chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost died; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a infant female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to DTPa vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient almost died from DTPa vaccine and the physician told the family that they could do nothing more for her. The reporter thanked god for sparing her life and the reporters family no longer gets vaccines.
This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012711 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
sneezing & coughing p/vax;by time got home 20min both eyes were red & puffy;
Patient was readmitted to hospital on 5/30 after transfer to skilled nursing facility.  Patient had post vaccination fever.
SERVIER HEADACHE, blurred vision, servier nausea, servier fatigue.
received shot in 2021, in Aug 2022 started again; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot (received the shot in January 2021) and Covid-19 vaccine  (received Covid-19 shot in the spring of 2021).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, 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.   Additional Information: GSK receipt date: 27-Jan-2023 Reporter's comment: The patient originally received the shot in January 2021 but failed to get the 2nd within 6 months. So in August of 2022, she started again and had planned to get the 2nd shot but ran into issues with the insurance not covering the cost. The patient went to pharmacy last night to get a 2nd (actually third) shingles shot and the pharmacist said she did not need a third shot.    The patient went to physicians and had a form that physician signed but still no luck. No further information was gathered.  Notified caller she would likely receive a letter from the safety department. Additional supportive information: The patient received the 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule.
extremely heavy bleeding as if there were a miscarriage -- and not at the appropriate time for my period.
Chills (He called back with new symptom since he called yesterday) Narrative:  ADDING this: Chills (He called back with new symptom since he called yesterday); No treatment medication reported.  Other Relevant History:
Client received both bexsero and menveo in L arm on 2/4/20. 3 hours later she developed a severe headache that necessitated a trip to ER 8 hours from vaccination. Arm started to swell. By morning, 2/5/20 client had head splitting headache then could not feel or move her L arm. Child went to ER twice more in next 2 days and was told that this was an inflammatory response and would get better in a few weeks. Today mother called me to report that child still cannot feel or move arm. Mother is seeking neuro consult.
after recv vax in 4/96 the pt in 3/98 was exposure to sibling who was not vax & infected w/a natural strain. pt presented w/lesions from head to toe, & fever 101. m.d. rpt pt devel ``typical varicella''
Intermittent headache, intermittent nausea and vomiting. Swelling of toes on both feet. Pain, redness, swelling, itchiness and hot to the touch at injection site.
Gave partial dose due to a faulty syringe; Faulty syringe; A spontaneous report was received from a healthcare provider concerning patient of unspecified age and gender, who received Moderna's COVID-19 vaccine but was of partial dose due to faulty syringe.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 16-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 16-Jan-2021, a healthcare provider was only able to administer a partial dose due to a faulty syringe and the reporter was not sure of actual CC's. No treatment information was provided.   Action taken with mRNA-1273 in response to the event partial dose due to faulty syringe was not reported.   The event partial dose due to faulty syringe was considered to be resolved on 16-Jan-2021.; Reporter's Comments: This report refers to a case of a male patient who experienced non-serious event of received Moderna's COVID-19 vaccine but was of partial dose due to faulty syringe.  (Incomplete dose of vaccine administered, Syringe issue) for mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of partial dose due to faulty syringe
chills; body aches; nausea; dizziness; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 42-year-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration in left arm on 29Jan2021 at 16:00 (at the age of 42-years-old) at single dose for COVID-19 immunization. Medical history included depression, obesity, hypertension, asthma. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. No allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 29Jan2021 at 19:00, the patient experienced chills, body aches, nausea, dizziness. The patient did not receive any treatment for the event. Outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Patient stated that she received the vaccination the evening of 9/19/19, and on the morning of 9/20/19 she experienced pain on the top of her head, right side of her face, and the right side of her neck. She stated that she does not know of any other reason why she experienced this pain. She did not present to a doctor or seek care for her symptoms. She stated that the pain lasted for a few days.
headache/ really bad headache/ (headache) moves from one side to the other/ (headache) comes and goes; arm pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headache/ really bad headache/ (headache) moves from one side to the other/ (headache) comes and goes) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No medical history information was reported.   Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and CHILLS (chills). On 23-Jul-2021, the patient experienced HEADACHE (headache/ really bad headache/ (headache) moves from one side to the other/ (headache) comes and goes). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and MAGNESIUM at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain) and CHILLS (chills) outcome was unknown and HEADACHE (headache/ really bad headache/ (headache) moves from one side to the other/ (headache) comes and goes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter was not sure about the lot number and did not know if it was a 2 or a Z, if it was a 1 or an L. Expiration date was unknown.
I contracted COVID-19. Some of my symptoms included were a sore throat, difficulty swallowing due to swelling in my throat, headache, muscle aches, back pain, and stomach pain. I went to urgent care. I was prescribed several medications.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23 (lot #: 665300/1314Y, Exp: 08-May-2011). The physician reported that in approximately March 2011 the patient developed itching and a feeling of malaise. She had to go to the emergency room. The physician reported that the patient is recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665300/1314Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The health care professional contacted during telephone follow up could not supply the following information: patient name or date of birth. This is one of several reports from the same source. Additional information has been requested.
RN received call from immunizations dept regarding possible adverse reaction to moderna vaccine.  Patient is also an employee of organization where vaccine administered. Patient was reporting tingling feeling in throat, possible swelling. Assessed patient, vital signs were BP 135/87 HR 55, o2 sat 97%, R 15, Temp 97.5. Patient was able to speak and communicate effectively. Patient appeared sleepy. No swelling present on face, inside of mouth, tongue. No wheezing present. Patient reported she has experienced similar symptoms with second dose of moderna vaccine. Provided report to Dr. Patient kept in patient room for observation. Patient reported their symptoms were improving. Following 30 minutes, patient allowed to return to work station. Vital signs upon exit from clinic were BP 132/85, HR 65, o2 sat 97% T: 97.5 Resp 16
Vaccines administered 7/27/2010. On 7/28/10 felt dizzy, generalized weakness, passed out in shower. Dizziness, weakness continued until at least 8/3/10.
This spontaneous report as received from an unknown reporter, as a part of a marketing research program conducted by a market research agency refers to some adult patients of unknown demography. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX23 (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. On an unknown date, the patients were reported to have PNEUMOVAX23 allergies. It was also reported that T cell response was not robust than PNEUMOVAX23 and the hospital had decided to administer PREVNAR. The outcome of the event was unknown. The reporter's causality assessment was not provided. Additional information has been requested.
Was the booster shot Left Arm pain - starting within 8 hrs (lasting > 24 hrs) Left Lymph node pain - starting within 12 hrs after arm pain (lasting > 24 hrs) Headache  - starting within 12 hrs  (lasting > 24 hrs)
Chest discomfort/pressure around the heart area began within 24 hours of the injection and has persisted through day 10 post injection.
After the Booster shot, My lymph nodes under my arms swelled to the size of golf balls and my menstral cycle started  (2 weeks before schedule) and has not stopped for 21 days.   I am still bleeding to date.
RED, FEVERISH, AND ITCHING FROM SHOULDER TO ELBOW. SOLID RED AND ITCHED. HAD PROBLEMS SLEEPING.  HYDROCORTISONE CREAM OTC DID NOT HELP. RUBBING ALCOHOL APPLIED TO AREA PROVIDED RELIEF.  PATIENT APPEARED TO SHOW ME AND HER ARM AND ITLOOKED FINE AND SHE SAID SHE WAS NOT HAVING ANY ISSUES AS OF 01/22/21. PATIENT DID NOT SEE A PHYSICIAN.
Just feeling really hot; Had the booster shot have a fever of 100.5; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Just feeling really hot) and PYREXIA (Had the booster shot have a fever of 100.5) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Just feeling really hot) and PYREXIA (Had the booster shot have a fever of 100.5). At the time of the report, FEELING HOT (Just feeling really hot) and PYREXIA (Had the booster shot have a fever of 100.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) 100.5.         No concomitant medication was provided. No treatment  medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Additional document received, outcome updated to recovered.
Client reported "red, hard, hot" area at injection site. Spoke to she reported having  a red, warm to touch, swollen hard area at injection in left deltoid site. Advised to contact primary care provider for treatment.
Fever 102 , body aches, chills, headache from 2am to 9am, rash left arm with extreme soreness for 2 days, dizziness/headache for 3 days
Information has been received from a medical assistant concerning an adult patient who on 08-APR-2010 was vaccinated inadvertently with a dose of VARIVAX (Merck) route and lot # unknown instead of ZOSTAVAX (Merck). No adverse effect reported. Additional information has been requested.
headahce; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headahce) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headahce). At the time of the report, HEADACHE (headahce) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Hospitalized with abdominal pain with worsening appendicitis,   COVID positive  1/8/2022  unrelated to hospitalization currently
Patient had red area that she described as little  harder than usual that was itchy.  Patient was counseled that she could take Benadryl to help with the allergic reaction.
patient complained of dizziness and was taken home by her uncle. 6 hours later she said she was feeling much better but not yet fully recovered  and was laying down
5 days after the vaccine 01/29/2021,  I started to get a headache in the afternoon and that evening  I had body aches on both sides of my body in the rib area, the pain was like my rib area was being crushed.  That pain  lasted 2 days. On the 3rd day that pain dissipated. On The 3rd day I had a fever (100),, the fever lasted 3 days . The headache lasted for 8 days, and it was a constant headache. On the 4th day, I broke out in a rash on my arms and upper body. On the 5th day , Doctor had me take a COVID-19 test and the results were negative. We stayed the course, during this period of time  I was very fatigue and it lasted for 3 day.  The rash started to dissipate within 8 days . After the 8th day I started to feel better. On February 14, 2021, I took the 2nd Dose of Pfizer and I had no reaction to the 2nd dose.
Received H1N1 on 10-14-09 at apporx. 4:00pm. Started getting sore the next day. Continues to be sore to this day, 10-19-09, Has pain if raises arm or if arm is down at her side. Pain is in shoulder joint and in arm pit. Takes TYLENOL for discomfort. Patient states arm pain and discomfort lasted about one week and is okay now. 11-25-2009
A spontaneous report has been received from a consumer concerning a 17 year old, female patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving nasal FLUMIST started on 11-JAN-2013. The reporter stated that the patient received FLUMISTS and 17 days later she had an anaphylaxis reaction on 28-JAN-2013. Her face and body broke out into a rash, throat closed, eyes swollen eyes shut, and blood pressure dropped. The reporter also reported that daughter was having exercise class the day the reaction occurred. The reporter stated that doctor did not feel like the reaction was attributed to FLUMIST. The patient recovered from the event of anaphylaxis reaction on an unspecified date. The company physician considered the event of anaphylaxis reaction to be serious with criteria of important medical event. Corrected report 29-MAY-2014; the key ingredient changed from QLAIV to FLUMIST. The product is reported changed from FLUMIST Quadrivalent to FLUMIST.
Presented in office on 10/07/2014 with redness and swelling at the site of the injection and complained of joint pain, reports nausea, vomiting and weakness beginning 09/30/2014. Took Benadryl (OTC).
Daily migraine headaches since receiving the vaccine. Not severe, but definitely impacting ability to do daily activities.  I haven't experienced this many consecutive migraines at this rate/period of time prior to now.  No treatment. Still ongoing.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an adult) female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
At 4 month and 6 month immunizations had purple ecchymoses in his lower legs and feet developed after getting shots.  Not in spots where he was being held.  They last 4-5 days and resolve.
Within 15 minutes of shot, swelling in left arm down to fingers. Dizziness and imbalanced. By 3 hours later, extreme tiredness and extreme pain through out my body. Heaviness, muscle cramps and unable to move or get out of bed.  Severe arm soreness. Exercise intolerance.
administration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old male patient who received HAB (Twinrix adult) (batch number DK23D, expiry date 8th February 2022) 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.   On 18th February 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 18th February 2022, unknown after receiving Twinrix adult and Twinrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Twinrix adult, which led to expired vaccine used. The reporter consented to follow up.
Flu like symptoms, fever, aches, stomach ache for 6 weeks or more, diarhea for 2 months
Local reaction day after varicella injection. Itching, redness, swelling at site of injection @ left arm. Swelling and itching now decreased w/o intervention.
Rash. Patient went to physician and received a rx for a Medrol Dose Pak.
One bruise on tail bone; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (One bruise on tail bone) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONTUSION (One bruise on tail bone). At the time of the report, CONTUSION (One bruise on tail bone) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.    No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event therefore, action taken with the drug in response to the event was not applicable.
Pt recvd 3 doses of Hep B vax 10MAY90, 18JUN90, & 21NOV90 & 6MAR91 it was determined that the titer was neg; booster dose was given 14MAR91 & 13JUL91 titer was neg;