chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An otherwise healthy 8 year old girl was admitted to the Emergency Department on February 10, 2005 with an acute onset of bilateral lower extremity pain and difficulty in ambulating.   She lives with both parents and sister but mother is originally from overseas. Patient traveled overseas 8 months before onset of symptoms but she had no illness or sick contacts. Eleven days prior to admission she had visited her pediatrician for a normal well-child visit at which time she was found to be healthy and received her second Hepatitis A vaccination. Her childhood immunization is up to date.  On admission she had a progressive and ascending sensory and motor loss. She was intubated for several days. Cranial nerves III  XII were grossly intact. Strength in the upper extremities was found to be normal but there was flaccid paralysis of lower extremities. Sensory level was approximately at the level of the nipples. An MRI of her spine second day on admission was normal, but the MRI of lumbar, thoracic, and cervical spine done a week later showed abnormal cord signal from C7 to the conus consistent with transverse myelitis or inflammatory myelitis. Spinal angiogram second day on admission showed enlargement of perforating vessels of anterior spinal artery from T10 to the conus which is consistent with vasculitis. Extensive serum and CSF examinations were consistently unremarkable. However urine culture was positive for E.coli and respiratory culture was positive for heavy streptococcus pneumoniae a week after admission; follow-up urine and respiratory cultures were negative. CBC shows 11/26.6/349/56% polys, 16% lymphs, 16% monos, 2% bands. CMP shows 133/4.6/97/26/10/0.3/119. Total protein 5.6, albumin 4.1. AST and ALT both 12.  Alkaline phosphatase 43.  Additional labs from 2/11 and 2/12: TSH 0.46. T4 unbound 1.5. P-ANCA negative. C-ANCA negative. Anti-RNP negative. Anti-FM negative. Anti-HBS positive. HPV surface antigen negative. HCV negative. HIV negative. C3 normal. C4 normal. Myelin basic protein negative, IgM normal, IgA normal. Anti-Ro negative. Anti-La negative. Anti-DNA negative. HIV antibody negative. CSF albumin VDRL IgG negative or normal. Mycoplasma antibody serum IgM negative. Mycoplasma IgG positive. VZV IgG positive. Lyme antibody titers negative. CSF PCR negative for HSV, VZV, CMV, EBV, enterovirus. CSF Cryptococcus antigen negative. Serum negative for HTLV-1 and 2 antibodies. Aspergillus antibody is negative. PPD negative.  She was treated with oxycodone, methadone, toradol, neurotin, prednisone, and plasmapheresis.   Patient has been improving slowly but still unable to walk. Information from Discharge summary states pneumonia, constipation, urinary retention. msv
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:54 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 83.61.  Concomitant medication of the patient was not reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature of 35 degrees Fahrenheit at 02:00 PM. These vials were moved to fridge on 08-Jan-2021 and beyond use date for the vials was reported as 07-Feb-2021. The vaccines moved to clinic on 11-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
So on the morning on Thursday the 4th of February 2021, I realized that around the injection site was red and raised and hot and painful. So after, I was sore for a day or two that was all relatively normal. But the week later that splotch did not go away and I had a tele-med Appointment with a DR on that Friday which would have been the 5th but it could have possibly been that Monday too, I would have to go back and look at my records, anyway and he suggested it was an allergic reaction to the vaccine. The big red circle lasted for just shy of a week before it went away, I did not take any medication and it was gone within a week.
numb arm; headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization and she was fine. The patient experienced numb arm for a little while, twenty to thirty minutes or so after the second shot and had slight headache. The events were reported as non-serious. No pain at all on the site, which was incredible, but she worked it out by doing kind of exercise like crazy. She expected much more problems. She knew some people with Moderna had muscle aches, chills, high fever. Anyone she had talked, who's taken Pfizer vaccine had no issues. The volunteer checked her notes and read that people can have a numb arm up to 30 mins after the shot. Caller inquired about her daughter who had allergy to aldehydes, she had an EpiPen. Her daughter works in a medical lab and was dealing with formaldehyde and got allergic to all aldehydes. She had a life-threatening reaction and was scheduled to take her first shot soon. The mother wanted to know about the ingredients and was wondering if there are any aldehydes in the Pfizer covid19 vaccine. She got a response that there was no formaldehyde in allergen VR. She was also wondering what 95% efficacy means. There were unaddressed medical questions referred or forwarded to medical information. The outcome of the event numbness was recovered and for the event headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client arrived to receive second dose of Moderna vaccine. Consent signed by the client's father. Client not eligible for the vaccine due to under age 18. Second dose of vaccine NOT administered due to ineligibility.  Per manufacturer's guidelines, client was not eligible for the  vaccine due to being under the age of 18.  Dr. notified Moderna and the Center for Disease Control and Prevention (CDC) of the incident.  Parents were notified that the first dose that was given to the child was not in accordance with the  CDC and manufacturer's guidelines. They were also informed  that the CDC and Moderna were notified of the incident and that the CDC has allowed the second dose series to be administered to children 16 years and older in similar situations.  The parent/guardian was given the option to return  to the clinic at the scheduled interval and for their child to receive the second dose series to provide better protection against the COVID-19 infection.
Pt reports that site was sore and started itching. A short time after it started itching, the pt noted that the injection site was swollen, red, hot to the touch, and was "hard as a rock". Pt treated symptoms with Benadryl PO, Benadryl topical, and hydrocortisone topical at home. Pt reports that site is less swollen today and that it is bruised, but no longer reddened.
The following day after #5 DaPT given in left arm the left arm became red, swollen and hot. Next day (today) rash had spread to proximal left forearm.
I was talking with a medical researcher friend of mine who works at one of medical schools. I'd seen an article about the COVID vaccine impacting women's cycles, and I was telling him my story about how the story was an "ah-ha!" moment for me -- because after I received the second COVID shot on June 18th I had the heaviest cycle with the worst cramping I've had in decades (July 19-21). I was bleeding through and had heavy, make-you-bend-over cramping. I compared it to some of the awful cramping I had at the end of my pregnancies. I typically have a simple 3-day period with no cramps, manageable bleeding, nothing to report. He suggested that it should be reported to VAERS since it is something that's being studied.
Coughing 1 month, Chest Congestion 1 month, loss of smell and taste 2-3 days, fatigue 2 weeks, headache 1 week, Dizziness, 2 weeks,   prescribed Z pack and Vantin due to chest congestion and yellow and brownish  sputem on 9/17/21. Prescribed Albuterol Inhaler and Benzonatate 100 MG PO TID  for 10 days on 10/7/2021
pt observed "passes out" by wife. Pt responded to touch and vitals taken and stable. . Food and water given.  VS O2 sat 99%  . per pt this has happened before. BS 96. EKG NSR -64
Vaccine exposure during pregnancy; arm hurt; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN IN EXTREMITY (arm hurt) in a 35-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 047A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1st dose. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Aug-2021. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient was treated with ACETAMINOPHEN for Chills and Pain, at a dose of 1 dosage form. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved and PAIN IN EXTREMITY (arm hurt) outcome was unknown.     No treatment medication details was reported.  This case was linked to MOD-2021-056023 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Internal review on 27-JUL-2021 resulted in update of Gravida,Birth type and fetal outcome
I had a sore arm after the vaccine but that is all.  I tested positive for COVID-19 on 06/21/22. I had congestion, coughing, slept for the whole day, my throat felt like I was swallowing broken glass and body aches. I took Tylenol to  help me with my symptoms.  My doctor ordered the monoclonal injection. I felt better for one or days. Then my throat started hurting and both ears hurt. I went to a urgent care center for antibiotics.
virus; hematomas; huge bruise; This is a spontaneous report received from a contactable consumer via Medical Information Team. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated her mother had virus, hematomas and huge bruise. 80Y. Mentioned to the hematologist. Health care professional declined association with vaccination. The patient had test with clotting factors similar to Heparin/Warfarin. A month and a half post vaccination, partial thromboplastin time (PTT), numbers were elevated. The reporter was really concerned and spoke with someone at medical team. The reporter stated that infection better have immunity than vaccination and stated that people who had a previous infection do not need to be vaccinated. The reporter stated that not susceptible to malaria and knew genetically speaking some people are susceptible. Referred to HCP. Attempted to warm transfer to DSU. Caller stated she did not have information. No PQC present. Outcome of the events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Patient received Prevnar 13 on 10-8.  The next day redness started at site on right arm and continued to get larger.  Came to pharmacy on 10/14 and redness was from shoulder to elbow.  Saw Dr and was prescribed doxycycline and Medrol DP and was advised to also get some Benadryl. Patient also stated there was previously some feeling of swelling in the mouth and throat area but that had subsided.
Information has been received from a physician concerning a female who on unspecified dates was vaccinated with 2 doses GARDASIL vaccine (yeast) and experienced upper leg ache. The patient contacted the physician. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Additional information has been requested.
Patient reported to the ED with complaints of right sided facial drooping. Right eye watering. Inability to close right eye.  No motor weakness in her body. Right sided ear pain. loss of right nasolabial fold.
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 3(booster), single (Batch/Lot number: unknown), in right arm, as dose 4(booster), single (Batch/Lot number: unknown), in right arm and in Jul2022 as dose 5(booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Many including autoimmune disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given on 09Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
mom stated approx 12 hrs p/vax pt devel fever of 102.5 was fussy had staring spells which seemed trance like did not respond to verbal stimuli but did respond when picked up;
Sudden onset extraordinary sinus congestion (within 4 hours of vaccine). Sinus inflammation and pain. Increased pulse. Agitated. Difficulty sleeping. Significant decrease in ability to taste and smell.
Lip tingling; numb lips/tongue numbness; injection site redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Lip tingling), HYPOAESTHESIA ORAL (numb lips/tongue numbness) and INJECTION SITE ERYTHEMA (injection site redness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PARAESTHESIA ORAL (Lip tingling), HYPOAESTHESIA ORAL (numb lips/tongue numbness) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, PARAESTHESIA ORAL (Lip tingling), HYPOAESTHESIA ORAL (numb lips/tongue numbness) and INJECTION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl. Concomitant medication was not provided.
No adverse effect reported; on11-NOV-2019, a dose of PROQUAD which expired on 21-OCT-2019 was inadvertently administered to the patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-NOV-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (exact dose and route of administration were not reported) (lot # R011802, expiry date 21-OCT-2019) for prophylaxis.  No adverse effects were reported. The outcome of the event was unknown.
Patient received their flu shot on 10/19/2020. The patient came to the pharmacy today 10/30/2020 to pick up Celebrex and Voltaren gel to treat a rotator cuff injury as a result of the vaccination.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, and also some myalgia, some muscle pain on an unspecified date. She said she got the shot on the night and she said it seems like it was getting worst. She guess, muscle and joint pain actually. The outcome was not recovered.
Case number PHEH2014US008638 is an initial spontaneous report received from a nurse on 28 Apr 2014. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that on 23 Apr 2014, she was inadvertently administered an intramuscular dose of Men A lyophilized conjugate component of MENVEO (batch number: M13047) reconstituted with another sterile diluent instead of MenCYW-135 liquid conjugate. No adverse events were reported following the maladministration.
high fever  redness/soreness at injection site  dropping things would fall down  joint hurt  back and pelvis pain
Patient came back to pharmacy 3 days after receiving vaccines. Reported that his upper arm became red and inflamed around the injection site and spread to most of his upper arm. At the time he came to the pharmacy the redness had subsided substantially and was only faintly visible even though he reported that he was still feeling pain in the area. Patient was told to take acetaminophen or ibuprofen for the pain and to seek medical attention if symptoms persisted or worsened instead of continuing to get better. Suggest patient use ice intermittently for pain in area.  NOTE: Patient received 2 IMZ in same arm due to recent surgery on the opposite side of body.
Tinnitus -- very irritating and worse in left ear, with an extra echo almost like a higher pitch and cymbal quality.
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional (pharmacy other). This case involves a two-months old patient who received only DAPTACEL (DTAP component) and IPOL (IPV component) was mixed with the sterile water and not the ACTHIB (HIB component) of PENTACEL lot number not reported on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that DAPTACEL and IPOL were mixed with Sterile Water. Also stated that he might have that mixed up and it might have been the ACTHIB mixed with Sterile water and not the DAPTACEL and IPOL. It was not reported if the patient experienced any adverse event or not. 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 the sender: none.
Patient was fully vaccinated with Pfizer, first dose 5/20/21 and second dose 6/10/21.  Patient tested positive for COVID-19 on 10/29/21.
Fever, chills, headache, nausea.  Symptoms began at 10:00 PM.  Fever and chills ended around 3:00 AM.  Nausea and headache continued until 8:00 AM.
Swollen, red, itchy, hives at and around injection site and hives go down my arm toward my elbow. I called Bellin Hospital a nurse called me back. She suggested benadryl and hydrochortisone. She advised if anything changed or if the itching got too bad to call them back.
Patient arrived at 10:36 am for 1st dose covid vaccine. Patient was accompanied by his mother, who is an employee. Pfizer covid vaccine (1st dose) was administered at 10:41am. At 10:49 patient states, "I feel faint". On assessment patient was AOLX3, diaphoretic, and pale skin. Patient was lowered to floor by 2 nurses. Feet elevated. Medical alert team arrived at 10:50 am. 10:50 am BP 97/61, HR 88, SaO2 RA 100%. 10:52 am BP 112/68, HR 86, SaO2 RA 100%. Patient was offered to be taken to ED. He refused and states, "I feel much better". 11:00 am BP 111/72, HR 75. 11:04 am patient left in stable condition, accompanied by his mother.
Pt. received shot on 9/24/17, left arm, intramuscularly. Came back on 10/7/17, complained for muscle pain around injection site and left upper arm (BTW shoulder and elbow); also mild headache for 1 or 2 days.