chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Red, swelling at inj site "Tennis Ball" plus itching and fever. States she took Tylenol off and on x's one week until "red/purple lump" was gone.
Information has been received from a female with allergy to several antibiotics including CIPRO and a history of shingles who on 14-FEB-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included TOPAMAX, PREMARIN, NEXIUM, simvastatin (MSD), acyclovir and aspirin.  On 15-FEB-2008, the patient removed a ring she was wearing since being vaccinated and found a slight red rash where the Onyx stone in the ring was against her skin.  She applied NEOSPORIN ointment and the area has improved.  No other symptoms were noted.  The patient did not seek medical attention.  There was no product quality complaint.  Additional information has been requested.
lt arm hurting, reddened area @ site 5cm, feeling feverish;DPH given, hydrocortisone cream to red, raised itching area;
Patient complained of lightheadedness to family member. Shortly after, he slumped over to his right and was aroused with a gentle sternal rub. Patient was diaphoretic and pale, but alert and oriented x4 once aroused.
12/29/20: rash on arms, sore arm, injection site redness 12/30/20: fever, chills, rash on arms, injection site redness 12/31/20: fever, chills, swollen lips, swollen ears, injection site redness
59 yo F s/p Pneumovax injection 48hrs.  Cellulitis 2nd to Pneumovax.
Information has been received from the mother of a consumer concerning her 16 year old daughter with acne who on an unspecified date in June 2007, was vaccinated with the first dose of Gardasil (Lot# not reported).  Concomitant therapy included antimicrobial (unspecified).  On an unspecified date in October 2007, the patient was vaccinated with the second dose of Gardasil (Lot# not reported).  Subsequently within 24 hours post vaccination her daughter developed a rash, which began as a few bumps on her torso in the mid-back and on her stomach area under the breast bone".  The consumer reported that over the past several weeks the rash became more pronounced and her daughter was seen by a dermatologist.  The date of this appointment and any treatment information was not provided.  The mother reported that her daughter had no reactions after her first dose of the vaccine.  At the time of this report the patient had not recovered from the rash. Additional information has been requested.
Patient stated she began to experience the reaction on the morning of 04/09/2017. The reaction included nodule formation, induration, and swelling at the site of injection. Cold compress was suggested for treatment of swelling.
Today , 7 days after shot,  the injection site is red, swollen and a bit sore.  Before today there has been no affect at all.   Don?t know if you would need to know this, but if you are recording this thought it might be useful.
no information except date of + covid test as        2-16-22                     and date of death as        3-26-22.                     .
Dermatographia, started on Dec 12th with large wheals on areas of pressure. Onset also started with arthralgia of joints and sore throat.
fatigue; Diarrhea; yellowing of urine.; nausea in response to food; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (yellowing of urine.), NAUSEA (nausea in response to food), ARTHRALGIA (joint pain), DIARRHOEA (Diarrhea) and FATIGUE (fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) and METOPROLOL for an unknown indication.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jul-2021, the patient experienced CHROMATURIA (yellowing of urine.), NAUSEA (nausea in response to food) and ARTHRALGIA (joint pain). On 07-Jul-2021, the patient experienced DIARRHOEA (Diarrhea). On 18-Jul-2021, the patient experienced FATIGUE (fatigue). At the time of the report, CHROMATURIA (yellowing of urine.), NAUSEA (nausea in response to food), ARTHRALGIA (joint pain), DIARRHOEA (Diarrhea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported.
Information has been received from a health professional concerning a 50 year old female with a history of depression who "ten years ago", month approximate 1997, was vaccinated with a first, second and third dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included duloxetine hydrochloride (CYMBALTA).  Subsequently, she was told by her physician that her "hepatitis titer was low".  The reporter has not experienced any symptoms.  No product quality complaint was involved.  Additional information has been requested.
The numbness began to intensify and I could not feel myself blinking or smiling on the left side of my face; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; This is a spontaneous report from a contactable nurse reported for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) via an unspecified route of administration on 07Jan2021 07:00 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was Workplace Clinic. Medical history included food allergy at shrimp. Concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 07:15 AM the patient notice pain and numbness to her left ear and left jaw that began to spread down left jaw and upward across left cheek, left eye, and left temple, and above left eyebrow. The numbness began to intensify and patient could not feel herself blinking or smiling on the left side of my face. The numbness slowly began improving over the next hour in the same order that it began, but she still have mild left ear and jaw pain and mild numbness. Events outcome are recovering. No treatment was received. The action taken was not applicable.; Sender's Comments: Based on the compatible time association, the facial palsy is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Fatigue, muscle soreness, injection site redness swelling and itching. Diaphoretic with activity, chills
This spontaneous report was received from a healthcare worker regarding an unspecified 6 patients of unknown age and gender. This report pertains to the patient who on 02-DEC-2013 was vaccinated with a dose of M-M-R II, (lot # J003002, expiry date 14-MAR-2015) (dosage regimen unspecified). The healthcare worker reported that 6 clients were vaccinated with the same lot of improperly stored M-M-R II. The healthcare worker reported details of a supported temperature excursion for M-M-R II that were exposed to temperatures of 47Fahrenheit (F) for 1 hour 48 minutes (min), 48.5F for 1 hour 13 min, and 48.5F 1 hour 13 min (also reported as the vaccine was not stored improperly, the products would not be adversely affected by this specific temperature excursion). No adverse effect reported. No further information was available. This case is linked to 1312USA005771, 1312USA010204, 1312USA010206, 1312USA010207 (Same reporter link)). Additional information has been requested.
2 weeks later; I have developed hives all over my body.  Lesser on my arms but a few individual hives on wrists, arms, hands.  Some on the back on my scalp.  A few have ranged under my chin and neck area but the primary location tends to be the base of my spine, my hips, the back of my legs, groin/pelvic region, and thighs.  A few noted on calves, especially in the joint areas, behind the knees, elbows etc.  The largest masses of hives tend to be along the belt area and extend down the legs from there.  All are itchy and white/red depending on irritation.  Hives appear splotchy and grouped in satellites; few are individual hives.  Unbearably itchy.  Note: I don't see anywhere requesting blood type.  I am A+.  This feels much like my severe reactions to mosquito bites.  Same hives, same itch, just at a much larger scale.  I am postulating there is a correlation of people experiencing these same reactions with those of a certain blood type; and I'm guessing it's type A.
Subsequent to receiving one dose of varicella virus vaccine on live on 8/9/97, the pt experienced chickenpox with a few lesions, on 5/3/99. No further evaluation was needed as the pt recovered without incident.
soreness at injection site after second dose; This is a spontaneous report from a non-contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. Patient experienced extreme fatigue after first dose of Pfizer COVID vaccine and soreness at injection site after second dose. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Pt presents to PCP on 3/1/22 with swelling in left arm, sob, and coughing after receiving the Moderna booster on 2/26/22. Previous vaccines received was Jansen.  Recommend supportive therapy. Pt advised to seek care in ED if having anaphylaxis.
Varivax underwent a temperature excursion and was then administered to a patient; This spontaneous report has been received from a administrator concerning to a 7-years-old patient of unknown gender.  The patient's concurrent condition, medical history and concomitant medications were not provided.  On 28-JAN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, dose, route of administration and anatomical location were not provided) (lot#: U022732, expiration date: 20-JUL-2023) as prophylaxis, however, the vaccine experienced a temperature excursion (product storage error). of 12.0 Fahrenheit (F) for a total time frame of 9 hours and 38 minutes. There were previous temperature excursions: 9.7 F for 2 hours and 41 minutes, 10.8 F for 2 hours and 45 minutes, 10.6 F for 4 hours and 16 minutes, 11.1 F for 3 hours and 14 minutes, 10.9 F for 4 hours and 43 minutes, 10.8 F for 2 hours and 17 minutes, 18.3 F for 2 hours and 36 minutes, 18.7 F for 3 hours and 4 minutes, 12.4 F for 9 hours and 43 minutes, 17.4 F for 24 hours and 19.9 F for 10 hours and 57 minutes. No further information was provided.
he started to have some blotches with pus underneath his armpits; he started to have some blotches with pus underneath his armpits; he feel irritation and raw in his skin.; when he wears T-Shirts, he feel irritation and raw in his skin.; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: RASH MACULAR (non-serious), PUSTULE (non-serious), outcome "not recovered" and all described as "he started to have some blotches with pus underneath his armpits"; SKIN IRRITATION (non-serious), outcome "unknown", described as "he feel irritation and raw in his skin."; SKIN EROSION (non-serious), outcome "unknown", described as "when he wears T-Shirts, he feel irritation and raw in his skin."; PAIN (non-serious), outcome "unknown", described as "pain".  Additional Information: Patient also mentioned that he needed took the pus out so he can relief the pain, but like two and a half weeks ago, this started again.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vomiting, diarrhea, soreness, stomach cramps, nausea, dizziness.
Fever for a couple days, weakness, arm soreness for 1 day, nausea, diarrhea. Thursday and Friday. Missed work both days. Treatment followed CDC recommendations for common side effects.
High fever, Headache, severe left arm pain radiating to shoulder down under armpit and left chest wall, severe swelling and redness at vaccine site, loss of appetite, fatigue, increase daytime sleepiness, increased weakness  Symptoms began approximately 28 hours after receiving vaccine.  Received flu shot the same day on same arm but flu shot was given slightly above where pneumonia shot was given (shots were given about 1 inch apart).  I asked nurse if it was ok to get both shots in same arm and was told it was fine.  I did not receive vaccine information sheets for either of the vaccinations I received and had to look up the information myself.  I reported my symptoms to my doctor on 10/15/19 at 9am and did not received response back.
soreness at the injection site; Arthralgia; Myalgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-OCT-2023, the patient received the 2nd dose of Shingrix (left arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the injection site), arthralgia (Verbatim: Arthralgia) and myalgia (Verbatim: Myalgia).  In OCT-2023, the outcome of the injection site pain was resolved. The outcome of the arthralgia and myalgia were not resolved.   It was unknown if the reporter considered the injection site pain, arthralgia and myalgia to be related to Shingrix.     It was unknown if the company considered the injection site pain, arthralgia and myalgia to be related to Shingrix.   Additional Information: GSK receipt date: 9-Oct-2023 GlaxoSmithKline employee who received second dose of Shingrix vaccine and according to the reporting, she had soreness at the injection site that went away then developed myalgia and arthralgia that persisted on the day of reporting. Did not consent to follow-up.
Lower right quadrant pain beginning exactly three weeks after second Pfizer shot. (First dose was on 5/16/2021).  Pain started around 4pm on 6/27/21 and continued till appendicitis was confirmed at hospital in the morning of 6/28/2021 and surgery was performed to remove appendix resolving adverse event
Severe skin rash. Inflammation and red ness from injection site (mid thigh) up to cheeks. Rash was warm to the touch for multiple days and presented like hives. After a few days, it became very dry and the skin is now cracking. The rash has lasted 11 days so far and is still bright red and very uncomfortable for my son who got the vaccine.
36 hours of depilitating headache, chills, body ache, and fever.  I was bedridden. Throat swollen, hard to swallow. Mild angina when reaching down to floor.  I have a history of high tolerance for pain.  This stopped my world for a day and a half.  Better now.
This case was reported by a consumer and described the occurrence of hair loss in a 53-year-old male subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. On 2 June 2007 and 4 July 2007, the subject received 1st and 2nd dose of ENGERIX B (unknown). In September 2007, within two and three months of vaccination with ENGERIX B, the subject experienced hair loss. The subject required attention at he doctor's office. Many lab test were done to rule out many other disease states. The immunization series was discontinued. At the time of reporting the event was unresolved.
Itching at the injection site; Hives all around it; Pain at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE URTICARIA (Hives all around it), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE URTICARIA (Hives all around it), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE URTICARIA (Hives all around it), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Large swelling over Right deltoid area - 5 - tan tender and warm to touch - lasting, several days. Arthralgia neck and shoulder.
Information has been received from a consumer concerning her 8 year old son with no pertinent medical history and no drug reactions or allergies who on 24-JUL-2002 was vaccinated with a dose of MMR II (lot # 642441/0340M, HSA). Concomitant therapy included Hib conj vaccine (manufacturer unspecified). On 21-SEP-2009 ("this past Monday"), the patient was diagnosed with a form of Autism. At the time of reporting, the patient's Autism persisted. The patient sought medical attention via visiting physician. Upon internal review, Autism was determined to be an other important medical event. No further information is available.
No adverse event; an adult received 0.25 ml of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (an adult received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 20-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (an adult received 0.25 ml of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (an adult received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (an adult received 0.25 ml of the bivalent vaccine).    Concomitant medication was not provided.  Patient received two primary doses and one booster dose.  Treatment information was not provided.
2 welt like bumps at injection area, swelling warm to touch no pain. Taking TYL/Ibp.
A little sluggish; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (A little sluggish) and PAIN IN EXTREMITY (My arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     It was unknown if patient had allergies to medications, food and other products. It was unknown if patient had Acute and Chronic illnesses at the time of vaccination.     On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced SLUGGISHNESS (A little sluggish) and PAIN IN EXTREMITY (My arm was sore). At the time of the report, SLUGGISHNESS (A little sluggish) and PAIN IN EXTREMITY (My arm was sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  On 11-Mar-2021, the patient received the full dose of Moderna COVID-19 vaccine.  No treatment medication was provided.   This case was linked to MOD-2022-561910, MOD-2022-561912.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow up includes no new information.