chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date the patient was vaccinated with GARDASIL (dose, strength and route was not reported). NO concomitant medication was reported. Physician reported that the patient was administered the third dose of GARDASIL series four weeks earlier than recommended in current prescribing information. No adverse events were reported. The outcome of patient was administered the third dose in GARDASIL series 4 weeks earlier than recommended in current prescribing information was unknown. No PQC was involved. No further information was reported. No PQC was involved. Additional information has been requested.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 5 year old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 04-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Returned to clinic 5/29/09 with 1 day of body, joint aches, radiating up from legs, associated with low grade fever.
Slight swelling of the back of the throat and tongue. I waited 30 minutes and was able to leave to take a Benadryl for the swelling. 15 minutes later I coughed a couple of times and then felt my throat constrict and had a hard time swallowing. My breathing became labored so I used my emergency inhaler and while trying to use my inhaler I started coughing and could not stop. Hard coughing. I work at a school that has a nurse on site and she helped the front office stabilize me after 30 minutes of coughing and not being able to swallow well. My pulse ox got down to 90 with a pulse of 122. I had a rash covering my throat and chest. I did take a Benadryl as well. An ambulance was called but by the time they got there the coughing was slowing down and my throat was opening back up. I was sent home to rest.
Rash on scalp; Rash around injection site; Flu like symptoms after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after second vaccine), VACCINATION SITE RASH (Rash around injection site) and RASH (Rash on scalp) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after second vaccine). On 07-Mar-2022, the patient experienced VACCINATION SITE RASH (Rash around injection site). On an unknown date, the patient experienced RASH (Rash on scalp). In November 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms after second vaccine) had resolved. At the time of the report, VACCINATION SITE RASH (Rash around injection site) and RASH (Rash on scalp) was resolving.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient received 2nd Moderna vaccine on Friday, March 5.  The next day, Sat. March 6, he started getting nauseated with a temp of 101.  Didn't eat all day.  This morning,  March 7, he said he felt better and slept well.  I fixed him a bowl of oatmeal.  He took one bite and said he couldn't eat anymore.  All of a sudden he appeared to fall into a state of unconsciousness and could not respond to anything I said.  I tried to shake him with no results so I decided to call 911 and when they got here he came around a little and said he didn't want  to go to the hospital.  Still not eating and just wants to sleep.  He is 88 years old.  I am the same age and had no adverse event (yet).
Eight days after the vaccine, the arm in which I received the vaccine became swollen, red, hot, and itchy.  "Covid arm" I put Benadryl cream on it to stop the itching, and the symptoms disappeared after three hours.
screaming & crying on & off for 24hr;restless-no sleep;poss 2hr sleep from noon 21MAY97 to 10AM 22MAY97;axillary temp of 101.0;afeb since 4AM 22MAY97;
pt recvd vax & immed started screaming & shaking; seen in MD ofc 2 hrs later; irritability & fever of 102.7; exam nl; dpt rxn ?
Dizziness; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CHILLS (Chills) and VOMITING (Vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, DIZZINESS (Dizziness), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were not reported  The treatment information was not reported.
"Sick for a few days"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Sick for a few days") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("Sick for a few days"). At the time of the report, VACCINATION COMPLICATION ("Sick for a few days") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
I had the vaccine and after 3 hours I was exhausted, I was confused, couldn't think through, fever, swelling on my arm. I slept all night long until the next day and I had like flu like symptoms. In that period my husband tried to woke me up and I would eat something but it felt like I was in a dream, I felt like a zombie. For about a week after I was sick but not sick to not go to work . I had swelling on my neck, clavicle, and armpit, they were obviously lymph nodes. I was thinking about cancer because my dad died of Cancer. I made an appt with a doctor for a cancer check instead of going for the covid. Which after about 15000 tests I am cancer free. I found out that those symptoms could actually be part of the vaccine. They took a good look at it and order some tests and they said it was a reaction to an infection and I told them I had just had the vaccine and they did some tests and they said it was most likely the vaccine. After 2 weeks the lymph nodes started to go down. After the second shot I had the same symptoms but not as intense.
area of injection very red, swollen, getting out of bed very difficult as body was stiff, chills, headache. Almost same symptoms as having Covid 19. These are the same symptoms I had when I had Covid in Dec.
Pt. tested positive for SARS-CoV-2 on 2/3/2021 and required hospitalization for associated diarrhea and dehydration with mild acute kidney injury. Of note, he has not been hypoxic and has not required supplemental oxygen to maintain his SaO2 as of 2/6/2021.
Received (2nd) injection of Moderna COVID vaccine, about 8:30am. Left Pharmacy, drove 1/4 mile to convenience store, to obtain breakfast. Drove 1/2 mile to clinic for scheduled appointment. Arrived approximately, 9:05am. Took seat, outside clinic, to await COVID screening. Nurse asked "How are you feeling?" I replied. "Not too good. Then I fell out of my chair. I awoke in Regional Medical Center, four days later. I had suffered, as my cardiologist put it, a "vaccine induced myocardial infarction". I am still attempting to recover.
reconstituted vaccine a significant portion of the substance sprayed from the stopper; reconstituted vaccine a significant portion of the substance sprayed from the stopper into face; reconstituted vaccine a significant portion of the substance sprayed from the stopper into eyes; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: reconstituted vaccine a significant portion of the substance sprayed from the stopper), exposure via skin contact (Verbatim: reconstituted vaccine a significant portion of the substance sprayed from the stopper into face), exposure via eye contact (Verbatim: reconstituted vaccine a significant portion of the substance sprayed from the stopper into eyes) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, exposure via eye contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter reported that a leaky vial of Shingrix lyophilized antigen component vial.  The reporter confirmed that all operations were performed appropriately before defect was discovered.  The step was the defect discovered during reconstitution. The mixing/shaking was performed after reconstitution that was gently and while swirling the vial. The reporter stated that when this occurred it sprayed him in the face and eyes.  The vial was held upside-down when the vaccine is being withdrawn. Never able to withdraw vaccine. The product was not administered or partially administered. The healthcare professional preparing/administering vaccine was an experienced user. The lyophilized antigen component vial. The customer did not inject air from the syringe into the vial during preparation. The leak was coming from the rubber stopper. The vial rubber stopper/metallic skirt not detached or became loosen during handling or without any manipulation. The customer only removed the plastic flip-off before handling. There was no any evidence of leakage in package or carton (e.g., wet PIL or faded label). The agent requested return of both the adjuvant and antigen vial for each dose related to the product complaint and the original packaging without further manipulation/handling.  The reporter did not consent to follow-up. During reconstitution of Shingrix, while gently swirling the vial containing the reconstituted vaccine a significant portion of the substance sprayed from the stopper, which led to occupational exposure while preparing product for administration, exposure via skin contact and exposure via eye contact.
Patient's daughter called to report patient was experiencing hives on trunk and face with extreme itching. Stated the only new thing was the SHINGRIX shot, and the reaction began approximately 48-72 hours post exposure. Patient's daughter stated she had used hydrocortisone cream, pharmacist on duty (not the one who administered) recommended oral BENADRYL and cold compresses. Recommended going to ER if developing systemic symptoms such as itchy or closing throat.
This initial non-serious spontaneous case was received on 23-Oct-2017, from a pharmacist, concerning a male patient of unspecified age. This refers to fifth out of 06 reports. The patient had no relevant medical history and concomitant medications. On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular, anatomical location: left deltoid). It was reported that, the vaccine was at a maximum temperature of 55F overnight and it was administered. The pharmacist stated that the refrigerator was at 40.6 f last night but that morning the temperature was 55F and that was the first-time excursion. Follow-up received on 27-Nov-2017: Added gender of the patient, route of administration and anatomical location. The narrative was amended accordingly.
5/10 71-year-old female with a past medical history of type 2 diabetes, CAD status post stents, defibrillator placement, stage III CKD, COPD, who presents with flank pain.
Tightening of throat, about 45 minutes after injections. Not anaphylaxis. Resolved about 2 hours later without assistance. Low grade fever (~100.9 at peak) - 9:30am-4:15pm next day (5/8/2021). Seemed to break around 3pm. Took Tylenol at 4:15pm on 5/8 (24 hours after vaccination) Headache - 9:30am-4:15pm next day (5/8/2021). Managed with Peppermint oil until 4:15pm. Got rid of it with Tylenol at 4:15pm.
Arm throbbed night after receiving vaccine.  Body aches and slight fever through that night and lasted 36 hrs.  Arm is still warm, tender, and sore on Saturday evening the 13th.  Took ibuprofen a few times but mostly let it run its course.
Information has been received from a physician, concerning a 10 year old female patient with no pertinent medical history and no known allergies, who on 11-OCT-2007 was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not reported).  There was no concomitant medication.  On 11-OCT-2007, following the vaccination (time to onset not specified), the patient experienced dizziness.  She was seen by the physician (details not provided).  After an unknown duration of time, she recovered.  Additional information has been requested.
Erythematous, warm area 7.0 x 6.5 cm 5 hours post vaccination of IPV and DTaP.
Three tonic clonic seizures one day post vax. The first 2 were very short. Mother was not sure. The 3rd was full tonic clonic lasting 40 seconds. Pt experienced another two, 2 days later. Pt is now taking phenobarbitol.
Headache; Burning eyes; Slight sore throat; Achy; Tired; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 09:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and overweight. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR) from an unknown date for an unknown indication and was unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Feb2021 at 10:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. On 14Mar2021 at 10:00, the patient experienced headache, burning eyes, slight sore throat, achy and tired. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, burning eyes, slight sore throat, achy and tired was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Within 24 hr of YF vaccine developed achiness. 48 hr after vaccine had pain and bleeding from both ears, low grade fever. Next day saw internist, referred to ENT doctor had bilaterally perforated eardrums, Rx with antibiotics and steroids.
Vasovagal reaction. Has a history of fainting with blood draws. Patient alert, oriented and left event on own accord. VS stable
Chills, temp 99.9, body aches, soreness at the site.. After 3 days it went away.  Left arm is still weaker than right arm. Generally tired. Flu like symptoms.
Severe pain in lower right abdomen; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetes and asthma. The patient was allergic to some antibiotics. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 20:00, the patient experienced severe pain in lower right abdomen. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severe pain in lower right abdomen was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Memory Loss; Loss of smell; Loss of taste; Cold Chills; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory Loss), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), CHILLS (Cold Chills) and HEADACHE (Bad headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-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 AMNESIA (Memory Loss), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), CHILLS (Cold Chills) and HEADACHE (Bad headache). At the time of the report, AMNESIA (Memory Loss), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), CHILLS (Cold Chills) and HEADACHE (Bad headache) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided by the reporter.
pt desaturated to 30%, no resp effort, heart rat dec 90-100BPM; this happened 3 times; 02 inc; physical stimulation just prior to CPR;
"... I felt a prickle across both arms. It was scattered like having metal shavings in the sleeves, and almost instant and want away.  Shortly thereafter, i tased metallic on the left side of my tongue,  followed by a tingle, as I was coming out a novocaine shot."  Which all resolved.  The next day he has some lightheadedness and reports forgetting things.
got really sick; had to be in bed for a whole week.; she is allergic to the Moderna shots; got a rash; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week.), ALLERGY TO VACCINE (she is allergic to the Moderna shots) and RASH (got a rash) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (amoxicillin) and Lactose intolerant.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-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 ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week.), ALLERGY TO VACCINE (she is allergic to the Moderna shots) and RASH (got a rash). At the time of the report, ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week.), ALLERGY TO VACCINE (she is allergic to the Moderna shots) and RASH (got a rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The patient went to office visit.   This case was linked to MOD-2022-555530 (Patient Link).
Symptoms started middle of night. 2am woke up to shivers, fever, headache, body aches, nausea and vertigo. Went to bathroom because of nausea and passed out. Woke up in tub. Continued to shiver, fever  for remainder of night. Restless. Fatigue faded around 8am. Nausea remained till 4pm on 2/4/2021
Headache, Fever, Pain in Extremities, nausea/stomach upset, weakness
Frontal headache began day of first dose of GARDASIL vaccine (05-02-2007) - Neurologist consulted 07/2008 after headache continued daily/constantly x over 1 yr - Neurologist states likely migraine cycle triggered by HPV vaccine - Condition now worsened to debilitating status for several days in a row. 5/12/10 Follow up: Residual migraine headaches with syncope and neurological signs.  1/21/2009 MR received from neurologist. Pt seen for several visits between 11/17/08 and 12/10/08 in f/u for Classic migraine. Seen 11/17/08 for migraine h/a sx which began 6 days prior including nausea and visual disturbance. ROS (+) for fatigue, blurred vision, eye pain, photophobia, dizziness, tachycardia, acid reflux sx of heartburn, nausea and vomiting, back pain, ataxia, confusion, fainting, headaches, memory loss, paresthesias, speech disorder, tremors, vertigo and weakness.  PE WNL. DX:  Classic migraine.  F/u 11/20/08 with no relief of sx-still with global H/A and nausea. Recent syncopal event with ER visit.  ROS now includes tinnitus, tooth pain, limb pain, myalgias. Tx with steroid, promethazine and dyphenhydramine.  F/U 12/10/08 Migraine now resolved.  ROS (+) for unintentional wt loss. On multiple meds.  1/29/2010 Chronic headache-migraine.
Experienced headache, fever, chills and anorexia x 6 days. Was instructed by her primary care MD to notify me as a vaccine adverse event.