chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling; Very painful arm,; wrist pain; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 11:30(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included rare arthritis condition. Patient had no known allergies to food, medication or other products. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and gabapentin (MANUFACTURER UNKNOWN); all for an unspecified indication from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 12:00, the patient experienced very painful arm, wrist, hand swelling, very painful. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event very painful arm, wrist, hand swelling, very painful was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
One week after injection I began having intermittent jaw pain on right side. My dentist after a thorough exam ruled out any tooth or root problem. Pain episodes last a few minutes to several hours, are moderate to severe, and are not relieved by ibuprofen. They are unpredictable and are not correlated with heat, cold, or any specific foods.
Shortness of breath, sore arm, fever, numbness of arm. Symptoms went away except the shortness of breath. After second shot symptoms got worse. Arm and face went numb. Went to ER and they found two blood clots. Lungs aren?t filling with oxygen and now on inhalers. Symptoms are still going on since shots.
Tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. It was reported on an unspecified date the patient tested positive for covid-19 after patient had been fully vaccinated. Reporter further stated that the symptoms were mild. The majority of the illness was around 3-4 days, though reporter believe that the patient who got covid-19 was still recovering. The patient was recovering from the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
"Janssen COVID-19 Vaccine EUA"         4 days after the vaccine was administered, my shoulder (muscle) began hurting slightly at the spot I received the vaccine.  This is now the 6th day after I received the injection and each day the discomfort is increasing.  Is this increases of discomfort normal 6 days after the vaccine was first received?
Information has been received, via the Merck pregnancy registry, from a licensed practical nurse (LPN), concerning a 25 year old female patient with a history of 9 pregnancies resulting in 9 miscarriages (details not provided) and a colposcopy with biopsy indicating low grade squamous intraepithelial lesion (lgSIL), who on 27-NOV-2007 was vaccinated with the first dose of Gardasil (lot 3654540/1209U).  On 20-DEC-2007 the patient experienced her last menstrual period, and subsequently became pregnant.  On 29-JAN-2008, prenatal vitamins were prescribed for the pregnancy.  On 12-FEB-2008, an ultrasound was performed, and the estimated date of delivery was 25-SEP-2008.  On approximately 20-FEB-2008 the patient experienced cold symptoms, and was prescribed treatment with loratidine and azithromycin.  The outcome of cold symptoms was not specified.  This is one of several reports received from the same source.  Additional information has been requested.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head) and DISTURBANCE IN ATTENTION (couldn't concentrate) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0Z1CZ1A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history were reported. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't concentrate), ILLNESS (feeling of sickness and flu), INFLUENZA (feeling of sickness and flu), FEELING ABNORMAL (not feeling great but felt a little better/it is not normal for her/felt really bad), ANXIETY (it is concerning), HYPOKINESIA (Couldnt move), HEADACHE (headache) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't concentrate), ILLNESS (feeling of sickness and flu), INFLUENZA (feeling of sickness and flu), FEELING ABNORMAL (not feeling great but felt a little better/it is not normal for her/felt really bad), ANXIETY (it is concerning), HYPOKINESIA (Couldnt move), HEADACHE (headache) and ARTHRALGIA (Joint pain) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant products included Birth Control. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Prior to vaccinations on 10/2/2015, the patient reach all developmental milestones. He was making eye contact, saying "duuhg" while pointing with one finger at a dog, and responding when his name was called. After getting the vaccinations: DTaP (Diphtheria, Tetanus, acellular Pertussis), INFs pres free 6-35m (FLUZONE) (Influenza), MMR (Measles, Mumps, Rubella), PNUcn13 (PREVNAR 13) (Pneumococcal conjugate, 13 valent), and VAR (Varicella, chickenpox) all on 10/2/2015, he lost all those skills. He regressed into a child that no longer: attempted to talk, point with a finger, make eye contact or any gestures for social communication. He was later diagnosed with autism.
Got aches through my whole body went to the Doctor and he put me on prednisone for 2 weeks. They didn't go away. I went back to the Doctor and they gave me stronger prednisone and it didn't go away. It go worse and I couldn't lift my arms or feet. Went to the hospital and they did tests, they had no beds so came back home. Then went to my Family doctor. Then  I went to the ER  and they sent me to the Rheumatology Doctor. He diagnosed me with Tillis Disease they gave me several pills (toradof, methotrexate 20mg, folic acid 1mg/daily, Prednisone, Fosamax) for this and I don't have the Charlie horses as much now. I'm still having aches, very tired all the time, occasional charlie horse in neck/shoulders. I have another appointment with him. They said my heart was a bit compromised and left lung.
Waited the 30mins after injection due to agioedema issues.  No problems. On 15min drive home started feeling drowsy by the time I got home I could hardly stay awake.  Sleep on couch for over 4 hours.  Woke felt sick like had the flu sick.  Tested for covid negative.  For the next 14 days I had sickness issues from chills with and without fevers, sweating fits during day and night, spliting headaches, nausea, throwing up, diarrhea, muscle aches and pains.  Felt like I had been ran over by a truck, everything hurt.  And from one hour to the next you didn?t know what symptoms you would have.
I have not had a period since March 23rd. I have been overly emotional and hormonal. Symptoms of periods but having none.
Parent reports onset of tics following above vaccine, which gradually improved over the course of the year, and with worsening again of tics following influenza vaccine on 10/22/20
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) 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 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever). At the time of the report, PYREXIA (slight fever) had resolved.            No concomitant medication reported. No treatment was provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Updated the outcome of the event (slight fever) from unknown to recovered.
engerix B 2 pediatric doses to adult patient; Engerix B 2 pediatric doses to adult patient; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 43-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2022, the patient received the 1st dose of Engerix B pediatric (intramuscular) .5 ml, Engerix B Pre-Filled Syringe Device, the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 28th April 2022, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and wrong technique in product usage process. On an unknown date, the outcome of the adult use of a child product and wrong technique in product usage process were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's comments: The patient received a pediatric dose of Engerix-B, in the right arm, on the date of reporting. The patient should have received an adult dose of Energix-B. While the patient was still in the office, a second pediatric dose in the same arm, same lot was given to the patient per the healthcare professional's supervisor on duty. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2 doses of Engerix B pediatric instead of Engerix B adult which led to, which led to adult use of a child product and wrong technique in product usage process
Urticaria over chest and back.  No respiratory distress.  Symptomatic care and referral to allergist recommended.
Patient with no know medical history reported dizziness, nausea and feeling generally unwell eventually progressed to agonal respirations and unresponsive to noxious stimuli. She was brought to the ED and found to have 6 mm pupils dilated and not reactive to light. CTA head showed a thrombus at the basilar artery tip, extending into the bilateral proximal PCA, the right proximal SCA. The left SCA appears occluded.
AE from 1st dose; A spontaneous report was received from a consumer concerning an unspecified patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse event.  The patient's medical history, was not provided by the reporter. No concomitant medications reported.   On 12 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced some adverse events.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the adverse event were unknown.
I woke in the morning and was feeling unwell, 09APR2023. I took a COVID-19 test and it was positive. I am currently recovering from the virus but my energy is low.
This spontaneous report as received from a nurse refers to a 71 year old patient. Medical history and concurrent conditions were not reported. On 14-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2013, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2013, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Patient experienced onset of right ulnar neuropathy with paresthesia/ numbness of the right ulnar hand and 4th and 5th digits 2-3 hours after receiving influenza vaccine. There was no other injury, no history of similar symptoms previously. The symptoms had not resolved when he was seen 3 days later. The most likely etiology given timing is thought to be the immunization with possible poor technique of administration causing an ulnar neuropathy.  This mechanism has been described in case reports. Technique of the personnel administering the vaccine is unknown.
12-18-20 Lot EH9899 1-18-21 Lot EK9231  Patient has laboratory confirmed covid 19 (Abbott PCR test) on 4-27-21 (symptomatic).
Pt was on apnea monitor and had an episode of bradycardia and apnea.
coughed up and a little bit red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMOPTYSIS (non-serious), outcome "unknown", described as "coughed up and a little bit red". No follow-up attempts are possible. No further information is expected.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #1892784, expiration date: 23-DEC-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000949:
Patient got flu shot (FLUZONE HD) 9/30/13 - patient reports pain in arm and trouble lifting arm today.
Had to go to the ER with stroke like symptoms.  Had an MRI and CT that ruled that out.
Upper back pain beginning on day 5.; Fever for two days after the shot; Severe muscle aches; Skin pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 05May2021 at 08:45(at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included triamcinolone acetonide (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 14Apr2021 at 08:45(at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 16:00 the patient experienced fever for two days after the shot, severe muscle aches, skin pain and headache. On 10May2021 the patient experienced upper back pain beginning on day 5. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever for two days after the shot was recovered with sequelae on 07May2021 while the events severe muscle aches, skin pain, headache and upper back pain was recovered with sequelae on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
12 days after vaccine, noticed L facial and lips drooping. Came to ofc for eval 3/29 w. L facial paralysis, L mouth drooping w/ inability to close L eye. Also hypoxic 84-88%. Sent to ER via ambulance She was subsequently diagnosed w/ Bells Palsy. Given prednisone, valtrex Flu 4/27/2021, condition improved but mild residual L facial droop remains.
Lesions on stomach and knee area that are infected. He is concerned about the infection spreading from his smallpox vaccination.
This is not a harmful AE. However, I wanted to report it for data purposes. I was diagnosed with Non-refreshing, Non-restorative Sleep Disorder about 8 months ago. I typically do not go into deep sleep and rarely ever dream that I am aware of. (I dream approximately 4-6 times a year.) After both doses, I noticed that I went into an incredibly deep, refreshing sleep! After the second dose, that was given on 15Apr2021 at 4pm, I fell  asleep at 7pm for a nap - and dreamed! I dreamed again that night and have dreamed each night since the vaccine for the past 9 days. Again, this is not a harmful AE, but I think there could be correlation between sleep/dreaming and the vaccine that could be further researched. Additionally, I had minor injection-site pain approximately beginning at 6:30am on 16Apr2021 (about 14.5 hours after receiving the shot).
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, overweight, and allergy to grass. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 24-MAY-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced product administered to subject of inappropriate age. On 24-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.
5/13 developed edema at sight of DTAP vaccine, fever with max of 102. Edema increased 5/14. (5/18 went to ED due to fever and swelling, sent home, no admission. 5/14 seen in office. Per doctor's note from 5/14, "left  arm with generalized swelling, increased warmth, non tenderness, very red with area of 16x22cm. Able to move arm." 5/15 Dad reported over telephone that swelling, redness were much better, overall "completely fine on 5/15," no fever.
Itchiness along left arm, lower legs, and back - improved after receiving Benadryl . BP 155/79 (pulse 65), 157/83 (pulse 68); O2 sat 99%-100%.
Recurrent erythema left deltoid where 5th DTaP was administered on 8/21/02.
Pt developed herpes zoster several days after receiving his first COVID-19 vaccination. I saw him for a televisit on 3/17/21, and the rash was already scabbing, so no treatment was indicated.
No symptoms noted.  Nurse inadvertently gave Tdap instead of Dtap.  Error explained to parent and then Dtap was given.