chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The person who received the vaccine on 06Jan had low fever, muscle ache and headache the next day after the second dose.; The person who received the vaccine on 06Jan had low fever, muscle ache and headache the next day after the second dose.; The person who received the vaccine on 06Jan had low fever, muscle ache and headache the next day after the second dose.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of bnt162b2 for COVID-19 immunization on an unspecified date. On 07Jan2021, the patient who received the vaccine experienced low fever, muscle ache and headache the next day after the second dose. There was no treatment for the events. She had the antibody test on 29Jan2021 and was found negative. Outcome of events was recovered on an unspecified date.  Information about Lot and Batch has been requested.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live (lot # not available). She indicated that the parent had contacted her concerning adverse events following immunization with varicella virus vaccine live. No specifics were available. She did not believe that the adverse events seemed severe. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that all of the reactions described by the physician were normal reactions. The reaction was described as local swelling. The child had a pox mark. Additional follow up received from the physician indicated that he did not have any patients with adverse reactions to varicella virus vaccine live. The reporter indicated that 2 other patients experienced adverse events (WAES0411USA03509). No additional information is expected.
Myalgia MALAISE, LETHARGY Narrative:  Other Relevant History:
64 YO got Havrix pediatric dose; 64 YO got Havrix pediatric; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 64-year-old patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 12th July 2022, the patient received Havrix 720. On 12th July 2022, unknown after receiving Havrix 720, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the adult patient received pediatric dose of Havrix vaccine. Additional Supportive Information: The adult patient was administered a pediatric dose of Havrix, which led to underdose and adult use of a child product.
HEMORRHAGIC STROKE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient experienced hemorrhagic stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hemorrhagic stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-hemorrhagic stroke. This event is considered unassessable. The event 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.
Tinnitus developed in both ears the evening of April 23, 2021.  Have sought treatment from two different ENT doctors, have received accupuncture and massages and have tried to cleanse my dietary intake.  No relief from symptoms as of this date.
Saw PCP 10/18/16 for Headaches/muscle pain that began one day after flu shot. Progressive pain and weakness in legs and arms since then. Now pain with walking and difficulty rising from chair. No documented fevers. Vomiting. Burning sensation in arms and legs. Was seen by neurologist on 10/19/16, who started Gabapentin.
patient is complaining of swelling, tingling and numbness in her right ar.  Still continuing today.  Dr. has told her that there is nerve damage but no testing was completed
covid antigen test positive; covid antigen test positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: CJ6742) at the age of 44 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2022, outcome "not recovered" and all described as "covid antigen test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive; (04Jan2023) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Client presented to our clinic for his 2nd dose of Moderna vaccine. His wife called the call center to report the following: "His arm is immobile ? he?s not paralyzed but paralyzed by pain. Cannot change shirt, has never had pain like this with a vaccine and noticed something was wrong immediately. 'He could feel the liquid going in.' Fine with the first dose, arm was tender. No pain, swelling, redness, tingling with this vaccine.  Very isolated, no unusual s/sx. Trying Motrin/Ice Pack. Didn?t know if he should be seen ASAP or wait it out." According to the caller, the vaccinator told the patient: "Pain at the injection site is normal after a vaccine, but if your husband believes the pain is unusual or concerning to him, he should follow-up with a PCP/provider." The call center representative told the patient the following: Suggested contacting 24/7 nurse hotline, as they can provide more assessment than we are able at this hotline and provide additional recommendations. Caller endorsed understanding but requested that we f/up with site to alert the nurse that she's administering the vaccine in the wrong spot. She said specifically that the site was much higher than the standard approx of 3 finger breadths.  Call center note/addendum: Contacted caller and spoke with patient directly. Patient confirmed that information provided by his spouse was accurate and also stated "Caller noticed more pain than with a normal shot, but not a sharp pain. Described as a deep pain and like "fluid was distributing throughout the shoulder as it was going in." Patient has spoken with 24/7 nurse hotline and instructed to wait a few days and see if the pain resolves because there isn't much that can be done. Encouraged caller to check in with provider if issue doesn't resolve. Caller gave permission for this information to be shared with the vax site and for VAERS report to be completed. Explained that site wanted to assure event is documented in the event that pain doesn't subside, endorsed understanding.
Fatigue; Chills; Arm pain; Unwell feeling; Body aches; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 07Apr2021 at 14:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included lisinopril (MANUFACTUER UNKNOWN) 20 mg per day. The patient previously took Atarax and experienced allergy to it. It was reported that, prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 06:00 the patient experienced fatigue, chills, arm pain, unwell feeling and body aches. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, chills, arm pain, unwell feeling and body aches was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Eight days after first Moderna Covid injection, rash and itching appeared at the injection site.  The rash is read and raised irregular shape . 7cm x 8 cm
On 11/8 Child had fever to 103 and above that did not respond to Tylenol.  On 11/9 first went to emergency - kept for a few hours then let him go with some Tylenol, saline drop and vaporizer.  Then patient continued to have fever with oral and suppository.  At no time had swelling/rash/or trouble breathing - no allergic sounding reaction. Then on 11/9 went back because fevers still not going down.  Then kept him on IV for three days due to fever that could not go down.  Was put in contact isolation.
Patient experienced sudden onset of dizziness, sweating, light headed, paleness and palpitations. Cold compress was used on patients forehead. His legs were raised up and offered cold water. Pt started feeling better after about 5 minutes and was monitored continuously for another 15 minutes. Patient stated to be feeling quite well after another 10 minutes. No doctor's visit was needed after patient recovered.
The night I started getting feverish. I rested. On Monday, I called out sick. Monday, Tuesday - it was chills, fever. 2nd day, my legs started having a sensation I've never ever felt - like cramping/charlie horse. I went to work on the third day but I needed to go home. When I came home, my legs were doubled the size. I tried to ride it out by resting. Ever since then, my legs have weird sensations - not cramps but aches. I have never felt this before. Once in a while, when I'm walking, I get cramps. It still hasn't gone away. At the end of the day, my legs will be swollen but not as bad as the third day after the vaccine.  I think my platelets are actually too high so I think that is a good thing. Upcoming doctor's appt on July 9 - she is going to do a whole physical with bloodwork.
had t102 ax, severe h/a, difficulty breathing, backache about 10hrs p/vax; seen @ ER for immunizations; 12JUN95 seen by RN feeling fine-no further problems;
The day morning my booster shot I woke up with gout in my right toe. I was prescribed colchine that morning but it didn?t help.  I tried to drink plenty of water and avoid gout inducing foods for 3 additional days but by Saturday night I could barely put pressure on my foot. I did another virtual appointment, where I was prescribed Methylprednisolone which seems to have started working very well.
History per chart review and husband. The patient is a 55 Years-old Female with a history of rheumatoid arthritis, anxiety/depression, overweight who presented with acute shortness of breath. 2 weeks prior to admission she filled her routine prescription for hydroxychloroquine for her rheumatoid arthritis, however husband reports that she stopped taking this and started taking a supplement from another country called RT King and reported improvement in arthritis symptoms.  She also had congestion and sore throat around this time and tested herself for Covid with a home test that was negative. Shortly after this she was performing her job as a provider for patient that passed away from Covid and attended the funeral.  On 9/8 she reported difficulty breathing and pain in the chest and back with deep breaths.  This spontaneously resolved.  Then on 9/9 in the evening she had fever, body aches, however she attributed this to her rheumatoid arthritis and the storm pressure changes.  9/12 she felt great then played at the beach with her grandkids running around.  Then 9/12 in the evening she felt ill and took a home Covid test that was positive.  Husband took a home Covid test that was negative.  She did not initiate any outpatient care other than Mucinex and vitamin C.  9/13 in the morning she had difficulty breathing, hyperventilating, blue lips, diffuse body pain, feeling very weak to stand.  She was not drinking or caring for herself.  She was able to walk to the truck.  Her family brought her to the ER freestanding.  At the freestanding ER, she had initiated and tested positive for flu and negative for Covid by antigens.  Covid PCR later returned negative.  She was transferred to the main ER and desaturated during the transport and stopped breathing.  She maintained a pulse.  In the ER she was intubated.  Pressors Were Started to Maintain MAP. CTA was negative for PE, however ED physician and family practice physician clinically suspected PE and that there could be multiple small thrombi in the lungs rather than a large PE detectable by CTA.  She was started on heparin drip.  ICU accepted the patient and began management. She tested negative for COVID IgM antibodies and positive for COVID IgG antibodies. She devloped DIC (disseminated intravascular coagulation) and TTP (thrombotic thrombocytopenic purpura). During the hospital course she had sputum and blood cultures positive for streptoccocus pneumonia. She later had pseudomonas VAP and Enterococcus faecalis bacteremia. She had failure of lungs, liver, and kidneys. She was treated with maximal critical care management including broad spectrum antibiotics, ventilation, continuous renal replacement therapy, blood/platelet transfusions, chest tube, OG tube feedings, and anticoagulation initially that was later discontinued. She had minimal responsiveness to pain only after sedation withdrawal and was unable to breath spontaneously. On 10/9 the family agreed to palliative vent withdrawal and she expired. I suspect her severe illness may have occured due to abrupt discontinuation of hydroxychloroquine for rheumatoid arthritis and antibody dependent enhancement of influenza due to COVID vaccine.
Within an hour after receiving the vaccine pt began a severe headache which has not subsided 8 days later.  Ibuprofen and a nap can temporarily (no more than 2-3 hours) reduce the impact of the headache.  This has caused missed events.  In creasing water intake is not helping.
V/S 124/88, 76, 18, O2 stat-100% on RA, pt stated, "she feels dizzy, room spinning".  Encouraged pt to push fluids, offered snacks, educated to stay til 11am to be monitored.  Reassessed at 11am, pt states, 'she feels better' Denies dizziness/room spinning, cleared for discharge. VS at time of dismissal is 120/70, 72, O2 stat-97% on RA.
New onset of severe facial pain on ipsilateral side as injection site -  right side. Diagnosed as Trigeminal Neuralgia by Veteran's Affairs ED by two providers. Refered to Neuro. Treated medically.
approximately 30 minutes after receiving vaccine pt had a coughing fit and then continued to have R sided chest pain/tightness causing continued throat clearing/coughing. Hoarse voice as well. We treated as allergic reaction with IV solumedrol 125mg, IV benadryl 25mg, and one 5mg Albuterol neb treatment with good resolution of symptoms.
Information has been received from a medical technician referring to multiple unspecified patients of unknown gender and age. The information of concurrent conditions, medical history and concomitant medications was not provided. On unknown dates the patients were vaccinated with GARDASIL (lot # K008931, expired date 04-MAR-2017, dose, frequency and route were not provided) that were improperly stored (incorrect product storage). The vaccines were stored at temperature of -0.5 degree C with time frame of 218 hours. There was no previous temperature excursion. No adverse effects reported. This is one of two reports received from the same source (linked report MARRS#1603USA006564). Additional information has been requested.
reaction started with hives, itching and facial swelling (mouth, lips, & eyes).  Progressed during that day to swelling of throat.  Pt took two Benadryl 25mg capsules.  Symptoms began to subside.
Arm so sore unable to sleep, onset of chills middle of night, no appetite, chills continued off and on through Friday night, extremely large red inflammation around injection site (8? diameter) hot and sore to the touch. Chills ceased Saturday morning and red inflammation subsided by Tuesday.
Initial report received from a health care professional on 18 Dec 2009: This patient was vaccinated with FLUVIRIN (batch no. 1013262P) via intranasal route instead of intramuscular route on 17 Dec 2009. No adverse event was reported.
administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 9th of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter
Stereotypical paroxysimal episodes of eye movements, staring, decreased responsiveness, perioral cyanosis. Seen in hospital and transferred to another hospital. Treated for seizure disorder. CT scan showed small subarch cyst. MRI scheduled.
Mild discomfort upon injection and the following 7 days. Day 8 after injection - severe itching and moderate burning at injection sight.  skin was very hard surrounding injection. Day 9  in morning injection area more inflamed , red almost bruised looking and still itchy.  Very very lethargic, upset stomach and inability to focus.
Information has been received from a registered nurse (R.N.), for the Pregnancy Registry for GARDASIL, concerning a 20 year old female with no medical history or drug allergies who was vaccinated with a dose of GARDASIL. There was no concomitant medication. The patient was pregnant 15 weeks and 6 days. No problems reported. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information was received concerning a female was vaccinated with the first dose of GARDASIL in May 2008. On 09-SEP-2008, ultrasound was performed and it was normal. Follow-up information on 01-JUL-2009 was received from a certified nurse-midwife who reported that on 21-JAN-2009, the patient delivered a female infant who weighed 6Lbs 14 Oz and had Apgar of 7 & 8 at 1 and 5 minutes respectively. The patient delivered vaginally and had a shoulder dystocia during delivery. The baby was fine and doing wonderfully. The patient developed a postpartum depression, but  was currently in treatment and her depression was resolving. As of 01-JUL-2009, the outcome of shoulder dystocia was unknown. Additional information is not expected.
Came to emergency room with complaints of increasing shortness of breath for 2-3 days.  He apparently tested positive for COVID-19 1 week ago.   EMS, his oxygen saturation was 87% on room air.  Chest x-ray showed multifocal diffuse bilateral pulmonary infiltrates consistent with moderate to severe COVID type pneumonia.  Started on oxygen supplementation and received IV dexamethasone.  Within 24 hours after admission patient had significant worsening of respiratory status and had to be placed on 60 L high-flow nasal cannula oxygen via Airvo and 100% FiO2 with non-rebreather mask.  Patient tried BiPAP and was unable to tolerated. Patient stated that he did not want to be intubated and did not want resuscitation. He was started on empiric antibiotics. As per patient request, hospice care was consulted and plans were made to transfer the patient home with supportive care. Unfortunately, even as arrangements were being made for the patient to go home with oxygen and BiPAP, patient died on 10/07/2021. Time of death was at 12:09 p.m. on 10/7/2021.
Hives (Itchy w/bumps) swelling, sore throat (w/over 3 weeks time period) Restless sleep. Adversity lasted for 7 days and sore throat all have 1 month later.
I have pretty severe shoulder pain in a specific spot in the front side of my shoulder joint when I raise my arm. I cannot lie on my left side to sleep because I wake up in pain. I cannot lift my arm at the shoulder higher than chest high out to the side before an excruciating, stabbing pain starts. I have to literally have to lift my arm the rest of the way with my other arm. I have had no prior injury or complaint with this arm. I am so disheartened because I am left handed. I got my vaccine 10 days ago and all my other vaccination symptoms went away after 48 hours but this has persisted and has NOT GOTTEN ANY BETTER AT ALL! I do plan to call my primary care physician to let her know and schedule an appointment.
pt recv vax 4DEC97 & 5PM 5DEC97 c/o chills, neck & chest rash & fever during the noc;sx cont for 3 days;pt did not seek med attention;sx have now subsided;
8x10 cm warm, red, swelling around injection site left thigh medial aspect fever, with cellulitis. RX Cephalexin PO Motrin, Prednisolone.