chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 2 shots of the vaccine and the booster; diagnosed with covid/experiencing runny nose, cough, and fatigue; diagnosed with covid/experiencing runny nose, cough, and fatigue; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 years old male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 2 shots of the vaccine and the booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with covid/experiencing runny nose, cough, and fatigue". The patient had received 2 shots of the vaccine and the booster, and was diagnosed with covid, was experiencing runny nose, cough, and fatigue. Event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101852679 same reporter/product/event, different patient
started w/dime sized red area & progressed to 80mm red, warm, raised area; slept for 2 days was lethargic, had muscle & joint aches until 7JUN93; DPH for itching; red, raised warm to touch;
itchiness; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (itchiness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Tobacco user (Five cigarette sticks a day) from 1979 to 2015, Rash (resolved) in January 2021 and Blood blister (resolved) in January 2021. Concurrent medical conditions included Penicillin allergy (manifested by hives and anaphylactic shock), Drug allergy (ENBREL and KEVZARA - hives and red rash on injection site; PLAQUENIL - big red rash on right arm; CYMBALTA - more pain, a lot of swelling) and Alcohol use (Hard liquor, occassionally) since 1979. Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRURITUS (itchiness). The patient was treated with BETAMETHASONE at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's past medications include PLAQUENIL, CYMBALTA, KEVZARA, HUMIRA, ENBREL for an unknown indication   This case was linked to MOD-2021-185971 (Patient Link).
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:41 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 53.29 for dose administered on 3/31/2021. No concomitant medications were reported.  Batch number 019B21A administered on 3/31/2021 underwent temperature excursion with temperature of 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
This spontaneous report as received from an unspecified reporter via company representative company representative referred to a 60 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose not reported) (Batch# H019037, expiration date unknown). Concomitant medication, medical history and drug reaction/allergies were not reported. On an unknown date the patient developed a 7cm x 10 cm whelp. The outcome of the event was unknown. The patient sought for medical attention, spoke with the original HCP. It was unknown if the patient received treatment. This is one of two reports received from the same source. Additional information is not expected.
This spontaneous report was received from a medical assistant who reported that VARIVAX (Merck) reached temperatures that were outside the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
COUGH; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1820095 expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced cough. On 22-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, and fever. This report was non-serious.
Local irritation and redness, mild fever and headache. Rash on arm and hands.
Swelling at site of injection; tenderness on area of the injection; itchiness on the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at site of injection), VACCINATION SITE PAIN (tenderness on area of the injection) and VACCINATION SITE PRURITUS (itchiness on the area of the injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at site of injection), VACCINATION SITE PAIN (tenderness on area of the injection) and VACCINATION SITE PRURITUS (itchiness on the area of the injection). At the time of the report, VACCINATION SITE SWELLING (Swelling at site of injection), VACCINATION SITE PAIN (tenderness on area of the injection) and VACCINATION SITE PRURITUS (itchiness on the area of the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  As treatment the patient was applying cold compress on the area.
This spontaneous report as received from Nursing Services refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored vaccine of M-M-R II (lot # H020255, expired date 08-NOV-2014). The original reporter is unknown. Additional information has been requested.
pt recv vax 2MAY97 & approx 30min post vax pt exp a hot flushed face that was hot to touch & no fever was present;approx 4-5hr later pt recovered;
Pt recvd 3 doses of Engerix-B vax on 20JUN90, 18JUL90, 11DEC90 & failed to convert to protected levels;
Fever of 102.0-102.9 onset by evening of shot, fever persistent and lasted until evening 5 days later.  Rash developed on head and neck on day 6.  Tylenol was given for fever as well as using damp washcloths to cool skin.
Pt resides in prison.  Received vaccine due to possible work rash (OSHA).  Vaccinated 12/11/03 @ 08:30.  Reports that on 12/26/03 woke up and was unable to move left side of face and blurred speech. Came to prison ER 12/31/03 with diagnosis of Bells Palsy.
Moderna COVID Vaccine given as a 3rd dose (booster) to 13 year old.  The 13 year old had previously received Phizer dose #1: 06/18/2021 Phizer dose #2: 7/18/2021
Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 2:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 2:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination  or at the time of the adverse event were reported as unknown. Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown. Vaccine went into 2-8 C thaw state on or about 24-Dec-2021. On 12-Feb-2022 at 02:18:50 PM, the patient took booster dose. No treatment information was reported.
the Moderna vaccine was administered to a patient who is not 18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (the Moderna vaccine was administered to a patient who is not 18 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (the Moderna vaccine was administered to a patient who is not 18 years old). On 28-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (the Moderna vaccine was administered to a patient who is not 18 years old) 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.   No relevant concomitant medications reported.  No treatment information was provided.
Black and swollen eye; Swollen, immobile left hand; Black and blue left side of the face; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Black and swollen eye), PERIPHERAL SWELLING (Swollen, immobile left hand) and CONTUSION (Black and blue left side of the face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Therapy change. Concomitant products included CELECOXIB (CELEBREX), BUPRENORPHINE (BUTRANS), FLUOXETINE HYDROCHLORIDE (PROZAC), LEVOTHYROXINE SODIUM (SYNTHROID) and PRAVASTATIN for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced EYE SWELLING (Black and swollen eye), PERIPHERAL SWELLING (Swollen, immobile left hand) and CONTUSION (Black and blue left side of the face). At the time of the report, EYE SWELLING (Black and swollen eye), PERIPHERAL SWELLING (Swollen, immobile left hand) and CONTUSION (Black and blue left side of the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in November 1989 and December 1989, respectively, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose and route were unknown). In January 1990, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot #, expiration date, dose and route were unknown) (Extra dose administration). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not want to be contacted.
Swollen lymph node on left side next to collar bone. Tender and the size of a grape. First noticed on 8/16 and after 7 days it is still there. The only other symptoms I've had are fatigue and sore arm where injection was given.
have the new vaccine and still got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had new vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Fever, high pulse, low O2, chest pain, congestion, runny nose, extreme fatigue, headache, and very mild arm injection pain. Still sick - day 6
1/23/17 - reports flu-like symptoms - including GI symptoms. 1/26/17 and 1/27/17 - reports joints swelled - burning pain. 1/28/17 tingling and weakness in legs, calves, wrists, hands. 1/30/17 seen by PCP, sent to ED. Seen by neurologist on 1/31/17. Follow up with PCP 2/14/17.
Redness, swelling, warm to touch, itchy, VERY tender, couldn't lift my arm. No fever.
1430 ?after recieving 1st dose of Pfizer lot#EN6207,  Pt sitting in clinic and states she feels like she was going to pass out. A&O x3, BP 80/70 both R and L. Pt states she is on BP meds but has not taken them today. Ate lunch recently. 1440 ? Pt given water and stayed with us for 30 min. Started feeling better after drinking a bottle of water. Pt did not want to go to the ER. Sister picked her up
At 12:15, pt c/o itching to top of nose, pt was offered emergency assistance by staff members, but continuously declined both pt and spouse by side, at 12:18, pt stated had Benadryl in her purse,searched purse but couldn't find, at 12:30pm Benadryl 25mg 1 tab by mouth was administered in  the presence of spouse and other staff members, at 12:40pm, per staff, Clinical Director, pt skin color returned to normal, pt verbalized
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 intramuscular, administered in the left arm on 15Mar2021 at 14:00 (Bath/Lot Number: EP7534) as a single dose, and dose 1 intramuscular, administered in the left arm on 22Feb2021 at 14:00 (Batch/Lot Number: EL9262) as a single dose (at the age of 34-years-old) for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested positive for COVID on 15Jul2021.  The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 15Jul2021 Nasal Swab. No treatment was received.  The patient recovered from the event on an unknown date.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Body pain; Low fever; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: OEN8732) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other 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 the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6206) via an unspecified route of administration in the  left arm on 11Mar2021 at 15:00  (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 13:45, the patient experienced low grade fever and body pain. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of low grade fever and general body pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
limp p/4PM feeding put on dressing table & vomited whole feeding, turned grey, eyes rolled back, hyporesponsive x 1 min; paramedics called; nl when paramedics arrived;
Left arm swollen, warmth, erythema (deltoid). Treatment: Advil alternate with Tylenol, cold compresses.
I was requested by the physician to administer a flu vaccine per patient request. After administering it the patient stated they may have already had one but "figured why not."
Shingles with ophthalmic complications; retinal detachment OD; dry eye syndrome; This case was reported by a lawyer and described the occurrence of ophthalmic complications in a patient who received  (Shingrix) for an unknown indication.   On an unknown date, the patient started Shingrix at an unknown dose and frequency. On an unknown date, an unknown time after starting Shingrix, the patient experienced Shingles with ophthalmic complications. On an unknown date, the outcome of the Shingles with ophthalmic complications was unknown.  The initial information was received on 31 March 2021 via medical record (case is now medically confirmed). Patient had used shingrix vial kit Intramuscular route on 14 Sept 2020. On 15 Feb 2021 noted that patient had a history of dry eye syndrome. Patient had History of retinal detachment OD. Patient had herpes zoster eye disease.
Appx 0930 - vaccination administered 0933 - pt. stated "light - headed, clammy, body feels tense, "really hot" BP = 120/80 P = 76 RR = 20 0945 - "increased Hot Feeling" ---> VSS, no apparent resp. difficulty nor distress --> 0956 Notified Dr --> 1005 - employer reported "increased lightheadness & nausea BP = 132/86 P = 76 m, increased body heat, less tense feel like jello - I feel like I could slide off the chair.
Numbness and shooting and consistent pain starting at the site of vaccination and extending medial and lateral down the upper arm into the forearm and extending into the left hand, pain at vaccination site with palpation, temperature changes of the left arm, discoloration of the left upper extremity, bruising. Intermittent pain shooting from site of vaccination into the left chest and neck region. Pain and inability to completely use the left arm following the steroid injection for 3 days.
(L) upper thigh with mild erythema, fine nodule, mild edema site (Varicella).
Patient reports over the last 2-3 days had increased pain and swelling and redness about the left proximal arm. No fever chills. No malaise. No numbness tingling or focal weakness. No rash otherwise. Just continues to have redness with swelling at this time. States its going on 6 days.
Received call from mother at 8:30pm at home that child had developed hives to trunk and face. Mom denies child having any difficulty breathing and had previously administered 2 doses of Tylenol 0.8cc. Advised to obtain Benadryl liquid and administer 2cc. Advised to call 911 if any breathing difficulties occured or if no response to Benadryl. 03/29/2006 Called Mom with no response but grandmother called back at 9:45 and stated that child had responded well to Benadryl. Verbalized child had not had fever or any other problems but that he had gone to visit with Dad after vaccines administered and does not know if anything new was introduced that could have caused hives.