chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had site reaction on 9/27/15. She received the Flu shot on 9/25/15 at about 12.30pm. Her site was swollen and red. Went away in a few days.
Sinus infection; This is a spontaneous report from a contactable consumer (Patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Jan2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced sinus infection. The patient was scheduled for her second dose 15Mar2021. The patient would like to verify her second dose schedule for tomorrow because patient was wondering why she received 2 emails for the confirmation of her appointment (first email is second dose appointment for Moderna) and (second email is second dose appointment for Pfizer). after the 1st dose and took 10 days antibiotics. Therapeutic measures were taken as a result of sinus infection. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates in 2016 (reported as "since 19-AUG-2016"), the patients received improperly stored doses of PROQUAD (lot # M006105 with expiration date 01-AUG-2017, therapy type rHA; lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; lot # M012987, expiration date 12-SEP-2017, therapy type HSA; lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; lot # M021427 with expiration date 29-OCT-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of two reports received from the same reporter. Telephone attempt on 19-DEC-2016 to obtain follow-up information had been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA011133: MERCK 1610USA011245:Mfr number.
Fatigue; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills) and FATIGUE (Tired) 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 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and FATIGUE (Tired). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.   Action taken with mRNA-1273 in response to the events was not Applicable.
Approx 20 mins after 1st set vaccines in car seat outside office with aunt- crying, quiet then face blue/no vomiting/no car. Position for picks  up - color pink - with cry, increase temp, resp response with cyanotic spells. Questionable vac rx- cyanosis.3/3/06 Received medical records from PCP which revealed patient experienced apnea, fussiness, pallor & cyanosis. 3/7/06 Received Discharge Summary which revealed patient experienced apnea, viral URI & was mottled in ER w/abdominal pain.  Admitted overnight for observation.  H&P: abnormal placenta w/thrombotic infarct.  Patient was SGA & had hyperbilirubinemia at birth.
On 12/21/2021, I displayed symptoms of COVID-19; I tested positive on a PCR test
Extensive erythema & pruritus area injection sites on both arms. Left arm 16.5 cm x 16 cm engulfing the arm laterally, anteriorly & posteriorly (R) arm 7.5 cm x 9 cm. Erythema was poorly circumscribed & faint. No tenderness.
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 68 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 1/19/21 .   Tested positive on 3/28/21.   NOT hospitalized. No symptoms reported, tested due to encounter with someone confirmed/suspected to have COVID-19 Exposure from husband.
Pain on the right side of neck; Pain on the right shoulder; Radiating pain; This is a spontaneous report received from a contactable consumer. A 42 years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 17Mar2021, at 10:00 (at the age of 42 years old), as a single dose, for COVID-19 immunisation. Medical history included crohns disease. The patient received Lomotil (MANUFACTURER UNKNOWN), Infliximab (MANUFACTURER UNKNOWN) medication within two weeks of vaccination. The patient did not have symptoms associated with COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19.  The patient had a nasal swab PCR test on 26Feb2021, 27Feb2021 and 03Mar2021 which resulted negative. On 18Mar2021, at 09:00 (day after the injection in left arm), the patient started feeling pain on the right side of neck and shoulder. Patient thought he slept wrong side but whenever that happened the pain would go away within a day. This has not resolved this time. The patient has a radiating pain (about a 5 with spikes to 8 if he moves it wrong) about mid neck down through shoulder and partially down back over his right shoulder blade. The level of pain had been fluctuating. Sometimes it was a dull pain and other times was extremely sharp pain in neck and shoulder. It has not gotten even a little better since it started two days ago. Patient was not sure if it was related to the vaccine. As a therapeutic measure patient had been self-medicating with heating pad with temporary relief and also received Advil (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of event pain on right side of neck, pain on right shoulder and radiating pain were not recovered.   No follow-up attempts are needed. No further information is expected.
Developed SOB, chills, fever 102.0, cough and posterior back pain with symptoms improving on 12/20/2020 in the PM. He did not seek care or report issue until now. States he feels fine now.
It was reported that an 11 month old male pt received his third dose of Hib vaccine on an unspecified date. Six days after receiving the third dose, the pt presented to the hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute. The temperature was 39.7 deg C and the oxygen saturation was 73% while breathing room air. Chest auscultation revealed wheezing, and retractions were apparent. Bilateral conjunctival injection was present. A chest radiography demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiraotry syncytial virus antigen by direct fluorescent antibody. The child was admitted and empirically treated with ceftriaxone and axithromycin. The following day, hib, susceptible to ampicillin, was isolated from the blood. CSF obtained on the third hospital day was normal. The pt received a ten day course of ceftriaxone and recovered without sequelae. He had received an Hib conjugate vaccine at approximately three and five months of age. The pt resided in an apartment with his mother and a four year old brother, who was attending a day care center at that time. No other info was provided at this time. The reporter of this case is the same as for case 2003-03330.
LEFT ARM VERY SORE, LEFT ARM WEAK, LEFT ARM PAIN WHEN I LIFT ARM, OR MOVE IN ANY MOTION, I HAVE PAIN CONTINUOUSLY, EVERY DAY, EXTREME WEAKNESS WITH ANY ARM MOVEMENT. My left arm continuous pain lack of movement since my Second Moderna Vac shot. I have enclosed my Moderna vaccine records , #1 then #2 then booster.
Received only the adjuvant; Received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number fb2bh, expiry date 26th January 2024) for prophylaxis.   On 3rd January 2023, the patient received Shingrix. On 3rd January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The pharmacist reported that the patient received only the adjuvant portion of Shingrix one day before reporting (no reconstitution).  The patient had no side effects and physician had been contacted. The registered pharmacist (RPh) declined to provide patient initials and date of birth (DOB) stating she did not thought that they were allowed to share. The reporter consented to follow up.  Additional Supportive Information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
received her first dose of BNT162B2 on 17Dec2020 for COVID-19 immunization. She received the second dose on 12Jan2021 (26 days after first dose); she got her period again today; this was the 3rd time since the first dose.; This is a spontaneous report from a  contactable consumer.  A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received her first dose of BNT162B2 on 17Dec2020 for COVID-19 immunization. She received the second dose on 12Jan2021 (26 days after first dose). It was reported that she got her period again today; this was the 3rd time since the first dose. Outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
13MAY92 pt was very weak, joints hurting, could hardly walk- couldn't lift head very well; 14MAY could hardly move wrist; both arms hurt; 14MAY to MD felt reactin from vax;
old vial that was stored at room temp was used for an injection; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (old vial that was stored at room temp was used for an injection) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (old vial that was stored at room temp was used for an injection). At the time of the report, EXPIRED PRODUCT ADMINISTERED (old vial that was stored at room temp was used for an injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.   Reporter did not allow further contact
Nausea, Malaise, diarrhea(flu symptoms) for 8 days following vaccination.
Booster. Left armpit swollen, warm and moderately painful. About 3 inches, or entire area of pit. Noticed upon waking in the morning.
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 72-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 23-Nov-2021 at 3:26 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 3:26 PM, 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 was provided by the reporter.  No treatment medications was provided by the reporter.  Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Information has been received from a health professional concerning a 7 year old male with no known medical history or allergies who on 2/16/1999 was vaccianted with a dose of varicella virus vaccine live (lot 628527/1834H). On 5/28/2005 the patient developed a mild case of chickenpox breakthrough. Unspecified medical attention was sought. There was no treatment. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
The site was swollen; Strictly an unusual injection site reaction-severe itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:15 as dose 5 (booster), single (Lot number: b1h9693) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "pre-diabetic" (unspecified if ongoing); "known allergies: all sulfa drugs" (unspecified if ongoing), notes: known allergies: all sulfa drugs. Concomitant medication(s) included: OXYBUTYNIN; LOSARTAN; OMEPRAZOLE; AREDS 2 VISUAL ADVANTAGE. Past drug history included: Hydrochlorothiazide, reaction(s): "known allergies:hydrochlorothiazide", notes: known allergies:hydrochlorothiazide. Vaccination history included: Covid-19 vaccine (Dose 1 Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 Manufacturer: Unknown), for COVID-19 Immunization; Flu shot (I am very glad I waited about 10 days to get my flu shot afterwards-and I got that in the right arm), for Immunization. The following information was reported: INJECTION SITE PRURITUS (non-serious) with onset 22Sep2022, outcome "recovered" (Sep2022), described as "Strictly an unusual injection site reaction-severe itching"; INJECTION SITE SWELLING (non-serious) with onset 22Sep2022 at 14:15, outcome "recovered" (Sep2022), described as "The site was swollen". Therapeutic measures were not taken as a result of injection site swelling. Therapeutic measures were taken as a result of injection site pruritus.  Additional information: Patient reported that strictly an unusual injection site reaction-severe itching starting a few hours after the shot and lasting 5-7 days. So bad she put Hydrocortisone cream on it so she could sleep, the first night. After that she just kept taking Acetaminophen and/or Ibuprofen the next few days to take the edge off. she was afraid that the Hydrocortisone might interact with the shot so she only tried that the first night. The sight was swollen but flattened out and returned to normal by the 7th day. The previous 4 doses did not bother me at all, so she was surprized by this experience. she was very glad she waited about 10 days to get her flu shot afterwards-and she got that in the right arm just in case. Patient received Other medications in two weeks Oxybutynin, Losartan, Omeprazole, Areds2, Multivitamin
Hives/rash from waist to ankles. BENADRYL. Symptoms began 3 days after shot. May not be connected to shot.
Severe headache started at 10:00 PM on 11/15/2013 and lasted until 12:00 PM on 11/17/2013. Nausea started at 9:00 AM on 11/16/2013 and lasted until 8:00 PM on 11/16/2013. Projectile vomiting started at 1:00 PM on 11/16/2013 and lasted until 6:00 PM on 11/16/2013.  Emesis episodes were preceded by flushed skin and diaphoresis.  Emesis episodes were followed by chills and feelings of exhaustion. Treatment:  ice packs applied to head, neck, shoulders; Advil; sips of clear liquids; small bites of fresh apple; rinsing mouth out with water and Peroxyl mouthwash after each emesis episode; thoroughly cleaning bathroom after each emesis episode; resting in bed between each emesis episode; changing all hand towels used in between each emesis episode; laundering all towels in bleach wash; gentle walk outside in fresh air/sunshine on 11/17/2013 in afternoon; opening doors/windows on 11/17/2013 to let in fresh air/sunshine.
Swelling under arm and on my side 24 hours after the injection. Not at injection site, but under the arm and in the armpit; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021, at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021, at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, 24 hours after the injection, the patient experienced swelling under arm and on her side and not at injection site, but under the arm and in the armpit, with no fever. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 24 hours after the injection, the patient experienced swelling under arm on side and not at injection site, but under the arm and in the armpit was resolved on 27Apr2021, which was lasted for 4days.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This report was received from the investigator in a trial on 07 June 2010. A 28 year-old female subject with a medical history of dizziness or fainting spells and numbness or paralysis received ACAM2000 (lot number not reported) on 12 January 2010. Fourteen days after vaccination, the subject was diagnosed with acute pericarditis,unspecified. On Day 14 (26 January 2010), the subject had an abnormal electrocardiogram, and a normal Troponin I and echocardiogram. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Hives. Started gradually and spread over entire body getting worse each day. Dermotologist put me on steroids and Benadryl today
Patient stated about 30 minutes after receiving vaccine her face became very flushed (red) and puffy. She also said her skin was very dry. Symptoms lasted 2 days, but then cleared with no other problems.
Initial misuse reprot received from a health care professional on 07 January 2014. A child of unspecified age had received 4th dose of DAPTACEL 23 days before the dose was due. The patient did not experience any adverse event. Documents held by sender: none
June 13th - developed sore throat, felt like a cold was starting. Test negative on Home Testing kit. June 14th - sore throat, tired, didn't feel good, cough Tested negative on home testing kit. June 15th - sore throat, tired, cough with phlegm, headache. Didn't test June 16th - woke up with sinus headache, felt like a sinus infection was starting, drainage, coughing with blood and phlegm. I made an appointment for urgent care but decided to test to make sure it wasn't covid. I tested positive. Called doctor's office. Taking ibuprofen, and Mucinex. Drank water and sports drink. June 17th - internet appointment with Dr office. Prescribed Paxlovid and Benzonatate. Took ibuprofen, Dayquil and NightQuil, Afrin, used humidifier.  June 21st - tested negative
This is a spontaneous report from a contactable nurse. A patient (age and gender unspecified) received a dose of PREVNAR 13 on an unspecified date. On an unspecified date, the patient developed a rash. The outcome was unknown. Follow-up (04AUG2011): Follow-up attempts completed. No further information expected.
Generally feeling unwell and fatigued for a week or so after the vaccine. 5 days after vaccine developed significant redness and swelling around eyes. Took prednisone and Allegra starting on day 6 post vaccine. Took 3-4 days of treatment to fully resolve.
Onset of symptoms 3/4/2021. Raised, red, and itchy bumps on hands and elbows. Benadryl taken with symptoms not subsiding. Still present today with no improvement.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-JUN-2016, the patient was treated in Medical Offices for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.