chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke; face sunk in and changed/Bells Palsy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 16Mar2021 at 14:00 as a single dose for COVID-19 immunization. Medical history included a mild case of COVID-19, last year, on an unspecified date in 2020. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks of the COVID vaccine. On 21Mar2021, the patient's face sunk in and changed. The patient's symptoms were not improving. Her eye and right side of her face are affected. She cannot close her right eye. She worked on it and is now able to close right eye not like the left eye closes, but it doesn't blink as the left eye does. She has been using eye drops for this. She said it was Bells Palsy. The patient added that it is hard to look in the mirror. She will not get the second dose. She was not interested in taking the vaccine now.  She wanted to wait and see. It being so new and see. Her sister took it and encouraged her, and said it is necessary because they like to travel. She got Prednisone when she was at the hospital, they gave her 60mg Prednisone. Her physician didn't want to keep her on it too long and said it may cause other complications.  Her physician cut her off, she weaned her down 50mg, 40mg, 30mg, 20mg, then 10mg. When the patient noticed her face start to turn, she went to the ER. She thought she was having a stroke. The patient was not admitted to the hospital. The outcome of the event face sunk in and changed/bells palsy was not recovered while the outcome of the event stroke was unknown.
I have been having upper right arm pain for a while now, this has happened in the past, I cannot remember the exact year, but it was about  10 years ago, maybe. That pain lasted about 6 months and just went away on it's own. At the time I had mentioned it to my PCP but she said that she had never heard of arm pain after so many months  as a reaction to a flu shot. At that time, I could not even lift my arm to dress myself, it was very painful but like I said it went away. This time, I felt it again and thought oh no, before when I would tell people of my reaction to it before they looked at me like I was weird. This time I googled it and found that there is such a thing now.  This is where I got the information to this site. The deltoid muscle can get pinched and can be very painful. I knew I was not crazy. I am having pain now everyday, as the day goes on my arm just gets painful, there are times when I have to literally lift my arm up with my other arm to move it while I'm in bed. I have muscle relaxers that I was given by my PCP for my lower back pain that I use when the pain is so bad on my arm  and then I can get some sleep.  I have read articles on it and have found that a MRI can be helpful in determining how bad it is. I have not gone to my Dr yet regarding this and it's just because I do not want to take the time to do all the visits that will probably be involved and also the cost of the MRI. I have medical insurance but I'm sure there will be a deductible that I have to meet.
6:00 pm right eye swelling, given OTC Triamedic. 9:30 pm to bed.  11/12/2009 at 6:30 am woke up with R side of face swollen. Had received seasonal flu shot on 10/27/2009 at PMD office.
Patient reported swollen at site of injection and rash and itchiness 2 days after vaccine was administered. Went to her physician he reported to her that she is allergic to the vaccine. He also gave her an antibiotic treatment.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via agency (Pfizer) concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (unspecified). The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: unknown) dose was not reported, 1 total administered on 03-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 45 years old. Concomitant medications included hydrochlorothiazide/olmesartan medoxomil, levothyroxine/liothyronine, and montelukast. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1).  The patient received two doses of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran), (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 017E21A expiry: unknown) dose was not reported, administered on 20-SEP-2021 to left arm and (form of admin, route of admin were not reported, batch number: 040C21A expiry: unknown) dose was not reported, administered on 22-SEP-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received booster with non-company suspect vaccine Moderna covid-19 vaccine (elasomeran), (Dose number in series 3) (batch number: 026L21B expiry: unknown, form of admin, route of admin were not reported) dose was not reported, administered on 25-MAR-2022 to left arm for covid-19 prophylaxis. On an unspecified date in 2022, the patient experienced suspected covid-19 infection (Dose number in series 3) The patient received non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: GA8778, expiry: unknown) dose was not reported, administered from 13-JUL-2022 to 17-JUL-2022 for treatment of COVID-19. On 22-JUL-2022, the patient experienced rebound post Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Dose number in series 2), elasomeran (Dose number in series 3) was not applicable and with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Awful itching  and very bad breakout  on back, upper and lower!  The first breakout not as bad as breakout from second SHINGRIX dose on 02/24/2021  ( 1st was listed earlier, 11/02/2020 )  The itching is almost unbearable, NEVER AGAIN!!!!  Also left with very black spots all across back!
1/8/21 DURING DAY: FATIGUE AND HEADACHE STARTED; DURING EVENINGS: CHILLS, BODYACHES, JOINT PAIN, SORE THROAT, AND FEVER (100.9 WHILE ON EXTRA STRENGTH TYLENOL). SATURDAY MORNING: RED, HOT, WELT (ITCHY AT TIMES) AND STOMACH ISSUES. TOOK ADVIL AND EXTRA STRENGTH TYLENOL.
On 1/15/21 I had pain in my right armpit upon raising my arm and a red swollen, itchy area about three inches wide at the injection site.  My primary care doctor prescribed Cephalexin 500 mg po tid which I began taking at 3 PM on 1/15/21. On 1/16/21 the redness and swelling continue to grow larger on my whole upper left arm. On 1/17/21 the redness and swelling was across a greater area and included the bottom of my arm.
During registration process, patient verbally denied to staff having received any COVID vaccine prior to 6/18/21. After vaccination with the Janssen dose - patient divulged she had received the Moderna vaccine "more than a month ago".  Patient refused to provide a telephone number to be contacted. CIR indicates that the Moderna doses were administered 3/4/21 and 4/1/21.
Can't use her left arm; Very sore left arm from injection; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Can't use her left arm) and PAIN IN EXTREMITY (Very sore left arm from injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LIMB DISCOMFORT (Can't use her left arm) and PAIN IN EXTREMITY (Very sore left arm from injection). At the time of the report, LIMB DISCOMFORT (Can't use her left arm) and PAIN IN EXTREMITY (Very sore left arm from injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no  concomitant medications are provided. treatment to the events not reported.
Had a 1 minute seizure the next morning around 9:15 (7/23/2022) Pt last seizure was approximately 9 years ago
General Malaise, Lightheadedness, Sleepy, Extended Throbbing Upper Left Arm, Excruciating Upper Left Arm Pain, Limited Left Arm and Shoulder Mobility
None- vaccine given 17 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient was given vaccine 17 days post expiry date. No treatment medication information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
14 year-old was given the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old was given the Moderna vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old was given the Moderna vaccine). On 17-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old was given the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Pt states that on Monday she noticed that she couldn't put pressure on her leg to walk. (04-12-21) Pt called and made an appointment on 04-13-21 and saw her PCP. Ultrasound was ordered  and was dx with near occlusive vein thrombosis  in the distal right femoral vein. Pt was prescribed Lovenox 100mg to take now and was also prescribed eliquis 5 mg twice daily, and  acetaminophen-codeine to help with the pain.
Arm sore Tired Nauseous Night sweat  Fast heartbeat, pulse Extremely jittery  Hot flashes Ocular migraine  Vivid dreams  Trouble focusing and remembering what I?m doing/saying  Heartburn? Not sure if that?s the right word but a pain/tightness in chest  The need to do a little cough Feels like not enough breath to talk  Wrist pain (feels like my blood is too thick or something. No other way to describe it)
Fever, muscle ache, shortness of breath, nausea, vomiting, diarrhea, weakness
pt recvd vax & devel erythematous area at inject site & hives;
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two shelters.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Call to agency, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
Shortly after receiving the injection my left arm locked up and was painful to move for around a day. Injection site soreness lasted about a week and impacted activities such as sleep (I was unable to sleep on my side as I usually do and would waken if I rolled on my side). Additionally, muscle and joint pain appeared shortly after the injection and lasted the better part of the following two weeks. Dizziness and headaches also occurred shortly after the injection and would erratically start and stop over the following two weeks. Fatigue and loss of focus have also appeared after getting vaccinated.   While the muscle and joint pain have largely subsided, the headaches and dizziness have not even though they have become less frequent. Fatigue and difficulty focusing have persisted.
Left Arm swelling in muscle at injection site  approximately 7 days post  Moderna (mRNA-1273) injection; pain to touch and when lifting arm above head.
Information has been received from a nurse concerning a 35 month old patient who on 16-JUN-2010 was vaccinated with a dose of VARIVAX (Merck) (lot# 666344/1657Y). The nurse mentioned that on 12-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow up information has been received from a registered nurse refers to a 3 years old male patient. The patient's medical history included contact dermatitis and bronchiolitis and none illness at time of vaccination. The patient was vaccinated subcutaneously in right leg with a first dose of VARIVAX (Merck) (dose not reported, lot # (666344/1657Y) on 16-JUN-2010. It was reported that the patient came to the clinic on 12-JUN-2012 with rash described as "erythematous papules some with vesicles on arm, legs, buttocks, few on face. Lesions appearing in different stages and some had crusted over becoming confluent on left forearm". Patient was diagnosed with varicella. No lab diagnostic tests were performed. At the time of the report the patient's status was unknown. This is one of several reports from the same source. Additional information is not expected.
Rapid onset in fever and myalgia.  Dyspnea and hypoxia developed over days, and eventually patient was hospitalized with bilateral pneumonia consistent with COVID-19, however patient had multiple negative tests for SARS-CoV-2, both antigen and PCR.  Patient eventually diagnosed with interstitial lung disease prior to expiring on 4/7/2021.
This spontaneous report as received from a Nurse refers to a 1 year old patient of gender. On 30-MAY-2014, the patient was vaccinated with PROQUAD (Merck) for (dosing regimen unspecified). Other suspect therapies included on 30-MAY-2014, VARIVAX (Merck) (dosing regimen unspecified). On 30-MAY-2014, reporter reports that a 1 year old child was inadvertently administered PROQUAD (Merck) and VARIVAX (Merck) on the same day. No adverse effects reported. There was no product quality complaint involved. The outcome of PROQUAD (Merck) and VARIVAX (Merck) on the same day was unknown. Additional information has been requested.
This spontaneous report as received from a consumer concerning a 5 year old male patient. The patient's had no concomitant medications, pertinent medical history and drug reactions or allergies. On 12-NOV-2018, the patient inadvertently was vaccinated with ZOSTAVAX for prophylaxis (dosing detail, route, lot# and expiry date not reported). On the same day, the patient developed a rash on his stomach and high fever. The patient spoke to the physician and took unspecified dose of ibuprofen on unspecified dates. On 14-NOV-2018, the patient's fever resolved. On 16-NOV-2018, the patient recovered from rash. The reporter's causality assessment was not provided. No product quality complaint was involved.
It was reported to me as the vaccine administration site that this person who was vaccinated last week developed very high blood pressure yesterday and was admitted to the hospital.  He is currently an inpatient at medical center.  I have not other information other than this.
The patient did not have an adverse reaction, however the shot was given to her prior to her 18 birthday.  She is currently still 17 and will turn 18 on date.
Chest pain (retrosternal with left side radiation, then becoming more generalized) 1 day following vaccine administration
severe diarrhea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter was to report a possible side effect. The patient experienced severe diarrhea in Jan2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 14-JUL-2017 the patient was vaccinated with an incorrect storage PNEUMOVAX 23 lot # M042324, expiration date on 10-JUN-2018; lot # N001007 expiration date on 09-SEP-2018; and lot # reported as M044564, expiration date on 22-OCT-2018, or prophylaxis. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1708USA002800: Original Case: 1708USA002800.
Got shingles 4 days after second dose; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0189) via an unspecified route of administration in the left arm on 20Apr2021 at 10:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 10:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Apr2021 at 13:15, 4 days after second dose, the patient experienced shingles. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of reported event which included treatment with valaciclovir hydrochloride (VALTREX). The clinical outcome of event shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected. .
patient had rash at injection site and itchiness all over body starting approximately 2 hours after dose . Patient applied hydrocortisone cream on rash and used diphenhydramine capsules to help with the itch...patient reported in the morning after receiving dose . With follow up call 8 hours later patient stated itching and rash improving . will continue treatment until gone
2 hours after receiving the vaccine, I grew exhausted and had to sleep into late evening and was chilled,  had a fever of 101 and developed severe pain and inflammation on the top of my collar bone that was feverish and migrated toward my shoulder region on the same side as my vaccine. Ibuprofen would not help with the pain but helped with the fever. My mind told me that I had things to tend to the next day, but still was forced to sleep off and on for 2 more days. After a week and a half, not only did I have thirst, but also food didn't taste right and was metallic.  This lasted for 2 days and finally my taste was restored. The exhaustion lasted off and on for 2 weeks and I just listened to my body. The pain and inflammation on my collar bone has subsided 4 days ago but still have pain in my shoulder when I sleep.  On April 5 around 8:30 a.m. a nasty virus hit me out of the blue. I grew week and tired and had to go to bed. I slept all day until around 9:00 p.m. and woke to uncontrollable diarrhea and fainting spell while in the bathroom. I had abominable pain and nausea that last for a half hour and then I returned to bed. The next 2 days, I was week and exhausted but continued with my regular routine.  My equilibrium is still affected from time to time.
Information has been received from a registered nurse who "heard" about a female patient that was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported) and developed seizures which reoccured. The female did not have seizures prior to the vaccination. Nurse stated this did not happen at her medical facility and she had no other information regarding this event. The patient's outcome was unknown. Upon internal review seizure was considered to be other important medical event. No further information is available.
Pt recvd 3 doses of Engerix-B & exp no medical problems or reactions;
Hand injury; Musculoskeletal disorder; Edema legs; Shortness of breath; Atopic dermatitis; Unevaluable event; Intentional dose omission; Skin breakout; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Hand injury), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath) and DERMATITIS ATOPIC (Atopic dermatitis) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB injection for Atopic dermatitis and Nasal polyps.    No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient started DUPILUMAB (Subcutaneous) 600 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB INJURY (Hand injury), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath), DERMATITIS ATOPIC (Atopic dermatitis), UNEVALUABLE EVENT (Unevaluable event), INTENTIONAL DOSE OMISSION (Intentional dose omission) and RASH (Skin breakout). The patient was treated with PREDNISONE for Limb injury and Musculoskeletal disorder, at a dose of 1 dosage form. At the time of the report, LIMB INJURY (Hand injury) and MUSCULOSKELETAL DISORDER (Musculoskeletal disorder) was resolving, OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath), DERMATITIS ATOPIC (Atopic dermatitis) and UNEVALUABLE EVENT (Unevaluable event) had not resolved and INTENTIONAL DOSE OMISSION (Intentional dose omission) and RASH (Skin breakout) had resolved.            Concomitant medication was not provided.  Action taken with respect to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: TCR received on 16-07-2021 contain no new information