chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.
pt recv vax 27JUN97 255PM;3PM noted localized rxn, liquid DPH given;318PM c/o tightening of throat, 320PM epi given responded appropriately to Epi & recovered;4:30 d/c w/mom w/instructions to cont w/DPH
Joint problem, nose drips, hot sweats, 96 deg Temp. 10 days weak in bed
heart was inflamed; hospitalized and was diagnosed with a viral infection; feeling chills; feeling headaches; joint pain specially in leg; A spontaneous report was received from a consumer  concerning a 46 year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experience the following:  viral infection/ viral infection, heart was inflamed/ carditis, feeling headaches/headache, joint pain specially in leg/ arthralgia, and chills.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 05 Feb 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly for prophylaxis of cCovid-19 infection.    On 05 Feb 2021, the patient started to have headaches and joint pain specially in the leg. The reporter stated the headaches and joint pain stopped, then came back this month (March).  The patient also stated they started feeling chills this month (March) as well. She was hospitalized (dates not reported) and was diagnosed with a viral infection and was told her heart was inflamed.   Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, viral infection, heart was inflamed, feeling headaches, joint pain specially in leg, and chills, were considered unknown.; Reporter'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 except for the events of headache, arthralgia, chills, and carditis.  The event of viral infection is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Myalgia, Fever, NauseaVomiting, CHILL/FATIGUE./BODY SHAKING Narrative:
11AM, 10/22/13 school called mom to notify her of edema with induration at site of injection mom applied ice and topical BENADRYL. 3PM, 10/23/13 mom went to Doctor since rash progressed to chest, arms and legs. Given oral BENADRYL and prednisone. Told to return if symptoms progress.
Day 2 my arm was sore as expected but over the days I felt nauseous and lower abdominal pressure and discomfort, I feel loped a welt on my left thigh then my abdominal pain increased and I felt a lot of pressure in my womb area then my left ovary became swollen and very tender (I am not sexually active) I took Motrin for the pain, it started to radiate toward my thigh it hurt to even touch this is going on the  fourth day and it seems to be going away, there still is a slight discomfort in my lower abdomin but not as bad as before. The tech who gave me my shot did a great job but I do believe this was a reaction to the vaccine.
Prevnar 13 Vaccine syringe broke into two pieces when the needle was screwed onto the syringe; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 07Apr2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group,  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EW2019, Expiration Date: 31Dec2023) for immunisation, Device Lot Number: EW2019, Device Expiration Date: 31Dec2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Prevnar 13 Vaccine syringe broke into two pieces when the needle was screwed onto the syringe". Additional information: It was reported that Prevnar 13 vaccine syringe broke into two pieces when the needle was screwed onto the syringe. The glass is still connected to the vaccine, which was further clarified that the piece where syringe is, caller doesn't know what the little piece is called, the area where the neck of the syringe screws into the vaccine is connected to the needle. It was also reported that the sample was available for return and it was confirmed that there was no patient involvement.  No follow-up attempts are possible. No further information is expected.
Left upper arm with wide red area below injection site. Measures about 7 x 7 cm spreading down to elbow then medial down lower arm about 1cm below her elbow. T 98.2, P 96, R 18, BP 151/91. Area is warm to touch with heat radiating from red area.  12/15/05 Review of D/C summary indicates final diagnosis of cellulitis L arm (site of pneumococcal vaccine). Arm was described as erythematous, swollen and uncomfortable. Treated with Timentin IV for 24 hours. She did develop some wheezing overnight in hospital and attributed it to the new carpet being put down near her room. She was treated with nebulizer and Solu-Medrol. She was d/c on PO prednisone in 3 tapered doses and albuterol inhaler two puffs qid.
Initial unsolicited report received from a physician on 8 September 2015. This case involves a 36 years old female patient who was vaccinated with a first dose of Flu vaccine (batch number, dose, route and site of administration were not reported) on an unspecified date in 2014. Illness at time of vaccination and concomitant medications were not reported. On an unspecified date in 2014, within three hours following the vaccination, the patient experienced coughing and wheezing, and then became disoriented, "feeling of doom". The patient sent to emergency room and the patient was treated for anaphylaxis. It was reported that "Patient states since this reaction has not "felt well" after eating eggs." Lab data was not reported. The patient received corrective treatment with oral dose with BENADRYL. The outcome of events were unknown. List of documents held by sender: none.
harder to breathe after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (harder to breathe after getting the vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M204) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DYSPNOEA (harder to breathe after getting the vaccine). At the time of the report, DYSPNOEA (harder to breathe after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided
Patient given Moderna 6/10/2021 Lot # 040B21A Rt arm .5 Patient given Pfizer .3 Lot# PAA165 Rt Arm 7/8/2021 *Medication* *ERROR*
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient was over 50 years old. The patient received dose of SHINGRIX around holiday weekend and the patient experienced pain or soreness at injection site that lasted about a day. The reporter agreed to be followed up from GlaxoSmithKline. For tolerance to 2nd dose see case US2019GSK005377, reported for the same patient.
6 hours after shot - uncontrollable chills for 4 hours. 18 hours after shot vomiting. 24 hours after shot fever of 101.3. Dizziness and weakness for 5 days.
Really sore arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 23Jun2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism for which patient hadn't taken any medicines for a while. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 19:45, the patient experienced really sore arm, especially on the first day. The patient stated that the vaccine was magnetic, a friend came up to the patient with a magnet and said they heard from somewhere that it was magnetic. To the patient's surprise the magnet stuck to the injection site, she quickly jerked it off because it felt really funny like it was pulling something out and it hurt a little. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event really sore arm was unknown at the time of this report.
23 hours following vaccination, uncontrollable and persistent cough with excessive mucus production and runny nose that did not respond to codeine, vomiting.  Injection site swelled to size of an egg that day with erythema and tenderness.  Could not speak because it would result in uncontrolled coughing.  Morning of day 3 a macular rash was noted in the lower lumbar region and under the breasts and upper abdominal wall.  Diphenhydramine 25 mg  qd was begun and continued for the next 3 days, without response.  Day 7, after the injection site faded from erythema to mild hyperpigmentation, swelling increased and erythema returned.  Morning of Day 8, injection site was very warm to touch and swelling the size of a baseball.  Evening of Day 8, increased diphenhydramine to 50 mg qhs then 25 mg the next morning and every 4 hours thereafter and symptoms began improving on Day 9.  Day 10 injection site began to fade and become slightly hyperpigmented.  Diphenhydramine was discontinued on Day 12 on the advice of an allergist, who recommended transition to Zyrtec because it is longer acting.  Day 14 symptoms and signs completely resolved.
Fatigue, muscle aches, joint pain, redness, swelling and pain at injection site.  All symptoms 18 hours post injection time.
Myocarditis chest pain, SOB with elevated troponin and CK, ESR and CRP. No signs of ischemia on echocardiogram
Vaccine administered to patient. Fridge temperature went out of range by 4 degrees overnight on Sunday due to storm, health department was closed 1/17/2022.
patient got GB from the flu shot; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a female patient(age not reported) who experienced GB (unevaluable event), while she received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed non-serious GB (unevaluable event) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. it was assumed that the consumer was referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
On 8/20/99, the pt was seen in the ER with an injection site reactions characterized by a painful 2-inch palpable mass. He was treated with ice and Tylenol.
A month after I was tried all the time, struggling to get through the day. I feel down a couple of times. I had dizzy spells. Fatigue.
Soreness at injection site lasting at least 12 hours (do not recall any adverse symptoms for doses 1-4)
Headache, Myalgia, tired, shortness, of breath,  Narrative:
11/22/2017: dull left lateral thigh pain that resovled in 3-4 days. 11/27/2017-11/28/2017: burning sensation in bilateral anterior thighs and bottoms of feet that resolved in 1 day. 11/29/2017: cramping in bilateral hamstrings that resolved in 1 day 11/30/2017: seen in Urgent Care for right cheek numbness in a V2 distribution. 21/1/2017: seen in Neurology clinic. Area of numbness in smaller and sensation returning to baseline.
Rash began on right anterior lower trunk.  Started itchy and had become sharp, pin point pain.
After my 2nd dose, what I was experiencing woke me in the middle of the night out of a sound sleep: teeth chattering, uncontrollable shivering, could not get warm even under multiple layers of clothes, sheets and a comforter.  I was able to sleep on and off for a few hours.  When I woke for work around 8am, I felt like I had been run over.  Every muscle in my body ached, and I felt exhausted and slightly dizzy.  I could not get warm for the next few hours.  Finally, around 1pm on 5/7, I crawled under an electric blanket to finally get warm, and napped for a bit.  When I woke up a few hours later I was beginning to feel better.  By the time I went to bed on 5/7, I felt practically back to normal.  Other than the dizziness, which has continued on and off until the present time.
Felt warm; Felt like heart was going really fast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt warm) and PALPITATIONS (Felt like heart was going really fast) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING HOT (Felt warm) and PALPITATIONS (Felt like heart was going really fast). At the time of the report, FEELING HOT (Felt warm) and PALPITATIONS (Felt like heart was going really fast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Extreme fatigue for 4 days, sleeping deeply and continuously for 10-12 hours (sleeping thru alarms), waking briefly, uncontrollable urge to go back to sleep thru 3rd day, then able to be up for a few hours then back to sleep. Only other side effect very sore arm and stiff neck 1st 48 hrs.
Vaccine administered at approximately 9:45 am.  Approx. 1 hour later patient "felt weak, felt like "heart was palpitating," had the shakes, was breathing hard and felt faint."  Wife states she took him to ER.  He was discharged with Benadryl and a "steroid pack."
Lost vision on her right eye; Numbness in Right side of Face; Numbness in  lip/Numbness in tongue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLINDNESS (Lost vision on her right eye) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O32M209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL (TENORMIN) for Hypertension, HYDROCHLOROTHIAZIDE for an unknown indication.    On 12-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 BLINDNESS (Lost vision on her right eye) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in Right side of Face) and HYPOAESTHESIA ORAL (Numbness in  lip/Numbness in tongue). On 12-Mar-2021, BLINDNESS (Lost vision on her right eye) had resolved. At the time of the report, HYPOAESTHESIA (Numbness in Right side of Face) outcome was unknown and HYPOAESTHESIA ORAL (Numbness in  lip/Numbness in tongue) had not resolved. Not Provided      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.   Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Vaccine Start date updated.
hive like rash that went up her arm and neck; swelling in throat; This case was reported by a nurse vi and described the occurrence of rash urticaria-like in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced rash urticaria-like and throat swelling. On an unknown date, the outcome of the rash urticaria-like and throat swelling were unknown.   It was unknown if the reporter considered the rash urticaria-like and throat swelling to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced a hive like rash that went up her arm and neck and swelling in throat. No further information was provided.
Patient came in and complained at pain and swelling at injection site. Right arm was swollen. Doctor prescribed Ibuprofen and to return if symptoms worsen or fail to improve.
PFIZER VAC COVID 5-11 WAS GIVEN AFTER SEPT 30TH EXPIRATION DATE, HOWEVER PFIZER STATES IT'S GOOD UNTIL 10/19/22
Patient was out of town and stopped into a local pharmacy. She was advised to go to urgent care. Her arm had grown increasingly red, swollen, painful. Per information from patient, MD at urgent care wasn't sure if she had developed cellulitis or was experiencing a reaction.  She was prescribed Doxycycline and Prednisone.
after 15 minute obs pt still complaining of lightheaded, dizzy blurry vision
SPORADIC MUSCLE CRAMPING IN LEFT LEG; EXHAUSTION; FEVER 100.4; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 32 year old of unspecified sex. 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced sporadic muscle cramping in left leg. On 12-APR-2021, the subject experienced exhaustion. On 12-APR-2021, the subject experienced fever 100.4. On 12-APR-2021, the subject experienced muscle ache. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exhaustion, fever 100.4, muscle ache, and headache on 12-APR-2021, and had not recovered from sporadic muscle cramping in left leg. This report was non-serious.