chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient who was previously administered a GARDASIL 9 dose in 'June and August' experienced an interrupted; NO additional AE; This spontaneous report was received from a pharmacist and refers to a currently 37-year-old male patient (also reported as a 36-year-old). No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in June 2020, 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) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in August 2020, he was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. By the time of this raport, the patient did not receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of drug administration). No additional adverse effect was reported.
broke out in rash this AM seen by MD dx chickenpox;hx of recent exposure;
Patient received FLUVIRIN vaccine in left deltoid muscle. Almost immediately the area swelled to about the size of a quarter. Patient was advised to stay in waiting room and to take diphenhydramine 50mg which he did. Swelling decreased within a 30 min time period of observation. Patient was advised to go to a walk-in clinic or ER if symptoms worsened or persisted. Patient did not feel need to go immediately and had no further symptoms. When contacted 2 hours later the swelling was significantly decreased with no further complications.
Approximately 9 days after his vaccines, patient started to become more irritable, clingy, and generally fatigued. By the 10th day, he had developed a fever that lasted for at least 3 days, reaching 103.3 at it's highest. He then began to develop mouth sores on his lip, tongue, and the back of his throat which caused significant difficulty and pain eating so had little appetite, was drooling,  was tired, irritable, and slept poorly most nights. Due to his continue fever and development of mouth sores, He saw his PCP on 12th day after vaccination and she stated it was unclear if his symptoms were Hand Food Mouth, cold sores, or another virus causing the lesions in his mouth. He also was diagnosed with an ear infection at this time and was  prescribed Amoxicillin. He had energy back by day 15 post vaccination, but continued to have mouth sores until 21 days post vaccination. During this time, he was unable to attend daycare and was also unable to engage in regular activities at home.
Started with a fever, headache, and extreme tiredness.  11/25/2009 brought her to see dr twice.  She was getting worse as the day went on and was given Tamiflu. 11/27/2009 woke up screaming and crying her head hurt. Noticed the arm she was given the injection was red and swollen and had a lump where the inj was given.  Gave Tylenol and iced her arm.  The next morning still had head ache and gave more Tylenol.  Arm looked better but later in the am she complained the same arm was numb (which lasted less than 5 min) and also said her throat hurt now.  Contacted clinic and spoke with nurses.  Mom also works at this clinic.  Watching and will bring in to dr again if any more side effects.  Concerned of onset of GBS.
Information has been received from a nurse practitioner who reported that she heard that a female patient developed GUILLAIN BARRE SYNDROME after the GARDASIL vaccination. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Upon internal review, GUILLAIN BARRE SYNDROME was determined to be an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PEDVAXHIB (route, dosage and dose number unknown; lot # reported as K002747 EXP 09-DEC-2016). On 13-OCT-2014 the patient received a dose of PEDVAXHB that was exposed to temperatures outside the proper storage range. No adverse effect was reported. This is one of two reports from the same reporter (1411USA003892). Additional information is not expected since there is no permission to contact physician.
Covid vaccine was administered on March 3 without any reactions or side effects afterwards.  On 3/8 she underwent a left molar extraction.  Afterwards she had persistent left-sided pain and was taking NSAIDs at the recommended doses.  She was also having intermittent nausea.  On 3/11 she developed a rash which appeared like erythema multiforme versus urticaria on her chest, back and extremities.  She also had very minimal swelling of her upper and lower lip.  She presented to the ED.  No fever or leukocytosis.  Noted to have AST of 10,133, ALT of 8717, T bili 2.2, ALP 143. PTT 17. We suspect NSAID induced drug injury and rash.
Agitation, Mood: Anxiety, heart: Arrhythmia, blood pressure: varies, concentration: difficulty, consciousness: blackouts, memory: trouble remembering recent information mood swings, nervousness (anxiety), sleep: insomnia sweats: inappropriately sweating, thinking abnormality, Tinnitus, vision problems.
This spontaneous case, initially received on 13-Jul-2016, was reported by a health professional and concerns a patient of unknown age and gender. Concomitant medication: Unknown, Drug reactions/allergies: Unknown. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced an anaphylactic reaction (medically significant, outcome: not reported). Follow-up information received 22-Jul-2016: The identity of the flu vaccine administered to the patient is unknown, no further information.
This is a spontaneous report from a contactable physician.  A 17-year-old female patient received the second dose TRUMENBA (lot number R24748, expiration date: Jan2018), intramuscular on the left arm on 04Dec2017 16:00 at a single dose as immunization (also reported as "It was indicated for her to receive the vaccine") at the private clinic. The patient's other medical conditions, concomitant medications and investigations were reported as None. The patient received the first dose of meningococcal group b rlp2086 (lot number R24748, Exp date: Jan2018), intramuscular on the left arm on 21Oct2017 as immunization. The physician (reporter) stated that she had a patient come in to receive her second injection of the vaccine around 4pm on Monday (04Dec2017). Then on 06Dec2017, the patient came in to the office to be seen because she was having pain at the injection site and when she looked, she noticed her  left arm was red and puffy on 05Dec2017. It was mentioned that the patient had redness to the left arm, pain at injection site and puffiness on her left arm. The reporter stated that when she saw the patient in the office today around 12pm, she did not notice any puffiness but there was redness about the size of a palm about 5cm below the injection site. However, when the physician took the Band-Aid off the injection site, there was no redness at the site, the injection site was fine. The patient also reported having pain 2/10 when the physician palpated the injection site - the pain isn't bad. The physician does not believe the events were medically significant; patient does not have any fever or other symptoms. No treatment given and the physician just drew a line around the redness and informed patient to notify her if redness increases. The pain at injection site was still ongoing (not recovered) while the patient recovered from the puffiness and redness on her left arm in Dec2017. The physician commented that she see this (redness and pain) maybe one other time in 7 years and it's usually with kids, not teenagers. This wasn't something you see a lot. She always advised her patients that they may have redness, pain and things like that with the injection, but she rarely ever sees it actually happen. The physician considered the events and the suspect drug related.
First  it was severe pain in all my joints and body, with fever on Saturday. Sweating all the timein bed but cold when im out of bed. Not so bad thensecond day. But still bad. No energy. Then I noticed a rash covering my chest Sunday night and then I woke up today sweating and hot. Get out of bed to be freezing. Took my temp multiple times with in a few hours and my body temp was 96.3 to 96.7 my normal body temp is 99.1 to 99.3
Back of Pts left arm was very red and swollen area about 15x10cm. Sent pt to Occ Health Clinic.
HEADACHES, LOWER BACK PAIN, RIGHT SHOULDER PAIN, CONTINUOUS THROAT INFECTIONS, INFLAMMATIONS OF JOINTS, INCLUDING BUT NOT LIMITED TO KNEES, ELBOWS, ANKLES, FINGERS, TOES AND SHOULDERS, CHEST PAIN.
BREAKTHROUGH INFECTION; This spontaneous report received from a patient via a company representative concerned a 30 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, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infection was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with asthma and chronic pain. The patient did not have any drug reactions or allergies. Concomitant therapies included PROAIR, TYLENOL with CODEINE #3, DYAZIDE and enalapril maleate (manufacturer unknown). On 30-DEC-2014, the patient was vaccinated with the first dose of ZOSTAVAX (lot #K012786, exp. date 28-NOV-2015, dose not reported, subcutaneously, injection site not reported). On 20-SEP-2015, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (lot #L011529, exp. date 03-JUL-2016, dose not reported, subcutaneously in the right arm). On 20-SEP-2015, the patient experienced injection site pain. On 21-SEP-2015, the patient experienced injection site redness and injection site swelling. The patient sought medical attention by visiting the pharmacist. She was treated with BENADRYL. No lab diagnostic studies were performed. The outcome of injection site pain, injection site swelling and injection site redness was reported as not recovered. The relatedness between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Numbness in Left Side of face, so far has persisted for 6 days after the vaccine.  Included Left side of mouth, left cheek/cheekbone area, and left eyebrow to midline. Felt like there was lidocaine in my face. Dizziness: still getting bouts of dizziness while sitting down and walking, world feels like its spinning Brain Fog: struggling to maintain train of thought, memory problems Fatigued Feels like there is a knot at the base of my throat, feel it when I swallow liquids, does not inhibit swallowing but is a nuisance Fever- lasted for 3 days Chills- lasted for about 24 hours Muscle pain and aching, soreness at injection site, intense shoulder and neck tension is still present but decreasing Headache- 4 days Ventolin Inhaler needed to be taken twice during the worst of the effects, asthma symptoms, specifically coughing and wheezing, have been continuing but decreasing Felt like vaccine exacerbated asthma symptoms Chest tightness, as though someone is sitting on my chest(not one of my usual asthma symptoms)
vesicular lesions at the site of injection; Lesions were uncomfortable; lesion, pruritic; lesion, mildly painful, stinging sensation; vesicular lesions at the site of injection; This case was reported by a physician and described the occurrence of injection site reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced injection site reaction, injection site discomfort, injection site pruritus, injection site pain and vesicular eruption. On an unknown date, the outcome of the injection site reaction, injection site discomfort, injection site pruritus, injection site pain and vesicular eruption were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, injection site discomfort, injection site pruritus, injection site pain and vesicular eruption to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR127528   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's comment: The patient received Shingrix vaccine and approximately 2 weeks after the vaccination experienced vesicular lesions at the site of injection. The lesions were uncomfortable (pruritic and mildly painful and had stinging sensation). After the 1st dose of shingles it took more than 2 weeks for the lesions to fully resolved. The reporter consented to follow-up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR127528; Sender's Comments:  US-GSK-US2022AMR127528:Same reporter
Sore arm/Soreness; This is a spontaneous report from a contactable consumer. A 57-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262) via an unspecified route of administration at left arm on 01Feb2021 at single dose for COVID-19 immunisation. Patient's medical history included headache. The patient's concomitant medications were not reported. It was unknown that patient took any other vaccine in four weeks. On 01Feb2021, the patient experienced sore arm/soreness. Soreness started about 4-5 hours after dose was administered and lasted approximately 14 hours. Treatment was not received for adverse event. There was no COVID prior vaccination and also no COVID tested post vaccination. The outcome of event was recovered.
Patient received their vaccine at 4:25pm, and fainted at 4:30pm, and at 4:35pm the patient was back to baseline. He drank a bottle of water and felt normal. He initially was sweaty, had a dry mouth immediately fainted. He stated he only had a pretzel before the vaccine, and had an issue with needles in the past.
Patient received a Pfizer COVID-19 vaccine today after having completed the Moderna series in July. The personal information given by the patient at the pharmacy was different than the information submitted in system. The patient refused to wait for the 15 minutes after the vaccine for observation, and has not received her Vaccination Record Card. It cannot be confirmed if she actually received both Moderna and Pfizer, but the name and date of birth match in system.
swelling to his eyes, lips and down on his neck; swelling to his eyes, lips and down on his neck; swelling to his eyes, lips and down on his neck; hoarseness in the throat and his voice is hoarse; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. Concomitant medication included power bowl (which had seaweed and all kinds of crap like that for health). The patient experienced swelling to his eyes, lips and down on his neck and hoarseness in the throat and his voice is hoarse on an unspecified date in Mar2021. It was reported that patient's wife blamed it on a power bowl, it had seaweed and all kinds of crap like that in it for health; she just dismissed it. Reporter was asking, this may not be related, but if it is, it will be a relief. She was not sure if this is related to the vaccine, but she thought it was weird. No relevant tests were performed. No treatment was received for the events. Outcome of events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
onset day 9 post #2 shot.  Woke up with muscle & joint pain. stiffness in fingers and joints in both arms. numbness in finger with diminished mobility and function. weakness. Finger numbness and weakness persists now at 20d Aches & pains wax and wane. weakness persists.
pt received Pfizer for 2nd dose  COVID 19 vaccine series after receiving Moderna for her first dose.
1/5/2023: Presents to the ED with exertional shortness of breath over the past month, continues to be worsening, chest pain. Patient also reports URI symptoms just prior to the onset of her symptoms. Patient desaturated to 83% with ambulation.  Anemia and Covid likely contributing to her symptoms. New dx emphysema Assessment/Plan Exertional dyspnea/hypoxia. Emphysema. Asthma. Coronary artery atherosclerotic calcification on CT scan. Anemia. Frequent PVCs. COVID-19. Incidental left adrenal adenoma/hiatal hernia/pulmonary nodule on CT scan. Interventions: Decadron, 90% on room air, placed on O2
Patient's arm at site of injection was bruised (yellow, green) and below the injection site was red and itchy.
Eight days after first Moderna injection, I developed a rash over a large area of my upper left arm starting just below the injection site.  It is red, warm, and burns/itches.  Now, on the second day of the rash, it is somewhat larger, and still burning/itching.  I saw my health provider the second day, and was told to treat it with ice, antihistamine, and Tylenol.  She said it is consistent with a delayed allergic response seen 5-9 days after Moderna injection.  I can't comment on my outcome, as this is only the second day.
Tenderness, swelling, erythema at injection site.  Myalgia, fatigue, nausea.
Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09248, -09249 and 2011-09250. A female child patient had received a DTP vaccine (manufacturer unknown) and OPV vaccine (other manufacturer) at five years of age (lot numbers, routes, sites and dates of administration were not reported) and two weeks post vaccination, she was exposed to measles while playing with an infected child in her neighborhood. Twelve days after the exposure, she exhibited CNS dysfunction and thereafter had a steroid-responsive waxing-waning disorder, diagnosed as multiple sclerosis. Cerebral biopsies were performed twice and showed a chronic viral-type meningoencephalitis; there was no evidence of a demyelinizing component. Pathological diagnosis was unknown. Outcome was not reported. Documents held by sender: None.
I felt fine after the vaccine initially and walked to the nearby store to take care of an errand. Upon entering the store and beginning to talk with the representative I felt woozy. I told him that I thought I was going to pass out. I sat down and became unconscious (passed out) and urinated on myself. The store representative called first responders. I regained consciousness prior to their arrival. Upon arrival my vitals were normal but I felt a little woozy again. The first responders strongly encouraged me to visit the ER but I did not want to spend the money and so I declined. They did do a heart reading that indicated a minor arrhythmic pattern.  I had a similar reaction to a Pfizer booster (#3) in January of 2022 and have never had vasovagal responses to vaccines prior to 2022.
Dtap on 8/23/18 is only 1/4 dose as family history severe rxn to Td and Dtap. Mom understands that this will not "count". 8/23 1/4 dose dtap, 8/24 noticed throat clearing/cough tic with facial tic, several times per day, lasted 3 weeks, then tapered off. Also had febrile seizure on 12/2/18 (first one) but doubt that is related.
Change in menstruation.  This is my first ever "long period" in my 24 years of menstruation. Usually, I have a 5 day cycle with extremely predictable flow.   Scheduled period dates were August 27 through August 31. I experienced two days of spotting commencing on August 28th before starting seven days of moderate bleeding, with the last day of normal menstrual bleeding occurring on September 5th. This last day of normal period bleeding was followed by three days of spotting.   This menses was accompanied by the extension of other menstrual symptoms including several days of migraines. Usually I experience a two-day easily manageable migraine beginning a day before my period and extending into my second, and another two-day, easily manageable migraine beginning on the last day of my cycle and extending into the day after. During the "long period" my migraine commenced on the first day of spotting and ended at the end of my first day of menstruation. The end-of-cycle migraine occurred from the last day of my regular period through the period of spotting after, lessening each day.   Emotional moodiness followed the same pattern as the migraines.
Patient was given immunizations on Monday, Dec 29.  She presented to the office 5 days later with poor feeding and increased sleepiness.  She appeared very pale and had an H/H of 4.1/12.4.  She was diagnosed with autoimmune hemolytic anemia and admited to hospital for transfusions.