chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. The reporter did not give consent to follow up. For tolerance after 2nd dose refer case US2018GSK216223.
Large local reaction (2 1/2 - 3"), cranky to PREVNAR - 13 booster (R) thigh.
Patient arrived to her scheduled appointment for the Moderna Vaccine Clinic being held at the above facility. She was accompanied by a parent who works at the facility. She received the Moderna vaccine. However, it was discovered she was under the age of 18 shortly after receiving this vaccine. No adverse reactions occurred. Parent was notified.
Expired vaccine administered to 26 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on website the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022.  No treatment information was provided.
Pregnant; Initial Report Received on 04-Nov-2022  This is a spontaneous report, received from a nurse regarding a female patient, aged 30 years, who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported. The patient was reported to have a low titer.  Concomitant medications were not reported.  On 03-NOV-2022, an unspecified dose of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # 43528-003-05), route and site not specified, was administered for hepatitis B immunization.   At the time of vaccination, the patient was 30+ weeks pregnant.  No further information was available at the time of the report.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
mom called 1 month p/vax given; 19MAR93 pt was given DTP/HIB; mom stated pt had reaction 2 hrs p/inject of pt lethargic, blue around mouth & nail bed, & little ridged; mom did not tkae pt to MD;
I walked into the ER room to note that patient's alarms are going off with him only saturating at 88% on 4-5 L nasal cannula and appears to be in respiratory distress.  I have increased his oxygen to sees 6 L until ABGs and completed.  He is diaphoretic.  CXR shows IMPRESSION: Bilateral consolidative airspace opacities consistent with multifocal pneumonia. This is an 81 year old male comes to the emergency department with a complain of shortness of breath and feeling very sick.  He has history of hyperlipidemia hypertension and nephrolithiasis.  Received 2 COVID-19 shots and states that he still got the COVID-19 virus.  I walked into the ER room to note that patient's alarms are going off with him only saturating at 88% on 4-5 L nasal cannula and appears to be in respiratory distress.  I have increased his oxygen to sees 6 L until ABGs and completed.  He is diaphoretic.  CXR shows IMPRESSION: Bilateral consolidative airspace opacities consistent with multifocal pneumonia.  I have spoken with the pharmacy to start patient on Remedesvir.  I have asked ABGs to be completed on this patient as soon as possible possible high-flow modality.  He does have mild leukocytosis of 13.87, positive neutrophilia, there is no transaminitis and he likely has a urinary tract infection where his urine culture still pending.  We will admit for further evaluation treatment.     7/23/2021 tested positive 7/29/2021: patient discharged.
77 year old female patient with PMH of CAD s/p stent approx 1 month ago, HTN, HLD, DM, peripheral neuropathy, uterine cancer s/p hysterectomy presents with worsening shortness of breath, fevers, weakness over the past 1 week. Some family members have been feeling unwell recently but have not been tested for Covid-19. She lives at home with her grandson. Denies chest pain/pressure, nausea/vomiting, diaphoresis, orthopnea, PND. Reports mild lightheadedness and decreased PO intake over the past few days. She is breathing comfortably on 2.5L NC sat 99%.
Patient came in office to receive booster Covid vaccine.  Pt was administered a booster dose of Moderna 0.25 for adults in error.  Patient waited in area for 15 minutes and reported no reactions.  As to date, patient has not notified office with any symptoms or reactions.
The vaccinator administered the COVID-19 vaccine in the left vastus lateralis using a 5/8" needle.
No additional AE reported; a dose of GARDASIL 9 was administered following a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent condition, medical history or concomitant therapies provided.  On 19-JUL-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T026954, expiration date 13-APR-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event was reported.  Administered dose of vaccine experienced the temperature excursion of 49.35 degrees Fahrenheit for 1 hour 24 minutes. Data logger was involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026954; expirationdate: 13-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Early symptoms were no appetite, nausea, extreme fatigue which lasted just over two days (did not have any energy). Then a sore throat and some mild coughing started and has lasted 6 + days (took aspirin).
Pt had PENTACEL given (never had this combo before) and within 2-3 minutes area red & swollen, 30 X 45 mm no SOB, wheezing ice applied on & off to site X 20 minutes.  Less redness and no increased swelling noted 30 X 45 mm.  Infant TYLENOL 0.4 cc given prior to shot by mother).  Decreased redness & swelling 30 minutes called mother.  12:05 - redness gone small "bump" left according to mom.
The freezer temperature was up o 14-20 degrees F then back down to 5 degrees F
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age with no drug reactions/allergies. On 23-OCT-2013 ("in the same day"), the patient received a "steroid" in her toe joint. On 23-OCT-2013, the patient developed redness, warmth and pain directly around the injections site. The patient sought medical attention via office visit and was seen by physician, no treatment recommended at the time of the report. No lab diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
1-2 days after vaccination developed myalgias, arm soreness, and n/v/d. unable to tolerate solids. myalgias and soreness improved in 3-4 days, persistent n/v for a week now milder for the past 3 days.
Almost died from it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: she has a end of stage COPD, and her doctor wanted her to get the abrysvo. The patient's concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Almost died from it". Clinical course: Caller calling in to check if there is a assistance program for abrysvo, she has a end of stage COPD, and her doctor wanted her to get the abrysvo and its not covered by her insurance and shes on a fixed income. She did have a RSV vaccine last year and a half and almost died from it and she cant afford the $(withheld) for the medication. Caller said she had taken the RSV vaccine before and almost died from it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Her menstrual period is inconsistent, her menstrual period is on and off; she has it once every other week; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week). At the time of the report, MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
The patient reported left arm pain and swelling after receiving the vaccine. Advised to take TYLENOL 500mg q 12h prn for pain. No joint pain, muscle aches, HA otherwise. No bleeding, bruising. No numbness, tingling. No difficulty breathing or chest pain. No abd pain, nausea/vomiting, diarrhea. No rash.
Mother brought child in with C/O fever during the night, with red, hot swollen area to right thigh. Child had 2 shots in each thigh on 1/7/17 at clinic. Mother is unsure what immunizations were given in which thigh.
pt recv vax; 24 hrs later, devel severe swelling & tenderness in arm of inject;3 days p/ inject, noted lymphadenopathy;tx w/ ATBs
Patient received his third anthrax vaccine on 22 AUG 2012. It was the only vaccine he received that day. He was feeling fine prior to vaccine receipt and denies a history of recent infection or viral symptoms. He had been following a healthy diet and performing PT without problems. Patient denies any unusual or prolonged local symptoms at the vaccination site on his right upper arm. Within 24-48 hours of vaccine receipt, patient was driving and said he was feeling "weird". As he read license plates and signs, he knew the letters/numbers/words as he was reading, but could not "say" what he was reading. He saw some "spots" and then his right arm, followed by his right leg went numb and then his tongue went numb. He then experienced an extreme pain in his right temporal area. He reports his head felt like "someone was punching their way out of my brain from the inside". He rates the pain intensity as a 10/10 and says he honestly felt like he was going to die. He called his boss near the onset of the episode and within 1/2 hour, someone took him to the local clinic for evaluation. On his way there, he had one episode of emesis and began to experience altered mental status - "in and out of it". He does not recall exact details of treatment course, but describes "arm muscle spasms" on the way to get a head CT, which he reports was normal. He was taken by ambulance for admission at a hospital where his headaches were treated with Morphine, VICODIN and steroids. He was an inpatient for approximately 4-5 days where he reports he had a normal MRI. He was started on TOPAMAX and was discharged with a headache (2-3/10) and then transferred. He had a second severe episode similar to his initial presentation that awoke him from his sleep, but the symptoms affected the left side of his body, as well as his tongue. Other headaches that were occurring daily were associated with seeing white spots, blurring vision and tingling in his fingers. If he takes IMITREX at the onset of symptoms, his headaches have been aborted. Admits to taking IMITREX if he even thinks he is experiencing the onset of a migraine. Patient denies a history of similar pain or symptoms in the past. Although some of his records report migraines during his teens, he says he sometimes experienced headaches if he played video games for too long. He never was evaluated for headaches or took any medications for headaches as a teen. These headaches were not accompanied by other symptoms like increased sensitivity to light or sound or nausea or vomiting. Patient was evaluated in MAY 2012 for a significant headache accompanied by N/V, weakness, dizziness, decreased appetite and chest tightness; he was told he had a viral illness and felt better after receipt of fluids. Patient denies a history of seizures. He denies a history of head trauma except a concussion experienced during football about 2 years ago.
Approximately 6-7 hours after injection, all over my body, my skin was "tingling" and right thumb and lower back pain increased.  The tingling all over my body was not really painful, more like the nerves were just very active.  It was hard to get comfortable to sleep.  The symptoms lasted approximately 6-1/2 hours.  No other symptoms.
Longer than recommended time from first vial puncture to vaccination. Vial was punctured between 3&5pm on 6/6 and patient was vaccinated 6/7 between 1&2 pm. Vial  remained refrigerated. Patient contacted 6/8, administration details were disclosed. Patient asymptomatic. consult requested, awaiting results from Janssen safety team regarding viability of vaccine.
3 days after the first dose was received, rashes developed under my chin and necks area with itching, and stinging sensation.  The symptoms went away a couple days later.  The same symptoms would appear a couple more times spacing out about 2- 3 weeks after the initial reaction.  Then on 2/17/2021, the same symptoms appear again but this time it would spread out to my entire neck and also my face. Symptoms included facial swelling, redness, blisters, along with stinging, burning, and itching sensation.  I did not crossed my mind that it was a reaction, but come to think of it, all of these happened after the vaccinations.  I did seek medical treatment on 2/18/21 and was treated with steroid pack. Although the medication treatment regime had completed, I still have symptoms of itchiness under my chin and neck as well as the rashes are still visible.
pronounced malaise including headache, slight nausea, muscle ache, shortness of breath, dizzines for three days followed by  heart palpitations on day four.  Palpitations continued for several weeks and then slowly cleared.  BP, heart beat all normal.  Palpitations were infrequent, then increased in frequency and the slowly diminished.
No side effects at time of injection.  Around Feb 12, site of injection became red, swollen and itchy. Didn't pay much attention to it.  After a couple of days, I began to feel unwell, chilled with body aches, head ache, weak and tired.  Symptoms have continued, lessening  each day.  Today I feel a lack of energy, no body aches yet..
My mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on Sunday!!!
That night he had a fever, palpitations called ambulance and was advised to take an aspirin and made a full recovery.
After about 7hours, I experienced sever chills and hot spells. At about 12 hours, I fainted after getting up to go to the bathroom. I then experienced headaches (a migraine was triggered) and great fatigue (I slept 12 of the next 16 hours). I also experienced a diminished appetite
RED WELT ON INJECTION SITE THAT IS HOT, ITCHY, BURNS, AND IS GROWING IN SIZE DAILY.  TREATMENT TRIED BENADRYL AND APPLIED CORTISONE CREAM.  IT IS NOW DAY 5 AND I HAVE CONTACTED MY DOCTOR TO TRY TO GET AN APPOINTMENT.
Ascending paresthesia started w left foot, then rt foot, then hands, pins and needles progressed up back to head over 30 hour period - also had stabbing pains, muscle fasciculation all over. Went to ER 11/15 2 am. Had spinal tap. Was released same day. Had EMG 11/19. Two weeks later began extreme pain and muscle weakness inability to stand for more than 2 minutes. Cannot sit up for more than 2 hours. Treated for low B12. Ineffective. Was told not B12 after 6 weekly injections. Went to neuro - MRI is clear. No diagnosis. Slowly recovering - currently in month 8 - unable to return to work.
Developed rash on chin, neck and arms the evening of the vaccination.  Took Benadryl and it resolved by next morning.
The day after the shot arm swelled, knots on arm, 102 degree fever and vomiting.
Information has been received from a registered nurse, concerning a 24 year old female patient, who on 22-MAY-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # 657621/0387U), and on 24-JUL-2007 was vaccinated IM, with the second dose, 0.5ml, of Gardasil (Lot # 658094/0524U). There was no concomitant medication. On 24-JUL-2007, about two hours after the vaccination, the patient experienced numbness in her left cheek and "slight tightening of her throat." She was instructed to take Benadryl, 50mg, and the symptoms resolved (duration not specified). The reporting nurse considered one or both of the events to be serious as an other important medical event, as intervention to prevent serious criteria was required. Additional information has been requested.
Has been quite ill; Nausea; vomiting; Bad Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Has been quite ill), NAUSEA (Nausea), VOMITING (vomiting) and CHILLS (Bad Chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced ILLNESS (Has been quite ill), NAUSEA (Nausea), VOMITING (vomiting) and CHILLS (Bad Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Has been quite ill), NAUSEA (Nausea), VOMITING (vomiting) and CHILLS (Bad Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Body temperature: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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.
Arthralgia and myalgia, diffuse and mod severe, no fever, +pain at injection site (unable to lie on that arm x 3 days). No fever. No redness.