chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.; Patient received Moderna Bivalent vaccine after temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Age-related macular degeneration.    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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion).    Concomitant Medication use information was not provided by reporter.  It was unknown that if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within this time line.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Initial and follow up information has been received from a physician and an office manager concerning a 12 month old white female patient with no past medical history who on 15-DEC-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant vaccinations on the same day included a first dose of measles-mumps-rubella vaccine (MSD) SC into the left leg, Hib conj vaccine (OMPC) (manufacturer unknown) and a first dose of varicella virus vaccine live (MSD) SC into the left leg. Other concomitant vaccinations included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (lot# 427U7AA) IM into the right leg. It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) by accident.  She was supposed to receive a dose of pneumococcal 4 6B 9V 14 18C 23F conj vaccine (CRM197) (PREVNAR). The reporter stated that the products were clearly labeled; there was not a confusion of products.  It was "lack of education" of the medical assistant working on the office.  The parents reported the patient had slight fever on 16-DEC-2006 (also reported as the 17-DEC-2006).  Subsequently, the patient was seen in the office on 18-DEC-2006 and had recovered from slight fever. There were no there reported problems or "any other adverse events." Additional information is not expected.
headache; This is a spontaneous report from a contactable consumer (the patient). A female patient (Age: 65, Units: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 08Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included reactions to 'every vaccine' (unspecified). Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. Prior to receiving the first dose of Pfizer COVID-19 vaccine, the patient took ibuprofen (ADVIL) 600 mg. After the first dose, she took Advil again. In the second dose of the vaccine, initially she didn't take Advil, but 2 days after the second dose, she took Advil again. The patient wanted to know if that would affect the effect of the vaccine, since she confirmed that she was having this headache in any vaccine. The patient asked if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She received her first Pfizer COVID vaccine; however, due to a history of reactions to 'every vaccine', she took 600 mg of Advil prior to her appointment. After her second dose, she took Advil for 2 days after due to her headache. The patient wanted to know how long after taking the COVID vaccine does Pfizer recommend taking the antibodies test, and if it was possible for her doctor to recommend a third dose of the COVID vaccine. The clinical outcome of headache was unknown.  Information about Lot/Batch has been requested.
Fever, body aches, headache- 1 day Mouth sores, swollen gums- has not resolved yet.
swollen lump; tender lump; lump; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number J7J4x, expiry date 31st January 2023) for prophylaxis.   On 16th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18th October 2021, 2 days after receiving Shingrix, the patient experienced swelling, tenderness and nodule. On an unknown date, the outcome of the swelling, tenderness and nodule were unknown.   It was unknown if the reporter considered the swelling, tenderness and nodule to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient for herself. The patient received shingrix vaccine on 16th October 2021 and today she noticed a tender, swollen lump near her left collarbone. The reporter consented to follow-up. The patient given consent for safety to contact her but did not want to provide physician demographics or give consent to contact her doctor at this time.
pt recvd vax;pt claims 12 days later, became achey,chills,d,ha;no fever;so sick,could not get out of bed;lasted 48 hrs;first sxs 29nov94; fine by 1dec94;
hyperglycemia post-influenza vaccine UNCLEAR WHICH INFLUENZA VACCINE PATIENT RECEIVED Patient noted blood glucose of 191 before breakfast and 233 after breakfast on 10/5/23. He stated that fasting blood glucose on 10/4/23  was much higher than normal (250). Received vaccine 2 days prior to report on 10/5/23.
Lt. thigh with redness & edema about 9-10 cm. No induration; afebrile; slight bruise. Dx at OV = Local reaction to vaccine. Tx = observe; ice - prn; call office if s/s increase.
Tongue got very painful/ as if he bit his tongue; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (Tongue got very painful/ as if he bit his tongue) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GLOSSODYNIA (Tongue got very painful/ as if he bit his tongue). At the time of the report, GLOSSODYNIA (Tongue got very painful/ as if he bit his tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication were reported.
(L) upper arm subcutaneous area with raised patch of eryth warmth tender 7cmx10cm. Started yesterday evening (day of vaccine) with itching; did not notice erythema. This afternoon (24 hrs later) with sudden swelling.
pt's arm was red and swollen from the top of her shoulder to the past the bend of the elbow.  It itched and displayed redness.  When pt reached the pharmacy she had pictures of the swelling. The swelling at reduced but the arm still displayed redness and fever along with itching.  Pt contacted the md and was given a antibiotic along with told by md to place cold patches on her arm.
Arm is really swollen, is red and blotchy; Arm is really swollen, is red and blotchy; Arm is really swollen, is red and blotchy; some slight headaches not really bad but they seem to be getting a little bit stronger; Few little things going on like a little of forgetness; Itchiness; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up in this morning on 06Feb2021 patient's arm was really swollen, was red and blotchy. On an unknown date in Feb2021, the patient had some slight headaches not really bad but they seem to be getting a little bit stronger, then what they were. Patient had been taking Tylenol and just a few little things going on like a little of forgetness and Patient didn't want to go to the emergency room unnecessary, will this just will. They told patient would have some side effects but they said if got like such as itchy skin or shortness of breath, the patient was Not short of breath and the swelling of the face and tongue to go to the emergency room. So with the itchiness on an unknown date in Feb2021 what patient have been doing, patient took a cotton ball and put some alcohol on it and rub it and it seems to like kind of ease off. The outcome of the event headache was not recovered and the outcome of the other events was unknown.  Follow-up attempts are completed, information about lot/batch number cannot be obtained. No further information is expected.
Fatigue set in on 12/27 and persisted through 12/28. Resolved by 12/29.
Patient received vaccine while in appointment with her PCP, within a few minutes, patient noted tingling of her lips and tongue.  Nurse administered Benadryl 50mg IM and monitored patient for any worsening of symptoms.  Patient did have some resolution prior to leaving appointment.  She reported some symptoms of tingling afterwards, but she felt she was able to leave and would call with any changes in condition.
swollen neck lymph gland 9 days p/MMR; maculopap rash on throat 9 days p/MMR h/a & sore throat 10 days p/MMR:
Sudden emergence of blistering just above elbow on right arm, then appearing on left arm.   Applied anti-itch salve.  Blisters beginning to diminish in about 2 hrs.
Patient received 2nd Pfizer dose on Monday at 11:45am. Around 3am that Tuesday night, patient began feeling extremely achey and didn't feel well. On Tuesday around 12pm, starting at her head and working its way down her body - she became flushed (no swelling, itching). She had no other symptoms besides headache and redness covering most of her body (torso, arms, legs, face, etc.)  She called her MD office, who told her to take a dose of Tylenol. Patient reports that almost immediately after Tylenol dose, she began to feel better. Now says she is feeling better than she did before COVID shots.
Engerix-B pediatric dose administered to adult; Engerix-B pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 35-year-old male patient who received HBV (Engerix B pediatric) (batch number YM444, expiry date 22nd May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th October 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 9th October 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter stated that, an Engerix-B pediatric dose was administered to an adult patient.  The reporter consented to follow up via mail. Additional Supportive Information: The reporter stated that, an Engerix-B pediatric dose was administered to an adult patient, which led to underdose and adult use of a child product. The case had been linked to US2022146203, reported by the same reporter for a different patient.; Sender's Comments:  US-GSK-US2022146203:Same reporter
Severe arm pain where injected. Hard to use my arm. Low grade fever. Headache. Nausea. Unable to do normal work or eat meals. Trouble sleeping at night after injection. Took Acetaminophen, used cold pack on arm.
subarachnoid hemorrhage; This is a spontaneous report from a non-contactable consumer (patient). A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Apr2021 (Lot Number: EW0151) at the age of 64-years-old as single dose for covid-19 immunisation. Medical history included high blood pressure, high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included flecainide, metoprolol, rosuvastatin, acetylsalicylic acid (BABY ASPIRIN). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 15Mar2021 (Lot Number: EN6207) at the age of 64-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced subarachnoid hemorrhage on 26Apr2021. The event assessed as serious, life threatening illness (immediate risk of death from the event), hospitalization for 42 days, disability or permanent damage. The event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, patient received treatment for the adverse event included life saving and rehabilitation. Outcome of the event was recovered with sequelae. Since the vaccination, the patient had been tested for COVID-19 (covid test type was unknown) in Apr2021: negative.  No follow-up attempts are possible. No further information is expected.
Patient came in to let RPh know that one week after receiving Shingrix Dose #1 she experienced severe weakness to the point of being exhausted from taking sHower. Episode lasted 5-6 weeks. Pt thinks vaccine likely exacerbated her myasthenia gRavis. could hardly get out of beD.
The evening after the shot, I felt common side effects like headache, lack of energy, weakness, fever, chills, body aches, and inflammation. But my skin was also very sensitive to the touch. Upon 100% recovery from the common side effects on Monday, April 19, my skin sensitivity went away but was replaced with intense itchiness that has continued and gotten more intense since then to this day (Wed.). I am developing a few small welts on hands and feet. So far, my symptoms are very mild and not alarming, but are noticeable and bothersome. I do hope they will go away soon. I thought you should know about the skin issue since I have not seen it reported anywhere this far after the shot.
tiredness; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date. The patient experienced tiredness on an unspecified date. The patient stated she has received both doses of the Pfizer BioNtech covid 19 vaccine series and the only side effect was tiredness. Patient was now seeking information regarding the 3rd booster dose of the vaccine. Response was given from CONS-Booster Dose (US) (v1.0) as well as press release from 08Jul2021 (website link). The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Receives Covid 19 Booster vaccine of Pfizer at vaccine event on 03/22/2022, starts to have side effects 03/23/2022 the next morning of headache, chills, and body aches, fatigue. Taken Tylenol to help alleviate pain and assist with fever. Continue to monitor for the next 48 hours. Did recover from side effects
Reported allergic reaction to the COVID-19 mRNA vaccine. High severity - hives.
Approximately 1 wk after receiving vaccines listed below mom c/o pt staring off into space and occasionally not responding to her. Pt has been set up for EEG at hospital. On 10/1 mom called our office and reports that pt is rubbing/holding head like uncomfortable 30-40x a day. Pt referred to local ER. To R/O neurological emergency.
No additional AE; Improperly stored ROTATEQ was administered to patient; This spontaneous report was received from a registered nurse and refers to a 3-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 06-JAN-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen was not reported), lot # 1691133 and expiration date 28-NOV-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 35.2 degree fahrenheit (°F) for 45 minutes on 06-JAN-2021 at 1:30 AM; no previous temperature excursion were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2101USA001927: US-009507513-2101USA003974:
Based on additional information received on 14 August 2015, this case initially considered as non serious was upgraded to serious due to important medical event Upper Respiratory Infection. Based on additional information received on 14 August 2015, this case became medically confirm. Initial unsolicited report received from a consumer (patient parent) on 5 June 2015. A 14-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of MENACTRA (batch number, route and site of administration were not reported) on 2 June 2015. Illness at the time of vaccination was not reported. On 3 June 2015, one day after vaccination, the patient experienced swelling and pain at injection site, sore throat, lightheadedness and during the afternoon had an episode in which his vision went black while walking from one room to another and he did not remember going from the first to the second room. On 4 June 2015, patient continued to experience same symptoms with addition of headache, weakness, dizziness, flu like symptoms, and fever up to 100.4 degree Fahrenheit. Laboratory investigations were not reported. The patient was treated with ADVIL and TYLENOL cold medicine. As of 5 June 2015, the patient was not recovered from the events. Documents held by sender: none. Follow up report received from a healthcare professional (Physician) on 14 August 2015. A 14-year-old-male-patient received 0.5 ml dose of MENACTRA (Batch number U4798AA) in right arm on 2 June 2015. Illness at the time of vaccination and preexisting physician diagnosed allergies, birth defects, medical condition was reported as none. Any other vaccination within four week prior to 2 June 2015 was reported as none. It was also reported that the patient did not receive any other medication. Adverse event following prior vaccination was reported as none. On 3 June 2015, one day after vaccination "reported as two days later" the patient experienced URI (upper respiratory infection). It was reported that there was no residual effect and the patient started with URI "around day 3-4". Other laboratory tests were reported as none. On an unspecified date, about 1 week after onset the patient was recovered from the URI. Upon medical review, the case was considered as serious due to important medical event: URI (upper respiratory infection).
EXTREME PAIN IN UPPER RIGHT ARM; This spontaneous report received from a consumer. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-APR-2021, the subject experienced extreme pain in upper right arm.  On 19-APR-2021 14:20, Laboratory data included: Fibrin D dimer increased (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme pain in upper right arm. This report was non-serious.