chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleed in white of left eye on 6/22/14. Not sure if related, but never had this happen before.
vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022; No adverse event; Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In October 2022,  after starting mRNA-1273 (Spikevax), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022).    No concomitant medication was reported.  The doses were administered on 14-OCT-2022 and 15-OCT-2022 for 2 different patient.  The vial did not undergo any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-661762 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661762:MOD-2022-661762 (patient case)
I woke up with chest pains and migraine at 5:00am.  Went to the ER at 10:15am.  I was told I had chest wall pain and it was a common reaction to the  COVID shot.
Red swollen area on left arm just below the injection area. Hot to the touch, and patient reports pain in joints.
On 6/2/23, PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years. Clinic aware of error and clinic notified Regional Director, and Immunization Program nurse of the error. Per nurset, the dose can be considered valid with no revaccination necessary. On 6/7/23, Patient's mother was contacted by PHN and notified of error. Mother verbalized no adverse reaction to vaccine administration.
red circle around injection site; hard lump; red circle does get itchy; arm was very sore/arm was achy; fatigued at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore/arm was achy), FATIGUE (fatigued at night), VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (hard lump) and VACCINATION SITE PRURITUS (red circle does get itchy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Claritin.). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI 24 FE) for Birth control, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 31-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (arm was very sore/arm was achy). 31-Dec-2020, the patient experienced FATIGUE (fatigued at night). On 01-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (hard lump) and VACCINATION SITE PRURITUS (red circle does get itchy). At the time of the report, PAIN IN EXTREMITY (arm was very sore/arm was achy), FATIGUE (fatigued at night), VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (hard lump) and VACCINATION SITE PRURITUS (red circle does get itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Light-headed and fainting, racing heartrate, drop in blood pressure, severe head pressure, abdominal pain, muscle and joint pain. Stomach aches and pains, vertigo, tightness in chest.
Received vaccine after allowed expiry at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
RN was called over to case, upon arrival, case was pale, diaphoretic, nauseated.  Attempted to ask case name twice, she did not respond, case was began ?snoring? for roughly 3 breaths, then began dry heaving, which produced minute amount of blood tinged phlegm.  At this time, case was able to tell me her name and was able to remember that she had just received her vaccine.  Per her mother and guardian, case has history of mental disabilities and allergy to oral penicillin.  Case also has history of childhood seizures that were so mild, she is not on medication.  Case requested to be taken to ED for evaluation.
Thoracic Outlet Syndrome; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable other healthcare professional reported that a 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on an unknown date as dose number unknown, single for an unknown indication. Patient received the second dose of Covid 19 vaccine and she said she has thoracic outlet syndrome, she was receiving Botox injection in her shoulder and lower back. Asking if there is any amount of time before receiving the Botox and after receiving the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
positive for covid; positive for covid; low grade fever; This is a spontaneous report from a non-contactable physician via a Pfizer-sponsored program. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 20Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Mar2021 the patient experienced low grade fever. On 03Apr2021 the patient experienced positive for covid, high grade fever. The patient was hospitalized for high grade fever (pyrexia) on 03Apr2021. The doctor was inquiring if patient should get the second dose tomorrow and the efficacy if the second dose was postponed.The reporter was going to cancel and reschedule in a week.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Apr2021. The outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective, COVID-19 and fever cannot be totally excluded.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA279742, 2018SA277209, 2018SA279741, 2018SA279740, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279748 and 2018SA279743 (same reporter). This case involves a patient (age, gender not provided) who received vaccine FLUBLOK QIV which was in shipping excursion as it was sent to her clinic on 27-Sep-2018 and was received on 01-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine lot number not reported via unknown route and site of administration. It was a case of actual medication error due to incorrect product storage. (The reporter did not have details of patient). It was not reported that if any adverse event was occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The next day she had axillary pain and myalgias Two days after the vaccine she developed fatigue and headaches.
Irregular menstruation; Polymenorrhea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 10:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Mar2021 at 10:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021, the patient reported that she was menstruating on April 1st when she has received her second dose, began menstruating again less than two weeks after finishing her period. She never had period come that early before. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular menstruation, polymenorrhea was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient felt warm night before visit. Temperature normal at exam. Got shots. About 2 hours later had 104 fever, shaking, eyes roll back x 5 min. Postictal for 30 min. Presume febrile seizure.
I had several episodes of dizziness on Saturday, December 26th, approximately 6. All of them occurred while I was sitting.  In all but one case, I had been sitting for long periods and had not recently stood or moved around. They started in early afternoon and continued through late night. I hope they go away tomorrow.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. The physician was informed that the patient had an immediate severe reaction, described as an immediate 10-15cm wheal, upon injection. It was noted that the reaction responded to dephenhydramine HCL (benadryl). Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a registered nurse concerning a female who on unspecified date, was vaccinated with a first dose of MMR II. On an unknown date, the patient had an allergic reaction. The patient did not receive the second dose of  MMR II. At the time of the report, the outcome was unknown. Follow up information was received from the registered nurse reported that she did not recall who the patient was that they were referring to. No further information is available.
EARS PLUGGED UP, NOT ALL THE TIME BUT MORE THAN NORMAL (AROUND 3 TIMES A WEEK); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bad hearing. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the patient experienced ears plugged up, not all the time but more than normal (around 3 times a week). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ears plugged up, not all the time but more than normal (around 3 times a week). This report was non-serious.
Patient cried for 1.5 hours after the vaccine was administered and then cried for almost 3 hours inconsolably (2 hrs. 52 minutes to be exact starting a little before 12:30pm).  She continued fussing and crying for several hours more and then started a high pitched squeal/scream that lasted almost an hour (7:15pm-8:11pm).  She slept and cried on and off that night and also made gulping noises frequently.  On 1/15/08 she continued to be fussy and irritable and cried frequently (very unusual for her).  She cried inconsolably again from 10:00pm-11:52pm and then she sat up in bed and acted like she did not know where she was or who I was (her mother).  She kept this confusion up for about an hour and half and kept looking at everything like it was new.  Eventually she went to sleep for a couple of hours and then woke crying again.  On 1/16/08 she developed a cough with congestion (first time she has ever been sick).  Smiled a little this day for the first time after the vaccine.  1/18/08 still not herself and has a cough with congestion.
FEVER     BODY ACHES    CHILLS    NAUSEA   HEADACHE
Significant fevers to 102.3 myalgias, arthralgias, chills, sweats, could not perform.  Could no perform tasks of daily living. This has gone one for more than 36 hours.
Dizziness, Headache, Myalgia, Fever, MUSCLE SPASMS Narrative: BETTER TODAY  Other Relevant History:
Sore throat; fatigue; head ache; head congestion; Diarrhoea; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient(non-pregnant) received unknown dose of BNT162B2 (PFIZER-BOTECH COVID-19 VACCINE, solution or injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether patient had other vaccine in four weeks, other medications in two weeks. The patient was not tested covid positive prior vaccination. The patient did not have covid prior vaccination. It was reported that on 08Mar2021 the patient experienced sore throat, fatigue, headache, head congestion, diarrhea. outcome of the events was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
hives appeared below site of Dt around MN 26JUN95; ice applied to arm; hives persisted-referred to family MD 30JUN95; hives beginning to fade but remain itchy;
Vaccine went in shoulder joint - hit nerve - left arm numb/tingling - since injection - now 3 days later
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 08-OCT-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No addittional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Patient came in Wednesday and showed me her arm. She had a red patch approx 4 x 6 inches wide where vaccine was administered. Said it was "hot, itchy and sore to the touch." She had applied hydrocortisone to help with the itching. Next day she said redness was the same.
mom states pt had fever, dec appetite, dec activity 2hr p/vax;5/26/99 had fever 103.8, child cried & projectile vomiting 5/26/99;no local rxn noted;
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Heart palpitations, dizziness, vertigo, nausea, moderate headache, and severe fatigue. Started 6 hours after shot, and have continued one week later.
About seven weeks after the second vaccine, my pulmonologist sent me for a routine chest CT. The chest CT had showed that I had enlarged lymph nodes under both arms. My DR advised me to wait three weeks and have an ultrasound. So after that I was advised to wait three months and follow up with another ultrasound. The lymph nodes size have not gone down at all. They do not look irregular, they are just enlarged. At this point they just recommend I follow up in December again. They cannot find any reasoning other than the vaccine.
5x4 cm area redness, warmth and tenderness. Started Sunday 10/10 (received vaccine 10/9). Seen by PMD 10/11/2004. Treated with Keflex.
feeling very achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feeling very achy) and FATIGUE (tired) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (feeling very achy) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (feeling very achy) and FATIGUE (tired) outcome was unknown.            Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2021-405640, MOD-2021-405674 (Patient Link).
with all the other shots, I had something like fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (with all the other shots, I had something like fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (with all the other shots, I had something like fatigue). At the time of the report, FATIGUE (with all the other shots, I had something like fatigue) outcome was unknown.            Concomitant medication list was not provided.  Patient had 2 full shots and 2 booster shots of the Moderna previously. It was reported that with all shots patient had experienced things like fatigue.  Treatment information was not provided.   This case was linked to MOD-2022-644029, MOD-2022-644032 (Patient Link).
having lots of problems with her menstrual cycle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "having lots of problems with her menstrual cycle". Additional information: his daughter had lots of problems with her menstrual cycle. He stated as well that it's been going for a year.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.