chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced Amenorrhea the day of vaccinations. Patient experienced heavy menstrual flow on day of vaccine. last menses was 09/02/2023.
p/vax pt woke early 2AM w/face, feet, hands, swelling, itching all over;saw MD couldn't say it was the vax but couldn't say it wasn't no other explanation;DPH & pred given;cortisone given also;
presented to ED confused, O2 saturation decreased, hx of COVID positive for approximately 1 week; hx of COPD; dyspnea; intubated, acute hypoxemic respiratory failure, COVID pneumonia; pt's condition deteriorated where he died in the hospital
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was inadvertently vaccinated with a dose of (Merck) VARIVAX (lot#, dose and route not reported) on 17-SEP-2012 instead of ZOSTAVAX. No concomitant medications were reported. There was no adverse effect reported. Additional information has been requested.
A female patient (age and date of birth not reported) developed a lesion/nodule which was tender and firm, 1 cm in size after receiving the injection of Adacel (lot number unknown) one month ago. It was reported the vaccine was administered intradermally in the forearm. The exact date of administration was not reported. Per reporter the patient was seen by a physician. No treatment was reported. At the time of this report the patient had not recovered. Per reporter, who is the responsible physician, he will fax additional patient information via completed VAERS form.
At 2am on 2/3/21 resident began having trouble breathing. She had an audible wheeze and gurgling and critically low O2 sats. She has no history of breathing issues. She did not have any issues earlier that day.  She was sent to the ER and admitted to the ICU for possible heart failure.
next AM woke up w/swollen throat, mouth felt coated, t102, ached to the bone all noc, couldn't move arm, arm started to swell 4DEC94 as big as a potatoe, itches & hurts, very red @ site;
Pt came in (2) days later c/o swelling, warmth and redness to L) deltoid.
10 min after vaccination patient complained of dizziness, feeling very warm.  reminded her of the aurora before migraine comes on. V.S. HR 75, Pulse ox, 99%  BP 102/76, 0800  cool cloth applied to back of neck and and we put her head down. 0810 dizziness better seeing spots,  0810 Dizziness better spots persisted, 0825 same monitored and patient drinking water ate some crackers. 0830 V.S BP 114/80 HR  71  Pulse ox, 99% . 0835 bent over to pick up phone off the floor developed  dizziness again cold, warm blanket applied monitored. 0850 feeling queezy and dizziness persistent 0900 sent to the ED per W/C.  2  sm. bottles of water taken in.
RED RASH EXTENDING DOWN LEFT ARM HEAD FEELS ITCHY NUMBNESS IN LEFT ARM
The evening of injection she had some redness and tender at injection site. She noticed the redness spreading from injection site around her arm and down to elbow. She said the redness turned purple color, swollen, and painful to move. The reaction resolved after 6-7 days.
Swelling, redness, slight itch at injection site. Fatigue for the next 48 hours.
Vaccine given at 1615. Soreness present within one hour but tolerable without nsaid. I went to sleep and woke numerous time throughout the night unable to move my arm from intense soreness. Got out of bed at 0530, walked to nearby room, sat down and instant my lighthead, dizziness, and hot. Ran to door/opened and woke up on the floor. I went back to bed and was unable to sit up or stand without getting dizzy until 1230. I was sore,  had fever/chills, and a headache through the rest of the day/night until 0400. Next day most of symptoms resolved expect headache, actually dizzy, and soreness. Friday sore mostly resolved, but headache returns every time I lay down, the longer I lay down the stronger the headache get. Also get dizzy if I bend over/look down, get up quickly, or move head                                  quickly.
patient passed out for a few minutes but regain conscious quickly, patient complained of being light headed and appeared pale. Paramedics arrived to check patient's condition. Patient blood pressure, heart rate and respiration was evaluated. Patient refused to go to the hospital and remained at our sigh for observation for 30 minutes
Had the body aches and really bad heachache / sinus pressure. Threw up a couple times Thursday. Now there is a rash at the site and heat (12/10)
Sore arm; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient (age at vaccination 35-years-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. At the time of the report, the patient recovered from the event on an unspecified date. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. It was unknown if the patient had been COVID tested post vaccination.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Some slight swelling of face, on and around nose. Also had a low grade fever, no appetite and some slight chills and sore arm. The face swelling was what surprised me as was not listed on possible side affects.
Pfizer COVID-19 Vaccine EUA  Pt received 1st dose of vaccine on 1/31/21. Afterwards, she developed a slight cough and chest pressure. Pressure is worse with deep breathing. Denies chest pain. Denies SOB or wheezing. Pt also had episode of loose stool x 1. States she has had an anaphylactic reaction in past, but it did not feel the same. Pt took diphenhydramine 50 mg PO before receiving her vaccine after consulting her PCP.  When pt presented to convenient care, vitals WNL. Pt given methylpredisolone 125 mg IM x 1. Pt prescribed epinephrine 0.3 mg injectable 2-pak kit. Provider recommended pt not receive the 2nd dose of vaccine unless PCP says otherwise. Pt discharged to home.  2/1/21: Pt continued to endorse loose stools, fatigue, and body aches.  2/2/21: Pt's PCP told her not to receive 2nd dose of vaccine.
I started with leg pain after my vaccine. I am dealing with this now. I diagnosed with Lupus on 02-14-2023. I experienced migraines at night time, I have stigmatism, my heart rate goes up to 120-130BPM. I also had a complete blood work for Lupus. I continue to this day having leg pain and migraines.
Enlarged and painful lymph node in armpit on vaccinated arm 6 days after vaccine. Tiredness and congestion as well starting at day 6.
heart palpitation- can not be traced as to why. Not saying it's the vaccine. But want to make sure that you are aware
Information has been received from a RN concerning a pt who on 03-DEC-2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt was seen in the ER on 03-DEC-2001 because her left arm was swollen and she had some SOB. She was treated with Benadryl and an unspecified inhaler. On 05-DEC-2001, the pt was seen in the office and was diagnosed with cellulitis. She was admitted to the hospital on 05-DEC-2001. The pt was treated with IV antibiotics and was discharged on 08-DEC-2001 with PO antibiotics. The pt's outcome was unknown. The RN was concerned and would like to obtain a lot check. No further information is expected.
Headache; Allergy; Exposure to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergy), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    The patient's past medical history included Exposure to COVID-19.   On 18-Jul-2022, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In July 2022, the patient experienced HYPERSENSITIVITY (Allergy) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). On 18-Jul-2022, the patient experienced HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Allergy), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that there was not have the lot number information, because the packaging was discarded. No treatment medications were reported.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 25-years-old female patient who received third dose of vaccine IMOVAX RABIES on day 14 instead of day 21. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 24 July 2018, the patient received a third once 0.5 ml intramuscular dose of suspect IMOVAX VACCINE in left deltoid lot number NIG401M exp date, 23 July 2019, strength was standard for immunization, pre-exposure. The patient received first and second once 0.5 ml intramuscular dose of suspect IMOVAX VACCINE in left deltoid lot number NIG401M exp date, 23 July 2019 respectively on 10 July 2018 and 17 July 2018, strength was standard for immunization, pre-exposure. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported that if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none Follow up information received on 10 October 2018. Patient demographic and age was updated. Vaccination details was updated.
Normal labor and delivery on 10/17/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
severe right thigh/calf pain, chills, diarrhea, vomiting.
1hr p/vax pt devel erythema of trunk & neck, pruritis, then devel pruritic papules
Mother states day of vaccination child c/o of "sore arm". Next day mother states she noted "red and hard to touch". Upon examination erythema noted 60 x 60mm and mild swelling to right deltoid area. Child able to move arm without difficulty. Hot to touch. Advised to take Tylenol as directed for pain and Benadryl/cream or PO for local reaction PRN as directed and to use cool pack to site.
Suspected vaccination failure; patient who received Shingrix and then had Shingles.; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included lyme disease.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 15th July 2019, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had no previous history of shingles, immunosuppressive disease or treatment. On 2018, the patient received both doses of Shingrix at an unknown pharmacy. On 15th July 2019, the patient was diagnosed with shingles and was clinically diagnosed by the reporter, but no PCR confirmation. This case was considered as suspected vaccination failure as details regarding time to onset for target disease was unknown at the time of reporting. The reporter consented to follow up.
No additional AE details are available; Gardasil 9 improperly stored vaccine administered to patient on 10/7/2020.; This spontaneous report was received from a registered nurse referring to a 11-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.     On 07-OCT-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of administration were not reported; lot number S010729 and expiration date 01-DEC-2021) (product storage error). No additional adverse events were reported.     According to the reporter, the temperature excursion was above 9 degrees Celsius (11.3 degrees Celsius) for a time frame of 55 minutes on an unspecified date, without any previous temperature excursion; which was detected by a digital data logger.  This is one of two reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry:  devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA003133:
Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL and 15 days later developed a rash. The patient did receive other vaccines (unspecified which ones). Unknown medical attention was sought. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. Additional information has been received from a physician indicating that no reaction occurred due to GARDASIL, at first she thought it might have been a reaction but clearly it was not a reaction to the GARDASIL because of the date the vaccine was given and the type of rash the patient had. No further information is available.
On April 2, 2021, person went to the ED at  10:15 AM, where she complained of shortness of breath, fatigue, mild headache and nausea.  Patient symptoms were going on for about 3 days.  She also reported feeling a bit achy and decreased appetite. She was treated and discharged home the same day.  It was later reported by a family member that this person was found unconscious on floor of her bedroom by family members and taken to hospital where she passed away. It was reported hat Doctors were thinking that this was caused by a rare blood disorder (Thrombotic thrombocytopenic purpura, a disease which causes small blood clots and interrupts the blood's ability to deliver oxygen properly).
Fever, muscle soreness, joint pain, swollen lymph node(s) in left armpit
1/21/23 This started with a dry cough.  Tested positive with an At Home COVID-19 Test.  Participant went to ER due to an unrelated injury and was tested there as well with a Rapid COVID-19 Test.  Doctor proscribed Molnupiravir and advised to treat symptomatically.  Post nasal drip and runny nose were also experienced, but after the second day on medication, symptoms disappeared. Participant returned to normal by 1/27/2023.
Red bumps appeared on patient's chest, back, neck and ears on 11/29/12. Patient has had flu vaccines in the past without any problems.
did not receive a full second vaccine dose; left arm painful; did not receive a full second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm painful), UNDERDOSE (did not receive a full second vaccine dose) and DEVICE CONNECTION ISSUE (did not receive a full second vaccine dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PAIN IN EXTREMITY (left arm painful) and UNDERDOSE (did not receive a full second vaccine dose). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (did not receive a full second vaccine dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (left arm painful), UNDERDOSE (did not receive a full second vaccine dose) and DEVICE CONNECTION ISSUE (did not receive a full second vaccine dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include inhaler, Action taken with mRNA-1273 in response to the event was not applicable.
within 30-45 minutes of leaving clinic patient was on his way back to school (driving) when he called me and said he was having trouble breathing and it felt like he had a cement block on his chest.  I told him to pull over and park his car and shut it off.  I drove to him and picked him up and took him back to the clinic.  They observed him for about 30-45 minutes and told us to go home if symptoms got worse take him to the emergency room.  Patient stayed home from school all day, didnt feel good
no adverse event; incorrect product storage/ temperature excursion; This spontaneous report as received from a Medical assitant, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-OCT-2020 the patient was vaccinated with the patinet was vaccinated with an improperly stored dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S031287 with expiration date in 08-APR-2022 (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis, however no adverse effects reported.    The vaccine administered was stored at temperatures that went to 47.7 F for a time frame of 20 minutes. It was not recorded by a data logger. There was previous temperature excursion of 47.1 F. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S031287; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt developed redness and warmth on her left arm.  It was looking lighter today per father.  Afebrile.  Pt received PCV13 in that arm.  Site measured 2.5 in x 2 in.
Vomiting, headache and body aches.  Patient was seen by telehealth on 7/3/20.  Zofran was called in.   Patient was back to normal on 7/4/2020 according to Dad
Patient said she had a small local reaction (red and swollen) which has gotten much larger in the last 2 days. The swelling appears to cover about 5 inches of her arm now.
4 hours started to feel weak, tired, heart felt heavy, had a hard time catching my breath and progressively was getting worse.  Stayed in bed, the first day and all day the second day, by the third day finally got up and went to work, still tired, weak etc. but thought it would go away, it was just a side effect from the injection which I was told would happen.  At work walked about 200 yards and literally couldn't breathe, heart beating very fast and at that point knew something was terribly wrong and went to the doctors.
Within an hour of the immunization patient developed tingling of the bilateral hands and the feet, vomiting as well as the development of significant headache. He was then seen in the emergency room and noted to have asymmetric neurological testing which then warranted further evaluation as noted.  He was given ibuprofen and acetaminophen for headache symptoms. Symptoms resolved by the end of the day. Injection sites were not noted to have any redness or swelling or have significant pain located in the areas.
1st injection: symptoms started 4 hours after first dose.  Flu symptoms. Extreme exhaustion. brain fog. 2nd injection: symptoms started almost immediately.same as above. plus left arm injection site still very sore EVEN TODAY. 2 1/2 months later; 6 out of 10. Extreme exhaustion. woke up next day with 105.8 fever. Took tylenol and ice bath as I had no one to drive me and I could not drive. within 2 hours temp down to 102.  temp remained at 101-102 two more days. since the 2nd injection, i have had bad balance problems which limit my usual activities. i have fallen while exercising. this has been constant since the 2nd shot. i feel like I am on a boat, and rocking all the time. i also have a severe sinus infection, which my doctor treated with steroids, amoxicillin with augmentin; I went to a walk-in when those were done (dr was away) and received pseudoephedrine--that made me drain a lot but the wall of snot behind my face did not go away. Back to my doctor, he gave 1 more round of antibiotics (doxycycline this time) but the exhaustion, the balance isuess, and the congestion in my head, behind my head persist
NURSE WAS DISTRACTED AND GAVE THE VACCINE VIA IV ROUTE, NOT IM.  AFTER THIS WAS REALIZED, SHE NOTIFIED THE MD WHO SAID TO GIVE ANOTHER DOSE IM.  SO PATIENT GOT 2 DOSES OF BOOSTRIX ON 4/25/22.  NO ADE WAS NOTED PRIOR TO DISCHARGE.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 03-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route of administration were not specified; lot # L019287, expiration date on 14-SEP-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Gout systems in right foot....pain, redness , warm to touch, unable to walk on foot without severe pain
Pt presented to Er w/fever 103.7 given Acetaminophen suppos @ 1040PM  temp @1130PM was 102.6;