chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received ENGERIX-B a total of 4 times / most recent doses where on 5/10/21 and 12/14/2020; The first two are historical / most recent doses where on 5/10/21 and 12/14/2020; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B (1st dose received on unknown date) and Engerix B (2nd dose received on unknown date).   On 10th May 2021, the patient received the 4th dose of Engerix B adult. On 14th December 2020, the patient received the 3rd dose of Engerix B adult. On 14th December 2020, not applicable after receiving Engerix B adult and unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too long. On 10th May 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient received 2 doses as history in past. The patient received the 3rd dose of Engerix B later than recommended time interval, which led to lengthening of the schedule and received 4th dose apart from the schedule, which led to extra dose administered. The reporter consented to follow up.
My son had begun to run fever earlier in the day.  Around 6:30 pm that evening, I had placed him in his high chair. A few moments later I noticed his head was turned to the side and his face looked very flushed.  Also, his eyes were open but he was unresponsive to me.  I immediately called 911.  He remained in this state a few minutes.  By the time the ambulance arrived he was better.  We took him to the emergency room and doctor diagnosed episode as a febrile seizure.
Redness, swelling with warmth and tenderness noted by mom next day after vaccines were given? time. Brought to clinic on the 11/13/08. Prescribed Motrin & alternate warmth & cold compress every 20.
red mottled skin .5 cm at area where DTaP was administered, area has continues but has faded.
Per hospital admission note - admitted on 11/17/07 for acute loss of consciousness. 6/23/08-records received for DOS 11/15-11/24/07-DC DX: seizure disorder. Presented with nonconvulsive status epilepticus demonstrated on EEG.
Nausea, Vomiting, Headache, Joint pain, Treated with ibuprofen.
Started menstruating 3 days after vaccine and haven?t stopped since (6+weeks).
On Oct. 18, 2004, four hours after receiving vaccine arm became red, painful, and hot to touch.  10/20; seen by doctor who stated "looks like staph".  Patient given Biaxin 1000 mg and responded with systemic redness and wheezing.  Admitted to hospital via ER.  Given Benadryl, Ancef IV, and an antiemetic.  Continued on antibiotics and discaharged from hospital on 10/22 on po Doxycycline. Discharge Summary received on 12/22/2004 states pt experienced cellulitis, allergic drug reaction, and COPD exacerbation.
Patient reported changed in systemic comfort following Prevnar vaccine.   Patient then developed weakness and peripheral neuropathy suggestive of Guillain Barre Syndrome the evening of 1/1/2023 and then woke up unable to walk on the morning of 1/2/2023 and was rushed to the emergency room.   MRI and blood tests were negative and patient was diagnosed with Guillain Barre Syndrome the afternoon of 1/2 and admitted to the hospital.   By mid morning on 1/3/2023 patient was admitted to the ICU and intubated with an endotracheal tube on 1/5/2023.   Patient experienced ascending and complete paralysis over the following 7 days.   Intravenous immunoglobulin was administered over 5 days from 1/2/2023 to 1/6/2023.   Clinical and EMG studies suggest AMSAN sub variant of GBS.    Anti-ganglioside serum assay came back negative.   Patient remains intubated and in critical condition in the ICU.
March 18, 2021 I noticed my arm was itchy but only had a few small bumps. Later that same day around 9:00pm I noticed a uncolored 2 1/2 inch in diameter welt on my arm and it was very very itchy. I took Benadryl and went to bed. March 19, 2021 I woke up and the swelling went down a little but now the area is very red. Slightly itchy.
Fatigue, headache, body ache but most concerning is that EYES ARE SWELLING
Attempting to get one drawn up but mechanism failed, unable to draw up injection. Drawing up and completely broke apart; Drawing up and completely broke apart/something popped off or something broke; This is a spontaneous report received from a contactable reporter (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit prefilled 2v (ABRYSVO), as dose number unknown, single (Lot number: HM7643, Expiration Date: Mar2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MECHANICAL ISSUE (non-serious), outcome "unknown", described as "Attempting to get one drawn up but mechanism failed, unable to draw up injection. Drawing up and completely broke apart"; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Drawing up and completely broke apart/something popped off or something broke".  The reporter considered "attempting to get one drawn up but mechanism failed, unable to draw up injection. drawing up and completely broke apart" and "drawing up and completely broke apart/something popped off or something broke" not related to rsv vaccine prot.subunit pref 2v. Causality for "attempting to get one drawn up but mechanism failed, unable to draw up injection. drawing up and completely broke apart" and "drawing up and completely broke apart/something popped off or something broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: Attempting to get one drawn up but mechanism failed, unable to draw up injection. Drawing up and completely broke apart, tried to draw up with another syringe and that was not possible either. Unable to clarify further what completely broke apart, just has note with information about what occurred. Thinks must have been drawing up and something popped off or something broke. Asking about replacement. They think they just tried to use a regular 3mL syringe that pharmacy has on hand. Does not have that syringe to provide information.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
1SEP92 10AM recvd vax-4-6PM non stop crying; 8PM started wheezing in bath, but quit; 3SEP92 7PM started wheezing during bath again; 4SEP92 approx 230PM quit breathing, heart stopped resuscitation unsuccesful;
C/0 feeling "hot flashes" an hour after vaccination given.  As the evening progressed  C/O joint aches, HA,  low grade temp (99.8 F at 6 p.m., muscle cramps and restlessness during the night (2 a.m.) and feeling of "electrical shocks" in his muscles.  1/27/21- C/O joint pain HA and muscle cramps-took gabapentin and Tylenol and feeling better.  1/28/21 Able to work, feeling better, but not 100% yet.
Off label use; Booster; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hbp" (ongoing); "type 2 dm" (ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Had neg antigen test 1 day after completing medication; Positive, notes: Return of symptoms 6 days later and a positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was treated with Paxlovid for treating COVID-19 from 08Jun2022 to 12Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Extreme neck and shoulder pain on the same side as the vaccination (10/10 pain scores) interfering with activities of daily living and sleep, requiring analgesia q2hrs "Round The Clock". Zero range of movement. Slight improvement in range of movement after 10 days. Able to decrease analgesia to q4-6hrs after 10 days. Able to decrease analgesia to q12hrs after 2 weeks. Able to stop analgesia after 3 weeks. Still have notable discomfort after 4 weeks. No contributing injuries / illness. No fever / headache. No discomfort on opposite side to the vaccination at any time. Mild discomfort at the injection site at 4 weeks post vaccination.
Pt. complaining of shoulder pain. Pt states vaccine was given too high on her arm. Pain was ongoing for two weeks. Pt went to PCP and had MRI.
Pt given vaccine on Monday. That Saturday arm began to hurt badly and began to swell. Monday AM pt called clinic with arm still swelling and itching. Pt has been taking Benadryl for itching. Pt advised to seek medical attention if swelling continues or respiratory problems. Pt given info on Td and that ibuprofen/Tylenol ok to take and Benadryl.
his arm felt sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 1st dose of Shingrix. In February 2021, an unknown time after receiving Shingrix, the patient experienced pain in arm. On an unknown date, 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.  Additional details was reported as follows: The age at vaccination was not reported but it could be 61 or 62 years. The patient received Shingrix 1st dose 3 months ago of the reporting date and his arm felt sore and it lasted for a couple of days. The patient had not received his 2nd dose yet. The reporter consented to follow up. The case is linked with US2021101408, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021101408:Same reporter.
hearing loss; 2 weeks after the 1st dose she had ringing in her right ear. she experienced hearing loss with that day being the peak of the ringing; She started with ringing and fullness and muffled hearing in the right ear; 2 weeks after the 1st dose she had ringing in her right ear. She started with ringing and fullness and muffled hearing in the right ear; This is a spontaneous report from a contactable consumer. A 34-years-old female patient (wife) received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), dose 1 via an unspecified route of administration on 15Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. 2 weeks after the 1st dose, patient had ringing in her right ear. She started with ringing and fullness and muffled hearing in the right ear. and on 05May2021 she experienced hearing loss with that day being the peak of the ringing. Patient seen by 2 ENT providers. Therapeutic measures were taken as a result of events with high dose of steroids. Patient reported her hearing only recovered 85 percent in her right ear. The outcome of events was unknown.  Information on the lot/batch number has been requested
Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were provided.; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected event of Myocardial Infarction. The event occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine). It's unclear if it was the first or second dose. The rechallenge was not applicable, as the event happened after a dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
I received the dose on Friday 1/29.  About 45 minutes after the left side of my face felt numb.  Over the weekend I then thought I was developing acne (which is strange because I don't get acne).  By Monday it was getting terrible on the left side of my face and by bedtime I thought it was shingles.  I went to my general practitioner on Tuesday 2/2 and was diagnosed with shingles and prescribed Famciclovir 500 mg 3 x daily for 7 days.
Swelling of cervical lymph node under right jaw line noticed in May, exact date unknown. At annual wellness exam on 6/9/2021, primary care physician referred for CT scan, then to ENT for further evaluation. CT on 6/28/2021 showed three enlarged right-side cervical lymph nodes - one right level IIA, 1.9 cm x 1.6 cm; and two  right level IV/V at 1.8 cm x 1.4 cm and 2.3 cm x 1.5 cm. CT for an unrelated matter on 7/16/2021 also showed an enlarged mesenteric lymph node, 2.4 cm. Excision of right level IIA lymph node for further biopsy pending availability of hospital services.
shingles; Information has been received from a lawyer and refers to a patient of unknown age and gender. In 2016, patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider  for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by healthcare provider  for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not reported. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a registered nurse (RN) concerning a 15-month-old white male with gastrooesophageal reflux, failure to thrive and coarctation of the bicuspid valve who on 09-JAN-2006 was vaccinated SC with the first dose of Varivax (Lot # 649281/0656P). Concomitant vaccinations administered on that same day included the fourth IM dose of Prevnar (Lot # B0863D). The RN reported that on 16-APR-2006, the patient developed a varicella rash/outbreak. Medical attention was not sought. At the time of this report, the outcome was unknown. Additional information has been requested.
PT RECIEVED VACCINE FRIDAY OCT 30.  WAS TREATED AT HOSPITAL FOR SOB-DX ASTHMA ON OCT 31.  PT CONT TO FEEL BAD, NO IMPROVEMENT WITH MEDICATIONS GIVEN IN ER.  11/04/09 PT WAS SEEN AT HOSPITAL AND IS HOSPITALIZED-TOLD PATIENT HER CONDITION WAS RELATED TO HER H1N1 VACCINE.  PER RN: "PT IS BEING DISCHARGED FROM THE HOSPITAL TODAY 11/12/09 AND HAS RECOVERED.  PT WAS DX WITH NEW ONSET OF ASTHMA AND BRONCHITIS".   11/16/09:  Hospital Records received for dates of service 11/4/09 to 11/11/09. Dx: Post H1N1 asthma, dyspnea, otthopnea and cough, twenty week IUP, cardiomegaly and mild pulmonary edema on CXR.  Assessment:  Presented to the ED with progressive dyspnea and wheezing with some rhonchi.  She was initially treated with a Z-Pak and inhalers and initially got better over a couple of days.  However, she developed a productive cough when she is coughing deeply, progressive dyspnea and a fever.  Initial CXR was unremarkable, but a follow up CXR shows a question of cardiomegaly with interstitial prominence and a question of CHF.  She is not continuing to improve on IV antibiotics, IV steroids and nebulizers as well as O2 by NC and IV Lasix.  She has gained 5 lbs. over the past month. Blood pressures running high normal for pregnancy 142/78.  11/17 and 11/18/2009 PCP records and ED record for 10/31/2009, patient with c/o's SOB and cough. Tx: bronchodilators.
Covid arm; Hot injection site; Red injection site; Swollen injection site; Bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump at the injection site), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition reported).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE MASS (Bump at the injection site). On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE MASS (Bump at the injection site), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, chills, fatigue, dizziness, headache, generalized weakness, shaking, muscle soreness at injection site, swollen injection site, from onset until AM of 07/28/2012.
On 5/27/2021 I woke up at 4am with an horrible headache  and vomiting, lasted about 4 hrs and then went way.  On 5/28/21 I developed petechiae spots about the size of bb's on the underside of my left arm, by my armpit. they lasted 2 days and then went away.  I sent pictures to my Dr and I saw her for an in person  a visit  on 6/9/21 she is ordering blood work will be completed 6/10/2021 at 930am  for the bruising and looking into a possible blood disorder. She also diagnosed me with shingles' at this visit. The shingles are located on my ride side of my torso.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL Lot #K008931, expiration date 04-MAR-2017; Lot #K01574, expiration date 08-APR-2017, (dose, frequency and route of administration were not reported). There was no adverse effect reported. Concomitant medications were not reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Dizzines, nausea, tingling in fingers, vasovagal reaction. Pt reports that has needle phobia and has not had blood draw or any vaccination for a long time. Pt reported nausea, but no vomiting, feeling dizzy, and tingling of fingers. Pt was transported via wheelchair and transferred to bed. Pt reported doing well after 5 minutes, water, crackers and juice was given. Pt reported doing well and was asymptomatic. Pt was observed for a period 20 minutes. BP: 110/69, HR: 62, R: 16, O2 sat: 98 to 100% room air. Pt was discharged in stable condition.
Patient given vaccine then mother was given her vaccine.  After RN administered vaccine to mother, patient reported he "felt weird." Patient suddenly got very pale in his face, so RN able to get patient to lie down and elevate feet. As patient was getting into supine position on exam table, patient passed out and was unconscious for one minute.  A second RN entered room at the time and obtained vitals. Patient had strong pulse and was breathing upon assessment. Pulse ox upper 90s the entire time. Initial HR 50s, BPs 80s/40s. Within 10 minutes, HRs 60-70s and BPs 100s/50s. Patient was able to sit up independently, answered questions appropriately. Patient able to eat crackers and drink Gatorade with no issues.  Patient able to stand without assistance and then escorted to observation room to be observed for an additional 30 minutes.  Patient left with family with no further complications.
Severe headache - stabbing pain.  It lasted about 36 hours.  I also had body aches for about 72 hours.  Advil helped some.
A report was received from a health care professional on 12/12/03 concerning approximately 25 vaccinees of unknown sex and aged between 6 and 35 months who inadvertently received Fluvirin over a 3 week period in November 2003. Approximately 25 vaccinees inadvertently received Fluvirin over a 3 week period in November 2003. At the time of the report no adverse events had been reported. There was insufficient to determine the reporter's causality assessment. Follow up pending.
Patients arm swelled at injection site about the size of diameter of a tennis ball. Site was warm and tender/ painful to touch for 4 days. Arm returned to normal on 10/16/2017.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 18:00 as dose 1, single (Lot number: EN6198), in left arm, on 22Mar2021 at 18:00 as dose 2, single (Lot number: ER8727), in left arm, on 13Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 14May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Walnuts/Pecans" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19: received Paxlovid for COVID 19 Treatment from 24Jun2022 to 29Jun2022.