chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Over the two days after the shot. Patient developed severe pain at the site of injection (left arm) that has persisted. Over the next 3 weeks, she developed bilateral thigh pain and lower back pain. She also developed upper arm pain on the opposite side.
FEVER, POOR APPETITE, MADE HIM DROWSY, IRRITABLE. WAS INSTRUCTED TO GIVE TYLENOL AND LIQUIDS AND MONITOR FOR 24 HOURS. LATER LOST SPEECH AND EYE CONTACT.
BLOOD CLOT IN RIGHT ARTERY; HEART ATTACK; FEELING POORLY; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown)1 total, dose was and start therapy date (earlier this year) were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, sometime after vaccination, the patient was feeling poorly and recently suffered heart attack due to a blood clot in right artery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling poorly, heart attack and blood clot in right artery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210900330-covid-19 vaccine ad26.cov2.s -Heart attack due to a blood clot in right artery. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Painful injection - quadrivalent vaccine. Upper right arm pain with persistent throbbing ache now for 6 months+, difficulty raising arm without pain.
Initial Complaint:  Felt off.  Raised hand and started to go down.   Clammy and sweaty.   Potential vasovagal response to needles.    1144  BP 100/82  HR 56  RR 16  Arms are tingly.  Patient put hand up and then went down with assistance of staff.  Patient only had one granola bar prior to vaccination.  Provided apple juice and granola bar.  Lungs clear, patient alert 1149  HR 72  RR 14  Patient states she is "feeling better."  Patient alert.  Color returning to cheeks.  Assisted to seated position and remains seated. 1200  BP 120/76  HR 65  RR 20  Feeling better.  Lightheadedness and dizziness resolved.  Color pink.  Alert and oriented.  Denies headache/blurred vision.  Drank apple juice and ate 1/2 granola bar.  Able to ambulate without assistance or dizziness.  Gait steady.  Discharged without further incident.  VSS
No additional AE; the doctor reported that she administered a third dose of GARDASIL 9 to a patient who was eligible for the two dose regimen.; the doctor reported that she administered a third dose of GARDASIL 9 to a patient who was eligible for the two dose regimen.; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2017, the patient was vaccinated with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, lot #, expiry date, route of administration and anatomical location were not provided) to prevent human papilloma virus infection. On 12-JAN-2018, the patient received the second dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Then, on 28-JAN-2022, the patient received a third dose of the vaccine (extra dose administered), however it was eligible for the two-dose regimen (Drug use for unapproved schedule). No additional adverse event or further information was reported.
ADMINISTRATION OF JANSSEN COVID 19 VACCINE TEMPERATURE EXCURSION; ADMINISTRATION OF JANSSEN COVID 19 VACCINE TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the patient experienced administration of janssen covid 19 vaccine temperature excursion. On 12-JUL-2021, the patient experienced administration of janssen covid 19 vaccine temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of janssen covid 19 vaccine temperature excursion and administration of janssen covid 19 vaccine temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915646, 20210916808, 20210915661, 20210915748, 20210915623, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916697, 20210916910, 20210915852, 20210916965 and 20210916959.
Chest pain (right side); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain (right side)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain (right side)). At the time of the report, CHEST PAIN (Chest pain (right side)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter
This spontaneous report was received from a pharmacist referring to a currently 22 years old male patient. None concomitant medication, pertinent medical history nor drug reaction/ allergy was reported. On 18-APR-1996 and on 15-JUN-1999, the patient was vaccinated with the first and second dose respectively of M-M-R II (lot number, expiration dates, dose and route were not provided) for prophylaxis. On an unknown date, when titers were drawn for nursing school entrance, the patient showed no immunity against measles, mumps and rubella. The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as not recovered / not resolved.
Patient has a history of COPD. She was seen in the ED on 7/21 with difficulty breathing and shortness of breath. Patient normally wears 7L O2 at home. She was placed on BiPAP in the ED, and had a COVID-19 PCR swab that was positive. She ultimately was admitted to the hospital from 7/21-7/23 and was diagnosed with acute on chronic hypoxic respiratory failure due to COVID-19 pneumonia, suspected acute on chronic diastolic heart failure, and COPD exacerbation. Patient is fully vaccinated and has received two boosters. This meets criteria for vaccine breakthrough case review.
Five hours after injection, started experiencing body fatigue, followed by chills.  increasing through the night to the point where I was having convulsions and entire body shaking uncontrollably.  Shivering and could not stay warm under multiple blankets.  irregular heart rate (very high).  then around 6am woke up in a HOT fever, broke a sweat.  the entire next day body aches, extreme fatigue, and headache. currently experiencing random cold sweats at night when I wake up intermittently.  poor circulation and sweaty hands and feet / unknown if it is related
Patient was inadvertently given expired dose of Pfizer (5 to < 12 y/o). The vaccine lot had expired on 9/30/2022. The expired vaccine was administered on 10/3/2022. A nurse technician had diluted/prepared the vaccine vial without checking the expiration date. A medical assistant then administered the expired vaccine without checking the expiration date. No treatment was required, patient's family did not report any signs of side effects or symptoms. Patient's father was called to notify family of the error on 10/4/2022 and the patient's father reported that the patient is doing well, no concerns noted. Relayed pediatrician's recommendation to revaccinate the patient, no waiting period required. Patient's family declined at this time but will reach out when they plan to do so.
Initial report received on 30 April 2008 from a nurse. A 43-year-old male (also reported as 44-year-old) patient whit no concurrent illnesses, had received on 25 February 2008 an intramuscular left deltoid injection of ADACEL (lot # C2904AA); an intramuscular left deltoid of TYPHIX Vi (Lot # Z0960-2) an intramuscular right deltoid injection of "HEP A" vaccine (manufacturer GlaxoSmithKline, Lot # AHBAB171AA); and an intramuscular right deltoid injection of "HEP B" vaccine (manufacturer GlaxoSmithKline, Lot # AHBVB517AA). The trade name for "HEP A" and "HEP B" vaccine were not provided. Twenty-four hours post-vaccination, the patient's left arm became red and tender at the injection site. Several days later the patient developed dime and nickel sized red, raised and dried plaques of skin on the left deltoid, legs, abdomen, and forearms. The patient was evaluated by a physician and prescribed BENADRYL with no results. The patient received further treatments, but also did not experience any change in her condition. No relevant diagnostic tests/laboratory data were performed. At the time of this report, the patient had not recovered.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient received 2 doses of GARDASIL (Lot #, dose and route not reported) in 2008 (day and month unspecified), and 2 doses of GARDASIL (Lot #, dose and route not reported) in 2010 (day and month unspecified). No adverse effects reported. It was not known if the patient sought medical attention. Additional information has been requested.
t99.6, PB 180/60, R18, P70 reg; pt c/o inability to move rt arm above waist level; reports an achiness from shoulder to elbow w/movement @ site; unable to adduct arm; rt hand cooler than lt; able to move fingers w/hand w/o difficulty;
The mother of a female reported that he daughter received in injection of DTP in 1988 at the age of 2 months. By 5 months of age, the infant had developed seizures. She was seen by the physician, who reportedly dx an allergic reaction to the Pertussis component of the DTP vaccine. The child was treated with Phenobarbital "for months". In addition, a dx of cerebral palsy was made.
A report was received from a health care professional on 12/4/03 concerning an unknown number of 2 year old vaccinees of unknown sex who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unknown number 2 year old vaccinees inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
again experienced bloody stools later that day; bloody stools later that day; irritability; This spontaneous report was received from a physician and refers to a 6-month-old male patient. The patient concurrent conditions included eczema. There was no information about the patients medical history, drug reactions or allergies and concomitant therapies provided.  On 27-AUG-2020, the patient was vaccinated with first doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dose was administered orally (lot # 1660992 expiration date 30-APR-2021), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose administered by unreported way (lot # s030965 expiration date 03-APR-2022), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) 1 dose (lot # sDK4D 5), pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) 1dose (DJ7721) for prophylaxis. The patient was also receiving unspecified vitamin D.  On the vaccination day, the patient had 1 bloody stool. The second vaccination took place on 27-OCT-2020, the patient was vaccinated with second doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dose was administered orally (lot # 1660999 expiration date 03-MAY-2021), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose administered by unreported way (lot # s030965 expiration date 03-APR-2022), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) 1 dose (lot # 47CK9), pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) 1dose (dl2862). On the second vaccination day, 27-OCT-2020, the patient also had 1 bloody stool. On an unknown date in 2020, the patient experienced irritability as only other symptom. It was reported that the patient sought for medical attention but he was not hospitalized. The physician reported that the dose from 21-DEC-2020 was held. The patient has recovered from the events and no additional bloody stools were reported.  The reporter did not provide a causal assessment between bloody stools irritability and the suspected vaccines.  Upon internal review, the events of bloody stools were determined to be medically significant.
Increased irritability, depression, anxiety. Suicidal thoughts, angry outbursts. Ongoing.
Pt is 36 yo female employee at this institution. She is s/p Moderna COVID-19 full vaccination: first dose on 12/31/2020, second dose on 1/29/2021. Underwent voluntary COVID-19 rapid testing on 7/14 after experiencing symptoms including headache, fever, and congestion/runny nose.  Pt reported exposure to COVID-19. PCR test resulted positive.
Headache, fever, muscle ache, chills, shaking, back ache and stomach ache.
Moderna Dose-1 on 02-AUG-2021 and Dose-2 on 24-AUG-2021; FELT VERY HUNG OVER DAY AFTER COVID VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (FELT VERY HUNG OVER DAY AFTER COVID VACCINATION) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose-1 on 02-AUG-2021 and Dose-2 on 24-AUG-2021) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HANGOVER (FELT VERY HUNG OVER DAY AFTER COVID VACCINATION). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose-1 on 02-AUG-2021 and Dose-2 on 24-AUG-2021). At the time of the report, HANGOVER (FELT VERY HUNG OVER DAY AFTER COVID VACCINATION) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose-1 on 02-AUG-2021 and Dose-2 on 24-AUG-2021) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with HUMIRA for the event of FELT VERY HUNG OVER DAY AFTER COVID VACCINATION was not provided. No treatment medication was reported.This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
I am currently pregnant. This is my first pregnancy.  My due date is August 29, 2021.  My pregnancy has thus far been really easy with no complications.  I had a low grade fever that I took Tylenol to treat.  I had pretty bad muscle and joint pain, chills, and could not stop shaking.  I just felt freezing.  Once my fever broke I felt extremely hot all night.  The next morning I was exhausted and had a lot of the muscle and joint pain still.  I marked on my report that it would've stopped me from going about my normal daily activities, as I could not have gone to work and spent most of the day resting.  For the next few days I was tired and my eyes ached.  On Monday and Tuesday I had a headache in the afternoon.  Yesterday afternoon my eyes finally stopped aching and everything seems to be back to normal.
Swelling in the arm; hives; I started having charley horses, cramps in my back; Underarm started hurting; Lymph is swollen under my arm and my lymph node around my clavicle; muscles are all tight, all my muscles around my leg, my back, my skull, underneath my neck and back of my leg; back of my knee is paining, aching, throbbing; Vision was a little blurry; I am itchy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 10May2021 as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had swelling in the arm and hives. The patient then started having charley horses, cramps in the back, and the patient's underarm started hurting. The lymph was swollen under the patient's arm and the lymph node around the patient's clavicle. The patient's muscles were all tight, all the muscles around the leg, the back, the skull, underneath the neck. The back of the patient's knee was paining, aching and throbbing. It was also noticed that the patient's vision was a little blurry and the patient was itchy. The patient wanted to call and make sure that the patient was okay and was asking of what should be done. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a nurse practitioner concerning a female who on 03-APR-2008 was vaccinated with a first dose of GARDASIL (lot #655327/1287U).  During administration of the vaccine, the vaccine leaked out of the syringe, ran down the patient's arm and then the patient received partial dose.  The patient also experienced a burning sensation when the vaccine entered her arm.  The nurse practitioner indicated that she put the needle on the syringe properly and she looked at the syringe after vaccination and didn't notice anything unusual.  At the time of the report, the patient's outcome was unknown.  The SR is 1-2829187985.  Additional information has been requested.
Developed bright red toes, toe next to big toe on right foot and week later on left foot the two toes next to big toe.  Did not hurt or itch.  Sluffed off dead skin from time to time.  I used Vaseline night and morning, also used aloe from my plant now and then.  Right toe is healed.  As of March  15 the toe on left foot next to big toe is still red and sluffing skin.
pt states that he thinks he got arm pain around the time of being vaccinated, no trouble moving arm ever, no trouble lifting arm ever, just some general mild pain, he says he is not sure if it is vaccine related or if it started at the exact time but months later he realizes he has some pain and wonders if it was the vaccine, i told him to see a doctor
GBS; Initial information was received on 26-Dec-2021 regarding an unsolicited valid Social Media serious case received from the patient  This case involves Adult and unknown gender patient who experienced Guillain-Barre syndrome (gbs) while receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concurrent conditions, concomitant medications 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 not reported via unknown route in unknown administration site.  On an unknown date the patient developed GBS (guillain-barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (GBS).  At time of reporting, the outcome was Unknown for the event GBS.  This case was assessed as serious (medically significant); Sender's Comments: Sanofi company comment dated 31-Dec-2021: This case involves Adult and unknown gender patient who experienced Guillain-Barre syndrome (gbs) while receiving INFLUENZA VACCINE. Information regarding lifestyle history, family history, concurrent conditions and event details will aid in comprehensive assessment of this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Rigors for 3 hours begininng abiut 6 hours after (this was a booster, original series given 12/20/2020 and 01/09/2021 with minimal body aches and fatigue after second does). Severe myalgias and arthralgias for 48 hour after rigors stopped; brown urine onset 2.5 days after dose evening of 11/22, which continued for several more days. Labs drawn 11/24/2021 below
back, chest pain; 25oct seen by MD; abd pain, severe constipation, unable to sleep @ night, hip pain, a lot of weakness, numbness of extremities, some confusion, drooping of mouth, loss of balance;dx w/ guillain barre synd by neurolog
Purirtis (itching) on 2nd day p/vax; fine pustule-like rash lt knee; 3rd day p/vax pin-prick like rash to upper aspect of chest & back on 3rd & 4th day p/vax resolved; 9th day p/vax got similar rash to face;
13OCT92 recvd flu shot evening had chills, perspiring, bad h/a & pains from back of knees to calves of lesg; slept all day 15OCT92;
c/o tenderness @ site lt deltoid following IM inject; 3OOCT92 began w/pain in shoulder, neck & between shoulder blades off to the lt side; unable to lift arm, cannot turn neck completely; limited ROM; seen by MD 13OCT92;
Mild injection site pain after vaccination; This is a spontaneous report from a contactable consumer or other non hcp reported for herself (patient). A 40-years-old non pregnant adult female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 09:00 (Batch/Lot Number: EN6203) (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not received any other vaccines in 4 weeks of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 04Mar2021 at 09:15, the patient experienced mild injection site pain after vaccination and then moderate injection site pain for about 2 hours starting around 6 pm et, then went back to being mild pain, continuing with mild pain the next day. The patient did not receive any treatment for the event. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Pfizer vaccine was administered outside of our facility - reported by patient  J96.00 ACUTE RESPIRATORY FAILURE 10/4/2021 ACUTE RESPIRATORY FAILURE
Weakness, hot and cold reaction for 5 days. Cough which later developed in chest congestion, expectorated thick mucous continues now 10/29/2016. Continued weakening and sweating.
When she received vaccine, felt it was a different shot than before.  Started to hurt and progressed to pain in several hours.  Four days later, feels "needles" in upper arm & pain "deep inside", more toward shoulder.  Orthopedic specialist consulted.  He will do MRI if no improvement.