chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Body aches; Second vaccine given 93 days after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given 93 days after first vaccine), PYREXIA (Fever) and MYALGIA (Body aches) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 025L201A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given 93 days after first vaccine). On 03-Apr-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given 93 days after first vaccine) had resolved. On 03-Apr-2021, PYREXIA (Fever) had resolved. On 05-Apr-2021, MYALGIA (Body aches) had resolved.            No concomitant medications were reported.  No treatment information for the events was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
15 yr female with PM hx of sz d/o. Seizure free for 2 years. Off meds for 1 yr. NL EEG. Off meds. 10 days after Gardasil, had seizure. Now with tremors in hand also.  3/12/09 MR received from PCP. Pt in for 14 yr WCC 8/6/2007 with impression: Well Adolescent. No seizures x 1 yr off meds. Vax given.  ER visit for "stiff convulsion" on 8/17/07.  To see neurologist 9/17/07. 4/8/09 Pt not seen 9/17/07. Saw another neurologist. 4/24/09 Neuro records received dated 10/12/07-7/2/2008 with DX: Seizures. Pt with PMH of seizures off tx x1 year with no seizures presented following seizure in 8/2007. PE WNL.  Anti-convulsants restarted. No EEG or imaging studies done. Pt returned 11/26/08 with c/o anxiety, poor concentration, panic attacks and fatigue thought to be side-effect of Keppra.  Med changed to Carbatrol with improvement in mood and concentration.
I had a migraine every day since from November 4th.  I went to doctor on Friday November 5th.  They did not any test but other than the exam.  He feels that my migraines was caused by the booster shot.
(My symptoms the same for that episode and current one.) Still had mild intermittent headache; (My symptoms the same for that episode and current one.) Still had mild intermittent headache, brain fog from first episode; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "allergic rhinitis" (unspecified if ongoing); "GERD (with h/o gastric ulcer)" (unspecified if ongoing); "GERD (with h/o gastric ulcer)" (unspecified if ongoing); "remote h/o asthma" (unspecified if ongoing); "remote h/o alopecia" (unspecified if ongoing); "h/o depression" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE, start date: Jan1990, stop date: 25Oct2022; MONTELUKAST, start date: Jan2000, stop date: 25Oct2022; PANTOPRAZOLE, start date: Apr2019, stop date: 25Oct2022; FISH OIL, start date: Jan2010, stop date: 25Oct2022; PROBIOTICS, start date: Jan2015, stop date: 25Oct2022; LEXAPRO, stop date: 06Oct2022. Past drug history included: Wellbutrin, reaction(s): "drug allergy". Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2588), administration date: 03Oct2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9261), administration date: 08Feb2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE; Lot number: FL3249), administration date: 18Jan2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "(My symptoms the same for that episode and current one.) Still had mild intermittent headache"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "(My symptoms the same for that episode and current one.) Still had mild intermittent headache, brain fog from first episode". Therapeutic measures were taken as a result of headache, feeling abnormal.  Additional information: the patient was on Lexapro for 25 years.
pt recv vax in 1996 & in 1997 pt titers were negative;it was reported that the pt is contemplating pregnancy;
One day following following vaccine, period started and went 12 days of flow or spotting (normally six) This same cycle went 32 days (normally 25) (negative for pregnancy) Subsequent cycle went 12 days (normally 25) Next cycle went 21 days (normally 25) Next cycle went 25 & anovulatory (normally ovulatory) Next cycle went 22 days (normally 25) At the time of this report this is the complete history, cycles have not returned to normal
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX (batch number T5242, expiry date unknown) and (batch number 5223C, expiry date unknown) for prophylaxis. Concomitant products included simvastatin. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, joint pain and fatigue. On 14th April 2018, the outcome of the injection site pain, joint pain and fatigue were recovered/resolved. It was not reported if the reporter considered the injection site pain, joint pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported 2 batch numbers 1 of adjuvant and other of lyophilized powder. The patient received SHINGRIX in left arm. The health care professional reported that the patient received SHINGRIX and developed pain at the injection site, fatigue and achy joints within 6 hours of vaccination. This case has been linked with US2018116408, reported by the same reporter.
sudden appearance of 2" diameter raised red blotches, one on forehead; one on chest, 2 on lt arm the noc of 17MAR & 18MAR96
Approximately 1:49 pm c/o not feeling well.  BP @1:53 169/108 HR 78, denies hx of htn.  At 2:08 164/103 HR78, 2:12p 161/103 HR 78, 2:21p 174/11 1 69, 2:30p 163/101 83, 2:55p 176/113 75, 3:10p 168/95 77, client left with  family member at 3:20p with an appt at PCP office for evaluation and in no distress
patient was accidently given 0.2ml of the adult formulation of covid-19 vaccination. This amounts to 2 pediatric doses at one time. Parent was called and advised to look out for any headaches, joint pain and elevated heart rate and to f/u with her daughter's pediatrician if so.
One of  our stores got confused with the storage parameters around the Pfizer vaccine and exceeded the 14 day freezer window.  The Vaccine was placed inside the freezer on 6/5/21 and taken out on 6/25/21 and placed into the refrigerator.  The store has vaccinated 50 people from 6/25/21 ? 6/29/21. The temperature range for the days the vaccine was in the freezer was -0.9 (warmest) to -5.9 (coldest) with an avg temp of -4.9
Quarter size bump with redness, itching and tender to touch appeared on 2/25/2021 at 8pm. By morning of 2/26 spot increased to 1 inch by 3inch, more itching and same redness. At 4pm on 2/26 still itching, increased tenderness, spot about 2in by 4in and larger bump with redness. Feeling sluggish since initial injection and has not increased or decreased. No other side effects other than headache first two days after dose.
Pt received wrong manufacturer for second dose. Vaccinator was educated and had remedial training.    Who: Patient What: Received wrong manufactured dose for second Covid-19 Dose (was suppose to receive Moderna, but instead received Pfixzer) Where: @ vaccine site When: 1400 on 10 April 2021 Why: Mistake by vaccinator
Pt. C/o nausea about 15-20min. after H1N1 Nasal Spray. No other c/o voiced. Temp 98.5 Resp. 16 regular. No S/S of allergic reaction noted. Sprite & crackers given. Pt tolerated well & went to lunch. Had eaten breakfast in a.m.
feeling dizzy and weak; feeling dizzy and weak; Fever; Nausea; throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 1, single (Lot number: FJ4911) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing), notes: Concomitant Products: No but has smoked weed, not sure if that matters; "ADHD" (unspecified if ongoing), notes: Tests: Did a mental health test online 4 days ago that said he had ADHD. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 14Jul2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 14Jul2022, outcome "not recovered"; DIZZINESS (non-serious), ASTHENIA (non-serious) all with onset 14Jul2022, outcome "not recovered" and all described as "feeling dizzy and weak"; VOMITING (non-serious) with onset 14Jul2022, outcome "unknown", described as "throwing up". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, asthenia, pyrexia, nausea, vomiting.  Additional information: Caller asks if they are someone is going to tell him what he can treat this with. Caller advised that he could be transferred to address any questions with the vaccine but that they would not be able to provide any specific medical advice.  Caller states that, If they cant help or give advice, he  thinks will end the call.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female who on 02-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y). There were no any concomitant vaccinations at that time. In February 2010, the patient missed her appointment to receive the second dose of GARDASIL. On 05-APR-2010, the patient came to the physician's office for a Prenatal Care Visit. The patient reported her last menstrual period was 07-FEB-2010. On ultrasound the patient's pregnancy was confirmed. The patient was 13 weeks +4 days pregnant at the reporting time. The patient's estimated due date was 14-NOV-2010. Follow up information has been received from a completed questionnaire and the registered nurse concerning the female patient with cystic fibrosis carrier who experienced anemia during pregnancy. The patient was treated with Fe supplement. On 25-MAY-2010 maternal serum alpha-fetoprotein screening (MSAFP) was performed and the result was negative. On 21-NOV-2010, the patient delivered a normal female infant. There were no congenital anomalies. The infant experienced respiratory distress syndrome (RDS) which has been captured in WAES# 1005USA00540B1. Additional information has been received from the registered nurse concerning a female patient who 02-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y) intramuscularly into right deltoid. The patient had pregnancy test on 04-APR-2010 which was positive. The date of ultrasound was confirmed as 03-MAY-2010. This was the patient's first pregnancy. The patient did not seek medical attention. No further information is available.
1st injection in left arm had a red ring about 2 weeks post injection. No other symptoms. Was told to do second injection.  4pm on 4/22 pain at injection site. By 7pm slightly red and swollen. 8pm-swelling moved lower than injection site. 6am on 4/23-pain and swelling at site. Very tired throughout the day.  Red red and swollen around site. Painful all day. 5am on 4/24 still red and swollen around the site, now a painful swelling in right armpit.
Pt received multiple vaccines and developed a fine macular rash over trunk, back around 10 minutes after injections. 20 minutes later, had hives moving from face to shoulders, back, and chest. Gave Children's Benadryl and called later that day with no other problems. Hives cleared by 8 hours.
Mother noticed that the child had a rash on 11/17/2014  the child received vaccines on 11/14/2014 and had grape flavored Tylenol, nothing else was new to the child.
The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He received the first dose of the Pfizer Vaccine on March 26, 2021. On March 27, 2021 at approximately 7:30 PM, the patient suddenly became unable to speak clearly and walk normally.  The ambulance was called at approximately 7:45 PM. The patient was evaluated and placed in the ambulance by approximately 8:15 PM. He stopped breathing in the ambulance. He was resuscitated and placed on a ventilator at some point. After evaluation at the hospital, it was found that he had suffered a pontine hemorrhage. He was kept alive until his heart stopped on March 29, 2021.
Friday 07/23/2021  LPN contacted Pharmacy regarding incorrect dilution of Pfizer Vaccine for 2 patients (husband and wife). LPN was directed to draw up left over diluent to determine how much was injected into Pfizer Vaccine. The leftover diluent was approximately 0.6 ml. Pharmacy directed LPN to contact someone else in the Pharmacy  LPN contacted pharmacy and informed in of incorrect dilution of Pfizer Vaccine. He informed LPN that patients receiving the first dose of vaccine usually do not experience side effects. He reports that, in the event that higher than authorized dose volume were administered, patients may experience elevated side effects (fevers, body aches, chills). He informed LPN that patients should be contacted to make aware of the error and to report any side effects.  He reports that depending on the patient side effects, if any, may determine whether patient receives a second dose of vaccine. He reported that errors needed to be reported, sent email with information on how to do this to both LOM and Practice Manager. LPN contacted Practice Manager and informed her of the incorrect dilution of Pfizer Vaccine, and the information that was given by Pharmacy.  LPN spoke with the patient's provider; who contacted both patients to inform of error and potential side effects. Patients comprehended and understood. LPN and practice manager discussed a strategy which will be implemented, so this does not occur again.  The plan going forward is the following:    When diluting Pfizer vaccine, will have another person verify correct dilution and correct dosing and initial (on a     copy of the schedule)  Practice manager contacted Dr, and informed him of the incident and follow up. Practice manager will enter the incident into VAERS, per the direction of the Pharmacy Director, and will also ensure the dosage is also entered into system, as per the direction of the CDC.
This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 13-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Resident received Covid vaccine Moderna on 12/26/26.  Unknown to the facility.  Resident received on 1/30/21 a Pfizer vaccine.  The facility was notified on 2/1/21 by a local pharmacy that they needed to administer resident's 2nd vaccine.  The facility had a signed consent from the resident's Medical Power of attorney that had no previous knowledge of resident receiving vaccine.  Resident's vaccination card has since been located and received by the facility.  The facility was advised by the board of pharmacy to consider vaccination complete and report to Vaers.  The resident did not suffer any ill effects after vaccination.
Cheeks and eyes swollen. 10:00 PM  Tightness in throat (no tx required). 7:30 AM 9/25/13 awoke with sticky, swollen eyelids.
Vaccinee has h/o hyperthyroid and occ PVC. No recent PVC. He was vaccinated on 2/28. Three days later (3/3) he developed sustained PVCs (3 hours). He was seen in ED. No CP, SOB, diaphoresis, fevers. PVCs had stopped by the time seen in ED. EKG was normal; cardiac enzymes were normal; TFTs were normal. On 3/17, he developed intermittent PVCs. On 3/18, PVCs were sustained (5 hours). He was seen by PMD, got 24 hour urine and EKG. EKG showed PVCs but was otherwise normal. He was put on atenolol 25 mg bid. PVCs stopped within 30 minutes after taking the atenolol. He decreased the atenolol to qd and then stopped it on 3/23. He has had no PVCs since. He had a normal stress test on 3/25.
Patient went to the office on 1/26 with a bump at the Vaxelis injection site; Rashes on right and left thigh; This non-serious spontaneous Safety Report, with reference number 2023SA031837, was received by partner on 26-JAN-2023 and forwarded on 27-JAN-2023 from other health professional.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Patient went to the office on 1/26 with a bump at the Vaxelis injection site".  Further information is expected.  Significant Follow-up information was received by the partner on 24-MAR-2023 and forwarded on 27-MAR-2023, from other health professional. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Patient went to the office on 1/26 with a bump at the Vaxelis injection site and Rashes on right and left thigh".  Further information is expected.
Mild erythema to immunization site about 5 mm to (R) upper leg.
05/23/2022 Vaccination 06/17/2022 Cough.  06/18/2022 COVID test at home. Chest was really tight, cough was not productive. Got some Mucinex. COVID- Sat. and Sunday progressed with symptoms. The worst was the HA. Coughing all night.  06/20/2022 COVID+ home test. I called my PCM. They prescribed Paxlovid and had a virtual health appt.  06/21/2022 First day taking Paxlovid treatment.
pt recv vax 12FEB97 &15FEB97 pt devel a vesicular rash on trunk consisting of approx 15 lesions;
Pain at injection site; Redness at injection site; blotchy at injection site; Itchiness at injection site; Fever; Fatigue; Aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The patient was a coworker. The age at vaccination was not reported. The reporter did not provide patient initial, date of birth or healthcare professional details. The patient received vaccine in unknown arm. The patient developed fever, pain at the injection site, aches, and fatigue. Patient also developed itchiness, redness, and blotches at the injection site. The patient's symptoms lasted for a few days before resolving. The reporter had limited information regarding this adverse event. The reporter consent to follow up. This case had been linked to the case US2019190821, reported by same reporter. For tolerance of 2nd dose of vaccine, refer case US2019AMR191514.
Had injection on March 31, 2021. Very sore arm with soreness and stiffness in the neck for a few days.  On April 8th woke up very dizzy, had to lay back down for a little bit.  On April 10th woke up not being able to take a deep breath without a very bad pain in my back (it felt like my right lung)  same issue the 11th, and 12th.  This pain was not severe unless I took a deep breath.  I was able to go about my daily activities.  Today April 13th still a little tight in my lung but do not have the pain in my back that I had the last few days.
Swollen and itchiness (day or two later); Psoriasis (end of month)?; Urgent care informed PCP per patient statement.
Muscular pain that continues as of 03/28/2023, but is improving  For a few days after vaccine= fever and chills, body aches and headaches, headaches tendering with earache but also gradually improving
Fever 101.8, achy legs, face extremely red and hot, headache, nausea
Noticed bug bite on Monday by Wednesday  a rash/blisters had spread all up leg.  Went to doctor Thursday...diagnosed with shingles. Doctor prescribed Advil 3x day and  starting 9/22/22 Valacyclovir  for 7 days. Shooting pain, charley horse pains,  burning while frequently urinating  (whole left leg and crotch area rash/blisters and pain). Barely able to walk. Rash lasted approx. 3 weeks, pain lasted approx. 10 weeks, still tender skin at 15 weeks.
The patient presents with SOB x one week. Pt states he was tested positive for COVID 6 days ago. Pt states he had regeneron done today and his symptoms got worse. Pt c/o nausea, fever, SOB, and cough, congestion  but denies V/D, chest pain, HA, myalgia, fatigue, chills.  The onset was 1  days ago.  The course/duration of symptoms is worsening.  Patient still admitted at time for was submitted
The patients parents came for the second covid shot, and the pharmacist realized that the patient is not old enough to get the shot. When the patient came to get the first shot, the parents told the pharmacist that he is autistic and they didn't bring the id or social security card for the patient, also they mentioned that he is 18 years of age, The parents assured that they will call us back to provide all the insurance info and ID info.   The parents filled the consent form for the patient since the patient is autistic. So just for a humanitarian consideration, we gave the first dose and plan to bill insurance once they provide all the relevant info, thru the phone.. Some how the  staff misplaced the consent form  and forgot to bill insurance or enter the RX into the system.                              When the parents came for the second dose only we realized that we didn't even enter the Rx into the system and realized that the patient is not old enough to get the shot.
no additional AEs; expired lot of MMR II was administered to patient; This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JAN-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneous injection, 0.5ml/once, lot number T037029, expiration date: 03-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). There was no additional adverse event reported (no adverse event).