime-sized knot at the injection site. It was red. Pt reported no pain associated with this. No itching either.
Narrative: Patient received his first Moderna COVID booster 5/3/2022 and developing some swelling to a left axillary lymph node the following morning. On 5/6/2022 the patient presented to the clinic and stated that he felt the swelling had increased but was nonpainful. The patient did report that he had some swelling with his second Moderna COVID vaccine in the primary series, and no difficulties with the first dose. The patient further stated that he has had a similar reaction to his second Shingles vaccination previously. The patient denied any fever, chills, rashes, or shortness of breath. The patient was instructed to monitor the swelling, and the reaction was subsequently documented in the patient's chart. The patient states that he cannot use anything such as Tylenol or NSAIDs and was content with this monitoring.
Headache began night of receiving shot, headache lasted 3 days. Back pain at the spine started following day, very intense, hurt to walk, lasted 5 days. Soreness at site of shot, lasted 1 day
Approximately 8 minutes after the patient was given the shot she reported feeling a little funny. She said she felt like the space between her nose and throat was congested. I asked her if it felt like it was her sinus area and she said yes. She was able to breathe and talk at the time, but her speech did not seem normal. I asked if she would like some liquid Benadryl and she said yes. I gave her 10 ml of liquid diphenhydramine 12.5mg/5ml. After about 1-2 minutes she said she felt better. I asked if she would like to repeat the dose of Benadryl and she said no she was feeling better. She was able to breathe and talk at this time. After her 15 minute time limit for observation expired I asked her to remain seated in observation. I again offered another dose of Benadryl and she said she did not feel like she needed it that she was feeling much better. I went to get her a cup of water and asked her to take small sips. She remained in observation for approximately 15 additional minutes. I asked the patient before she left if she wanted another dose of Benadryl but she said she felt good and had Zyrtec if she needed anything, but didn't think she needed any more medicine. The patient was able to breathe, carry on a full conversation in her normal voice with no problem, and swallow with no problems at this point. I offered for the patient to remain in observation longer if she felt comfortable, but said she felt good and will call the pharmacy with any questions or concerns. I tried to call the patient about 8:30pm to follow up, but did not get an answer and was not able to leave a voicemail.
Rash on legs, starting approx 20 hours after receiving the booster. Itchy, widespread, small red dots, bilateral legs going from ankles to upper thighs. No other symptoms.
Loud buzzing in left ear and fullness in right ear - Tinnitus - started one week after vaccine. Some nausea and dizziness.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 10-JAN-2013 the patient was vaccinated intramuscularly with a 0.5 ml expired dose of PNEUMOVAX23 (Lot# 667912/0933Z, expired on 25-FEB-2012). The patient was revaccinated on 14-JAN-2013 using 0.5 ml dose PNEUMOVAX23 (Lot# reported as H010515, expired on 13-FEB-2014), intramuscularly. No adverse effects were reported. It was not known if the patient sought medical attention. This is one of several reports received from a same source. Additional information is not expected.
Within 24 hours- Left arm (between elbow and deltoid) became swollen 3x normal size at site of varicella vaccine.  Within 48 hours red welted rash developed on upper arm as well.  Steroids, benedryl and motrin were prescribed.
This spontaneous report was received from a female patient of unknown age referring to herself. The current condition, medical history and concomitant therapy were unknown. On unknown dates the patient was vaccinated with two doses of GARDASIL 9 (lot#, dose and route not reported). On 09-JUN-2016, the patient received the third dose in the series. The patient stated that the dose she received on 09-JUN-2016 might have been GARDASIL (lot#, dose and route not reported) (interchange of vaccine products). No adverse effects were reported. Additional information is not expected since no consent to contact.
had unspecified injection side reactions; had unspecified injection side reactions and unspecified side effects after a Shingrix injection; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction and adverse event. On an unknown date, the outcome of the injection site reaction and adverse event were unknown.   It was unknown if the reporter considered the injection site reaction and adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced unspecified injection side reactions and unspecified side effects after a Shingrix injection. The reporter did not consent to follow up. This case is 1 of the 4 cases, reported by same reporter.
After patient received the vaccine, she sat down in our waiting area. She began to feel nauseous and lightheaded. She very briefly went unconscious. Her father was with her and helped her lay on the floor. She immediately regained consciousness and after 1 minute. She said she felt much better. This was a typical episode of syncope.
administering vaccinations past the expiration date for the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administering vaccinations past the expiration date for the Moderna COVID-19 vaccine) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administering vaccinations past the expiration date for the Moderna COVID-19 vaccine). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administering vaccinations past the expiration date for the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Number of doses/vials were 63 doses, 3-4 vials; date the vial was initially stored in the refrigerator was on 01-Dec-2021 and the vial did not undergo any temperature excursions.  It was reported by the reporter that, some patients had reported flu-like symptoms after receiving the vaccination, but she did not have details on that.   This case was linked to MOD-2022-449465 (Patient Link).
Patient received Tdap into the left shoulder on 10/31, the arm developed pain, swelling, heat, and itching at the site since then.
Second dose to be taken 60 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose to be taken 60 days after the first dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose to be taken 60 days after the first dose). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose to be taken 60 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received.
DIED; This spontaneous report received from a consumer via a company representative through social media concerned multiple patients of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported,1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death after they were fully vaccinated. It was unspecified if an autopsy was performed. The reporter stated that, "They were right the only people that I know who have died are fully vaccinated". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20221243109-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Mother called stated child started running T last night about 100 degrees (o). Today child called mother & said she felt like she was going to pass out when she tried to stand up. Still running T 100 degrees (o). Advised mother to call MD.