chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pediatrician concerning a male baby born to a 23 year old female who on 16-SEP-2010 was vaccinated with her first dose of GARDASIL (lot #660387/1967U) and subsequently was determined to be pregnant by a pregnancy test. Concomitant therapy included PROVENTIL and prenatal vitamin. On unknown date during pregnancy, it was found the size was less than dates. On 23-APR-2011 the patient was born on 38 weeks from mother's LMP who is 3505g, length 20.5 inch, Apgar score 9/10, head circumference 14m. The baby is normal, and no congenital anomalies and no other complications. The mother's adverse event was captured in WAES 1009USA03595. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 73-year-old male patient who received SHINGRIX. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, pain in hip, limbs stiffness, ankle swelling and swelling of feet. On an unknown date, the outcome of the general body pain, pain in hip, limbs stiffness, ankle swelling and swelling of feet were not recovered/not resolved. It was unknown if the reporter considered the general body pain, pain in hip, limbs stiffness, ankle swelling and swelling of feet to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. This case was reported by the patient's wife. The reporter did not wish to provide the patient's concomitant medications. The patient experienced pain in his hip joints and achiness all over. The patient's hands were hard to open and close and his ankles and feet were swollen as well. The patient denied permission to contact their physician.
Pain in my arm muscles; Rashes; Swelling; Miserable; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia upper extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced myalgia upper extremities, rash, swelling and feeling miserable. On an unknown date, the outcome of the myalgia upper extremities, rash, swelling and feeling miserable were unknown.   It was unknown if the reporter considered the myalgia upper extremities, rash, swelling and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and the vaccine gave him/her pain in his/her arm muscles, rashes, swelling and miserable. Additional supportive information: Follow-up would not possible as no contact details were available.
Parent noticed on arm 08/30/2005 left arm red and tender where vaccine given, called provider at 6pm that evening with increase swelling Benadryl given at home. Physician seen in the office and treatment 08/31/2005 10am, Prelone, Benadryl and rest recommended.
I experienced shortness of breath, pressure changes in my chest and I would feel like my heart was skipping beats. My heart would pause then start pounding real fast, I would wake up in the night due to the rhythm of my heartbeat, I have no cardiac history so this is a first for me. I saw a Cardiologist and he advised a two week monitor and once I was done with that and turned it in, I did a stress tread mill and came back to see the Cardiologist and it showed no blockages and everything was normal, but he said we need to check the two week monitor and it showed I was having irregular heart rates and PAT, the monitor showed I was having pauses in my heart and it was skipping beats.
pt devel a painful rash described as shingles w/in 2 days of receiving the flu vax;
IMMEDIATELY AFTER VACCINE PT EXPERIENCED A "HOT FEELING" AND LIGHTHEADEDNESS. PT WAS TRASNPORTED TO OBS VIA WC AT 1032. PT REPORTS HE IS FEELING BETTER ALREADY. WATER AND SNACKS GIVEN. VSS. PT RELEASED BY SELF AT 1043. PT ESCORTED BY STAFF TO EXIT WITH NO FURTHER ISSUES. VITALS AS FOLLOWS: 1036 SITTING BP 122/81 HR 86 SPO2 98 1042 STANDING BP 116/73 HR 72 SPO2 98
fever of 101; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101) and HEADACHE (really bad headache) in a female patient of an unknown age 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, the patient experienced PYREXIA (fever of 101) and HEADACHE (really bad headache). At the time of the report, PYREXIA (fever of 101) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: patient has history of passing out because he gets nervous according to mom
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age and gender started to receive PREVNAR 13, lot number and expiration date were not reported, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) stings going into the arm on an unspecified date. The outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves 6 months old female patient who was vaccinated with a 0.5 ml instead of 0.25 ml dose of FLUZONE QUADRIVALENT (batch number UI975AC and expiration date 30-JUN-2019) via unknown route in the left thigh On 24-Sep-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to 6-months old child have been given 0.5 ml FLUZONE QIV. It was reported that the patient did not have any reaction last night, no fever or side effects, did not go to the ER or seek treatment. 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. List of documents held by sender: none.
10/26/2021- 10/27/2021  sore arm. fatigue. headache  10/28/2021  delayed skin reaction, large red, swollen, hot & painful below injection site
Body aches, fatigue, joint pain, injection site pain from three hours following injection through the night and the following day. Took naproxen sodium to reduce pain.  Symptoms finally abated by next morning.
Patient felt like passing out, diaphoretic, BP 73/42, HR 43, rr 16
Presented to local ER with joint pain, severe abdominal pain, achiness, vaginal bleeding, no relief with OTC MIDOL.
Patient received vaccine earlier than guidelines on day 23 of 28. (guidelines allow 24 to 28)
Left shoulder swollen. 3 in circle where BOOSTRIX was administered. Swelling started Saturday 4/2/16 and has dull pain in shoulder. Upon raising arm, sharp pain down arm.
Started with chills about 15 hours later. 21 hours later had three almost consecutive fainting spells. Hit head, face, and chin, bleeding from chin which required stitches.
Warmth, edema, erythema at injection site on left deltoid; induration and pain less than 24 hours, post vax.
Patient experienced fever, chills, nausea, faintness, dry mouth, throat swelling, and difficulty breathing. Called paramedics who hydrated her and treated her for hypotension. ER treated the case as an allergic reaction. Patient received two vaccines the same day and believes it was the shingles vaccine. She had never experienced any issues with influenza vaccine but it was her first year of receiving the high dose for over the age of 65.
Approx. 12cm X 9cm red, hot to touch, painful area on right upper arm at injection site.
Patient vaccinated x2 (Moderna: 3/20/21, 4/17/21.   Pt hospitalized with COVID infection 7/11/22
Had 2nd dose of COVID vacccine 2/17/2021.  On 4/8/2021 developed headache, loss of taste/smell, and rhinorrhea.   Tested positive for COVID.
Pt given TDaP < 10 yrs of age.  No adverse reactions noted or reported.  No treatment indicated.
DIAPHOERTIC, DIZZY, SYNCOPE, ALTERED after 7-8 minutes of vaccine administration  legs raised on chair across, fan air, v/s monitored, apple juice, crackers, icepacks to neck. EMS called but by the time they arrived patient was smiling and talking, refused to go to hospital. was discharged in stable condition after monitoring for additional 30 minutes 1322-60,16.110/84. 99% RA 1330- 69, 18, 110/78.97%
had both shots and still got them/suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both shots and still got shingles. The doctor said vaccine made them not as bad, they suck big time. This case was considered as suspected vaccination failure since the details regarding  time to onset and laboratory confirmation was not provided. Note: the event feeling bad was not coded as event as it seems that it was physician opinion.
Patient presented today for update on immunizations that are required for school.  She was due today for her Tdap and meningococcal vaccine. Administer Tdap and meningococcal serotype B (Bexsero).  She noted that system was still showing that she was due for her meningococcal vaccine and asked me to review her chart and then it was discovered that she was given the serotype B instead of Menactra.  Discussed the medication error with her father.  Answered his questions and he agreed to proceed with the Menactra vaccine which is the required meningococcal vaccine for school that was supposed to have been given.   Explained that the Bexsero is recommended and is approved in her age group, although not required for grade school some colleges do require the vaccine, but she would require an additional dose to complete the series if they choose to do that.  Provided handouts for both vaccines on AVS.  Medication error was documented and follow-up plan for reducing such errors was discussed
Vials were initially stored in the fridge on 08-Jul-2022 and administered on 09-Aug-2022; HCP was not aware of any symptoms for any patient after the vaccine was given; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 09-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 09-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 09-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 09-Aug-2022).    No concomitant medications were reported.  It was reported that the vial had not undergone any temperature excursions.  No treatment medications were reported.
patient had red, swollen, warm to touch left arm following immunization given 11/3/20
Pt recvd MMR vax in 1982 & in DEC91 devel clinical mumps w/swollen parotid glands, trisums, low-grade fever, & anorexia;
FEELING WEIRD SENSATION IN THROAT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination.  Concomitant medications included orlistat. On 13-APR-2021 13:00, the subject experienced feeling weird sensation in throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling weird sensation in throat. This report was non-serious.
Headache, CoughWheeze, chills Narrative: onset of flu-like s/s morning after second injection.
My son has been unable to concentrate, stares for long periods of time, is unable to attend school. He sits in one area for the entire day and has for several months now. I have taken him to doctors, had test run with no other conclusion other than since he took this vaccine...he is not the same.
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of M-M-R II, lot #N031294 with expiration date 21-AUG-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003.
L arm swollen, red, itchy, no pain no fever. Red ring present around immun. site. Was on Amoxicillin far OM and switched to Augmentin po bid.
This spontaneous report as received from a other health professional refers to a 11 year old female patient. On 29-AUG-2018 the patient was vaccinated with GARDASIL 9 for prophylaxis. Concomitant therapies included MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID). On an unknown date the patient experienced adverse reaction. The outcome of adverse reaction is unknown.
Monitor post vaccination. No adverse events reported.  Patient received 0.3mL instead of 0.2mL
Pt received multiple injections on 6/7/11 & 6/9/11 for travel. Sx began after she received typhoid inj. Initially arm was very sore; erythema & pain resolved after 10 days, but since then has had persistent pain in posterior deltoid area. Constant dull ache, pain increased when she moves her arm, worst when reaches over head.
Intussusception, admitted to hospital on 09/20/2007 with vomiting, dehydration.  Reduced by air enema.  Discharged in good health.  9/28/07 Received pcp medical records & vax records which confirms RO dose & lot # as reported. 10/30/07 Reviewed hospital medical records which reveal patient experienced abdominal tenderness, vomiting & reduced oral intake x 5 days.  Admitted 9/20-9/21/07 for observation s/p barium enema reduction of IS.  Progressed well & d/c to home. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.
I received my 2nd Covid booster and 1st Shingrix vaccination on the same day 07/02/2022, before taking a trip to visit family. My lymph nodes were inflamed, body aches and a fever for 2 days after the vaccines. 07/14/2022, I flew.  07/16/2022, my family tested positive for Covid. I have tested negative despite having a sore throat, runny nose and slight headache. 07/19/2022, I lost my memory for about 6 hours. I had no idea where I was, or why. I knew who I was but kept repeating myself. I went to the ER, they admitted me for two days to do extensive tests on my heart and brain. All test results were good. I was discharged 07/22/2022. Diagnosis was Transient Global Amnesia.
increased temp and generalized rash. Temp 102.7 on arrival to ED. Admitted and discharged back to nursing home 5 days later. Rocephin empirically. Stool, urine and Blood cultures no growth. Chest xray and ultrasound of kidneys unremarkable. 12/15/08-redords received for DOS 11/9-11/13/08-DC DX: Fever of unknown origin. Presented with fever and recent rash.
Approx 12 hours after vaccine, Woke up with my Left arm with excruciating pain. Limited range of motion, pain, and neuropraxia. Pain limits ADLs, failed RICE. Interrupted sleep as pain is worse at night.
BLIND; STROKE; This spontaneous report received from a patient concerned a female 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) dose and therapy start date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in MAR-2021 (reported as last week), the patient had a stroke and made her blind. There was no other information known about the patient or vaccine administration site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blind and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333599- Covid-19 vaccine ad26.cov2.s-Blind, Stroke. This event(s) is considered unassessable. The event(s) 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(s).
Patient complained about having "screaming in my mind", increase of headaches, eyes hurt with lights off and on.  Off and on of pain "in his head", at office visit during exam, found he had double vision when looking to both sides.  These events happened quite frequently in the beginning (multiple times a day).  Within a 3 month period of time, these symptoms slowly decreased to patient not having an episode for a multiple of weeks now.    2 years ago, patient had the same Flu vaccine and we had a very similar outcome that was never reported to VAERS.  Because of that incident, I'm convinced these two events are related to the Flu vaccine.
Severe numbness and tingling in hands and feet. Symptoms ascended up legs to thighs, resulting in imbalance and inability to walk. Diagnosed as Guillain-Barre syndrome.
Joint swelling, pain and loss of mobility 2 to 6 weeks after immunizations. Resolving.
On 8/13/2018 I received a phone call from the pt who stated she received 3 vaccines on 8/11 and she is experiencing pain on the injection site, redness and swelling at the affected area. I recommended cold compresses for inflammation, ibuprofen for pain, and diphenhydramine for itch. I asked the pt to call me back if symptoms persist. Also to call MD if symptoms do not go away. Pt did not call me back. I called her at 8 pm. She was not available. I left a message to call me back. She did not call back before closing.
Patient said that a rash started on the back of his legs and his waste area 3 days after receiving the vaccine.  The patient has not been to a dr for the rash yet. The rash does not seem to be getting worse. Patient taking antihistamine to help with the itching. no signs of swelling or difficulty breathing at this time.
I have had them 4 times and I had the shot/Suspected vaccination failure; I have had them 4 times and I had the shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient have had Shingles vaccine and had them 4 times. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.