chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That night I was feeling groggy in the head which I knew is a normal side effect. But later that night I couldn?t go to sleep and began to shake all over my body. I did not have shortness of breath, or heart pains- I just couldn?t stop shaking. I tried to control my breathing to help but it did nothing.  After the shaking stopped I tried to sleep again but I threw up twice and could not fall back asleep.
Patient states after shingrix vaccine was given approximately 12 hours later she began to have muscle pain throughout her body. Patient came back to clinic today 2/13/2023 to be seen by PCP . PCP prescribed a Toradol IM injection 30mg given today. Patient has an appointment 2/15/2023 and PCP has written that patient my benefit for another Toradol injection on 2/15/2023.
pt recv vax & devel warmth & redness (10cm area) @ inj site & pain on 25FEB97 p/inadvertently recv flu vax instead of APlisol;fluogen was given SC on lt arm;pt has not yet recovered;
Client was given a pediatric dose of Pfizer for her second booster. Client was immediately notified and revaccinated with adult Pfizer per CDC guidelines.
Lymphangitis spreading proximally up arm. No fevers. Only systemic symptom is fatigue. Lymphangitis has continued to spread since initial onset day after injection.
Pt recvd 3 doses of Engerix-B 26SEP91, 30OCT91, & 30MAR92 & 2MAY pt titer was non-reactive; 4th dose given 11MAY92;
Patient received ZOSTAVAX on 8-8-16 in left upper arm subcutaneously. He presented to the pharmacy on 8-11-16 and was concerned about the injection site. It was a raised, firm 2-3" in diameter area (very red) that was itchy. 2 Pharmacists confirmed a local allergic reaction.
no additional AE; Vaccine expired on 08-JUL-2021 was administered on 21-JUL-2021; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   On 21-JUL-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R029515, 0.5 milliliter dose for prophylaxis (route and site of administration were not reported).  The vaccine expired on 08-JUL-2021 (expired product administered).  No adverse events were reported.
Arm pain (R)  muscle pain, weakness (R) chills redness at site shoulder pain (R)
Starting 7.5 day after the vaccination, hives appeared around the injection site . The next day a red and endured area was present (size 3.5x4 inches). Patient used some corticosteroid cream. It resolved after 14 days
1 week after injection in left arm awakened with itching, fever and rash in left arm from injection site to about 2 inches below elbow.
Patient without a prior history or risk factors for DVT, developed acute DVT left leg confirmed by U/S; WBC mildly elevated and platelets were low.  Treated with DOAC
Patient's mother states that patient was crying and nauseous and had loss of appetite. She was not able to sleep and was shaking and feeling nervous and her eyes were rolling back. There was no loss on consciousness. No reaction at the site of injection. Symptoms presented on and off for 3 days. Patient was examined on 09/09/2019 and is feeling better.
received 2nd dose late; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix) (batch number H3SG9, expiry date 3rd January 2025) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (on an unknown date received 1st dose).   On 26th January 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: The nurse reported that the patient received a late 2nd dose of Twinrix as she received this dose more than 9 months after the 1st dose. At the moment of the call, the HCP called to request information about an alternative schedule for the vaccine, so 3rd dose was still not given. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
COAGULOPATHY, UNSPECIFIED TYPE 9/26/2022 -- RECURRENCE OF SAME SYMPTOMS
Heart palpitations, tingling and heaviness in limbs, feeling dizzy and faint, chest feeling heavy, persistent headaches
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-JUL-2015, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt complained of extreme right arm pain, post vax, on 11/3/00. Pt attempted to treat with Tylenol and heat to extremity. On 11/6/00, pt states arm became red and swollen at injection site. Went pt PMD, who prescribed Amoxicillin for cellulitis.
Varicella vaccine breakthrough. developed rash 7/23/06. No fever. Seen in our office on 7/25/06 and diagnosed with atypical varicella. Had 2 dozen papules and vesicles on chest and legs.
103 fever - 2am 3/18/2021 Chills - 8pm 3/17/2021 Body pains - 10pm 3/17/2021
About 6 hours after receiving the Janssen shot, I came down with a fever, muscle aches and chills. My fever peaked at about midnight with a temperature of 101.8. At that point, I took two Tylenol. Had a rough night and didn't sleep well. Continued taking Tylenol the following day to manage the low grade fever. I seem to back mostly back to normal today (two days after receiving the vaccine), however I do still have soreness in my left arm where I got the shot and some residual aches and pains.
Patient came to pharmacy to get covid shot.  we typed it for and administered Pfizer.  Patient was wanting Moderna.  Our company protocol says to keep with same vaccine.  Patient had no adverse event.
Case was vaccinated and boosted with Covid vaccine, then hospitalized for Covid 7 weeks after being boosted.  Admitted 12/17/21 for confusion and weakness, found to be hypoxic and Covid positive. Required up to 4 litres of oxygen, and weaned back down to room air.
A RN inadvertently administered 0.25 ml of Moderna instead of 0.3 ml of Pfizer vaccine.    The recipient and his mother were immediately notified. Recipient was observed for 15 minutes with no reaction to the Moderna booster dose. This RN contacted the mother this morning, 2/17/22.  Patient continues with no reaction to the Moderna dose.  Will continue to monitor.
The patient reported having had a reaction to the Shingrix vaccine. On 6/10/2019 she received her first dose of Shingrix and later that day experienced fever, chills, headache, nausea, injection-site redness, and joint pain. She was subsequently given steroid injection which has helped according to the patient.
she has not received the second dose yet due to financial problems; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received in June of 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she has not received the second dose yet due to financial problems). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 11-JUL-2023 The reporter was the patient who stated she had not received the second dose yet due to financial problems.  Education provided to patient regarding dosing schedule and CDC guidance per content.  Did not consent to follow-up.
blood & mucus diarrhea,  temp 101.8 R, fussiness, dehydration, weight loss, gastritis, gastroparesis
Delayed widespread rash covering entire body. Rash is sandpaper-like texture with mottled appearance. Severe itching and mild burning sensation. Symptoms began approx 5 days post injection.
I had a histamine or allergic reaction about 3 hours after my second Pfizer vaccine and then another stronger reaction about 7 days later.  I am having histamine reactions intetmittantly still.
pt c/o tickle in the throat, he said "it feels like something in my throat". VS assessed. BP  135/82, O2 sat 99%, HR 93, respirations are normal and unlabored. EMT spoke w family advised to take Benadryl if not feeling better once at home. Pt and mom verbalized understanding.  Pt was in stable condition upon departure at 1625
Myocarditis, duration post vaccine 5 months - two days after second vaccine total body collapse. Fever, racing heart, body pains, nausea, vomiting, diarrhea, heart inflammation, heart pain
Pt admitted with RLL Pnuemonia.  Final Dx of Fever secondary to DTAP, Hep B, Polio, HIB, and prevnar.  "Unspecified vaccine or biological substance causing adverse effects in therapeutic use."  Doctor states this is a normal reaction to this medication.
?covid arm? - large red and itchy splotch right by injection site appeared 8 days later.
This spontaneous report was received from a health care professional refers to an unspecified patients of unknown demographics. On 20-JUL-2015 the patients were vaccinated with GARDASIL (lot # K011562, expiry: 08-APR-2017; K010215, expiry: 05-MAY-2015; K016966, expiry 10-MAY-2017) (dose and route unspecified) which were exposed to temperatures outside of the recommended range. No adverse effects have been reported. There was no product quality complaint involved. No additional information was provided. The outcome of incorrect product storage was unknown. Additional information has been requested.
On 10/21/10 (24 hours after vacc), experienced general body aches and low grade fever, relieved w/TYLENOL. On 10/22/10 felt better, afebrile; but c/o "very sore" left arm. 10/25/10 - seen at Urgent Care for (L) arm soreness and erythema at injection site (L) deltoid. Dx cellulitis (L) deltoid. 10/28/10 - no further F/u needed from Urgent Care.
A report has been received from a Physician concerning a 3 year old, Female subject, who had been receiving nasal FLUMIST Quadrivalent, 0.2 milliliters. Once/Single administration. FLUMIST Quadrivalent started on 28-OCT-2015. The patient experienced abdominal pain and vomiting. The patient recovered from the event of abdominal pain and vomiting on an unspecified date. The report was considered to be non-serious.
PNEUMOVAX given at 10:35, within 60 seconds mom ran out of room stating he was having an allergic reaction to it.  Patient found shortness of breath, cyanotic, diaphoretic.  Epipen injection given by mom, followed by arapred and Benadryl.  Pulse ox 86% - 02 started at 2 for 1 minute.  AP 120 R-60.  911 called.
This spontaneous report was received from a physician refers to a 21 year old female patient. The patient did not have any drug allergies or reactions. On 19-SEP-2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23, intramuscularly lot number reported as 0225AE, expiration date 03-JUN-2013. Concomitant medications included: Birth control (hormonal contraceptives (unspecified). On an unknown date in SEP-2012, the patient experienced "swollen, red bumps several inches around the injection site, limited mobility, and flu-like symptoms of fever, fatigue and feeling achy" after she was administered the PNEUMOVAX 23. On 20-SEP-2012, the patient contacted the physician's office and was directed to apply ice packs to the injection site and prescribed Ibuprofen as a treatment. The outcome of the events were reported as recovering at the time of this report. The patient sought medical attention (notified office). This is one of several reports from the same source (MARRS#1210USA00130), please do not forget to add the MARRS# of the third patient. Additional information has been requested.
I had a very sore arm and did not feel great for a few days. On 04/11/2021, I started not feeling well with aches all over my body, not able to mover, no energy, nauseated and congestion. On 04/15/2021, I tested positive for COVID-19 with a home test, and I went to a walk-in clinic, and I got prescription for PAXLOVID. I also went to the emergency room because I was having difficulty breathing. I had a chest x-ray, put on oxygen and wore a heart monitor. It was determined that I had severe bronchitis secondary to COVID-19.
passed out/hit the ground; felt weird/loopy; injured himself in the fall; injured himself in the fall; feeling lightheaded; walking really slow; didn't look like he felt well.; This is a spontaneous report received from a contactable pharmacist via a Pfizer-sponsored program. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 08Sep2021 11:45 (Batch/lot number: FF2588; Expiration date: Dec2021; NDC number: 59267-1000-1), at age 21 years old, as dose 2, 0.3 ml single, for COVID-19 immunisation. Relevant medical history was reported as none. Concomitant medications were not reported. On 08Sep2021 at 11:50, 5 minutes after the second vaccination, the patient felt weird, stood up to get attention and then passed out and hit the ground. The patient was alert and fine but injured himself in the fall, the pharmacist stated that it had nothing to do with the vaccine itself. The patient was feeling lightheaded, looked a little loopy and was walking really slow. The patient did not look like he felt well. The patient had to be rushed to the hospital. The events resulted to hospitalization. It was reported that the patient fainted or passed out before and nothing like this, this was new to him. The outcome of the events was unknown. The reporting pharmacist stated that the events were serious.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient is having a localized reaction to 3 of her 4 shots, especially those that were injected on the right leg.  I expected the slight redness on the top left, as I know that was the dtap, but I am not sure which the others were.   The right leg sites are warm to the touch and seem to be uncomfortable if I lightly touch.  I am not overly concerned, but thought it should be noted for future boosters since I am not sure what she got on the right. Thanks! Hello,  thank you for getting back to me.  Patient has never had anything more than mild redness the day of an injection.  She has been running a slight fever, 100.5 today that responded to Tylenol, and has been fussy.  The right injection sites are swollen/raised.  I noticed slight redness last night (dime sized) and this morning but it has become more pronounced this afternoon, (larger than a quarter).  The previously sent pictures are from the same time as the email.
Patient received her Pfizer vaccine around 12:13pm. While sitting in the observation area she reports dizziness within 10 minutes of receiving her vaccine. She denied SOB, itching, nausea and pain. No swelling or erythema at the injection site. As the patient walked with EMS over to the stretcher, she had a syncopal episode. EMS was able to help her to the stretcher without falling to the floor. Her symptoms lasted only a few minutes. Her vital signs were all within normal range. She was given water and rested for about 30 minutes and symptoms resolved.
Patient came to the ED after becoming more lethargic and listless after testing positive for Covid.  Patient was admitted to the hospital with Covid and treated with remdesivir.
tingle, numbness on left hand.  Initially the two middle fingers, but then spread to entire hand.  Same sensation on the right side of face that started on lips.  Lasted about 10 minutes.
All of the other symptoms that I had when I had COVID returned for about four days; All of the other symptoms that I had when I had COVID returned for about four days; I had a high fever; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 31Jan2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date was not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID and a COVID infection which the patient recovered maybe for two weeks when she received the first dose of the vaccine. The patient's concomitant medications were not reported. The patient mentioned that she had fever for four days after receiving  vaccine, and had covid and received 1st dose of vaccine only a few weeks later, wanted to know if she should receive the 2nd dose of the vaccine. The patient received first dose of the vaccine and mentioned that she was reluctant to receive the second dose based on the reaction that she had. She mentioned that she had recovered from COVID and a COVID infection. She recovered maybe for two weeks when she received the first dose of the vaccine. She mean, then she had a high fever, all of the other symptoms that she had when she had COVID returned for about four days. The high fever was what concerned her because it wasn't that high when she was ill. So, she wasn't sure whether it was advisable to get the second dose and if she should, she queried, how long should she wait before she get it. The onset dates for the events was unknown. The outcome of "All of the other symptoms that I had when I had COVID returned for about four days" and 'I had a high fever' was recovered on an unknown date (duration of 4 days).; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
shingrix approximately 2 years ago both doses / shingles outbreak; non rash shingles outbreak; seems to have developed into PHN; covid; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and covid-19. On an unknown date, the outcome of the vaccination failure, shingles, post herpetic neuralgia and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and covid-19 to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received 2 doses of Shingrix approximately 2 years ago. Recently after developing covid had a non rash shingles outbreak that seems to have developed into post herpetic neuralgia. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for shingles was not provided.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of vaccinated with GARDASIL 9 injection (lot # M034780, expiration date 15-APR-2019; lot # M016193, expiration date: 24-APR-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 46 but below 77 degrees Fahrenheit for 40 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012827: US-009507513-1702USA006073: US-009507513-1702USA006071:
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of PEDVAXHIB injection (dose and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.