chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At approx. 1155, pt  reported dizziness and blurry vision. pt assisted into anti-gravity chair. Pt  was diaphoretic and nauseous.  Pt stated dizziness and  nausea "comes in waves". At 1156 vitals assessed. BP 102/60 mmHg, and PR 60 BPM. Pt reported no history of reactions to prior vaccinations.  BP reassessed at 1230. BP 108/72 mmHg. Pt refused transportation. At approx. 1231, pt left facility with steady gait and unlabored breathing.
Headache, Myalgia, local pain/swelling at injection site, fatigue Narrative:
Received Varivax on 3/21/2006. Seen in office 4/1/06 (had broken out with chicken pox 3/31/06) for cellulitis put on clindamycin 75mg TID. Seen in office 4/2/06 referred to hospital for incision and drainage. Admitted with D of left suprapubic abscess and right flank abscess. Cultured out MRSA. IV Clindamycin. Discharged 4/5/06 on oral Clindamycin x 10 days.
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 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 12:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 53.72  for dose administered on 03-APR-2021. No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-APR-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-MAR-2021and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-APR-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 brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
VACCINE EXPOSURE DURING 24 WEEKS OF PREGNANCY; TERRIBLY SICK/GENERALLY FEELING SICK/UNBELIEVABLY SICK; ACHES; FEVER; EXHAUSTION; WEAK; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of reporting. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during 24 weeks of pregnancy, terribly sick/generally feeling sick/unbelievably sick, aches, fever, exhaustion, and weak. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, exhaustion, weak, vaccine exposure during 24 weeks of pregnancy and terribly sick/generally feeling sick/unbelievably sick was not reported. This report was non-serious.
Numbness over my whole body.  I have CIDP which is the chronic version of Guillain Barre Syndrome.
on 2/8/22 at ambulatory care clinic: NAUSEA/VOMITING HYPOXIA, RELATIVE HYPOTENSION Ambulatory de-sat to 86% and 24h GI and constitutional symptoms concerning  for COVID v Flu v other illness - sent to ED for further workup.  Tested positive for covid and admitted to inpatient Family Care Unit for 4 days. Discharged to home.
THERE IS ACTUALLY NO KNOWN ADVERSE EVENT YET, BUT THE PATIENT RECEIVED THE 1ST DOS OF MODERNA VACCINE AT OUR STORE. WIFE CALLED TODAY AND SAID THAT THEY RECEIVED THE FIRST DOSE OF PFIZER ON 04/20/2021. THE PATIENT APPARENTLY DIDN'T REMEMBER  THAT HE HAD PREVIOUSLY RECIEVED A DOSE OF THE PFIZER VACCINE. ADVISED PATIENT TO CALL DOCTOR AND ADVISE SO HE CAN DETERMINED WHETHER HE SHOULD STILL RECEIVE 2ND DOSE OF PFIZER WHEN SCHEDULED.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  Vial was punctured on 11-Nov-2021 and kept in refrigerator after puncture.   This case was linked to MOD-2021-418964 (Patient Link).
1:45pm- Vaccine administered, metallic test in mouth for a couple of hours.  10:00pm- Pain, swelling, rash at injection site and took 600mg of ibuprofen.  4:00pm- pain, swelling worsens and took 600mg Ibuprofen with full glass of water.  9:00am- chills, stomach upset with nausea, extreme arm pain and took 600mg of ibuprofen.  10:00am all symptoms except arm pain resolve.  2:00pm-fever,  chills, stomach upset with nausea, extreme arm pain returns and took 600mg of Ibuprofen and 25mg of diphenhydramine with 2 glasses of water.  Symptoms persist the rest of the day.  Took another 600mg ibuprofen and 25mg diphenhydramine at 11:00pm slept with heating pad on arm all night long.  4:00am- fever broke, woke up drenched in sweat.  8:00am only symptoms were  arm pain and a headache and took 600mg of ibuprofen with full glass of water.  As of 3:00pm arm pain,  swelling and metallic taste in mouth only symptoms with no additional ibuprofen since 8:00am.
The day after the vaccination I woke up extremely dizzy and after several hours realized it was vertigo. I?ve had vertigo ever since.
Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of the vaccination. Day after vaccination I have fever, nause, joint pain, chills, and the pain in the arm persists.
pt recvd Tetanus toxoid vax inadvertently injected into the bursa; pt exp immediate pain; devel dec strength & ROM; also had MRI which showed mild to moderate rotator cuff tear & involvement of the supraspinatus tendon;
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a female student who experienced fever, headache, nasal congestion, swollen tonsilar glands, sore throat and vomiting.  The pt received a dose on 12/11/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  The pt experienced fever "subjectively higher over the weekend" than a temperature of 99.1 deg F on 12/16/03.  She also developed headache, nasal congestion, swollen tonsilar glands, sore throat and two episodes of vomiting on 12/13/03.  No additional information was available at the time of this report.
Taken vaccine and within 15 minutes pt fell from a sitting position to floor.  Within 3 sec pt was up on his own with other nurses from recovery assisting.  Pt was a/o x3. No physical wounds noted to pt.  Asked did he want to seek EMS for further care. Pt refused and stated that he felt fine. V/S obtained with b/p 124/82, HR 92 O2 98% on RA.  Denies any acute distress.  We asked pt to stay 15 more minutes he agreed.  1600 pt ambulated out of post vaccination with steady gait and a/ox 3.
injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; chills; nausea; diarrhea; site remains red swollen and little soreness area below injection site.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose in left arm (Lot number: EL3302) at 1.00pm on 20Jan2021 for COVID-19 Immunisation. COVID was not found prior vaccination. Medical history included hypertension. The patient's concomitant medications were not reported. Other medications were received in two weeks but not specified. The patient experienced injection site became red swollen and firm and warm within 24 hours of injection, chills, nausea, diarrhea and site remains red swollen and little soreness area below injection site. Treatment was not received. The outcome of the events was recovering for chills, nausea and diarrhea whereas not recovered for the other events.
Pt woke up feeling "room was spinning" the next morning and vertigo continued intermittently. seen by myself at clinic on 2/5/2020. Rx meclizine PRN. rest and fluids
Client call c/o redness, pain, swelling on her left arm. The redness start from the site extended under arm to above elbow about hand sized after 24 to 48 hours after administration.
Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side of neck... Then underneath my eye / crawl / felt strange like swelling. Then within 5-10 min my skin on left side of head crawl .... But ok within an hour. Only on left side. Also, no pain at all didn't even feel needle go in but had lump at injection site and painful when touched until Day 12.
Headache, Myalgia, Arthralgia, ARM REDNESS, CHILLS Narrative:
pt devel fever, severe muscle pain & pt unable to dress self or walkup stairs, diff swallowing & Raynaud's;pt seen by MD & biopsy of rash take;result of biopsy poss lupus;another MD dx mixed connective tissue disease,muscle;inc enzymes;
Administered Novartis H1N1 (4yrs and older) vaccine 0.25mL IM right deltoid - Should have given Sanofi Pasteur 0.5mL IM for ages 6 months and older.
PATIENT REPORTED HAVING SEVERE HIVES AFTER INJECTION.  THEY DID NOT APPEAR ON SAME DAY, BUT ON ONE OF THE FOLLOWING DAYS (HE COULD NOT SPECIFY). PT REPORTED THEY WENT AWAY AFTER A WEEK AND HE DID NOT "FEEL RIGHT" FOR ABOUT A WEEK AROUND THE HIVES.
Metal taste in mouth,frontal face numbness, extremely tired, began having chills, fever 102.4, headache
Vaccination site discoloration; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN CALCIUM and IRBESARTAN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient had itchiness and stated it was pink only 3 inches.
Severe arthritis and swelling in right hand, ring finger and wrist. Psoriasis on topside of both hands
Severe  joint pain in areas already associated with arthritis and DDD Headache  Elevated heart rate >120bpm Severe nerve stimulation over entire body -felt like hitting funny bone with no stopping -was given atavax x1each 25 mg dose and sent home from first ER visit after being told it was anxiety driven -symptoms returned 8 hours later which resulted in second ER visit-was prescribed 12 each 25 mg dose every 8 hours for three days. No follow on symptoms passed 5 days post vaccination
Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhausted) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Exhausted). At the time of the report, FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
This spontaneous report was received from a health care worker regarding an unspecified number of patients of unknown demographics. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD lot # L005297, expiration date- 17-AUG-2016. No adverse effects reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
7MAY93 pt recvd shot 2 days ago 7MAY93 this AM noticed rash/hives 2" from site below it, cressent shaped; tx cool compresses no itching noted; plans to take to MD today; rash devel on arm, leg mom also had rash; allergic type rash;
LEFT ARM PAIN W/ INCREASING REDNESS STARTING TODAY, 3 DAYS AFTER RECEIVING TYPHOID AND ANTHRAX VACCINE . ASSOCIATED SYMPTOMS INCLUDE MILD SWELLING, WARMTH TO TOUCH, NAUSEA, NIGHT SWEATS AND CHILLS. SHE DENIED ANY ADVERSE REACTIONS IN THE PAST.
This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The nurse reported that on unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M043310, expiration date 24-APR-2018; dose, route of administration, and frequency were not reported) for prophylaxis that were reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). The vaccine data logger measured a temperature range from 6°F to 14°F for a total time frame of 30 min. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA005229:
I tested positive for COVID - 19 on December 26, 2022. My symptoms started with cough and throat irritation, and then I had a lot of fatigue and elevated temperature (100.0). I has a decent amount of body aches and congestions, my eyes were also itchy as well as a elevated heart rate. Before I got diagnosed with COVID I had a sinus infection so I was taking amoxicillin abound the same time. I was also prescribed paxlovid. I ended up rebounding and didn't test negative until weeks later, I was more drained than before. I also have been dealing with post COVID fatigue.
1/3/22 pt in Medical Center for AMS; tested positive for COVID; hx of falls at home; NRB in hospital; dobhoff tube placed, but pt ripped it out; family decided on comfort feeding with comfort measures and hospice; 1/11/22 admitted to Hospice with dx COVID PNA; on O2 6 L via NC for SOB; pt found by nurse without a pulse or heart beat; expired in Hospice
Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient received a flu vaccine, then a few minutes later did not feel well and vomited twice. The patient then drank some water and laid down. They felt better after about 15 minutes and went home.
Diabetes type 2 after receiving my second dose of Covid vaccine; This is a spontaneous report received from a contactable Consumer (patient) for a Pfizer sponsored program.   A patient (no qualifiers provided) received BNT162B2 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes type 2 after receiving my second dose of Covid vaccine".  The Lot number for BNT162B2 was not provided and will be requested during follow up.
On 05/01/2022 I started with a runny nose, Monday I took the COVID-19 test because my sister called and told me they all had COVID-19 and we were all at the same event. I did a home test that was positive. And then I went and did a PCR, I called the doctor and told him I was positive and he ordered Paxlovid and I started it that night. On 05/04/2022 the PCR came back positive. I had very mild symptoms, no fever, just the runny nose and a little bit of a headache. I isolated for 5 days. On day 4, I was feelin fine, and I was over it.
This regulatory authority case was reported by an other health care professional and describes the occurrence of BACK PAIN (Back pain) in a 27-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Dec-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Aug-2022, the patient experienced BACK PAIN (Back pain) (seriousness criterion hospitalization). At the time of the report, BACK PAIN (Back pain) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details were reported. The worldwide unique id was reported as PH-PHFDA-300153509. No treatment medication details were reported. Company Comment: This is a regulatory case concerning a 27-year-old female patient with no reported medical history, who experienced the unexpected serious (Caused / prolonged hospitalization) event of Back pain which occurred approximately 7 months after receiving a dose of mRNA-1273 Vaccine, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a regulatory case concerning a 27-year-old female patient with no reported medical history, who experienced the unexpected serious (Caused / prolonged hospitalization) event of Back pain which occurred approximately 7 months after receiving a dose of mRNA-1273 Vaccine, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Dizziness; weak; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "weak"; HEADACHE (non-serious) with onset 25Mar2021, outcome "unknown", described as "Headache". Additional information: The patient was waiting to see if she had a reaction. After an hour, she got dizzy. The patient had a headache, dizziness, weak, and hard to get out of bed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days after receiving his first dose of the Moderna COVID-19 vaccine, the patient noticed a pink spotty rash all over his chest and shoulders. About two days after that (four days post vaccination), his rash had not gone away and had spread to his arms in addition to the chest and shoulders. The patient reported that the rash itched a lot and stung. As of March 7, 2021 (ten days post vaccination), his rash had still not gone away even with antihistamine treatment. The patient did report that it was looking and feeling a little bit better after the antihistamines, which he had been taking for a few days. (First, diphendydramine in the evening, then later, cetirizine daily and diphenhydramine each evening.)