chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VAXELIS and ROTATEQ were administered on 2/13/2023 after a temperature excursion.  Temperature: Above 9°C; This non-serious spontaneous safety report, with reference number 02335318, was received by a partner on 13-FEB-2023 and forwarded on 14-FEB-2023, from a non-HCP.  Due to the nature of the event the causal relationship between Vaxelis and "VAXELIS and ROTATEQ were administered on 2/13/2023 after a temperature excursion. Temperature: Above 9°C." was not applicable.    Further information is expected.  FOLLOW-UP INFORMATION, with reference number 02335318, was received by a partner on 16-FEB-2023 and forwarded on 17-FEB-2023, from a non-HCP. The case is maintained as non-serious.  It was reported that VARIVAX and PROQUAD might have been also administered to the patient post-excursion (yet to be confirmed).  Due to the nature of the event the causal relationship between Vaxelis and the reported event "VAXELIS and ROTATEQ were administered on 2/13/2023 after a temperature excursion. Temperature: Above 9°C" remained not applicable.  Further information is expected.
10-20-11 rash in armpits (bought BENADRYL) 1 wk followed by fingertips completely numb, vision went totally blurry, then had no balance, speech slurred, finally went to ER on 11-15-11.
7 yo given dose #2 of H1N1 vaccine. However, parent took child to PMD on 11/26/09 for dose #2 of vaccine and child did not inform school. Mom said he had fever on night of 12/14/09.
Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 67 years or 68 years. The case was reported by patient's ex husband. The reporter stated that the patient had pain at injection site with first dose. The reporter was unable to give consent for follow up but will ask patient to contact GSK to provide more information. The case has been linked to the case US2019154030, reported by same reporter.
Patient received vaccine at approximately 12:30pm on 9/11/2021. At approximately 12:45pm patient began having trouble breathing and experienced numbness in her lips, arms , and legs. Patient was helped to lay flat on the floor where she was administered 0.3mg epinephrine autoinjector in the right upper thigh at 12:47pm. At approximately 12:49pm police arrived and took over the scene. Patient had began to breath better but still experienced numbness in her lips, arms, and legs. Police communicated with EMS and were advised not to administer any further doses of epinephrine. EMS arrived on scene at approximately 12:55pm. They assisted patient to the cot where she was set to be taken to the local emergency room for further observation.
1 1/2 days later my left arm had swollen to a 1 inch welt that went half way around the circumference of my arm! I had asked for a quadravalent flu shot but was told by the pharmacist that he could only give me a high dose shot. I read online that the shot was equal to 4 adult flu shots. I think a secondary prodical should be written for those of us who overreact to vaccinations. Maybe I could have a booster shot in a month or something. Please do not make me take a high dose shot next year. Thanks for listening.
received an expired dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HAV (Havrix) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided follows:  On 30th April 2021, the patient received Havrix, which was expired on 6th March 2021. The reported batch number 37RYN4 was not found in sales data sheet, hence correct batch number was updated as 37RY4 as per sales data sheet. The reporter consented to follow up.
Gastrointestinal issues including severe nausea, diarrhea, and loose stools. Difficulty eating due to tightness of stomach and feeling full after only a few bites. Sharp chest pains, including racing heartbeat and pressure which induces coughing. Various sharp body pains, mostly in the chest and torso. Uncontrollable shaking, and a buzzing electric feeling throughout body. Flashing in eyes when closed. Head feels heavy with constant vertigo and brain fog. Muscle spasms all over and twitching in left index finger. Insomnia due to listed issues. Nystagmus and feeling of eyes vibrating.
Vaccine received by 9am. Start having fever at 4-5pm, 38.3 for 6-8 hours, chills, fatigue, pain at injection site, took 325mg Tylenol once , fever broke. Next day, temp 37.6, took another Tylenol 325 once. Symptoms resolved in the next 24 hours
Fever/myalgia/local reaction 3 hours after vaccie - at 24 hours; myalgia with temp = 102.8.
PAIN TO INJECTION SITE RADIATING THROUGHOUT RIGHT SIDE TO A DEGREE THAT CAUSED THE PATIENT TO VISIT A LOCAL EMERGENCY ROOM.
Modern a COVID-19 Vaccine EUA 11pm started getting sore arm and headache 12am terrible chills: uncontrollable shaking, teeth chattering. 12:30am took temperature: 100.3 Throughout the night terrible chills, cannot get warm.  Muscle and joint aches that keep waking me up - generally feeling terrible. Highest temperature was about 3 or 4 am of 100.9, then slowly subsided.   Alternating between taking ibuprofen and tylenol ever 3-4 hours. Not much help, but a little.  Had to call off of work.  11:30am took hot bath and that helps the achiness.  Temperature still 99.2
Arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Radiation, Chemotherapy and Antibiotics. Concurrent medical conditions included gingival infection, lipoma and anal cancer.   In OCT-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm soreness).  The outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date- 03-MAR-2023 The reporter was the patient.  The patient received the first dose of Shingrix at the end of October 2022 on a Friday and experienced a little arm soreness and the arm soreness went away on Monday.  The reporter gave consent to follow up with HCP (pharmacy).
Lightheaded, shortness of breath, HTN; given 50 mg. benardyl with resolution in 15 min.
The night of the vaccination- dizzy, cold sweat, uncontrollable shivering, muscle pain, headache
Large red swollen circle on arm (about 3 inches by 2 inches) and between 1/4 inch and 1/2 inch raised.  Skin is red and hot to the touch in the swollen area.  No fever but general tiredness.  Pain in swollen area when raising or moving the left arm.
Extreme muscle pain that disturbed sleep and could get no relief even taking advil.  Wanted to sleep all the time.
Hypersensitivity to sounds, movement. ?I feel really weird. Everything around me feels overwhelming. I hear a bird?s wings flapping the same as people talking next to me, and notice any movement around me ?  Started about 4 hours post vaccination  and  lasted at least 6 hours.  Headache later developed.
HCF nurse, LPN administered patient 2nd Pfizer dose of Covid vaccination in lab. Per nurse patient stood up quickly, immediately after injection saying that he was ready to go. Injection was given in LD at 1532, timer started. Patient was accompanied by mother due to Autism diagnosis. Mom states that she thought he had to use the restroom since he'd gotten up so quickly and she proceeded to walk him to the restroom. Midway to restroom, mom told clerk that she needed a nurse. I was paged and I instructed the clerk to call 911 for EMS assistance. I found mom and patient in women's restroom lobby getting ready to exit. She said that he was sweaty, pale, that his eyes looked differently and that he took 2 big breaths. Per observation patient was, cool, clammy, pale and gait was unsteady. No visible s/s of dyspnea or SOB. He was assisted to front clinic room and sat down, I instructed LPN to get ER cart and O2.Vital were taken at 1534 ,O2 applied at 6ml via mask, turned down to 2ml due to patient intolerance. No s/s swelling, hives, SOB, N/V, patient was verbal and "ready to go home"EMS arrived at 1542, observed patient vitals taken O2 sats remained at 99% with no s/s SOB. Patient's color returned, skin dry/intact after several minutes. Mom encouraged to have patient taken to hospital. She states that she will observe him at home, since he'd returned to normal and was ready to go. After last observation EMS released patient and assisted to vehicle to return home with instructions from EMS. Patient and mom left at 1604
0747 Pt. received first dose of Moderna COVID vaccine. 0805 - pt. c/o SOB and throat tightness.  Pt. evaluated by the provider -- pt. placed on oxygen - 911 was activated. 0811 IM Benadryl and Kenalog given.  0815 Epinephrine IM was given.  0824 - pt. verbalized that tightness of throat and SOB was improving.  0826  EMS arrived and pt. taken to the local ER.  1400 - Pt. returned from the ER.
death; severe headache; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program.  A male patient of an unspecified age (Age: 83, unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EH9899), intramuscularly in the left arm on 20Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient previously took azithromycin [MANUFACTURER UNKNOWN] and experienced allergy on an unspecified date.  On 22Jan2021, the patient experienced severe headache (non-serious). On 28Jan2021, the patient experienced death (death, medically significant); 8 days after receiving the vaccine. The patient died on 28Jan2021 due to unknown cause of death.  It was unknown if an autopsy was performed. The clinical outcome of the event, death, was fatal. The clinical outcome of the event, severe headache, was not recovered.  No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death
Approximately 8 hours after the vaccination, I had a high fever and bad nausea. I threw up three times within 8-9 hours after vaccination. I was able to sleep for 2 hours (because it was evening time), then woke up with chills and a fever and an urge to vomit again. I tried to drink some water and threw up that water twice, now approximately 14 hours after vaccination. The nausea subsided after that and I did not throw up again, but the fever and chills remained for days after (coming and going, subsiding and then re-emerging).
Shoulder pain radiating to finger tips, red swollen rash that is continuing to spread, headache, fever, rash is warm, rash currently on back of upper arm - pt is taking diphenhydramine and acetaminophen with no relief - told her to check with her MD.
Pt recvd vax 8SEp92 & approx 15 mins following vax devel a high grade fever, nausea & delirium; pt recovered on 11SEP92 & on 12SEP92 seen by MD;
Patient came with her right arm in the deltoid area being red, sore to the touch, and tender about 3/4th of the circumference of the arm. Advised patient to talk to her physician about the reaction so they can document and possibly treat.
second dose/given less than 2 months apart. First dose/ 05/30/2021 and second dose/ 06/29/2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number X7Z52, expiry date 5th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th June 2021, the patient received the 2nd dose of Shingrix. On 29th June 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On 29th June 2021, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 30th May 2021. The reporter stated that, second dose of Shingrix given less than 2 months apart to the patient, which led to shortening of vaccination schedule. The reporter consented to follow up.
At 10 pm the patient woke up feeling cold, clammy, dizzy and feverish. On the way to the bathroom he fell from excessive dizziness and had a fever of 102 degrees. His wife encouraged him to go to the Emergency Room and the patient wanted to just go back to bed. He woke up again at 4 am, took 1000 mg of acetaminophen and went to work. He still had general body aches and continued to run a fever until noon the following day.
Patient experienced bleeding at the injection site and immediate bruising and "goose egg" at site. I applied pressure with a cotton ball and stopped bleeding after 1-2 minutes. Once it was clotted, I went ahead and gently rubbed the deltoid to get the immunization to go into the muscle. I had the patient use some exercises to increase blood flow to the muscle to help immunization get absorbed. After 5 minutes, the swelling had gone down. Patient was instructed to apply a cold compress if it was uncomfortable and to follow up with pharmacy if any questions.
This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (parent, reporting for her sons). This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A male patient of an unspecified age and ethnicity received first dose of TRUMENBA, via an unspecified route of administration on an unspecified date in Jul2017 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and headache, which lasted two days. The patient also stated that the pediatrician office does not seem to know what was going on with the dose schedule. The outcome of the events was recovered. The patient will be getting the second shot at the end of Nov2017, which would be 4 months after the first dose. Sender's Comments: Linked Report(s): US-PFIZER INC-2017479987 same drug and event/ different patient.
I was fine for the first few hours, however as the day wore on I felt massive pain in my left arm at the injection site. Became fatigued early in the evening. Stayed home. Woke up at 7am on 05/02/2021 with brutal headache, took Tylenol, went back to sleep. Woke up with no headache. Pain in arm subsided. on 05/04/2021 pain in arm was definitely irritating where the injection was given. No matter what I did to relieve the pain, either pain relievers, or by doing muscle exercises, the pain did not subside, and got worse over the course of the next two weeks. About 05/16/21 the pain subsided at the injection site,however I started to develop extreme anxiety, and morning sweats I have never had this before. The sweats lasted until July 2nd, and have not come back. Every single morning for about an hour I could not get comfortable until they passed. Along with this about 05/30/21 the pain in my left arm at injection site came back, and was with me everyday until about 07/04/21. The pain has not come back, although I feel a slight swelling in the area. It no longer hurts. I told a friend about it, and he said the injection caused some sort of trauma/injury to my arm, and may or may not heal properly. I think it healed, but would not be surprised if at some point it manifested itself again.  I will NOT be getting any BOOSTER SHOTS no matter how many times and the rest of  tells me I am a murderer and a bad person for not doing so.  is responsible for this mess and should be held accountable. No one should ever be forced into getting vaccines, or made to feel guilty for not taking one. Whatever happened to "My body, My choice?" The vaccines were rushed through and were only allowed to be used under a national emergency are not proven to be safe. Otherwise there is no way any of the vaccines would have ever been allowed to be used in the US by the FDA.  The COVID Vaccines are showing adverse reactions in about 1 in 13000 patients, while the normal acceptable rate is closer to 1 in 100000. That means these Vaccines are about 8 times more dangerous than vaccine for the flu. We rushed into this and now we are reaping what we have sown. Only time will tell what other adverse reactions will manifest 1-2 years down the road. This is my statement. It is 100% true. I stand by my words, and my experience.
New onset of vertigo.  Daily heart palpitations.  Md reports hearing a gallop
Two days after my most recent vaccination. I had a headache, arm was extremely sore, I also had nausea and headaches as well. I was also having abdominal pain which led us to the diagnosis of diverticulitis. I have had a continuous headache that seems to persist. Cipro was prescribed to me to help with my diverticulitis and it is starting to help my symptoms, however, it will most likely take a while until I am feeling back to normal.
Starting at 4pm muscle ache starting in my lower back and hips, by 7pm full body  muscle and joint aches 7-8 on the pain scale. I felt like I had a high temperature but each check I was never higher than 98 degrees accompanied by chills. No headache at anytime. 3 Tylenol tabs taken every 6 hours but it gave minimal relief from the muscle/joint pain
On the morning after I received my second dose of the Moderna injection, I took the Band-Aid off and there was a giant welt-like thing on my left arm.  It doesn't itch, very mid redness and just feels sore like you normally are after getting a shot.  No other signs or symptoms, just sore arm (feels like a bruise) and red welt-like circle on my arm.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 01-DEC-2008, patient received improperly stored VARIVAX dose 2, from lot # 661445/0525X expiry date: 27-MAR-2010. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
patient received 4 doses of Shingrix; patient received 4 doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 97PL2, expiry date unknown) for prophylaxis.   Previously administered products included shingrix (received 1st dose intramuscularly on unknown arm on 13th November 2019, batch number: 2CP9B) and shingrix (received 2nd dose intramuscularly on unknown arm on 17th April 2020, batch number: 73E59).   On 4th January 2022, the patient received the 4th dose of Shingrix (intramuscular). On 5th January 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 5th January 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 4th January 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The reporter was the retail pharmacist. The reporter stated that patient received 4 doses of Shingrix and all were given on arm intramuscularly at the same pharmacy which led to extra dose administered. The reporter consented to follow up. This is 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002784:same reporter US-GLAXOSMITHKLINE-US2022002785:same reporter
From faxed correspondence received at manufacturer on 11/15/02 regarding an adverse event, which occurred during a Phase IV study for Daptacel. It was reported that a 4 mt old female received Daptacel. Pneumo Conjugate, IPV, PRP-T, and Hep B vax on 10/9/02. The PT expired on 10/30/02. "Per [a local county gov't office] provisionally diagnosed as SIDS death pending remaining test results from toxicology, etc." The event is not considered to be related to vax. Follow up info recieved on 12/11/02 included additional pt details, medical history, and atuopsy results. Info has been received from an investigator concerning a 4 month old female who received her second dose of Prevnar along with Tripedia, IPOL, ActHIB, and Engerix B vaccines on 10/9/02 as part of the Post-Marketing Safety Surveillance Trial. THe pt was a twin born prematurely at 31 weeks gestation to a mother with nail-patella syndrome in renal failure. At birth, the infant experienced respiratory insufficiency of prematurity, apnea, bradycardia and hyperbilirubinemia. During a well-child visiton 9/12/02, the infant showed early physical findings suggetive of nail-patella syndrome. On 10/30/02, the infant died. An autopsy was performed. The infant was described as well-nourished and well-developed. Findings included petechial hemorrhages on the thymus as well as pulmonary congestion and edema. There was no external or internal evidence of injury. The autopsy-reported cause of death was SIDS. Both the investigator and the medical monitor considered the SIDS death to be unrelated to Prevnar administration. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA.
The patient called on 5/27/2023 to report that she had a nodule at the injection site. She stated that the nodule is sore at the injection site.  I advised the patient to visit her PCP to have this nodule looked at, but that it is likely a reaction to inactive ingredients within the vaccine (ie: Aluminum).
This spontaneous report was received from a pharmacist via company representative referring to a patient of unknown age and gender who 3 years ago, approximately on 2010, the patient was vaccinated with a dose of ZOSTAVAX (lot not reported). On 2010, the patient developed a rash and the worst case of shingles ever, after having ZOSTAVAX administered. The outcome of the worst cast of shingles ever and rash was unknown. Additional information is not expected.