chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CC: itching rash to meningococcal vaccine site since June 2005.    History of Present Illness:    Immunization: Meningococcal (manuf: PMC Vaccine Date: 6/27/2004 Onset date: day of vaccination Symptoms:  This 44 year old received his Meningococcal and Typhoid vaccine on 27 June 2004.  Within minutes he complained of itching to the left arm (Meningococcal site) which has persisted intermittently as of 8 August 2005. He reported to medical and was advised "things were fine" with no further evaluation completed.  He denies any nausea, vomiting, headaches, myalgia, arthralgia, rashes, cardiac or respiratory complaints, blistering, nodules or site erythema. He reports a history of peanut allergies and "skin reaction" to thimerosal per allergy testing. He has a history of "dry skin", seborrhea, moles, nodular cysts to groin and eczema (see ROS below).
feel Sleepy; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feel Sleepy) and HEADACHE (headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (feel Sleepy) and HEADACHE (headache). At the time of the report, SOMNOLENCE (feel Sleepy) and HEADACHE (headache) had resolved.            No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-280620 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Followup received contained no new information.
Pt presented with SOB and tested positive for COVID. Was treated with decadron, supplemental O2, and Bactrim
pt began crying-high, shrill inconsolable-about 6PM;began running fever of 102 @ 3AM on 31JUL96; temp remained @ 102 p/APAP;taken to MD on 3rd day MD said pt had rxn to vax & should not recv pertussis anymore;
1) pain in scrotum starting approximately 3-4 days after 2nd dose.  Much improved as of 6/30/21, but still mild, occasional pain  2) Ciprofloxacin prescribed resulting in severe reaction with tendon pain and neuropathy.  Onset of reaction about 6-7 days (4/10/21) after prescription started, 2 weeks after vaccination.  Tendon pain improved but still present as of 6/30/21.  Neuropathy still present and unchanged since onset.
Vomiting; fatigue and grousy; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and FATIGUE (fatigue and grousy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting) and FATIGUE (fatigue and grousy). At the time of the report, VOMITING (Vomiting) and FATIGUE (fatigue and grousy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-406019 (Patient Link).
Systemic: Dizziness / Lightheadness-Medium, Systemic: fainted upon standing but was responsive-Severe, Additional Details: patient got up to go to bathroom and fainted but was responsive. mother came picked her up, patient was drinking gatorade
Joint pain, headache, rash, trouble breathing, and unexpected period with heavy flow and pain. (Menopausal woman without period for almost a year now.)
pain at injection site; bruising and tingling all the way down arm to 4th/5th digits.; bruising and tingling all the way down arm to 4th/5th digits.; This is a spontaneous report from a contactable other hcp.    A 64-years-old female Non Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: Unknown), dose 2 other, administered in Arm Right on 22Apr2021 14:30 (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. Medical history included arthritis, drug hypersensitivity. Concomitant medication(s) included ascorbic acid, beta carotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50); vitamin e nos (VITAMIN E NOS); vitamin b complex (VITAMIN B COMPLEX); linum usitatissimum seed oil (FLAXSEED OIL NATURE MADE); fish oil (FISH OIL); slippery elm (SLIPPERY ELM); magnesium (MAGNESIUM). The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, on 22Apr2021 Patient received second COVID-19 vaccine dose injection below deltoid muscle. Within a few hours developed pain at injection site, bruising and tingling all the way down arm to 4th/5th digits with outcome of recovering.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse practitioner refers to a 7 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 14-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Chills, low grade fever, total lethargy, loss of appetite, weakness, lightheaded, swelling area of injection, I slept almost constantly for a day and a half. This is extremely unusual for me. I never nap, yet all I could do was sleep. On 8/28/2017 at my daughter's urging, I phoned my physician's office and spoke with his nurse. She said I should feel better today, if not and injection site worse, to call again. I did awake feeling considerable better. Injection site still sore, though less so than past few days.
My baby started crying hysterically and uncontrollably in the early evening after his shots. He never was a baby that cried as soon as I would nurse him he would instantly stop so this was VERY out of character for him. He would not nurse or take a bottle. We took him to urgent care once I told them he had his shots that morning they said that is probably why he won't eat and was upset. He did not eat for 36 hours except one small nighttime nursing session. Complete loss of appetite due to the shots I believe. It came back and he was back to being normal 36 hours later.
Papular rash beginning on interior of arms and on legs becoming diffuse over next 2 days to include trunk, all aspects of arms and legs, scalp and back.  Treated with high dose antihistimines, steroid ointment.  Resolved over approx. 30 days.
Again a couple of days ago he started having slight rednes; Noticed yesterday he started having redness, 4x5in wide, 6-7 in long, 2in below the injection site; Soreness at injection site; Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Again a couple of days ago he started having slight rednes), ERYTHEMA (Noticed yesterday he started having redness, 4x5in wide, 6-7 in long, 2in below the injection site), INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness). On an unknown date, the patient experienced ERYTHEMA (Again a couple of days ago he started having slight rednes) and ERYTHEMA (Noticed yesterday he started having redness, 4x5in wide, 6-7 in long, 2in below the injection site). At the time of the report, ERYTHEMA (Again a couple of days ago he started having slight rednes) and ERYTHEMA (Noticed yesterday he started having redness, 4x5in wide, 6-7 in long, 2in below the injection site) outcome was unknown and INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness) had resolved.            Concomitant medications were not reported  No treatment was specified
Sore arm; Pharmacist administered the shot a little bit higher in the arm of an HCP, so the HCP/Patient asked to repeat it again and the Pharmacist gave the shot again; Pharmacist administered the shot a little bit higher in the arm of an HCP, so the HCP/Patient asked to repeat it again and the Pharmacist gave the shot again; This is a spontaneous report from a Pfizer-sponsored program by a contactable other health care professional (patient). A female patient of unknown age received first dose of bnt162b2 (COMIRNATY, Formulation: solution for injection) via unknown route of administration on an arm, on an unknown date in Jan2021 as FIRST DOSE, SINGLE for COVID-19 immunisation. The medical history and concomitant medication were not reported. It was reported that a pharmacist administered the shot a little bit higher in the arm of a health care professional, so the health care professional(patient) asked to repeat it again and the pharmacist gave the shot again on an un-specified date in Jan2021. The reporter enquired weather it can be considered as double dose. On PRD 03Feb2021 it was reported, phone out 11:18 PM EST. 2nd attempt for Vaccine Call with HCP 1st tab. Call answered by HCP who stated she was busy and could not take the call but suggested to send the forms by email. HCP stated the patient had experienced sore arm. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable Other HCP. This Other HCP reported via telephonic follow-up activity that included: event (sore arm).   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Left arm (she of vaccine) became progressively more swollen and painful.  Painful area at deltoid 12 cm X 8 cm.  Pain radiated down left arm past elbow and caused numbness to fingers left hand.  Developed temp of 101 degrees.  Ordered DOXYCYCLINE 100 mg PO BID X 10 days by Dr.  Developed Angioedema of the upper airway with DOXYCYCLINE - Seen in ED.  DOXYCYCLINE iced began a course of BACTRIM.
Case number PHEH2011US01395 is an initial spontaneous report received from a nurse on 05 Aug 2011. This report refers to a 15 years old female patient. She was vaccinated with MENVEO (batch number: A10047) intramuscularly on an undetermined date. After vaccination she experienced lightheadedness. The reporter also had other patients, who experienced similar symptoms of lightheadedness and fainting after receiving other unspecified vaccines, but the reporter did not have details regarding any other patient or any other adverse event experienced. No further information was available.
2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dry next morning and a couple hrs later it switched to increased salivation.  The evening after injection I had a headache and  just felt general malaise and fatigue, "run down". Difficulty sleeping that night due to body aches. HEadache, neck and lower back pain. Skin sensitivity when touched, bed sheets kinda hurt my skin. The bodyaches and malaise persisted through out day 2. Tylenol seemed to help.  I slept better that night but woke up with night sweats, completely drenched.  Arm pain at injection site on day 2 that resolved by mid day.  Now 1 week later I have extreme fatigue yesterday and today. I do have hypersomnia but not even my adderall is helping. Not sure if this is related or not.
Pain in left testicle; This is a spontaneous report from a contactable consumer or other non hcp.   A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration left arm single dose on 11Feb2021 16:30 for covid-19 immunisation. No other vaccine was received in four weeks.  Medical history was none. The patient's concomitant medications were not reported. The patient experienced pain in left testicle on 12Feb2021 16:45. No treatment received. The outcome was not recovered.   Information on the lot/batch number has been requested.
Pt arrived with abdominal pain and it was discovered that he had a perforated appendix.  He was admitted and tested for COVID due to surgery, but found to be positive and asymptomatic.
Redness, swelling, pain, itching at vaccine site - approximately 2 x 3 inch size lump and bright red spot.  Continuing on 1/17/2014 as well.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates, between 02-FEB-2016 to 02-APR-2016, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot# M012495, expiration date 09-OCT-2017, dose was not reported; orally). It was also reported that an improperly stored sterile diluent (lot# K023007 with expiration date 24-SEP-2017, lot# L017417 with expiration date 02-FEB-2018, lot# L015432 with expiration date 24-JAN-2018, lot# reported as L03221 with unspecified expiration date; dose was not reported, oral route of administration) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot# L03221 has been verified to be an invalid lot# for sterile diluent. This is one of several reports received from the same reporter. Additional information has been requested.
Immediately after the injection I got a metallic taste in my mouth.  They had me stay for 30 minutes to watch me a bit longer.  All was fine; breathing, etc.  No issues.   On Saturday, two days after the injection, I noticed a rash covering my torso- down my chest, extending down to the elbow area of my arms, and about an inch below my belly button.  It appeared to be on my back some as well but it was not as prominent.  The "rash" did not hurt, itch, nor was it raised.   It was similar to a rash I had when I had strep throat prior to being treated.  I called my doctors office, I was on the phone with the nurse for an extended time, she asked about my breathing (all normal) any wheezing, etc.  EVERYTHING was fine except for this rash/hives  She said to go to ER if breathing is bothersome, etc.  She had me take benedryl and apply I believe it was cortisone over the counter to my torso. It subsided by 3/7, and by 3/8 was barely visible.
Case number PHEH2013US026177 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to a 03-year old female child. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13109801, expiry date 31 MAY 2013) intramuscularly at a dose of 0.5 ml on 15 NOV 2013. No adverse event was reported following this administration error.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unknown number of patients had received doses of GARDASIL (dosage details, route, lot# and expiration date were not reported) which underwent temperatures which fell outside the prescribing information. Among these improperly stored GARDASIL vaccines were these that were supported and these that were not supported. No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning her daughter who was vaccinated SC with a 0.5 ml, third dose of Measles virus vaccine live (Enders Edmonston). Subsequently, the patient failed to seroconvert after three administrations of vaccine. Schedule of vaccinations in unknown. Unspecified medical attention was sought. The patients outcome was unknown. Additional information has been requested.
-Active symptoms : Right lumbar kidney area intermittent pain has been happening since vaccinated.  -Inactive symptoms: Flu like symptoms for 2 weeks only. Fatigue for 3 weeks
Pt reported that approx midnight of 4/17/2021 he started experiencing chills, fever, headache, and tired; pt slept until noon today. At time of call approx. 1pm, pt reports still have body ache and pain, slight HA, slight chills (but not as cold), and not as tired.  Pt reports took Tylenol a little after midnight when the symptoms came on, and took 2 more tablets of Tylenol this afternoon. Pt contacted his MD via phone today and was advised to report ADEs.  Recommend pt to continued to keep hydrated, rest and consume adequate meals. Advised that ADEs usually occurs within 72 hours of rcvding the vaccine, and symptoms should clear in couple of days after. Also recommend to take Tylenol PRN; counseled to not exceed 4,000 mg per day or consume alcohol while taking Tylenol to avoid liver injury. Recommend if symptoms does not get better to contact MD. Also advised these symptoms are not a contraindication to rcvding the second dose.
4/20/12 Seen at facility for Tdap reaction after vaccination 4/17/12. Reports having fever, body aches and chills starting at 8pm after vaccine administration with symptoms continuing through 4/19/12. States that she feels better today but still with sore arm and body aches. Left delt site with erythema and induration measuring 16cm x 17cm starting 4cm inferior to L acromion. No epitrochlear or auxiliary lymphedema. Temp 36.8, BP 106/80 HR 64 S1S2, RR 14 lungs CTA. Chem 7 and CBC sent stat. Evaluated by ARNP.
I received the first dose of the Covid vaccine. I then contracted Covid; I received the first dose of the Covid vaccine. I then contracted Covid; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was contracted covid and received a Regeneron infusion. The patient was told that the infusion clinic had to start patient vaccinations over again in November, 90 days after the infusion. The outcome of the events was unknown.
Patient complained of redness and swelling at the injection site on 1/21/12 (right lateral thigh), one day after vaccination (DTaP). No fever. Ambulating well. On 1/22/12, swelling and redness increased in size to cover lateral thigh extending from injection site to knee (8 inches x 5 3/4 in). Still not painful, still ambulating well, not itchy. Area around injection site described as initially "slightly hard to the the touch" on 1/21, but soft by 1/22. An area of central clearing developed around the injection site on 1/22. Treatment consisted of cool compresses and ibuprofen prn. I saw the patient on 1/22/12.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details reported as follows: This case was reported by a physician assistant-certified (PA-C). The patient's body temperature was recorded to be 101 degree F. The reporter did not agree to be followed up from GlaxoSmithKline. Lab Comments: Lab test was done on an unknown date.
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 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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.   Age of patient was reported as 71.47 .  No concomitant medications were reported.  Batch number 031L20A administered on 17-Feb-2021 underwent temperature excursion with temperature range 20 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021.  Product moved to clinic on 17-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  Vials were only punctured right before administration. Vaccines were not frozen at time of 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. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Shingles vaccine on Friday afternoon 11/24/06.  On Saturday 11/25/06, red, bumpy rash about 1 inch diameter on forehead at hairline.  Showed it to pharmacist on Sunday.  Emailed Dr on Monday.  Thursday 11/30/06 still there and sore.  Possible shingles.