chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 03-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
fever; nausea; Lack of appetite; increased tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-month-old patient received BNT162b2 (COMIRNATY), 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: PYREXIA (non-serious), 3 hrs after the suspect product(s) administration, outcome "recovering", described as "fever"; NAUSEA (non-serious), 3 hrs after the suspect product(s) administration, outcome "recovering"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Lack of appetite"; FATIGUE (non-serious), outcome "unknown", described as "increased tiredness". Therapeutic measures were taken as a result of pyrexia, nausea.  Additional information: Symptoms reduced with dosage of Tylenol 2.5 ml. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
22 hours later had fever of 102.5 degrees, 103 degrees on the next day, controlled by TYLENOL/MOTRIN every 4 hours. Called doctor the first day but was told it was probably viral. Fever lasted 3-6days. Went in to see doctor on 2nd day sent home no treatment was given. On 2/28/09 rash appeared on chest/back/neck, towards head, also complained of pressure on chest, muscle aches fever. Doctor advised parent to take child to ER; was there for 7 hours and then released. Today still feel tired, weak, rash has gone away.
Joint pain in left arm/arm joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in left arm/arm joint pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced ARTHRALGIA (Joint pain in left arm/arm joint pain). At the time of the report, ARTHRALGIA (Joint pain in left arm/arm joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had came home the next night after work and took a bath and starting itching with dry skin.
Diarrhea; Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip; Hives broke out on blisters; Redness on fingers; Hives broke out with blisters, itching; Tired, wanted to sleep, fatigue again; Really hungry; R hand fingers and palms itching that come and go; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go), DIARRHOEA (Diarrhea), PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip) and BLISTER (Hives broke out on blisters) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, METOPROLOL, AMLODIPINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go) and FATIGUE (Tired, wanted to sleep, fatigue again). On 16-Mar-2021, the patient experienced PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip), BLISTER (Hives broke out on blisters), ERYTHEMA (Redness on fingers) and URTICARIA (Hives broke out with blisters, itching). On 17-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with HYDROCORTISONE (ITCH-X [HYDROCORTISONE]) for Itching, at an unspecified dose and frequency. At the time of the report, HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go), DIARRHOEA (Diarrhea), PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip), BLISTER (Hives broke out on blisters), ERYTHEMA (Redness on fingers), URTICARIA (Hives broke out with blisters, itching) and FATIGUE (Tired, wanted to sleep, fatigue again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: unk (normal) blood pressure stable.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An 85 year-old female patient of an unspecified race and ethnicity received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen arm for 10 days after the vaccination. Outcome was recovered.
Patient received Yellow Fever Vaccine on 11/04/2016 (Lot: UI293AA and Exp: 04/20/2018 Reconstituted with Sodium Chloride Diluent Lot: UI564AA and Exp: 11/2019 Administered by RN.  Patient developed an oval, red and raised area to the left arm due to the injection or the vaccine itself.  Dr. was made aware and she saw the patient.  She stated she wants the patient to come back on Monday and see me regarding the swelling and soreness.  She also prescribed the patient medication to take. A Stars report and a Vaer's report will be entered regarding this adverse reaction. Thank you.
Patient stated she received the H1N1 vaccine on 1/5/10 and on the evening of 1/6/10 started to have chills (could not get warm), weak, nausea.  She stayed in bed all day on 1/7/10.  Feeling a little better by the evening of 1/7/10.
Presented to ED w/sob, hypoxia, dx COVID 8 days; admitted for COVID pna; tx w/abx & steroids; dc'd on po abx and steroids and on room air.
pt reports day of vaccination having typical mild arm soreness with movement but the next 5 days had severe arm pain and now has had persistent arm pain and decreased ROM
Numbness in the site of the injection which is the left side, my arm, only on the left side; Bloody nose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 04Jan2021 on the left arm at a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On an unspecified date, the patient had numbness at the site of the injection which was the left side (arm), and only on the left side; and had bloody nose. The patient had received treatment for the reported adverse event. The outcome of the events, 'numbness at the site of the injection' and 'bloody nose', was unknown.
After the second dose  of moderna, in the afternoon around 3pm, I began feeling feverish.  By the time I got home around 6pm, I had a fever of 101.8, chills, body aches, and was sniffling.  The symptoms stayed the same the next day with now having congestion and cough.  The fever only lasted two days,  but the body aches, congestion and coughing continued for a week.  After that, I continued with congestion and cough; and now my left ear hurts.  I have not been able to get rid of those symptoms.  I    just saw doctor today, 4/16/21, and he stated he will order labs.
Out of my left eye, I saw shooting stars, like I was having a stroke, or something; laid out & shivering; Inappropriate schedule of vaccine administered; had flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu-like symptoms), FEELING ABNORMAL (Out of my left eye, I saw shooting stars, like I was having a stroke, or something), CHILLS (laid out & shivering) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (had flu-like symptoms), CHILLS (laid out & shivering) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-May-2021, the patient experienced FEELING ABNORMAL (Out of my left eye, I saw shooting stars, like I was having a stroke, or something). At the time of the report, INFLUENZA LIKE ILLNESS (had flu-like symptoms), FEELING ABNORMAL (Out of my left eye, I saw shooting stars, like I was having a stroke, or something), CHILLS (laid out & shivering) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high cholesterol I've had blood work done. Everything shows up normal. It did show high cholesterol.         No Concomitant product use was reported.  The patient received second dose of Moderna Covid-19 vaccine on 06-May-2021 and on the same day the patient was laid out and shivering and had flu-like symptoms.  On approximately 08-May-2021, Out of patient's left eye, the patient saw shooting stars, like the patient was having a stroke, or something. It was also reported that the patient had seen doctors and they said there were no conditions. Reportedly, the patient had blood work done and everything showed up normal, but it did show high cholesterol.  No treatment information was provided.   This case was linked to MOD-2022-513804, MOD-2022-513827 (Patient Link).
she was sick over the weekend; This is a spontaneous report from a contactable consumer (patient sister). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had second dose of vaccine and she was sick over the weekend she does not know if that is relevant. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Had no energy at all; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Had no energy at all) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced ASTHENIA (Had no energy at all). On 29-Oct-2021, ASTHENIA (Had no energy at all) had resolved.            No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.  Patient received the regular flu shot two weeks ago (did not specify date).   This case was linked to MOD-2021-369248 (Patient Link).
Within one week of second shot on 02/07/2002, the pt developed a raised rash on back of right leg where shot was given. This lasted for over a month and a slight rash still exists on that leg. Two weeks after the shot she was sick with a cold and fever. Also, she was irritable for one week after both shots (1st and 2nd).
Pain in my lymph node areas,foot,groin especially on my left side.the pain comes and goes and it moves to different area
swelling and redness around both eyes, rash/hives on left arm, upper chest and abdomid I was given an oral steriod (unknown) given a pepcid, and perscriptions for pepcid, benedryl, and calamine lotion eye swelling was partially reduced, itching could be controled wit benedryl and calamine, as of today 1/8/2021 I still have some redness and swelling around the eyes and also still have the hives and itching
felt like she was going to have a stroke; weakness; head throbbing; could not walk; head felt like it would explode; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2019, the patient received the 1st dose of Shingrix. On 4th April 2019, 1 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant) and weakness. On 5th April 2019, the patient experienced head throbbing, unable to walk and head pressure. On an unknown date, the outcome of the stroke, weakness, head throbbing, unable to walk and head pressure were recovered/resolved.   It was unknown if the reporter considered the stroke, weakness, head throbbing, unable to walk and head pressure to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient received dose of Shingrix in the pharmacy. On the same night of the day of vaccination, the patient felt weak and the next day the weakness was worse that the patient could not walk without assistance. On 5th April 2019, the patient's head was throbbing and get worse and felt like was going to to have a stroke and her head felt like it would explode. The patient took 2 weeks, to feel better. The patient did not want to take 2nd dose, and get encouraged to discuss this with health care professional. The patient consented to follow up. The patient know the 2 other patients with adverse events after the Shingrix shot, she would give them the number to report their experiences. Hence 2 cases were created for same. This case was 1 of the 3 cases reported  by same reporter.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored doses of GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This was the Pfizer Booster shot. The adverse effect and events were: Slight Fever the next day (101 degrees), Seizure occurred the day after the booster 11 December, 2021: completely blacked out, convulsed/twitched, and was transported to the ER for blood tests and observations, CT Scan and MRI were conducted, Two subsequent seizures have occurred within 10 weeks of the first seizure, Prescribed Keppra while EEG is being scheduled.
This spontaneous report as received from a certified medical assistant refers to an adult patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with M-M-R II (lot # N002337; expiry date: 20-JAN-2019) by intramuscular injection rather than subcutaneous (inappropriate route of vaccination). No adverse effects reported. The outcome of the events was unknown.
Headache, Myalgia, Arthralgia, arm pain and swelling Narrative:
About one hour after receiving the vaccination I got a strong, terrible tasting metallic taste in my mouth.  Seriously like I had a mouthful of copper pennies in there!  It has now been 4 hours later and it is still there, yucky.  Food, drink, gum, etc and it is still there.
Severe headache at approximately 3:330 am on Sunday April 11th,  took two extra strength excedrin,  (day after vaccine).  didnt help much.  Stomach pain started on Monday 4/12. nausea, felt like I was in a fog, very very tired. Called primary on Tuesday the 13th and was instructed to go to ER. Waited 8 hours and was unable to see MD for another 10 hours due to ER was 20 hours behind. I left and continue to have stomach discomfort, nausea, headache, chills, body aches, shortness of breath on exertion, lethargy, and brain fog.
3 days of right side back pain. I couldn't stand up straight for 3 1/2 days .The pain was horrific, it felt like back pain. I didnt go to the Dr or Hospital. It subsided and I didnt get my second shot out of fear.  Please let me know if I should get the second one.
shingles; This case was reported by an other health professional via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 3Z53C, expiry date unknown) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix. On 13th April 2019, 5 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the patient presented with a case of shingles on 15th April 2019, symptoms began on 13th April 2019.  The patient came to office where the physician diagnosed shingles.  The reporter could not rule out if the event is related to the receiving the shot a week earlier. The reporter did agree to follow up from GlaxoSmithKline.
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (Lot number L028281 and expiration date 28-OCT-2016) administration route reported as intramuscular (dose and strength were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 12:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was not aware of any allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN)  ROVUSTATIN and MULT-VITAMIN from an unknown date, for an unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 03Apr2021, at 14:30 the patient experienced nose bleeds. It was reported that the patient experienced nose bleeds (heavy) started on 04Apr2021 and have recurred on subsequent days, no particular changes in activities or exercise habits.  On 15Mar2021, the patient underwent blood test and the result was negative. The patient did not receive any treatment for the reported adverse event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nose bleeds was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Medical Assistant and  refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 09-JUN-2017, the patient was vaccinated with an unspecified dose of VAQTA intramuscular for prophylaxis (lot # M031695 with an expiration date of 26-MAY-2017) (dose and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Bleeding 2 weeks prior to period; This is a spontaneous report from a contactable other-HCP (patient herself). A 40-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0193, Expiry date: Unknown) via an unspecified route on 02Jun2021 at 14:00 (at the age of 40-years) as 1st dose, single dose in the right arm for COVID-19 immunisation. The patient medical history included anaemia. The patient concomitant medications included fluoxetine 40 mg (FLUOXETIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Jun2021, the patient experienced bleeding 2 weeks prior to period. The outcome of the event was not recovered.
At 8 pm on the same day of vaccination, patient experienced headache, upset stomach, terrible pain on the right arm and felt hot to touch/inflammation at injection site. Patient emphasized it's very severe for her. However, it was improved on Sunday (no more headache/upset stomach), but there is still sore (difficult with range of motion).