chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-2022; No adverse event; 4 adults patients received doses after its beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-2022).    No concomitant medication was provided.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Vial size included 2.5 mL and vials did not undergone any temperature excursions.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706651, US-MODERNATX, INC.-MOD-2023-706894, US-MODERNATX, INC.-MOD-2023-706901 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706651:Master case - 1st adult patient US-MODERNATX, INC.-MOD-2023-706894:Master case - 2nd adult patient US-MODERNATX, INC.-MOD-2023-706901:Master case - 3rd adult patient
No additional adverse effects.; patient received a dose of PROQUAD on 12/2/2019 that was improperly stored; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about medical history and concurrent conditions was not provided. Concomitant therapy included sterile diluent.     On 02-DEC-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S017251, expiration date 01-DEC-2020; strength, dose, route, and were not reported) for prophylaxis (improper storage of product in use). Temperature excursions ranged 47 degrees Fahrenheit to 77 degrees Fahrenheit (59.9 degrees Fahrenheit) for 24 hours, 15 degrees Fahrenheit to 46 degrees Fahrenheit for 9 hours and 30 minutes and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 6 hours and 30 minutes. There were previous temperature excursions. On 10-SEP-2019, 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.7 degrees Fahrenheit) for 30 minutes. On 13-SEP-2019, 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 1 hour and 10 minutes. On 22-SEP-2019, 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.7 degrees Fahrenheit) for 2 hours and 5 minutes. Data logger was involved. No additional adverse effects were reported.
2 nosebleeds within an hour; Arm is hurting; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (2 nosebleeds within an hour), PAIN IN EXTREMITY (Arm is hurting), NAUSEA (Nausea) and FATIGUE (Tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM and PANTOPRAZOLE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced EPISTAXIS (2 nosebleeds within an hour), PAIN IN EXTREMITY (Arm is hurting), NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, EPISTAXIS (2 nosebleeds within an hour), PAIN IN EXTREMITY (Arm is hurting), NAUSEA (Nausea) and FATIGUE (Tiredness) 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.   2-3 hours after receiving the vaccine, the patient experienced a severe nosebleed. 45 minutes later she had another episode of nosebleed. She states that it was running like water and filled up the whole bathroom sink.   No treatment information was provided.  Company comment: 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.
Developed Alopecia Areata Universalis beginning three days after receiving third GARDASIL booster, Tetanus with Pertussis injection, and Flu vaccine.
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All    COVID VACCINE CLINIC 3/22/2021                                                                           Date:  3/22/2021                                                                                            Subjective Patient is a 42 y.o. female who was seen at  COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience racing heart and face tingling.  She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes.   ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, rash, hives, dizziness and headaches    +facial tingling:     Previous Reactions: Denies    Objective    Vitals Vitals:   03/22/21 0811 03/22/21 0819 03/22/21 0834 BP: (!) 153/90 134/87 118/85 Pulse: 87 80 80 SpO2: 98% 100% 99%      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Her symptoms completely resolved prior to discharge.        PA-C Electronically Signed 3/22/2021 9:02 AM
Myalgia, Fever, Fatigue Narrative: low grade fever, malaise, myalgias, took Tylenol OTC.
swollen nodes in armpit that same evening.; Sore neck glands 2days after shot; Swollen Lymph Nodes on right side of body.; Unusual Right knee pain next morning/day after shot; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the right arm on 24Mar2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN); all for unspecified indications, from unspecified start dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm on 03Mar2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 03:00, the patient experienced swollen lymph nodes on right side of body and unusual right knee pain next morning/day after shot, and gone by following day morning. On 26Mar2021, patient had sore neck glands followed by swollen nodes in armpit that same evening. Day 3 after receiving the vaccine, nodes were still swollen. All issues are on right side of body. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of right knee was recovered on 26Mar2021 and sore neck glands, swollen nodes in armpit, and swollen lymph nodes was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Chills; Metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) and CHILLS (Chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concurrent medical conditions included Diabetes.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-1900, the patient experienced DYSGEUSIA (Metallic taste in mouth). On 16-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, DYSGEUSIA (Metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported was the patient was taking blood pressure, antidiabetic and cholesterol medicines on daily basis.  No treatment medication was reported.
pt recvd vax 24AUG092 10AM & by 6PM pt was cranky & shaking, t102-105 until 8PM 25AUG92; APAP was given; pt c/o h/a, nausea, vomiting; mom sent pt to school 26AUG92;
Patient was vaccinated with a COVID 19 Moderna Vaccine at the age of 17 yrs and 9 months   No adverse reaction to vaccine reported
side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shot on Tuesday. The patient was experiencing side effects after receiving a Shingrix. The patient enquired how long would the side effects last.
Fever & chills Administered shingrix 0.5ml injection single dose in the muscle
Starting 12/23/2021, I started developing symptoms consistent with a flu: overall body aches, fatigue, sore throat and congestion. Fever was 101 for 2 days then the symptoms started to subside after that. I tested positive for COVID-19 on 12/24/2021 and 12/26/2021 via PCR tests. I remained out of work for 3 weeks due to the ongoing fatigue and ringing in the ears. Then, on 02/11/2022, I returned from a vacation and I felt like I had a blocked ear. It continued for 10 days. On the 11th day, I woke up with pain in the ear and almost total deafness. Since then, I have seen a serious of doctors: ENT and PCP. They initially treated it as an ear infection, but it never went away. Currently, they have diagnosed it at Mastoiditis. They are unsure what it may be caused by. The condition is ongoing and we are still trying to treat it.
fatigue, severe body aches making it hard to move at all, fever, sweats, severe headache making it difficult to see straight
Extreme sorness and pain upon raising arm and sleeping on right side continues to date, 2/8/2004.  Examined by a physician who felt there may be a hematoma in the muscle tissues.
Dizzy, diaphoretic, fainted, unresponsive for approximately 1-2min, woke up was coherent, BP 103/68, patient was stable and able to go home.
Got home, after eating dinner felt nauseous on the verge of throwing up, indigestion.  Very tired, and went to bed.  Started feeling sick during the night, knew something was wrong.  Could barely get out of bed, was hot, possibly low grade fever, had chills, was achy, bad headache like you feel when having the flu, weakness.   Took Tylenol and her regular medicines.  Today, 1/29/21 when she woke up still has extreme soreness, hot to touch.  She looked at her left arm and it's all swollen, red and itchy.  She's now afraid to go back for the 2nd vaccine.   Caller her pharmacy due to her arm and she was instructed to take Benadryl and Ibuprofen, which she only takes Tylenol.
Lost all sense of smell and taste; Lost all sense of smell and taste; Pain in the injection site; Chills that he could not shake; Upper arm discomfort; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 16Jan2021, the patient had upper arm discomfort. On 17Jan2021, the patient had pain in the injection site and chills that he could not shake. On 20Jan2021, the patient had lost all sense of smell and taste. The outcome of the events was recovered on 19Jan2021 for 'upper arm discomfort'; was recovering for 'chills that he could not shake'; was not recovered for 'lost all sense of smell and taste'; and was unknown for 'pain in the injection site'. The patient had COVID-19 test on 08Jan2021 (results were not provided).  Information about lot/batch number has been requested.
Diarrhea; Erythema; Cephalea; Arthritis; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 17Jan2022 19:15 (Lot number: FE3594) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1 manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 manufacturer unknown), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; ERYTHEMA (non-serious), outcome "unknown", described as "Erythema"; HEADACHE (non-serious), outcome "unknown", described as "Cephalea"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis". Therapeutic measures were not taken as a result of diarrhoea, erythema, headache, arthritis. No follow-up attempts are possible. No further information is expected.
Patient and family reported needing a booster dose of Moderna COVID-19 Vaccine.  Booster dose (0.25ml) was administered and it was later discovered that the patient had already received a booster dose from another provider on 12/14/21. No reaction/adverse effects have been reported by the patient, patient's family, or home health.
pt recv vax 15OCT96 & p/vax devel soreness for 3-4 days, then on 25OCT pt had pain in that area;arm hasn't stopped aching since then;doesn't feel that it is the joint but has limited ROM, pt has not yet seen MD;
Patient came to pharmacy 11/18/20 stating that the flu shot given was too high on the arm and developed tendonitis.  About 4 to 5 days after receiving the flu shot she experienced arm pain and had difficulty lifting her arm.  She went to the doctor and was diagnosed with tendonitis.  She was given meloxicam to treat the tendonitis.
I got the vaccine and went into menopause; I too have experienced menstruation changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENOPAUSE (non-serious), outcome "unknown", described as "I got the vaccine and went into menopause"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "I too have experienced menstruation changes".  Additional information: Patient reported she was not a conspiracy nut. She know that this is being studied right now in a scientific way, but she also know that it's not being taken seriously by some people in the scientific Community. But she want it on record that she too have experienced menstruation changes. She got the vaccine and went into menopause. She discounted this at first, as 45 is the youngest age that it is "normal" to experience menopause.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"Covid Arm", 2-3 inch diameter redness, pain, swelling, hardness with mild itching to injection site 24 hours after 2nd dose to left arm, (1st dose was also left arm). Applied heat 48 hours after injection with considerable relief of pain but still tender to touch.  It has been 72  hours and continue to have redness, swelling, firmness, mild itching, tenderness to touch
Became lightheaded/pale/weak. Heart rate dropped to 40's/BP dropped to 64/40, then she vomited within 10 mins, then recovered. This occurred within a few mins of getting vaccine administration.
The morning after receiving the Tdap, along with a trivalent flu shot, the patient reported jaw pain on the left side that "hurt like hell" and persisted for several days.
Initial headache, body aches, shaky hands and body,  swelling of fingers(pinky, ring and middle fingers of right hand), pain in finger joints(pinky,  ring and middle fingers)
Information has been received from a health professional concerning an 11 year old white female, with no allergies and no medical history, who on 10/14/99 was vaccinated with a SC first dose in the left arm of varicella virus vaccine live (lot 1130S). It was noted that she had an upper respiratory infection at the time of vaccination. It was reported that on 8/11/04, bumps were noticed on the patient's abdomen, and on 8/13/04 she was seen in the office and diagnosed with varicella. Supportive care was given and included acetaminophen, diphenhydramine hydrochloride, and calamine lotion. Subsequently, the patient recovered. It was also noted that her sibling, at 8 years of age, experienced varicella following vaccination with varicella virus vaccine live (WAES0408USA01569). Additional information is not expected.
15MAY97 pt recv vax 17MAY97 lt thigh doubled in size-red, hot, painful;temp low grade 24-36hr p/vax;
This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tight chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tight chest was not reported. This report was non-serious.
This is a spontaneous report received from a non-contactable reporter (consumer) via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. The reporter is the patient.  A 32 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 18Nov2021 at 15:00 (Lot number: FH8028) at the age of 32 years as dose 1, single for COVID-19 immunization. The vaccination facility type was a pharmacy or drug store. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies (NKA). The patient had no other vaccine in four weeks. It was unknown if the patient had COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset 19Nov2021 17:00, outcome "not recovered", described as "mental brain fog"; LIP SWELLING (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "Lip swelling"; SWOLLEN TONGUE (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "tongue swelling"; DIZZINESS (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "lightheadedness"; CONFUSIONAL STATE (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "some confusion"; BODY TEMPERATURE DECREASED (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "lower body temperature". Therapeutic measures were not taken as a result of mental impairment, lip swelling, swollen tongue, dizziness, confusional state, and body temperature decreased.  No follow-up attempts are possible. No further information is expected.
Initial report received from the patient on 18 May 2011. This case is not medically confirmed. A female patient reported that 30 years ago (date unspecified) when she was a child, she received a second dose of DTP (trade name, manufacturer name, and lot number unknown) and experienced a seizure following the vaccination. The outcome was not reported. The reporter declined to provide any further information regarding the event. She declined to provide any other contact information for follow-up, and she did not wish to be contacted any further. No further information is expected. The reporter for this case is the same as for case 2011-02909. Documents held by sender: None.