chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN IN BOTH CALVES OF LEGS/LEGS SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain in both calves of legs/legs sore. Laboratory data (dates unspecified) included: Sonogram (NR: not provided) Did not have any clots. The action taken with covid-19 vaccine was not applicable. The outcome of pain in both calves of legs/legs sore was not reported. This report was non-serious.
I had my vaccination on 07/25/2022. I started to experience severe headache, fatigue, achy on 10/31/2022. I tested COVID-19 positive on 11/01/2022. I am still having sinus issues, cough, and headache on 01/24/2023. I initially had COVID-19 positive 12/2020.
An attack of neuromyelitis optica occurred.. High strength steroids and plasma pheresis were necessary in order to restore eyesight.
Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue Narrative:
HYPOTENSION 12/4/2022 CHF EXACERBATION, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/15/2023 CHF EXACERBATION, UNSPECIFIED HYPOXIA 9/26/2022 CHF EXACERBATION, UNSPECIFIED HYPOTENSION 12/4/2022 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/15/2023 PNEUMONIA HYPOXIA 9/26/2022 PNEUMONIA
Pt with a history of tongue swelling, numbness after immunization with Zoster vaccine 6 months prior. Pt requested flu vaccine, and AFLURIA was selected for him because he had received AFLURIA in the past and tolerated. Six to seven minutes post AFLURIA vaccine, pt again reported tongue swelling and numbness; no dyspnea. He was evaluated in the ED, given SOLUMEDROL, ranitidine and BENADRYL, after which symptoms resolved. Methylprednisolone 125 mg once, ranitidine 50 mg once, diphenhydramine 50 mg once.
Patient  age 75 Admit 3/7/2023 for respiratory failure. COVID positive 3/7/2023 Date of death 3/23/23. County: reported Medical center
Hives that went from her stomach to her neck; chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives that went from her stomach to her neck), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives that went from her stomach to her neck), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives that went from her stomach to her neck), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 22 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
pt recv vax 3MAR99 & was observed to have 4sec apneic episode associated w/pallor, hypotonia, dec responsiveness;
Large local reaction: 10X10 erythematous warm patch with discrete edges over deltoid (less erythematous) and medial to inner arm above olecranon. (+) mild edema and tender to touch. No lymphadenopathy to axilla or epitrochlear adenopathy. No papules, pustules, vesicles, or scale. 10 inch diameter to her left upper arm. She reports the onset was about 2 days after vaccine receipt. It is erythematous, edematous, and tender; when seen at day 7 she stated the site has improved. It is mildly pruritic and burning starting today. Her entire arm was sore. She had mild fever 99-101 the first 6 days. She was treated with ice, prn antihistamine for comfort, topical LIDEX, and ibuprofen. At telephone follow up on 20 APR 2015, reports pain resolved, local inflammation much improved in intensity and diameter of affected area.
Big red welts at the site of the injection that are super itchy and raised. Feels very uncomfortable
Got hit the 2nd day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got hit the 2nd day) in a male patient of an unknown age 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 VACCINATION COMPLICATION (Got hit the 2nd day). At the time of the report, VACCINATION COMPLICATION (Got hit the 2nd day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-238346 (Patient Link).
A nurse reported that an 11 year old male received an injection of Flu Shield '00-'01 on 12/15/00. That same day, the pt developed an injection site reaction characterized by pain and hives. Within 48 hours, the hives spread over his entire body. The child was treated with Benadryl and prednisone and the child "seemed to be getting better." Follow up states hives resolved in one week. No residual problems at this time.
pt recv vax 7JUL95 PM devel muscle ache, feeling & stiffness, chills & fever devel next day but fever not documented;also devel swelling & soreness @ vax site;seen back in clinic 10JUL95, t98.3, lt deltoid firm, erythema papule @ inj site;
CHOKED ON DRINKS; DIFFICULTY SWALLOWING, EVEN LIQUIDS; BOUTS OF SLURRED SPEECH; MUSCLE CRAMPS; MAKING IT DIFFICULT TO STAND, BEING OFF BALANCE; DIFFICULT TO WORK; WEAK MUSCLES IN NECK AND SPINE; This spontaneous report received from a patient concerned of an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccine, the patient experienced deteriorating health. On an unspecified date, the patient had muscle cramps, being off balance, made it difficult to stand, as well as weakness in the muscles in her neck and around the spine. She also noted that lately, the muscle cramping was worse and she had bouts of slurred speech. She had difficulty swallowing, even liquids, noting she choked on her drinks. It was reported that it made difficult for her to work.  She had numerous healthcare professionals (HCPs), including rheumatologists and neurologists. On unspecified date she visited Emergency room  and Physician office for events difficulty swallowing even liquids, weak muscles in neck and spine, bouts of slurred speech, muscle cramps and making it difficult to stand. On unspecified date she had numerous tests done, including C-reactive protein test (CRP) and it was normal and a spinal tap was negative for meningitis. She felt that she was declining rapidly.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty swallowing, even liquids, weak muscles in neck and spine, bouts of slurred speech, muscle cramps, making it difficult to stand, being off balance, and difficult to work, and the outcome of choked on drinks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211011611-COVID-19 VACCINE AD26.COV2.S-choked on drinks. 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).
I had the Phizer booster shot.  My arm was sore on Sat & Sunday, and I literally slept all night Friday night - Monday morning.  I could not wake up for longer than 30 minutes at a time.  Monday when I woke up, my left armpit (same side I received the shot on) was very swollen and it hurt.  I can barely put my arm down because my armpit is swollen all the way down to my breast.  I do not want to go to a doctor yet, I want to see if this goes away on its own
After approximately 10-15 minutes from receiving vaccine patient felt hot and experienced flushing in her face. She felt nauseous and dizzy and alerted the nurse. Patient was then to be taken to a separate room and patient reports upon standing she blacked out because the next thing she remembered was lying on a couch in a separate room at the clinic site. She took 50 mg of oral Benadryl and also Tylenol. Patient was given something to eat and drink and sat on the couch for an hour, and then she felt fine. Vitals: BP 112/70 mmHg, HR 84 beats per min, PO2 98%
I received the second dose of Shingrix and became ill. I expected a sore arm but not the headache, fever and body ache that I experienced. I did not have any reaction to the first one. I felt terrible and was basically ill for 1.5 days. I felt like I should tell someone in case there was a bad lot.
Starting 4 hours post injection, I had uncontrollable shaking, feeling freezing cold and could not get warm, exhaustion, 103+ fever, body aches, chills, then I woke up 8 hours post injection with violent vomitting, SEVERE headache, severe nausea, unable to keep down any fluids. These symptoms lasted 48 hours. I continued to feel exhausted, unable to think clearly, mild fever(100) and headache, decreased appetite, slight nausea for 5 additional days. Then brain fog and malaise for another 5 full weeks.
pt recv vax & devel a fever & an inj site rxn characterized by erythema, edema, & pain;pt tx w/ATB & recovered p/1wk;
Developed sore muscle pain after the injection; Little more tired than normal/had to go to bed earlier than usual, around 10-10:30pm instead of midnight to 1am; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old female patient received bnt162b2, via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was asked that if patients develop sore muscle pain at site of injection, did that mean the body was mounting an immune response to the vaccine? The patient developed sore muscle pain after the injection on 21Dec2020, it continued 22Dec2020, but it is gone and better on 23Dec2020. It was also reported that the last few nights, she had been a "little more tired than normal". She had to go to bed earlier than usual, around 10-10:30 pm instead of midnight to 1am. The outcome of event tiredness was unknown; of another event was recovered on 23Dec2020.  Information on the lot/batch number has been requested. .
Raised heart rate 168-203 bpm dizzy numbness lips tongue face  flushed skin lasted approximately 45 minutes   Severe headache for 48 hrs  occasional lightheadedness  is still present  Monitored by nurse and dr on site for 2 hrs reclined on floor
Red patch at injection site, then got swollen, hard, and white. After some research, it matched "Covid Arm"
This spontaneous report as received from a nurse refers to an 11 months 8 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. 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.
Patient received immunization on 10/13/2017 at 1:30 PM. The next day at around 3 PM, she started with fevers that lasted all day until 10/15/2017. She states she had noticed pain on her left deltoid but thought it would go away. Inflammation and redness started to be visible on her left arm as of 10/16/2017.
Blood disorder; This case was reported by a consumer via interactive digital media and described the occurrence of blood disorder in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included MMR (MEASLES/MUMPS/RUBELLA) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and MMR (MEASLES/MUMPS/RUBELLA). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced blood disorder. On an unknown date, the outcome of the blood disorder was unknown.   It was unknown if the reporter considered the blood disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient got a blood disorder after her 12 month flu shot and MMR. This case is one of the 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225504:same reporter US-GLAXOSMITHKLINE-US2020AMR225505:same reporter US-GLAXOSMITHKLINE-US2020AMR225503:same reporter
Swollen, red, tender.   Parent said they gave the child Tylenol before getting shot
Severe l shoulder and arm pain, Advil for pain--some relief from pain. Follow up with Dr end of April -- possible pinched nerve per PCP prescribed muscle relaxer-- 5 day prescription, after 5 day June 12 ER visit severe pain in neck down to hand shaking and numbness. ER prescribed Sling for arm, cold packs and new prescription for muscle relaxer same as prescribed by PCP. PCP gave MRI order June 19. Follow up with neurologist  in July, neurologist order for Physical Therapy. August 27 EMG test -- result no muscle or nerve damage. Patient has had some relief with Physical Therapy -- PT finished in September.  Hand pain at times and arm tires easily when stressed.
Fatigue; Muscle pain; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  fatigue, muscle pain/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced fatigue, muscle pain.  Treatment details included Unknown.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of  fatigue, muscle pain/myalgia was unknown.
This spontaneous report as received from a nurse refers to a 7 months 19 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. 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.
A 66 year old male patient received once weekly treatments of Tice BCG starting in October 2002 for 6 weeks and was currently on a maintenance regimen of once weekly treatments for 3 weeks followed by a 2-3 month period of no treatments (in total 21 instillations). The last treatment was 27AUG2003 and in September 2003 the patient experienced significant red and tender joint swelling. The patient's family physician has ruled out gout as a cause of the swelling.
A nonserious report of chest congestion, coughing with phlegm, night sweats, nasal congestion, lip swollen, and poor appetite has been received from a consumer concerning her son, a three-year-old male. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age Flumist. No medical history nor concomitant medication were provided. The patient received Flumist on 07-Dec-2007. On 08-Dec-2007, the child experienced chest congestion, coughing with phlegm, night sweats, nasal congestion, lip swollen, and poor appetite. No outcome for the events was provided by the reporter; although the symptoms were reported to be somewhat better. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006289, a report for the patient's mother.
Approximately 4 hours after injection, laid down to sleep, was woken up by moderate pain in/ around the right hip bone, It was progressed to thigh being very tender/sore, as well as whole right leg ached/hurt with feelings of neuropathy. About 8 hours after injection continues to get worse, with right calf "burning situation" and soreness to the touch on right thigh. Cold chills  Arm appears to be fine. No pain.
Patient was vaccinated for the second dose of COVID vaccine on the 21st day after receiving the first dose - Moderna recommends administering the vaccine at least 24 days apart
Hives started on the 2nd day after the 2nd shot, severe all over my body, by the 5th day I started taking Claritin and they went away for a few days but returned and now over a month later they are still severe. After 2 doctor appointments, one primary care and a dermatologist, I am on 2  24 hour Claritin a day and Hyroxyzine 10mg at night. Still wake up with them covering my entire body.
The baby had just gotten done eating and she and I were playing and her face started twitching. This happened several times in a few seconds. Then she had a full body seizure and small facial spasms, thereafter. Immediately I called the MD and was advised to observe the baby and document the seizures. Between the time of the shot and the seizures was about 9 hours. She had 20 seizures by the time she was admitted to the hospital and several after that. A follow up report received 8/3/2000 adds: Consult report from neurologist received 7/26/2000. Seizures documented. Development subsequently is found to be NL, no recurrence of seizures. Advised to avoid pertussis vaccines. Neuro exam of 4/25/2000 NL, no meds for seizures.
At 6 months of age my son recvd the following vaccines.  DTaP 1, Hib1-Hep B1, IPV1, & a Flu shot. Loose stool began daily with periods of crying daily, difficulty sleeping within 24 to 72 hours of these vaccinationsbeing given. Eye contact decreased. Development stopped progressing. Poor eating habits. I expressed concern to  pediatrician of loose stool 3 times in 6-8 month time period, I am advised that my son is drinking to much formula and other liquids. GI functioning poorly.  I consult with two GI Doctors with little direction.  Neurological delays confirmed and diagnosed as autism at 22 months. My son has been confirmed to have high levels of Lead and Mercury. 9/22/2008 PCP records received. 7 month WCC 10/20/2004. Parental concerns re: not bottle holding or sitting yet. Developmental screening to be scheduled. Recieved 1st set of vax.  Seen 9/7/05 for 12 month WCC at age 17 months.  Parental concerns re: development. Concerns for speech at age 22 months.  7/17/08 Developmental eval received from parent dated 2/20/06 with Diagnostic Impression:  Global Developmental Delays. Impairments in Social Interaction. Childhood Autism Rating Scale placed child in the moderate range of the Autism Spectrum. F/U visit 2/21/07 with Diagnostic Impression Autism.  Global Developmental Delays 7/17/08 Developmental eval received from parent dated 2/20/06 with Diagnostic Impression:  Global Developmental Delays. Impairments in Social Interaction. Childhood Autism Rating Scale placed child in the moderate range of the Autism Spectrum. F/U visit 2/21/07 with Diagnostic Impression Autism.  Global Developmental Delays.
Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Shingrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius on 7th August 2022 (for 48 minutes).   This case is for 8 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118570:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118572:Same reporter US-GSK-US2022118612:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118616:Same reporter. US-GSK-US2022118615:Same reporter.
Initial and follow up information has been received from a physician, who was told by one of his patients, that the mother of a consumer was told by a neurologist that there were 4,400 kids who have died following vaccination with GARDASIL. No product quality complaint was involved. Attempts are being made to verify the existence of patients. Additional information has been requested.
Patient complains of swelling and redness left arm at site of PCV-13 vaccine injection given yesterday. Also felt fatigue and chills.