chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 in left arm for covid-19 prophylaxis. On an unspecified date in 2021, patient experienced upper left shoulder pain (minimal) that lasted one day (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-NOV-2021 in left arm for covid-19 prophylaxis. Age at time of vaccination 63 years old. No concomitant medications were reported.  On 31-DEC-2021, patient developed symptomatic covid (confirmed covid-19 infection) and he tested positive 2 days later with a rapid test (got the result within the hour) which resulted to confirmed clinical vaccination failure (dose number in series 2). Patient had quite the fever (lasted 4 days before it broke), had no thermometer, didn't know temperature. He felt his head was full, but there was no congestion. About a week later, he developed a cough and it lasted a month. He took 5 days off of work. He didn't see a doctor when he got covid, so his doctor was not aware. On 02-JAN-2022, Laboratory data included: COVID-19 rapid POC test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000242713 and 90000242714. This case, involving the same patient is linked to 20220737591 (dose number in series 1).; Sender's Comments: V0-20220735184-covid-19 vaccine ad26.cov2.s-Confirmed Clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
rash on arm a day after 2md shot. 2 days after rash is continuing to spread over arms and chest.
Swelling, redness and induration distal to vaccination site with severe pain about 12 hrs after injection. Next day redness increased in size with fever 101.3 degrees F, needed TYLENOL/MOTRIN and steroid cream.
Awoke with severe vertigo, nausea, vomiting on Sunday morning. Went to MD on Wednesday. Given instructions on maneuver to recalibrate equilibrium + Rx for meclazine
irritability, fussiness, looked glassy-eyes for 6wk;no high fever or prolonged episodes (i.e. >3hr) of screaming;no tx given;
I've had shingles around the back of my neck  for three days so far, diagnosed by by Primary care. Treatment: Prescriptions  for Valcyclovir and Gabapentin. As this came out of nowhere just two weeks after my first Covid shot andI have seen reports of a few  similar cases around the world, I thought  that CDCshould at least have this information as a possible side effect , worth some later research.
(R) leg received VZV SC. Pt. parents present nickel sized red raised area over injection site with 3 small vesicles appearing to be chicken pox.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:43 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown whether patient was ever diagnosed with COVID-19.  The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been.  The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator.  The vials were returned to the freezer/refrigerator, or maintained at room temperature.   The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.  No vaccine state changes were noticed. The vaccine was never refrozen.  None of the vials were punctured. No Previous temperature excursions was reported.  No treatment medications were provided.
Debilitating lethargy and body aches for 72 hours. Severe arm pain at sight and down arm for 48-72 hours. Moderate dizziness for 72 hours
Patient's mother states child had a fever on the night of 05/01/2019. Patient states that on 05/02/2019 child has redness and swelling on right arm. Redness and swelling starts at injection site and ends halfway between the injection site and elbow. Right arm is also warm to touch and child states that it hurts. Mother states she administered Tylenol.
About 4 days after the second dose my lymph nodes near the injection site started to hurt. Over the next few days the pain got worse so that I couldn't lie on that side of my body. The symptoms progressed towards my shoulder and neck and other lymph nodes became painful. The next phase a few days later was red spots and blisters around the injection site on my chest near my neck on my left side. At the present time the blisters have mostly gone away but they've been replaced by welts where the red spots were these are swollen and red. All of these symptoms are accompanied by fatigue and muscle pain also around my left shoulder. I have been treating it for the past 3 days with ice and am now taking an antihistamine Benadryl.
4 days to get her energy back; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (4 days to get her energy back) and MYALGIA (Body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Asthma and Chronic bronchitis (She usually took a medication for Bronchitis, 6 doses.). Concomitant products included CETIRIZINE for Allergy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ASTHENIA (4 days to get her energy back) and MYALGIA (Body aches). The patient was treated with POTASSIUM CHLORIDE (POTASSIUM [POTASSIUM CHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 22-Feb-2021, ASTHENIA (4 days to get her energy back) had resolved. At the time of the report, MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient drank too much water with potassium and electrolytes and felt better.   This case was linked to MOD-2021-392451, MOD-2021-392574 (Patient Link).
The pharmacist gave me the vaccine very high up into my shoulder(bone), and I was bleeding, she pulled the needle out and poked me again near the same site. The vaccine is deposited in the wrong spot( according to doctors), and since that time I am in severe pain and discomfort- I am not sleeping all nights, I have multiple problems due to this vaccine injury. I am not the doctor and cannot explain, but I've seen my doctor multiple times, two specialist.
Left arm was red and swollen and a rash was present. Patient indicated that pain and swelling continued down the arm since 10/1/2018. She also had diarrhea on 10/3/2018. All of arm was tender. RPh advised for pt to see Dr to evaluate.
12 year old patient was given the pediatric (10MCG/0.2ml) Pfizer vaccine instead of the adult Pfizer covid vaccination.
Pt recvd 2nd dose of vax & exp pain @ the inject site; & 10 mins following vax exp lightheadedness, palpitations, diaphoresis, dyspnea;
1 dose of pediatric Engerix-; Inappropriate Dose Administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 25-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 1 dose of pediatric Engerix-) and adult use of a child product (Verbatim: Inappropriate Dose Administered). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 Health care professional (HCP) did not have any details regarding administration date or patient demographics for adverse event.  No additional data available. Licensed practice nurse (LPN) reported the administration of 1 dose pediatric Engerix-B to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up.
a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (a little bit of an issue, we should be able to look up to see if it's a monovalent or bivalent/ This will help us to determine whether a patient is due for further vaccination or not).    No concomitant medications details were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP was calling from a hospital who wanted to confirm whether a lot number was bivalent or monovalent. Caller declined providing contact info and stated she was on a hurry. It was reported that, it was assume to be bivalent vaccine.   No treatment medications details were reported.   Reporter did not allow further contact
Within 5 minutes after receiving his vaccinations the infant began having hives, got lethargic, not responding to normal stimuli, respirations shallow at 26, rash on face and body. The doctor was notified. Benadryl IM was administered. The infant was monitored for 5 minutes the injection rash disappeared. The baby then became responsive, respirations increased to 42, HR at 128. The baby was released home after monitoring for 30 minutes.
Student scheduled for second dose Pfizer vaccine and received Moderna vaccine instead of Pfizer vaccine.
A week later the site turned bright red, warm to the touch and itchy.  This then extended through most of my upper arm and traveled to my inner arm.  At this point 1/26 site is painful and red with some itchiness.
Vaccine stored in refrigerator on 09/21//2021, expired product 10/09/2021, administered date on 10/19/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 09/21//2021, expired product 10/09/2021, administered date on 10/19/2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 09/21//2021, expired product 10/09/2021, administered date on 10/19/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 09/21//2021, expired product 10/09/2021, administered date on 10/19/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. The date of placed in refrigerator was on 21-Sep-2021 and vaccine did not undergone any temperature excursion. No other adverse events were reported for patient. No Treatment information was reported.
Moderna COVID-19 Vaccine EUA I received the first dose of my vaccine at about 8:30am on January 12. Around 6pm on January 12 I started to experience chills. As the night went on the chills got worse and I developed a terrible throbbing headache. In addition to that I was feeling hot and sweating profusely. I fell asleep around 10pm and woke up around 11pm, at this time the headache was worse, the chills were getting better, and I was still hot and drenched in sweat. I was able to fall back to sleep shortly after. I then woke up at 1am on the 13th, I still had a headache, the chills were gone, I was still hot and sweaty. At this time I also started vomiting. I preceded to vomit until there was nothing left in me and went back to bed. I woke up at 3am and proceeded to dry heave as there was nothing left to come up. My headache was extremely bad at this point and I was still hot and sweaty. I could not keep down Tylenol so I used a cold wet rag to help with the headache. I was finally able to sleep again. I woke up at 5am still with a headache and still hot at this time I was able to take my temperature and it was 99.8. I fell asleep again and woke up at 9am with a temperature of 100.1, at this time I was able to take Tylenol and keep it down which broke my fever and alleviated the headache. Now at about 1pm on the 13th I am still only able to sip liquids and my stomach is upset. This was the sickest I have been in a long time. I have spoken on the phone with a triage nurse at my doctors office and I am waiting for her to consult with a doctor and call me back.
10pm that  the same night  following the vaccination I had a fever -48 hours and you took Tylenol. Extreme body ache Rashes appeared a week and half after the vaccination-Rashes on my arm and legs.- lasted for 2 and a half months Increased heart rate - still experiencing this. I have a monitor is attached to my skin to monitor my heart rate  from the 12/06/2021 to 20th. Resting Heart rate- 98-134
3-4 day after severe headache, facial pain, and nausea along with stiff neck began and has lasted over a month now. The first two days after the vaccine I was fine but then side effects appeared.
Slight dizziness, forgetfulness, increased sinus discharge, headache, memory lapse
The night of my flu vaccine I got a terrible metallic taste in my mouth.  The following night I got a severe headache (so bad that it brought me to tears) and just felt awful.  I felt weak. I don't know any of the information about flu vaccine. I was vaccinated at work.
tested positive for Covid/lost his sense of taste and sense of smell/really tired/lost appetite/upset stomach/body aches/had a low grade fever; This is a spontaneous report from a contactable consumer via a Pfizer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 03Mar2021 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included hypertension from an unknown date diagnosed ten years ago. The patient's concomitant medications were not reported. On 06Mar2021, patient tested positive for COVID and experienced symptoms reported as lost his sense of taste and sense of smell, was really tired, lost appetite, upset stomach, body aches and had a low grade fever. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Mar2021. Outcome of event was not recovered.   Information about the Lot/batch number has been requested.
Information has been received from a medical assistant concerning a 21 year old female patient with no known drug reactions/allergies or pertinent medical history who on 25-FEB-2009 was vaccinated with the first dose of GARDASIL. On 05-OCT-2009 the patient was vaccinated with the third dose of GARDASIL. The medical assistant reported that as soon as the third dose of GARDASIL was administered the patient experienced injection arm numbness. The injection arm numbness resolved before the patient left the office. It was reported that later the same date, on 05-OCT-2009, the patient called back to the office to report that her finger tips were numb. No lab tests were performed. On an unknown date, the patient recovered. Additional information has been requested.
Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009c21a and 46017821A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) had resolved.            Concomitant medication include blood thinner and blood pressure medications. No treatment medication was provided.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19 Jul 2021 contains no significant information
31 -year-old male who had both Vaccines. His first Vx was 7 Feb 2021; to this he did not have an adverse reaction. He had his second vaccine on 03/07/2021 (10:30am),  and  began to have symptoms approximately 1 hour later. His symptoms  lasted 3 days,  and  consisted of fever for  up to 102, body aches. He also had nausea and vomiting (no blood, 15 times) this lasted FOR 20 hours, diarrhea -watery  (no blood; unsure how many times) which lasted about 20 hours as well. All symptoms have resolved.
I didn't see the doctor until later. I had diffuse joint pain all over. It wasn't horrible and I tried to ignore. It was a 4-6/10 on the pain scale. I   ended up seeing my doctor 6 months later because the pain was still present. I asked her if I would have this pain the rest of my life and she recommended celebrex. I took it and got sick so I hat to stop. However, the next day the pain was completely gone.
ACHY; CHILLS; FLU LIKE FEVERISH; MILD/SEVERE HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was in excellent health, exercises and eats vegetables.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, treatment medications included: acetylsalicylic acid, and naproxen sodium. On 05-MAY-2021, the subject experienced sore arm. On 05-MAY-2021, the subject experienced mild/severe headache. On 23-JUN-2021, the subject experienced achy. On 23-JUN-2021, the subject experienced chills. On 23-JUN-2021, the subject experienced flu like feverish. On 27-JUN-2021, Laboratory data included: Lab test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, chills, and flu like feverish, and sore arm on 12-MAY-2021, and had not recovered from mild/severe headache. This report was non-serious.
Red, swollen, warm, itchy, firm to touch left arm from top of arm at shoulder down approximately 12 cm total length x8 cm width.
second jandj vaccine on 12-17, that evening face and chest were red.  On 12-18 in the afternoon tongue started swelling, no problem swallowing or breathing. Says does have difficulty swallowing when mask in place. No chest pain or dysnpna , no nausea or vomiting or diarrhea. No rash but feels her tongue is swollen. Allergy to latex but denies exposure.  No history of anaphylaxis or adrenaline use. Patient took 25mg benadryl 1 hour prior to arrival in ED.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 12-MAY-2015, the patient was vaccinated with improperly stored PROQUAD lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.