chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid; she did not have any taste for two weeks; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EM9809; Expiration Date: Jun2021), via an unspecified route of administration, administered in left arm on 09Feb2021 (at the age of 74 years) as 1st single dose for COVID-19 immunization. Medical history included pulmonary fibrosis from 2015 and it was ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021, after vaccination the patient tested positive for COVID and she did not have any taste for two weeks in Feb2021 (date unspecified). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Feb2021. The patient received antibody infusion as treatment for event on 12Feb2021 and she thought it was the monoclonal. The patient was scheduled to receive the second dose on 02Mar2021 and enquired if it was safe to take it or does she need to it put off until she has been COVID free for 3 months. On 28Feb2021, the patient recovered from events.  No follow-up attempts are possible. No further information is expected.
Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: pt's eyes rolled back in head, went limp, fainted-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Pt is very phobic concerning shorts, high anxiety, I accidentally hit a vein when giving shot, applied pressure to stop bleeding & applied cold pack for swelling - hematoma at site of inj. when pt started to feel worse, called ambulance and when pt fainted, layed her on floor and put feet up and pillow under head, by time ambulance arrived, pt coming around, talking, squeezed my hand, they checked all vitals and all good
high pitched screaming, unconsolable crying, fever 105, loss of muscle tone, complete paralysis (neck down); depression of consciousness; MD's office denies this was a react to vax, & gave post vax dx of pneumonia;
No adverse symptoms or outcome. There was an administration error.  The patient was 17 years old and 8 months.  The vaccine is only approved for ages 18 and older.  He was a Health Care Associated Worker and sent to our vaccination event by his employer.  He will not receive the 2nd dose at this time.  Our processes should have prevented this error, however, we have now implemented additional processes to prevent this error in the future.  (We have added to our pre-COVID checklist, "Are you at least 18 years old?"). We have also created a training video for our employees involved in vaccine registration that emphasizes checking date of birth. Of note, patient had no noticeable side effects from the vaccine.
I became very weak and had difficulty breathing. The feeling lasted for several hours. Later in the evening, I had heart palpitations.
Fever, chills, myalgias, arthralgias, fatigue. Injection site pain
Initial unsolicited case received from a consumer (patient himself) on 17 Nov 2016. This case involves a 70 year old female patient who was vaccinated with a second dose of FLUZONE HD (Batch number: UI636AB, Expiry date: 27 Mar 2017, route of administration was not reported) in arm right site on 06 Sep 2016. The patient illness at the time of vaccination was reported as none and the patient had allergies to dust mites and ragweed, asthma and aortic valve leak, the patient was previously vaccinated with Fluzone HD one year before, and the patient any other vaccinations within four weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 06 Sep 2016, few hours after vaccination the patient right arm began to feel pain at the injection site and was painful for approximately one week and a week after receiving the vaccine the injection site began to itch and the patient stated that the itching is constant and on an unknown date the patient stated that when her arm is warm, the itchiness increases in intensity, and the patient stated there is nonvisible rash at site. The patient required emergency room or doctor visit. (Reported as she is making an appointment to see her physician) The patient lab tests were reported as none. The patient had taken Benadryl for the itching, and applies cortisone cream alternating with gold bond cream with lidocaine, and applies ice to the area. These methods give her temporary relief. The outcome of the events were reported as unknown. List of documents held by sender: none.
Sudden onset severe throbbing HA, photophobia, hyperacusis, myalgias, shaking chills tx with IV fentanyl, BENADRYL, ketorolac and IVFs.
Syncope- a year after the second dose was given.  The patient fell and hit his head.  One physician noted it was likely due to a pill being stuck in his throat.
Initial and follow up information has been received from a health professional and a physician concerning a 27 year old male student with no past medical history, who on 11Aug04 at 2:15PM was vaccinated IM in the left deltoid with the first dose of the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot 646124/0615N). Concomitant therapy included hep B virus vaccine rHBsAg (yeast) in the right deltoid. On 23Aug04 (previously reported as 26Aug04) the pt developed a widespread rash which was itchy. The red papular rash was reported to be all over, including the face and right postauricular LAP. The pt also reported experiencing a mild fever and swollen lymph nodes. The pt was diagnosed with German measles. The pt was seen by a dermatologist and subsequently recovered in Sept 2004. The German measles was considered to be an other important medical event (OMIC). No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly female patient who received SHINGRIX for prophylaxis. Concomitant products included amlodipine, acetylsalicylic acid (Aspirin), gabapentin, thyroxine sodium (Levothyroxine), metolazone, guaiphenesin (Mucinex), docusate, dorzolamide, apixaban (Eliquis), hydralazine, furosemide (Lasix), latanoprost, metoprolol and repaglinide. On 7th June 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 7th June 2018, less than a day after receiving SHINGRIX the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX was given in right arm. The patient planned to follow-up with her physician on an unknown date.
Severe left shoulder/arm pain, long-lasting. Severe pain happened a few days after initial shot. Severe pain to the point where I cannot lift my left shoulder or use my left arm to reach for anything or carry anything with any weight. I cannot lay on my left side either.
Pt received Tdap and Hep B. Approx 5-6 mins post immunization pt c/o headache, became diaphoretic. Laid pt down on cot. BP 120/80 P84 resp 16. Pt c/o heart beating hard, blurred vision. Had seizure type activity for 3-5 seconds. 911 called and military rn called. pt cont with headache and blurred vision. Pt was up and walking around an hour after.
Pt was given PNEUMOVAX 12-11-12; on 12/12/12 he was seen for redness, pain & localized swelling at site.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", COVID-19 (medically significant), outcome "recovered" (18May2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Body temperature: low-grade; SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: [product=COVID 19 Treatment, brand=Paxlovid, treatment start date=13May2022, treatment stop date=17May2022}. From Paxlovid - had "rebound" symptoms (congestion and low-grade fever) and positive test a few days following negative home test and no symptoms. This was 6 days after finishing 5-day Paxlovid. This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for a lack of effect in a vial of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled, and packaged by Pfizer. The final scope was determined to be lot 30155BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior to any lot being released to the market.
Sweaty; Threw up; Lethargic; Fever; Chills; This is a spontaneous report from a contactable consumer (parent). A 12-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date: unknown), via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration on unspecified date for COVID-19 immunization. On 05Jun2021, the patient received the vaccine in the morning and developed a fever and had chills. The patient was given Tylenol before bed around 21:00 and he woke up sweaty and threw up around 03:30 (on 06Jun2021). The patient went back to bed and woke up Sunday (06Jun2021) with a fever of 100.2 and was lethargic but in good spirits. The patient underwent lab tests and procedures which included body temperature: 100.2 on 06Jun2021. Therapeutic measures were taken as a result of fever and chills. The outcome of the events was unknown.  Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible. No further information is expected.
Initial report received from a consumer, who is also the patient's mother, on 14 August 2014. The following is verbatim from the report: "I lost my son at year and a half. But after 10 months. After he got the meningitis enoculation. He became brain dead blind dead outward posturing constant seizes. Gastrostomy tube and a shunt in his brain. Shot was what killed him. Panhandlers health." No further information was available at the time of the report. The patient outcome was fatal. Documents held by sender: None.
This spontaneous report as received from a registered nurse refers to a 4 month old female patient. Pertinent medical history, drug reaction or allergies were denied. On 04-OCT-2013, the patient was vaccinated with ROTATEQ dose 1 (concentration, route and lot # were not reported). On 02-JAN-2014, the patient was vaccinated with ROTATEQ dose 2, 2 ml, oral, lot# J008383, expiration date: 28-NOV-2014. None concomitant medication reported. On 08-JAN-2014, six days after receiving the second dose, the patient experienced intussusception. On 08-JAN-2014, the patient was admitted to a hospital. The nurse stated that the patient had an ultrasound, stool culture and unspecified labs during her hospital stay (results were not reported). On 09-JAN-2014, the patient was given a barium study and the results showed "no reoccurrence". 48 hours after admission, the patient was discharged from the hospital. On 10-JAN-2014, the patient was seen in the doctor's office and the nurse stated that the patient's stool were back to normal and that she was back to eating. On 10-JAN-2014, the patient recovered from intussusception. Causality was not reported. Additional information has been requested.
Pt had MODERNA (COVID19) Vaccine 5/8/21; went over VAR questions, administered vaccine, pt was asked to wait for 15 minutes for monitoring. Pt reported feeling faint, dizzy, sweating and went pale. Laid him on flat surface. Pt was responsive and breathing. Called 911 immediately
REPORTER: The other morning the day after the vaccine I woke up the next morning I had water blisters around the injection site looked and felt burnt, still having symptoms till the elbow, with a burning feeling with blister and a brown burnt looking skin. Went to the doctor today and doctor prescribed me antibiotics. Was not able to work due to the arm pain and the burnt feeling symptoms.
Started with a cramp feeling next to my left shoulder blade, Then the feeling moved up my left side of my neck (like I had slept wrong) and began giving me a headache. Because of this, I was getting nauseous and fever spikes. Then about 3:30am, I had water like diarrhea. After that, I started to feel dizzy (I was fine as long as I still) with cold chills along with being very tired.  When I got home, I took some Ibuprofen and took a nap (4 hour nap). Began to feel much better. When I woke up, I felt better but still had a stiffness in my shoulder blade area and left side neck.
Approximately 5 minutes after vaccine patient had a suspected stroke.  Patient was in observation area and reported right side weakness, facial droop and slurred speech.  Patient was attended to by EMS service and transported to a local hospital.
Flu shot given 12-18-13 (L) deltoid. Patient reports on 19th midday she noticed site was sore and a circle area swollen and slightly red. No treatment. 12-20 injection site - 40 mm circle - slightly raised and red, warm to touch. Advised by NP to take ZYRTEC and apply ice. 12-23-13 site fully normal - Patient said it was gone by next day.
Lip swelling at site of previously administered HA filler; This is a spontaneous report from a contactable Physician. A 25-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via intramuscular on 10Feb2021 16:30 as single dose for covid-19 immunisation. Medical history included previously administered HA filler from 26May2020 to an unknown date (had Restylane Silk injected in lips 26May2020). There were no concomitant medications. Historical vaccine included first dose of BNT162B2 via Intramuscular on Jan2021 for covid-19 immunisation. Other vaccine in four weeks and other medications in two weeks reported as none. Patient did not have covid prior vaccination. Patient did not test for covid post vaccination. The patient experienced lip swelling at site of previously administered HA filler on 11Feb2021 04:00 PM. Patient did not receive treatment for the adverse event. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Arm was red size of palm; Arm was hot; Arm was itchy; Arm was hard; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red size of palm), FEELING HOT (Arm was hot), PRURITUS (Arm was itchy) and INDURATION (Arm was hard) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm was red size of palm), FEELING HOT (Arm was hot), PRURITUS (Arm was itchy) and INDURATION (Arm was hard). At the time of the report, ERYTHEMA (Arm was red size of palm), FEELING HOT (Arm was hot), PRURITUS (Arm was itchy) and INDURATION (Arm was hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.
Pt recv vax on 11/24/97; 2 hr later pt exp fever (103F) &somnolence; tx=Children's Tylenol.
Information has been received from a nurse concerning a 17 year old female with a history of allergies and reactive airway disease (RAD) who on 29-AUG-2007 was vaccinated intramuscularly in the left deltoid with her first dose of Gardasil (lot# 658556/1060U).  Concomitant therapy included MENACTRA (lot #U2379BA) intramuscularly in the left deltoid.  On 08-JAN-2008 the patient was vaccinated intramuscularly in the left deltoid with her second dose of Gardasil (lot# 659435/1265U).  On 08-JAN-2008 the patient was concerned that she had no menstrual period since last summer prior to the first dose of Gardasil.  She had had a couple times with 1 day of "dark spotting."  Periods were irregular prior to the vaccination, but not this far apart.  On 21-JAN-2008 the patient was again seen in the office and still no period.  She was referred to a GYN and for a pelvic ultrasound.  On 17-JAN-2008 the patient had a pelvic ultrasound.  Also the patient's HCG was negative.  On the day of vaccination, 08-JAN-2008, the patient was having reactive airway exacerbation.  The patient's outcome was not reported.  Additional information has been requested.
Pt presents to the clinic (10/24/23), states that she got rash on the left arm 3 hours after flu vaccine on 10/13/23 at hospital.  Patient states that the rash is itchy and like patchy , and appears at different area of the body over the course of 10 days since the vaccine received. Patient took 1 dose claritine with no relief, and calamine lotion that seems works better. Patient denies of tongue swelling or shortness of breath.  Patient is prescribed with solumedrol pack, and benadryl 25 mg p.o every 6 hours as needed for itch. Patient is advised to continue with calamine lotion and follow up with PCP or UC if symptoms worsens or persists.  Follow up call also is placed in the next few days.
Patient received flu shot yesterday morning and reported to us this afternoon that she has red/raised slightly itchy spot where shot was given.  Slight hot to touch.  Assessed and reccommended to put ice packs on and keep and eye on.  To report any changes to HC provider/ED if necessary.
I asked if there was any swelling or redness at the injection site and she said no.  Patient states that she had an overall body rash 24 hours after the vaccine that looked more live hives. She said she took benadryl and that helped significantly. Patient states hives have diminished with the passing of each day.  I suggested she take a second antihistamine such as Zyrtec or Claritin during the day and she said she would.  Will follow up with patient to see how she is doing in 24 hours.  She was not sure if it was the vaccine or if it was something she came across that caused her to have an allergic reaction.
Vomited, feels warm B/P 114/80 T99:-82-16 1415 vomited x II. 1505 home with mom.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after first dose), FATIGUE and PRODUCT DOSE OMISSION ISSUE in an 82-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Stroke (occurred last year). Concomitant products included AMLODIPINE, ATORVASTATIN and METFORMIN for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after first dose). On an unknown date, the patient experienced FATIGUE (Feeling tired) and PRODUCT DOSE OMISSION ISSUE (Over 42 days from first dose). At the time of the report, COVID-19 (Tested positive for COVID-19 after first dose) and FATIGUE (Feeling tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Over 42 days from first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.
may 18th I notice small bumps on my upper right ribcage under my arm. three days later the bumps had grown in size and hurt went to doctors office and was told I have shingles.  I have been given oral meds for shingles.
I had some right ear pain, I made an appointment to go in and see an ENT. He examined my ear did not find that I had an infection. He gave me steroid ear drops that I am not completely sure if they have helped or not as I had been taking Augmentin earlier.
I have received 5 shots for vaccination against Covid -19 (2 Moderna Vaccines 2 Moderna Boosters, and 1 Pfizer-BioNTech Bivalent Booster). After the first Moderna booster on 9/1, I developed hypertension a few weeks later. After each additional booster listed below, the hypertension was destabilized and I needed, with each booster, additional hypertensive drugs. My doctors was informed and I needed to see a cardiologist to help with the medications and dosages. This only happened after each booster.  Second Booster: Moderna, 5/18/22, Lot# 005M, Intramuscular, Arm Side Unknown Third Booster    : Pfizer-BioNTech Bivalent, 10/21/22, Lot# GJ6739, Intramuscular, Arm Side Unknown