chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching has gotten worse; broke out in hives and welps; My skin is still inflamed and painful; My skin is still inflamed and painful; I cant eat or sleep well due to the pain and itching; I cant eat or sleep well due to the pain and itching; This is a spontaneous report from a contactable consumer. This consumer reported for a patient in response to non-HCP letter send in cross reference case that included: A 54 years-old female patient received bnt162b2 (COMIRNATY; Lot Number; EW0178) Intramuscular administered in Arm Left on 18May2021 at 09:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient received second dose of bnt162b2 (COMIRNATY; Lot Number; EW0181) Intramuscular administered on 19Jun2021 at 16:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none reported. Concomitant medications were none reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date the patient experienced that the week before I received my first vaccine dose, I was working in my garden and bitten by Chiggers. Once I got the vaccine, the itching become more intense, burning and painful. After about 10days on 29May. I went to the E.R. The doctor said he couldn't give me anything because i'd taken the vaccine for Covid. He also said that I should take the 2nd dose because it's better than dying from Covid. On his advice, I took the second dose/vaccine, and the itching has gotten worse. I broke out in Hives and welps. My skin is still inflamed of painful after (3) weeks since getting my second dose. I can't eat or sleep over due to the pain of itching. The patient visited emergency room due to events. The patient did not receive treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Pain in muscle exactly where the injection was.  When she holds her arm in a certain position she has extreme pain.  No redness, swelling, or weakness in arm.  She did have typical pain on injection, swelling and redness after injection that lasted about 1 week after shot but it improved.  This pain started about 2 weeks after initial shot.
Painful site of vaccine area for 3-4 days.  Headache and body aches beginning the evening of the vaccine (Friday 2/12/2021) and still continues.  Itching around the mouth the next day(Saturday).  Red spots on chin started appearing on (Sunday) the third day. Red painful spots continued to come up on scalp, eyelid, eyebrow, and forehead all on the left side of my head.  Finally went to a Clinic (Saturday 2/20/21)and was diagnosed with Shingles.  Prescribed Valacyclovir Hcl 1 gram tablet.  Was told to contact eye doctor since most of the red areas were around left eye.  Also scheduled with family doctor to get something prescribed for nerve pain.
This spontaneous report was received from a physician refers to a patient of unknown age who on 29-JUN-2012 was vaccinated intramuscularly (IM) with the first 0.5 ml dose of GARDASIL (Lot number not reported) and on 01-OCT-2012 was vaccinated intramuscularly (IM) with the second 0.5 ml dose of GARDASIL (Lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician also noted that the patient was in the office today to receive the third dose of GARDASIL on 28-DEC-2012. No adverse event reported. Patient's outcome was unknown. Additional information is not expected.
A non-serious report of runny nose and fever has been received from a parent of the patient concerning a 36 month old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 13-Oct-2008. The patient received a total of one dose before onset of the events two days after their only doses of FLUMIST. The mother of the patient reported that two days after receiving FLUMIST the patient developed a runny nose on 15-Oct-2008. The following day 16-Oct-2008 the patient developed a fever. The mother reported that on 17-Oct-2008 the patient was symptoms free.
Several days after receiving the first dose, my arm was red at the injection site, hard, warm, and itchy.
SORE ARM, SWOLLEN AND RED.  HEART PALPITATIONS ON OCCASION SINCE RECEIVING VACCINE.  NO HISTORY OF PALPITATIONS PRIOR TO VACCINE ADMIN.
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in elbow) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in elbow). At the time of the report, ARTHRALGIA (pain in elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment was not provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI case  No Follow up required.
Narrative:  Patient received an additional booster (she reports 4th dose, Pfizer, however this, nor the alluded to 3rd dose, was not received at agency MC) on 12/29/21. That evening, he began to feel poorly and they noted tachycardia, hypertension, fevers, and chills. This prompted a call to the agency nurses line which is documented 12/30/21. Unfortunately, during that call, his wife reports that he had a "seizure" and lost consciousness. She called EMS at that time, and states she performed some chest compressions as the paramedics were on their way. Patient was pulseless upon their arrival and declared dead at home shortly thereafter by the coroner. Given the proximity to the booster, autopsy was requested by coroner and wife consented to this. This is still underway at this time and the body has yet to be released to the funeral home. Of note, patient's spouse reported increased chest discomfort prior to this event and the patient has been battling chronic stable angina for quite some time. The time frame and details of that discomfort were not further examined given the purpose of this call. Additionally, the patient notably developed a ACPA positive polymyalgia rheumatica earlier this year.
Adverse cellulitis on right upper arm measuremnt of 11in (from elbow to 2in under arm x 5in) On 14 Nov 02, patient stats upon waking up, arm had fever and itched. At approximately 1200, patient noticed spreading of cellulitis, fever and itching. On 15 Nov 02, upon waking up patient noticed cellulitis, itching, whole arm with aching. Patient state shoulder and elbow joints ache and arm has been falling asleep continuously - approximately 10 times. Patient reported to the Combined Task Force Clinic and referred her her for VAERS Reporting. Patient states she had no lump in right arm from #1 series given on 30 Oct 02 in same approximate area. Patient states #2 was injected approximately 1in high then the 1st shot.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 1:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 1:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.45.  Concomitant products were not provided.  On 28-Apr-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41, 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
no additional AEs; CMA called to report TE from 2/22/23 and states that 4 doses of PROQUAD were administered prior to stability evaluation on 3/2/23; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown ages and genders. Information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 22-FEB-2023, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (once, 0.5 mL, lot number: W034977 has been verified to be a non-valid lot number, expiration date: 05-MAY-2024, routes of administration and anatomical locations were not provided) for prophylaxis (product storage error).   On 22-FEB-2023, the vaccines experienced a temperature excursion from -14 to -10 (-13.6) degrees Celsius for 21 minutes. It was stated that 4 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were administered prior to stabilty evaluation. There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No further information was provided. The outcome of product storage error and no adverse event was unknown.   This case is non-valid due to an unknown number of patients and lack of patients' identifiers.  Follow-up information has been received from a medical assistant on 16-MAR-2023  The patient was a 12-months male, who had a birth weight 9lbs 3.5 oz.  On 28-FEB-2023, the patient was vaccinated with improper storage vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W028568 has been verified to be valid lot, expiration date 06-MAR-2024), subcutaneously in left thigh (product storage error). The outcome was informed as recovered.  The reporter considered the event to be attributable to the suspect vaccine, and important medical event (medically significant).; Sender's Comments:  US-009507513-2303USA006894: US-009507513-2303USA000873:
Broke out in blisters to sites of vaccination of MMR and Varicella. Pain at both SQ sites bilat. arms.  Loss of appetite for a few days.  Also had blister on Right lower leg. All sites scabbing over at time of exam on 03/19/2015.  Anti-bacterial ointment to blisters to avoid infection.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 18Feb2021 as dose 2, single (Lot number: EL9267), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "depression" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: known allergies Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received treatment with Paxlovid, treatment start date=31May2022, lot number=GA1189, indication=Treatment of COVID-19.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
A few minutes after receiving the Moderna Covid vaccine, Patient reported a flushing feeling in her face along with tingling around her mouth. She was monitored by a RN closely. After five minutes, Patient reported a stiff feeling in her neck and tightening around her throat, as well as a scratchy feeling in her throat. The RN administered 0.3mg epinephrine IM and activated EMS. Patient was transported by ambulance to a local hospital, where she was treated with IV diphenhydramine, solu-medrol and fluids. Patient was discharged from hospital same-day. Patient reported itching and upper-body flushing again the next day (February 4) and was told to go back to the emergency department for evaluation by clinic staff. Treatment at this visit is unknown, but patient did discharge the same-day.
No adverse event reported.  Reporting due to administration error.  Pt received Dose 1 of Moderna on 2/3/21 and Dose 2 was administered 2/8/21.
Pt received 3 vaccines. Pt became dizzy and fainted as he finished receiving 3rd vaccine. Pt given ice pack for forehead, and he was informed to follow-up with outpt primary care and to observe for post concussive s/s.
Hemorrhage right index finger, middle joint, swelling, discoloration, tightness, lack of mobility.
Information has been received from a health professional concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, two weeks later, the pt experienced a generalized rash. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pt reported headache within first 5 minutes of receiving vaccine. Pt then became unable to answer questions for a brief period of time (approx. a minute or less) . Pt was breathing entire time. Pt then able to answer questions but was sweating and said had tingling in fingers. Pt also had vomiting.
2 Months old  Female with no contributing comorbidities with fevers x 1 day.  Per mother, patient received vaccinations earlier today, then, 6 hours later, developed a fever.  Mom was unsure what to give patient, if anything, for fever control. Currently, patient is awake, alert, and active.  patient is feeding on bottle at initial encounter.  Vaccines administered on 3/15/23: PCV, diphth/tetanus/pertussis/acel/hepB/polio, Hib (unknown manufacturer, route, location). Oral-rotavirus Vaccines administered on 1/13/23: hep B pediatric vaccine (unknown manufacturer, route, location)
After receiving a Shingles vaccine on 4/23/07 I initially had only a swelling at the injection site.  However, in the next 3 days I began to suffer from asthma like symptoms, coughing, sore throat, and hoarseness.  I am still experiencing these symptoms.
This spontaneous report was received from a pharmacist refers to a 59 year old female patient. The patient's medical history and concurrent conditions were not reported. On 18-JUN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009874, expiration date: 19-MAR-2016, 0.5 ml, intramuscular). Concomitant medications included unspecified blood pressure and thyroid medications. On an unknown date in June 2015, 3 hours after receiving vaccine, the patient experienced significant swelling of the right arm. The reporter also stated that the patient's right arm was significantly swollen, red and warm to touch from the elbow to the shoulder and the patient felt painful to lift her arm. The patient had been treating her arm at home with ice. The patient sought medical attention by visiting pharmacy and pharmacist prescribed unspecified dose of TYLENOL on an unspecified date for pain. The outcome of the events was reported as not recovered/not resolved. The causal relationship between the events and PNEUMOVAX 23. No further information was provided. Additional information has been requested.
Slight/mild dizziness and slight/mild numbness sensation of left arm, five minutes after vaccine administration (left deltoid). Patient stated she had not sleep last night. Patient reported feeling better after sitting in the clinic. Vital signs within normal limits. Advised to follow up with PCP. ER precautions given.
Child received Aventis flu vaccine dose #2 12/01/2004. History of asthma. Developed drooping of her left hip. Report received on 02/22/2005: Age of patient: 2yrs, 6 monts. Vacine:  FIV No other vaccines give with Flu vaccine.  Diagnosis is Bells Palsy, made by the Pediatrician.  Main symptoms are drooping left hip.  The symptoms occurred the next day after vaccine.  There is documentation of Bells Palsy on the other side 10 months before vaccine.
A report has been received from a Health Professional concerning a 13 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 17-Dec-2013. It was reported that patient was inadvertently administered with expired FLUMIST QUADRIVALENT which started on 17-Dec-2013. The outcome of the event of we inadvertently gave expired doses of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Arm pain - not just at the injection site but down my entire arm.  By the evening (4-5 hours after shot), it got to the point that I lost range of motion.  The suggestions online for exercising the arm after Covid vax were impossible to even do.  Extreme arm pain all night.  It progressively got a little better starting about 24 hours after vax but even 2 weeks after vax there are still movements that hurt my arm and sleeping is uncomfortable.  It feels like I have an arm injury.    I have an appt with an Ortho.  It seems likely to be SIRVA based on what I?ve read, considering I?ve had zero previous issues with this (non-dominant) arm.
parents describe pt having stiff or staring rxn about 3hr post vax;possible febrile sz?dystonia?hypotensive episode-syncope?somnolent rxn?;
This case was reported by a physician via call center representative and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain, influenza-like symptoms, fever and feeling bad. On an unknown date, the outcome of the pain, influenza-like symptoms, fever and feeling bad were unknown. It was unknown if the reporter considered the pain, influenza-like symptoms, fever and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, but it was taken as an adult, as per vaccine indication. The patient experience adverse event after receiving 2 doses of SHINGRIX vaccine. Till the time of reporting, the reporter decline to report and would update safety via correspondence. The Vaccine Administration Facility is the same as Primary Reporter. No additional details were provided. This case was 1 of 3 cases, reported by same reporter.
UTI symptoms, severe low abdominal & low back pains; went to walk in clinic, put on antibiotics, after finishing pains came back; saw urologist; finally no UTI'S. uthera doesn't relax to allow freer flow of urine. Urodynamic test done 7/28/21
Severe pain, swelling from shoulder at injection site down to wrist. Lasted for 1 week. Took non-steroidal anti-inflammatory medications. Patient is a physician.
Phone call received from parent regarding event child experienced today. Child was vaccinated on 11/7/21 per mother. 11/10/21- Per mother, at approximately 3:30PM, the child was at school, her eyes rolled in the back of her head, and she slid down in her chair. The child's lips appeared to be bluish in color and the child "passed out" for approximately 10-15 seconds. Vital signs taken by the school nurse were reported to the parent to be within normal range. No identifiable cause noted to cause the child to lose consciousness per mother. Parent has already reached out to pediatrician and is awaiting callback for further guidance and follow up.
Sweating on first day, fatigue from first day persistent for 3 days. On day 5 (12/23) pain under the arm pit began. From 12/23-12/25 pain worsened into arm pit, down back, into breast, and into right side of neck. Swelling of lymph nodes in that area
Onset of chronic headaches 21/2 month following HPV #2 Diagnostic w/u (-) .11/30/2009 PCP records 2-9/2009, ENT consult 7/2009 and Neuro consult records 4/2009. Dx tension headaches  Patient with hx of headaches, dizziness, vision changes with headaches. Neuro consult neg, ENT consult dx'd as tension headaches. Tx PT
4/6/21 - 4/8/21  High blood pressure 170/100, Muscle aches, 102 fever, diarrhea, severe dehydration 4/12/21 - Posterior Vitreous Detachment of the left eye with visible black lines in field of vision.  Seen by retina specialist on 4/13/21 4/20/21 - Tears in the retina (left eye), treated with laser surgery 5/11/21 - More tears in the retina (left eye), treated with a second laser surgery; being followed by the retina specialist for next year.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K008931, expiration date: 04-MAR-2017; dose and route were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Temp of 105.6, headache, sore throat, stomach ache, cough, lethargic and Shortness of Breath, runny nose, flushed, and listless.