chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received ZOSTAVAX - on 9/17/08 in left upper deltoid. On 12/19/08, pain in left arm, left neck, left cheek occurred. Herpes lesions occurred - left nostril. Dr ordered VALTREX 1 gm TID - 10 days and pain meds.
No adverse effects reported; improperly stored MMR II was administered on 8/15/2019; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 15-AUG-2019, the patient was vaccinated with an improperly stored dose of mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously (lot # R027063, expiry date 20-SEP-2020, albumin status rHa; exact dose and injection site were not provided) for prophylaxis. The vaccine was exposed to a temperature of 70 Fahrenheit degrees (F) for 4 days. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.
17x19cm red, warm over left arm - pruritus. Developed about 5-7 days following immunization
Healthcare provider is reporting administration of vaccines involved in a temperature excursion. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp) PEDVAXHIB W021183 2/22/2025 VAQTA W028554 7/10/2024 Temperatu; No additional AE reported; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W028554, expiration date: 10-JUL-2024; and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W021183, expiration date: 22-FEB-2025, administered for prophylaxis (strength, dose, and route of administration of the vaccines were not provided) (product storage error).  Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit (F) for 23 minutes. The previous temperature excursion was 35.2 F for 9 minutes. There was no adverse event reported.
Left thigh at vaccine site with induration, tenderness, redness, warmth 5x7 cm.
This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 24-year-old male subject had received the following vaccinations: On 24 November 2011, an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number not reported), INFLUENZA, LIVE, INTRANASAL (manufacturer and lot number not reported) and an injection of HEPATITIS A - HEPATITIS B (manufacturer and lot number not reported). The subject's troponin I, ECG, echocardiogram, MRI (brain, spinal cord and heart) and lumbar puncture results were not available. The subject was diagnosed with other, chest pain on 05 December 2009. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspectevaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Case number PH#H2014US003823 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on an undetermined date in NOV 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
anxious, nervousness; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (anxious, nervousness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension (Patient have blood pressure). Concomitant products included FERROUS SULFATE, METFORMIN, FUROSEMIDE, AMLODIPINE, SIMVASTATIN, CARVEDILOL and RIVAROXABAN (XARELTO) for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced NERVOUSNESS (anxious, nervousness). At the time of the report, NERVOUSNESS (anxious, nervousness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No corrective treatment was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Event Outcome updated.
Patient was given fluarix vaccine in the left arm deltoid region on 10/27/21 she comes back on 10/28/21 to say the front part of her arm was swollen and red and warm to touch and she believes she was given the vaccine in that area.
After Receiving the second dose on February 9, 2021 I was very ill.  Chills, fever, tired, achy.  The next day I was great.  Then, 9 days later my left side went numb.  My arm, leg and face went numb. 20 minutes later all feeling did come back.  I went to the Emergency Room and was diagnosed with a TIA.  I had many tests completed.  (MRI, EKG, CT SCAN, Echocardiogram)    The only thing that was found was that I have a PFO in the heart.  I am healthy, I eat great, exercise daily at the gym.  AFter an overnight hospital stay and being put on PLAVAX and aspirin my life has changed forever.  I had a doctor's appointment to discuss the PFO, a meeting with a neurologist and they are not sure why.  The paperwork shares that I had a TIA or a migraine which is not possible because I do know what migraines are like as I had these as a young child. I am now looking into closing the PFO.  I am going to get a second opinion on this based on what happened.
pt recvd vax on 16MAR93 pt seen in ER, then later in office, then admitted to hosp; had high grade fever (102-104.5), irritability, head holding, maculopapular rash face, extremities, & trunk seen & admitted 25MAR93; had LP due to crying;
2/9/04 Pt. received Td in left arm, HAV in right arm. Developed pain in both arms the next day. Pain was worse in right arm. Also developed tingling in right arm. Slight erythema over injection site. Right intense pain on exertion. Rx with ibuprofen. Pain persisted. Seen by neurology 2/20. Bilateral pain radiating from shoulders into arms with some parathesias which were positional and associated with exertion. Rx: Prednisone X 100 days, Tylenol
significant swelling & erythema around inj site;numbness in lt little finger & diff moving;
4/16/2021 9:45pm Severe nose bleed, went to Emergency Room, stopped bleeding, used Afrin to constrict nasal vessels, sent home - 2.5 hrs 4/18/2021 11:45pm Severe nose bleed, went to Hospital Emergency Room, stopped bleeding, used Afrin to constrict nasal vessels, sent home - 3.5 hrs 4/19/2021 8am Severe nose bleed, went to ENT, doctor packed nose for 5 days, sent  home - 2 hrs  **DOCTORS ESTIMATED 2 PINTS OF BLOOD LOSS TOTAL**
Fever, chills and extreme fatigue for 48 hours followed by diarrhea for 24 hours which subsided to headache and fatigue for the past 4 days
Patient received the Fluvirin vaccine in left deltoid and developed redness, swelling at injection site. Warm to touch. Also developed diarrhea.
Information has been received from a 22 year old female health professional who on 25 Jan 2006 was vaccinated with a first dose of Gardasil. The patient reported that within 24 hours of vaccination she experienced a yeast infection. It was reported that the patient sought medical attention for this event. The patient recovered after approximately 2 days. Patient would complete her vaccination series. Additional informatio has been requested.
Severe vomiting for 2 1/2 days, severe chills  and the arm is incredibly sore and swollen 3 days later. This was the booster shot. I had less intense vomiting with the other doses, this was worse for me. I can?t afford insurance so I didn?t go to a doctor
severe edema of lt arm, shoulder to 3" above wrist lt upper arm 7 3/4" rt 6.5"; t99.2 oral,  c/o severe pain red raised area 3.5in x 4; 5" x 2.5" on outer aspect of arm, inject site in ctr of red area;
itching was in the arms, head, legs, everywhere; allergic vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching was in the arms, head, legs, everywhere) and ALLERGY TO VACCINE (allergic vaccine) 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 PRURITUS (itching was in the arms, head, legs, everywhere) and ALLERGY TO VACCINE (allergic vaccine). The patient was treated with HYDROCORTISONE, OXYTETRACYCLINE (HYDROCYCLIN) for Adverse event, at a dose of 25 mg every four hours. At the time of the report, PRURITUS (itching was in the arms, head, legs, everywhere) and ALLERGY TO VACCINE (allergic vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported.   This case was linked to MOD-2021-322809 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of RASH (The caller spoke about a neighbor friend that had a bad rash but was fine a few days later) 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 RASH (The caller spoke about a neighbor friend that had a bad rash but was fine a few days later). At the time of the report, RASH (The caller spoke about a neighbor friend that had a bad rash but was fine a few days later) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.
LEFT ARM UNDERNEATH THE ARMPIT AREA WAS SWOLLEN; LEFT ARMPIT AREA WAS PUFFY, FELT LIKE THE MEDICATION DRAINED INTO THE LYMPH NODES; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-JUN-2021, the subject experienced left arm underneath the armpit area was swollen. On 11-JUN-2021, the subject experienced left armpit area was puffy, felt like the medication drained into the lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm underneath the armpit area was swollen, and left armpit area was puffy, felt like the medication drained into the lymph nodes. This report was non-serious.
A pharmacist reported that a 44 year old female received an injection of Pnu-Imune 23 on 10/28/99 and subsequently developed an injection site swelling which extended to the entire arm. No further information was available at the time of the report.
The pt called complaining injection site redness, induration, warm to the touch. Treated with Motrin, and warm compresses.
noticed a rash along his belt line on 01/16/2021.  He saw his doctor on 01/19/2021 diagnosed with shingles.
Fatigue, sluggishness and difficulty breathing for a week to 10 days after vaccination. Difficulty breathing continues to date (April 28. 2021), with slight exertion - going up stairs or up a gentle slope. Prior to vaccination jogged 5 miles three times a week. Now barely able to jog 1/8 mile without having to stop because I cannot breath. I simply cannot breathe.
This case was reported by a nurse via sales rep and described the occurrence of rash in a child female patient who received FLULAVAL QUADRIVALENT 2017-2018 season for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The reporter thought the event rash on arm after immunization lasted two weeks if not longer.
Pt received Hep A & Menactra on the afternoon of 15JAN08.  Reported swelling, warmth, redness and itching around site on morning of 17JAN08.  Pt reports symptoms begining evening of the 15JAN08.  Pt reports that symptoms have worsened slightly from this time until the morning of 17JAN08.  Pt reports scratching at the site.  On assessment right upper arm appearing to have mild swelling with red, warm area of approximately 6-7cm in diameter.  Pt denies any fevers or other symptoms. Site also assessed by physician and determined to be localized skin reaction.  Pt instructed to use hydrocortisone cream and Benadryl to help control itching at site as well as cool compresses.
Outbreak of T10 right sided shingles after given ZOSTAVAX 12/29/16.
Symptons day after:  Headache, Bodyaches, Slight fever Sore arm, Rash on arm where injection was administered and no appetite Tylenol taken every 6 hours on first day; and second day only once. Second day only slight headache but no appetite until evening.  Rash on arm still present 3rd day the only  symptom is rash on arm and it begins to itch.
This spontaneous report as received from a registered nurse refers to a 26 years old female patient, who is a healthcare worker. The patient had no pertinent medical history and no drug reactions/allergies. On 08-NOV-2013, when the healthcare worker was draw up the vial of PROQUAD (Merck) (Lot # J007863, Exp date: 28-DEC-2014), was entered to remove the dose of PROQUAD (Merck), the dose sprayed all over and got in the patient's right eye. Patient's concomitant medication included "birth control pills". On 08-NOV-2013 the patient experienced redness in the eye and had difficulty opening the eye. On 11-NOV-2013 the patient experienced eye itches. The patient also stated that she was not experienced an any other adverse effects on 11-NOV-2013. PQC filed for pressure irregularity of PROQUAD (Merck). Patient stated that immediately after PROQUAD (Merck) solution "sprayed into her eye", she consulted medical attention, and her eye was flushed every 15 minutes with water as treatment on the day the event occurred on 08-NOV-2013. She denied any loss of vision or any other adverse effect. No lab diagnostics studies performed. The outcome of the events was reproted as not recovered/not resolved. Additional information has been requested.
The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022; No adverse event; patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a child 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. 030G22B) for COVID-19 vaccination. No Medical History information was reported. On 14-Nov-2022, 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 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022).    Concomitant product use was not provided by the reporter. The vial size was reported as 2.5 ml. It was initially stored in the refrigerator on 12-Oct-2022 and beyond use date was 11-Nov-2022. The vial did not undergo any temperature excursions. Treatment information was not provided.  This case contains information for the first of the 2 patients of 6 to 11 year old group described by the reporter.
States that after receiving the flu shot it was a little itchy. The next day she started scratching at injection site and it was tender and warm. She looked at the site and saw the whelp. Contacted me today and stated it has still a little tender to the touch and red but the whelp had not gotten any larger. Remeasured whelp at 65mm. Redness has decreased per patient. Advised patient compress/Ibuprofen if needed. Denies fever or rashes.
Pt recv vax on 10/22/98; on 10/23/98 pt exp chills, fever, upset stomach, sore arm
4 days p/vax devel typical pop lesions over arms & hand & on side vaccine given;
fast heart rate that lasted for 5 to 6 hours.; he felt a numb, tingling sensation down his arm, hands, palms, and fingers; he felt a numb, tingling sensation down his arm, hands, palms, and fingers; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Immediately after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, he experienced a fast heart rate that lasted for 5 to 6 hours. Then with the last 3 days, he felt a numb, tingling sensation down his arm, hands, palms, and fingers. He wants to know if this is a normal reaction to the vaccine, and if it is still safe for him to receive the 2nd dose of the vaccine. Outcome of the event fast heart rate was recovered; other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore at injection site; Flu-like symptoms; Testicles are sore; 1st dose on spring/summer 2021, 2nd on 03Nov2022; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vasectomy. Previously administered products included Shingrix (received first Shingrix dose 0.5 ml intramuscular in spring or summer of 2021 in arm).   On 3rd November 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd November 2022, 4 hrs after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, testicular pain and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain, influenza-like symptoms and testicular pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and testicular pain to be related to Shingrix.     Additional Information: GSK receipt date: 04 Nov 2022 Reporter comment: The reporter was the wife of the patient. The reporter reported that patient received his second Shingrix vaccine in left arm. The reporter reported that about 4 hours after the injection patient's arm became sore at the injection site, he began to feel flu like symptoms patient awoke this morning, patient was better, but the symptoms have not resolved.  The patient testicles were sorer than when he had a vasectomy.  Caller does not give permission to contact HCP, they have not contacted him yet. Additional supportive information: As patient received 2nd dose of Shingrix lately which led to drug dose administration interval too long. Note: Patient route of administration is intramuscular, however in source document as per code it is Intraparietal, however intramuscular was captured conservatively.