chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L028666, exp. date: 04-NOV-2016) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. 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 has been requested.
Patient reported injection site warm to touch, red, itching and swollen a week after immunization.  Recommended Benadryl and hydrocortisone cream.
On day 8 after injection red rash on injection site; hot, severe itch, swollen. Approx 3 inches x 2 inches oblong shape/size.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received vaccine from a punctured vial/the vaccine administered from a punctured vial refrigerated past 12 hours) in a 19-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016C21A) for COVID-19 immunization. No medical history or concomitant medication provided. On May 10, 2021, at 12:25 pm, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 10, 2021, patient administered expired product (patient received vaccine from a punctured vial/the vaccine administered from a punctured vial refrigerated past 12 hours). On May 10, 2021, administered expired product (patient received vaccine from the punctured vial/the vaccine administered from a punctured vial refrigerated past 12 hours) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. Most recent follow-up information incorporated: On Jun 8, 2021: Updated patient demographics, vaccination details and vaccination facility details.
ON 9 JAN 06, PT WAS SCREENED & RECEIVED TD VACCINE IN RT UPPER ARM AND FLU VACCINE IN LEFT UPPER ARM. HE RETURNED TODAY COMPLAINING OF CONSTANT DEEP STABBING PAIN IN UPPER RIGHT ARM FOR APPROX 6 WEEKS. STATES THE PAIN OCCURS WHEN HE DOES LATERAL FULL ARM RAISES, OR BACKWARDS ARM MOTIONS. HE VOICED NO OTHER ADVERSE SYSTEMS REACTIONS. PT IS DIRECTED TO SEE HIS PRIMARY CARE MANAGER TODAY. PT REPORTS TODAY THAT HE HAD COMPLETED A REGIME OF PREDNISONE 4 DAYS PRIOR TO RECEIVING THE CURRENT VACCINATIONS.
Chills, fever 100.1-102.9, headache, nausea and vomiting. Lasted from 12:30am on 2/1 - 1:30am on 2/2. Due to N/V I could not take my oral steroids. I did take my emergency injection, but not until 7pm on 2/2.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild
Patient likely was administered 0.25 mls of adult pfizer vaccine rather than full 0.3 mls. Patient will be in Friday to repeat dose.
3JUN92 became fussy & screamed for several hrs; 4JUN92 began screaming @ 300PM for several hours; 5JUN92 became pale, clammy, non-responsive; brought pt to hosp & was admitted;
N/V, fever of 101, rash on face & all over body x 3 days. rash very light & started to fade after 1-2 days.
patient came in with red swollen arm and itching and warm to touch. i told her to go to the dr. she never returned and i was unable to get any further info. i tried contacting her to no avail
Severe chill, weakness, freezing cold 3 days after the first SHINGRIX. Productive cough developed the after that. Chest X ray showed no pneumonia 6 days after the shot. Patient was instructed to take Robitussin and Tylenol. He felt better now and was advised to take Gatorade and light food for dehydration.
AFTER SHE GOT HER BOOSTER, SHE REPORTED TO THE PHARMACIST HAD DIFFICULTY TO SWALLOW AND DRYNESS IN HER THROAT.  DIPHENYDRAMINE 50 MG CAPSULE WAS ADMINISTERED.  WE KEEP HER FOR AN ADITIONAL 30 MINUTES IN OBSERVATION. THE SYMPTOMS WERE IMPROVED AFTER THAT TIME.
No additional AEs; Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W039293, expiration date: 11-DEC-2024, administered intramuscularly for prophylaxis (strength was not provided). This vaccine underwent temperature excursion before administration in 18.3 degree Farenheit (F) for 1 hour 5 minutes. No additional adverse events were reported.
Patient developed a red itchy warm indurated rash at the injection site, exactly 1 week after vaccine administration.  Resolved in 2 days without intervention.
pt recv vax 11DEC98 & 16DEC98 pt came into office w/hives over entire body;pt devel them 15DEC98 @ noc;review of hx found only thing different was vax;no new foods/no rxn since;
Patient reported getting hives, urtacaria about 1/2 hour after getting vaccine. Hives on back of legs and stomach. Itching & red. warm to touch. Patient took Claritin.
No problem with discomfort after shot, just a little sore arm for a day.  No flu symptoms.  Eight days after the shot, however,  my right arm started to itch  in the morning, and by nighttime, the shot site was no longer itchy but swollen, red, and hot.  I applied ice treatment which helped relieve the heat and swelling.  Today, my arm is much better.  I still have a slight swelling with a  light redness around the shot site, but no discomfort, no heat.  I reported this delayed reaction to the shot to my doctor?s office, and they referred me to you to report my experience since they thought it was an unusual reaction.
Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration; The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient had no known reactions at office. The vial was thawed same day of administration. The vials did not undergo any temperature excursions.  No adverse events were reported.  No treatment medications were provided.
1/16/14 - Neck pain and shooting pain. 1/17/14 - excruciating back pain and across the shoulder blades. 1/20/14 - went to emergency room for the back pain. Blood work and urine tests were done, along with chest x-ray, CT scan of abdomen, and EKG. Rubbery legs. Instructed to follow up with PCP, which I did on 1/22/14 and was instructed to go to physical therapy. My legs felt rubbery, heavy, and weak. I was very unsteady and began tripping and falling. I had many sleepless nights due to severe pain. 1/27/14 - first physical therapy appointment. 1/30/14 - appointment with neurosurgeon who ordered a cervical MRI which I had done that day. I have been having numbness and tingling in toes. 1/31/14 - appointment with PCP and neurologist. Exam noted Areflexia in the lower extremities and I was admitted to hospital to have many tests done including cervical thoracic MRI, nerve conduction tests, and lumbar puncture. I had rib tightness and headaches. I was treated with IVIG for four days and was hospitalized for seven days. I am diagnosed with Guillain-Barre Syndrome. I was given prescriptions to take. I also had eye twitching and muscle spasms and I still experience numbness and tingling in my fingers and toes, still have back pain, and I currently go to Physical Therapy.
Starting having aches all over the body. On 11/5/02, he started to hyperventilate. He passed out, was sweating tremendously. Was brought to the hospital and received IV. His eye rolled up to the back of his head and was slurring his words really bad.
Started having muscle pain and weakness and feeling lethargic same day of the vaccine. Started having migraine type headaches 4 days after the flu vaccine (extreme sensitivity to light and sound). Ended up in the Hospital ER Nov. 2, 2019 from intense headache.Two weeks later started having tension type headaches.  Dec. 3, 2019 headaches continued then started having respiratory disturbances and tremors all over and ended up being hospitalized. Afterward, I started having facial muscle pain and facial tightness.  I ended back in the ER a  3rd time for facial pain/headache. Even today, 8 months later, my head and forehead stiffens with touch, and I am still having extreme sensitivity to sound.
not have any effects to the vaccine,other than a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "not have any effects to the vaccine,other than a sore arm.".  No follow-up attempts are possible. No further information is expected.
Developed diarrhea, joint aches and fever leading to being unable to work for the next two days
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 23-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 528 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 01-APR-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB (Lot # J008505, expiration date 07-FEB-2016) intramuscular, anatomical location and dose were not reported. There was not concomitant medication reported. No product quality complaint was involved. No adverse effects were reported. Additional information has been requested.
7/23/21, Developed drop foot of my right foot, began to resolve September 2021. 8/1/22, Tingling and numbness in both hands became noticeable . It has progressively gotten worse and still persists.
Severe sudden onset headache located in the temporal region of head, states this  lasted short time then was a low grade HA for several days, pt also describes malaise, muscle and joint discomfort,  chills and sweats, and overall feeling of "unwell"
tired; chills; Sleeping more than ever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2, DOSE 1, SINGLE for covid-19 immunisation. Patient was a consumer who wanted to know when she will be fully protected after receiving both doses of the Pfizer-BioNTech Covid 19 vaccine? She had both doses when it takes effect. So tired and some chills. Sleeping more than ever. She did take something to help me sleep but I was really sleeping a lot. Can she take all my medications, again? Patient was a consumer who reported feeling tired and some chills after receiving both of her doses of Pfizer-BioNTech Covid 19 vaccine. She also stated that she "takes something to help me sleep" but since receiving the vaccine she was "been sleeping a lot". The clinical outcome of the events was unknown at the time of report. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Numbness, facial paralysis- Diagnosed with Bell?s Palsy. Treatment Oral Steroids, Eye drops, Speech Therapy, Accupuncture.
Pain in the left side Ribs under shoulder blade; Difficulty breathing; Pain was worst with deep breaths (Left Ribs); Difficulty getting up from the chair; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain in the left side Ribs under shoulder blade), DYSPNOEA (Difficulty breathing), PAIN (Pain was worst with deep breaths (Left Ribs)) and DYSSTASIA (Difficulty getting up from the chair) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain in the left side Ribs under shoulder blade), DYSPNOEA (Difficulty breathing), PAIN (Pain was worst with deep breaths (Left Ribs)) and DYSSTASIA (Difficulty getting up from the chair). On 17-Mar-2021, MUSCULOSKELETAL CHEST PAIN (Pain in the left side Ribs under shoulder blade), DYSPNOEA (Difficulty breathing) and DYSSTASIA (Difficulty getting up from the chair) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Nausea and fatigue. Difficulties with concentration. Epistaxis. Decreased strength in lower extremities. Evaluated at the office again on 3/26/19. Evaluation and testing recommended in the emergency department. Did not go for evaluation.
2 days post-vaccine patient reported a painful rash/lesion approximately 2" in diameter on the palate of the mouth.
Pt stated whole shoulder sore-rash/reddness 3/26/07 he says spread down arm and across shoulder and chest. (Asthma attack mild 5/25) he reported on 5-26-07
Narrative:  Per note: "CC Dizzy; Pt seen after 1st Vaccine Moderna reported lightheaded some blurry vision mostly L eye and CP 5/10. Pt denied any palpitations SOB or HA. Pt denied any cutaneous symptoms no rash noted. No Airway complaints. Vitals taken in chair at vaccine station brady and hypotensive. Pt Son stated always has low BP and did not take his medication this afternoon unable to identify medication." Patient seen in outside hospital ED, but no records available at this time. Appears patient has been discharged to home.
Acute left arm swelling, pain over deltoid. Fever to 103, headaches, nausea, vomiting, diffuse aches.
FEVER 101.6 DEGREES, CHILLS, NAUSEA, MILD HEADACHE, VOMITING, STRONG HEADACHE, UNCONTROLLABLE VOMITING, DEHYDRATION
This spontaneous report as received from a medical assisstant refers to a 4 year old patient. Information on medical history, past drugs, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, at 15:45, the patient was vaccinated with second dose of VAQTA (lot # N005796, Exp date: 26-MAY-2018) dose 1, 1 DF, intramuscularly in the left arm for prophylaxis. Other suspect therapies included PROQUAD, (lot#N013270, Exp date: 25-OCT-2018) 1 DF, into left arm subcutaneously for prophylaxis on the same day. Also the patient was vaccinated with fifth dose of DIPHTHERIA TOXOID (+) PERTUSSIS VACCINE (UNSPECIFIED) (+) TETANUS TOXO, (05102AA) 1 DF, into right arm, intramuscularly for prophylaxis on the same day and on an unknown date, fourth dose of POLIOVIRUS VACCINE INACTIVATED (UNSPECIFIED), (N1G41) 1 DF, was administered into right arm, intramuscularly for prophylaxis. On 02-AUG-2017, at 08:45 am, the patient experienced incorrect product storage. No adverse symptoms or reactions were reported. This case is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005166: US-009507513-1708USA005167: US-009507513-1708USA005169: US-009507513-1708USA005170: US-009507513-1708USA005168: US-009507513-1708USA001493.
"Covid Arm" Yesterday my left arm at the vaccination site started itching and burning around midday. By evening my arm was swollen and painful (I usually sleep on my left side and couldn't because it hurt so  bad). There was also a slight rash around the vaccination site about 3-4 inches in diameter. Today my arm is not as itchy but is still swollen and painful.
developed pain 1 week later that has not resolved.; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a infant female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   The patient's past medical history included shoulder injury (MVA Left shoulder injury) and automobile accident (a motor vehicle accident May 2023). Previously administered products included Flu Vaccine.   On 29-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and FLU VACCINE (NAME UNKNOWN) (right deltoid). In OCT-2023, 1 week after receiving Shingrix, the patient experienced pain (Verbatim: developed pain 1 week later that has not resolved.). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK receipt date: 26-OCT-2023 The customer reported that she was in a motor vehicle accident May 2023 and sustained a left shoulder injury.  The patient received her 1st Shingrix vaccine and developed pain 1 week later that has not resolved.   She received her flu vaccine at the same visit. It was unknown if the reporter considered the pain to be related to Flu vaccine. The reporter did not consent to follow-up.
painful swelling of the upper arm down to below the elbow; painful swelling of the upper arm down to below the elbow impacting mobility; painful swelling of the upper arm down to below the elbow; This spontaneous report was received from a consumer via a company representative and refers to a female patient of unknown age. There was no information about her concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, she experienced painful swelling of the upper arm down to below the elbow impacting mobility.   The outcome of the events and the relatedness between the events and the suspect vaccine were not provided.
Shortness of breath, chills. tingling, metallic taste, nausea, headache
Pt recvd vax & w/in 5 mins p/inject exp dizziness, pain & swelling @ inject site, grey & white color around inject site, trouble seeing, tightness in throat & had a BP of 156/86; pt took DPH @ home;
This report states that in February 2001, the pt fell while skiing. Approximately 3 days later she began experiencing numbness of the entire left side. She received an initial evaluation from local physicians who attributed the symptoms to her fall. She was diagnosed with muscle strain, put on a 2 week profile and prescribed Tylenol. The symptoms only slightly resolved with some residual numbness in the fingers of her left hand. on 06/03/2001 she presented to the medical clinic with complaints of a headache times three weeks with increasing pain in her right eye with decreased and darkened filed of vision. Within a few days she had total loss of vision in her right eye. She was evaluated locally and referred to optometry. That same day, optometry reported a +2-3 afferent papillary defect OD and severe color vision loss OD; fundus esam of healthy retinas OU with cup-to-disk ration approximately 0.4 with physiological cupping and lamina OU. She was treated with Solumedrol 1 gran /IV for five days then put on a Prednisone taper of 60 mg x 5d, 40mg x 3 days, 20 mg x 2 d. Her eyesight slowly returned-initially seeing shadows, then light and eventually full vision. She had not had a recurrence of these symptoms. During the evaluation of the optic neuritis, an MRI of the brain showed findings consistent with a demyelinating disease such as MS or Lyme disease. Further evaluation and lab tests ruled out Lyme disease. A second MRI of the brain two weeks later showed an area of hyper intensity in the spinal cord at C4-5 consistent with demyelinating plaques as in MS. One neurologist remarked that the left-sided numbness the pt experienced in February could not be attributed to a fall that happened five days prior and considered that set of symptoms the first sign of the demyelinating disease. Furthermore, combination of symptoms was definitely multiple sclerosis. During the time of this evaluation, the pt was pregnant; therefore other neurologist were hesitant to make a definite diagnosis of MS. In December 2001, she had a normal vaginal delivery without complications. A MRI done following her delivery showed the plaques were unchanged. Treatment with medication was delayed due to breastfeeding but she is currently on Avonex injections once a week for her symptoms. She has expereinced flu-like symptoms for 24-48 hrs following both of the two Avonex injections she has received. These are fairly common effects of the medication. The pt has a history of migraine headaches; however, these headaches have become more severe. Currently she experiences these pains once or twice a week at the same level of intensity. She noticed increasing fatigue and still experienced daytime somnolence. On July 5, 1999 approximately 5-6 weeks after anthrax vaccine #4, she developed pruritic papules over her entire body and began to experience swelling over her entire body.  She also has short term memory problems.