chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; SMALL SCAB ON HER LEFT ARM WHERE SHE HAD RECEIVED THE  SHOT; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient had no known drug allergies, had no known medical conditions, and no medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: unknown) dose was not reported, dose number in series was 1, 01 total was administered on 10-SEP-2021 in her left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient contracted Corona virus disease (COVID-19) (suspected covid-19 infection) despite being vaccinated with the Janssen COVID-19 vaccine. On 23-DEC-2021, she stated she was tested at her work place COVID-19 virus test (two days before Christmas with a pool test) which was unknown, and hence resulting in suspected clinical vaccination failure (dose number in series was 1). She did not know if it was polymerase chain reaction (PCR) or rapid antigen but did state that the results did take a day or two from the hospital where she worked at and she was informed on Christmas day. She stated that her symptoms after contracting COVID were mild which included allergy like symptoms including nasal congestion and cold like symptoms. She also noted that she had a small scab on her left arm where she had received the shot. She stated all symptoms had gone away.  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from suspected clinical vaccination failure, suspected covid-19 infection, and small scab on her left arm where she had received the shot. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority. The suspected regulatory authority has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on RA evaluation/investigation performed. This case, from the same reporter is linked to 20220124168.; Sender's Comments: V0: 20220124447-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. 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
After receiving the third booster vaccine in December last year, I went to the urgent room with bell palsy the next day and then developed some symptoms in the next two weeks, such as a sudden drop in blood pressure, rapid heartbeat, and nerves twitches  in the back of ear . It has been more than seven months so far, and not fully recovered, especially the eyes are prone to tears, and the back of the head sometimes twitches nerves, I am  very worried that it will become permanent.
Initial report received on 23 February 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3635AA received on 24 August 2010, lot number C3664AA received on 11 October 2010 and lot number C3732AA received on 13 December 2010 (routes and sites of administration not reported). On 08 December 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 21 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 01 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 55 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL (this patient was due for a booster dose). Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 51 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 February 2012. These 51 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
VACCINE WAS GIVEN 22 DAYS(10/26/22)  AFTER USE BY DATE(10/4/22)
Initial unsolicited report received from a physician on 10-May-2018. This case involves a female patient of unknown age who was vaccinated with 0.5 ml of PENTACEL, frequency once (Batch number, expiry date, dose in series, route and site of administration were not reported) on an unknown date at 3 pm. Patient's medical history and concomitant medications were not reported. It was reported that child is not allergic to milk and has not seen the allergist at this time. On an unknown date, following the vaccination, patient experienced constipation related to a case amino acids sensitivity, few hours following the vaccination (reported as that night during the night) patient experienced 6 bouts of diarrhea with mucus and blood. It was also reported that child had primary constipation issue and is on ALLIMENTUM. Patient's mother became aware case amino acids are used in the Dtap portion of the PENTACEL. Physician will likely send this child to an allergist for further evaluation before giving vaccines. Lab data and corrective treatment were not reported. On an unknown date, (reported as by the next AM) patient recovered from the event diarrhoea and outcome of the event constipation was unknown. List of documents held by sender: none.
Severe body aches 24 hours after the vaccine was administered.  These aches lasted throughout the day.  I took three doses of 800mg Ibuprofen and tow doses of 1000mg Tylenol to get through the day.  They were gone by the next morning (48 hours after administration) and no additional pain medicine was needed.
A few weeks post booster I began experiencing extreme bodily itching. Sometimes with accompanying raised areas, sometimes with small bumps, sometimes no bumps or raised areas. It is in a different area every time and has occurred on the top and side of my feet, legs, inner thigh, crooks of my arms, shoulder, stomach, chest, front of neck, back of neck up into hair, sides of face, sides of back, lower back, middle of back, and upper back (all separate times). I have tried using heavy lotion in the event that it's dry skin, calamine lotion, hydrocortisone, Benadryl, Zyrtec, changing/washing clothing items. No new shampoos, detergents, or foods. Itching usually is strongest in the afternoon and around 7-9pm.
Information has been received from a physician concerning a 15 year old female who on 15-JUN-2007 was vaccinated with the first dose of GARDASIL IM in the right upper arm. At that time, she also received MENACTRA in the left upper arm. Subsequently the patient developed red, itchy blisters around injection site of the right upper arm one day after GARDASIL administration. The rash spread to the patient's abdomen and lower back. The patient called the office but no therapy was required. The patient fully recovered. The physician discontinued the remaining GARDASIL. Additional information has been requested. Information has been received from a physician and a medical assistant concerning a 15 year old female with no pertinent medical history and no prior history of drug reactions who, on 15-JUN-2007, was vaccinated with the first dose of GARDASIL (Lot #657006/0188U) intramuscularly (IM) in the right upper arm. At that time, she also received MENACTRA in the left upper arm. On the morning of 14-JUN-2007 (also reported as "the morning after she received the GARDASIL injection"), a rash erupted. The rash was described as "like poison ivy" and began at the right arm injection site, then the other arm and lower body/abdomen. The rash was itchy and lasted several days (5-7 days). On approximately 21-JUN-2007, the patient recovered from the rash. The physician discontinued the remaining GARDASIL. Additional information is not expected.
Severe pain, redness and swelling of my upper arm that spread through out the night down my arm, into my hand, up into my left shoulder, neck and into my face.  I took 3 Benadryl and ibuprofen.  My doctor told me to stay home, not be alone, use my Epi-Pen if needed and to continue monitoring the situation.  Even today, Sunday, my upper left arm is still tender to the touch.
Pt 8/16/05 mother informed MD that pt with max temp 100.4 on and off day received vaccine on 7/8/05 but day 1 inconsolable with minimal appetite. After falling asleep that evening mother heard pt crying, mother stated pt pale (white), cold to touch (97.7R) and not moving as vigorously as normally does when crying. Pt picked up and did turn to normal color  and temp. Eval t.c: Pt in NAD since.
Rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in an unspecified number of adult patients 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 rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but captured as adult as per vaccine indication. The reporter briefly mentioned that, he had seen rash with other patients whom he had vaccinated Shingrix in the past.  No further details were provided. This case has been linked with the case US2019112256, reported by the same reporter.
Patient reporting:  left arm painful weakness numbness he can hardly lift with it.  This started the same day of 1st covid shot.   Symptom duration: 10 days Patient calling for Acute COVID-19 Vaccine Reaction.  Symptoms started 10 days ago.  Symptoms include: Constant Mild and Moderate numbness and tingling with pain at injection site of COVID 10 days ago. States that arm feels heavy.  Patient Has not attempted treatment at home.  Pertinent negatives include: Afebrile. No breathing difficulty. No rash.  from PCP notes: (09.29.21)  Patient ID: Patient is a 53 y.o. female Chief Complaint: Arm Pain HPI:  Left arm pain after getting covid vaccine. Having weakness and dropping things, dropped her coffee two days in a row and could not actually feel the heat on her skin. Understandably, she is scared to go back and get her second dose.  No fevers or chills after the vaccine.  No redness, tingling. No headaches, vision change. Assessment / Plan: 1. Left arm numbness - EMG   - I would be surprised if this was an adverse effect from the COVID vaccination given the widespread area of symptoms and the relatively shallow injection.  On chart review, and discussion with the patient, we realized that she did have some left upper extremity paresthesias last year as well though she does not remember details of this.  This is documented in her active problem list as arm paresthesia, left and arm swelling from 1-4 years ago. - proceed with an electromyogram and consider an MRI in the future
4 days following her second COVID vaccine (4/30/21) reported headache and her coworker felt she had slurred speech. She had an episode of vomiting and chills. Noted double vision the day after she was vaccinated, but that resolved prior to her headache 4/30/21. She later reported that following her first vaccine she had a headache, vertigo, and double vision. Negative lab and imaging work up. Was treated with Toradol, droperidol, Tylenol, and meclizine. Headache significantly improved after treatment. She was discharged to home.
A non-serious spontaneous report of administration of FLUMIST to a 19 month old was received from a health professional concerning a 19-month male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 26-Jan-2012, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 11-Apr-2012 and incorporated into the narrative. No late occurring adverse event.
stiffness in her left shoulder and Feels stiffness on her left side of neck; Pain and stiffness in her left shoulder; Could not sleep on her left side position; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in her left shoulder and Feels stiffness on her left side of neck), INSOMNIA (Could not sleep on her left side position) and ARTHRALGIA (Pain and stiffness in her left shoulder) 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.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced INSOMNIA (Could not sleep on her left side position). On 24-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in her left shoulder and Feels stiffness on her left side of neck) and ARTHRALGIA (Pain and stiffness in her left shoulder). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in her left shoulder and Feels stiffness on her left side of neck), INSOMNIA (Could not sleep on her left side position) and ARTHRALGIA (Pain and stiffness in her left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug reported were blood pressure pill and stomach pill. Treatment for the event was not reported.
Case number PHEH2014US018209 is an initial spontaneous report received from a nurse on 09 Sep 2014. This report refers to a 62 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml 09 Sep 2014. It was reported that FLUVIRIN reached a temperature of 50 degree F (10 degree C) for 30 minutes. No adverse events after the maladministration.
new onset systemic lupus erythematosus; This is a literature report.  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (unknown manufacturer)), for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "new onset systemic lupus erythematosus".; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Allergic reaction, urticaria - Prednisone burst X 5 days - ZYRTEC 10mg QD x 30 days
Patient had fever, headache, swollen arm.  Was taken to the hospital and treated for 12 hours.
Vaccinated 1/25/2021 and 2/8/2021.  Diagnosed with Multiple Sclerosis on August 16, 2021.  Never before had experienced symptoms or a relapse.  First-time event.  Spent one week in the hospital when my entire body went numb, weak (predominantly on left), my speech and hearing was impaired.
5 hours after doc appt, had 103 fever, chills, headache, sore throat, wheezing, fever increased to 104 by morning; once at urgent clinic, started passing out after they gave steroid injection
Gum bleeding and thrombocytopenia (platelets 41k) found on lab drawn one week after first dose of vaccine.
Narrative:  Other Relevant Hx: Symptoms: Diarrhea Treatment:
Cellulitis at injection site, confirmed by PCP and given antibiotics for treatment. Pain, swelling, redness, fever, malaise.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Patient was found at 6 AM on 01/21/2021 - he passed away during his sleep
sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EN6204) at the age of 48 years as dose 2, single and administered in arm left (Lot number: EN6198, Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Hepatitis d vaccine. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (Mar2021), described as "sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The caller is a pharmacist who received the first and second dose Pfizer Covid Vaccine and finished second dose Pfizer Covid Vaccine in Mar2021. The caller had a sore arm after receiving both the first and second dose Pfizer Covid Vaccine, but really nothing. The caller states the sore arm was gone in less than a week after receiving first and second dose Pfizer Covid Vaccine. The caller did not feel the administration of the first and second dose Pfizer Covid Vaccine, but knew it was done because the caller later had sore arm. The caller got a sore arm but the arm soreness was just around deltoid area in upper arm. The caller has seen the doctor once because the caller had shingles at the beginning of the year. Caller clarifies she had shingles prior to receiving any dose of the Pfizer Covid Vaccine. Received the first dose Pfizer Covid Vaccine in the left arm and the arm soreness began the same day the first dose was received. Unknown date received first dose Pfizer Covid Vaccine, caller does not have date to provide. Second dose: had a sore arm: The sore arm began the same day received second dose, 18Mar2021. First dose: Unknown, caller states the date received is not on the vaccine card and caller does not recall the date first dose Pfizer Covid Vaccine was received. The caller stated the hand writing on the vaccine card is hard to read. Caller stated it was the worse soreness ever gotten and caller received the Hepatitis D Vaccine and the Hepatitis D Vaccine was so bad. The caller had to get up in the middle of the night and take Ibuprofen for the arm soreness the caller had after first and second dose Pfizer Covid Vaccine. Caller did not have NDC/lot/expiration date for the Hepatitis D Vaccine.   Follow-up attempts are completed. No further information is expected.
Fever 100.7, chills, fatigue, sore throat onset 2 days after 1st dose
This spontaneous report was received from a licensed vocational nurse and refers to four patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# L021214, expiration date 10-JUN-2017, anatomical location was not reported) 0.5 ml, subcutaneously. No adverse events were reported. Additional information has been requested.
Covid diagnosed by home antigen test after symptoms of headache, sore throat, hoarse voice, and cough. Called physician office and had virtual visit after which she prescribed Paxlovid at a reduced dose. Paxlovid, reduced dose, begun on Friday 7/15 with symptom improvement that day.
This spontaneous report as received from a medical assistant refers to a 26 year old patient. On 08-SEP-2014 the patient was vaccinated with third dose of GARDASIL (dose and route of administration were not reported). Reporter stated that patient received first and second dose on unspecified dates in 2009. No adverse effect reported. Additional information has been requested.
Tigthness in chest, burning inside body, headache & dizziness, sweaty.
pt recv vax & 48 hr later, pt exp abd cramps & devel diarrhea, edema of the face & hands & itching of eyes & face; pt did not see a MD or take any medication for sx;
Around 6pm I noticed a rash surrounding the area where the bandaid was. I initially thought it was due to the adhesive. The next day I had hives all over my back that persisted for 48 hours even with Benadryl.
Ended up in the ER 8 days after the first shot with dizziness, imbalance and vertigo-like symptoms.  Got a shot, several medications and sent home, I told the ER PA that I had my first vaccine 7 days ago but she figured my symptoms were strictly vertigo which I have never had.  After doing some research I'm finding others via the internet with the same symptoms after their shots, with sustained or prolonged side effects.  Currently headaches, imbalance, trouble focusing or brain fog.
chills: began around 7:00 PM, no treatment, resolved overnight fever: began around 8:00 PM, reached 102.7, took tylenol, resolved overnight
Pt first experienced dizziness, where the whole room was spinning, nausea, extremely heavy headache, pt was very weak, vomiting, couldn't eat - pt is sitting up for the first time today (11/21) and the dizziness is improving.
Fever within 12 hours after receiving vaccination (99.9), achiness, fatigue, joint and muscle pain.