chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; one patient received an improperly stored VARIVAX; This spontaneous report was received from a nurse, concerning to a 5-years-old patient of unknown gender. The patient's medical history, concurrent conditions and past drug allergies or reactions were not reported.  On 12-AUG-2019 and on 13-AUG-2019, varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine experienced two temperature excursions. On 04-SEP-2019, the patient received an improperly stored dose (product storage error) of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, schedule, anatomical site of injection, route of administration were not reported). Lot numbers R006221 and R029517 have been verified to be a valid lot of numbers for varicella virus vaccine live (Oka/Merck) with expiration dates on 29-FEB-2020 and on 14-OCT-2020 (reported as " 14/2020) respectively. It was reported that the vaccine was reconstituted with properly stored sterile diluent.  The reporter did not have the specific lot and expiration date administered to the patient, but it was one of two listed above.    The administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of -14 degrees Celsius to -10 degrees Celsius (-11.91 degrees Celsius) for 8 hours as recorded by a data logger. There was no adverse effect reported.  No product quality complaint was involved.
cold; body hurts; pain in both legs; had fever; tired; muscle ache; ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever) and FATIGUE (tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-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 started PARACETAMOL (TYLENOL) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever), FATIGUE (tired), MYALGIA (muscle ache) and ARTHRALGIA (ankle pain). At the time of the report, NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever), FATIGUE (tired), MYALGIA (muscle ache) and ARTHRALGIA (ankle pain) had not resolved.            Patient took Tylenol for her symptoms. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-065229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065229:First dose
Left arm turned red immediately after injection. Right arm turned slightly red after injection. Left arm redness spread outward. Ice packs given PO Benadryl given.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; REBOUND OF COVID AFTER 14 DAYS OF LAST INFECTION; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma ((from adolescence to young adult) occasional issues with coughing when sick), and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported,1 total administered on 20-DEC-2021 14:00 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-May-2022, the patient received paxlovid for treatment of Covid-19 that was last administered on 16-MAY-2022. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. On 04-JUN-2022 at 15:00 hours the patient experienced rebound of covid after 14 days of last infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, was recovering from rebound of covid after 14 days of last infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000235961.; Sender's Comments: V0. 20220630163-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Employee received rubella vaccine on 10/31/2005 on 11/08/2005 she stated that she began to feel like she had a fever and general malaise, also noticed tender lymph nodes left past neck and right upper chest area.
Moderna Covid vaccine arm (red round blotchy and itchy at the site of injection); itchy at the site of injection; a shooting pain (very quick) in collar bone on the left side; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (a shooting pain (very quick) in collar bone on the left side), RASH MACULAR (Moderna Covid vaccine arm (red round blotchy and itchy at the site of injection)) and VACCINATION SITE PRURITUS (itchy at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, ROSUVASTATIN, AMLODIPINE and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced BONE PAIN (a shooting pain (very quick) in collar bone on the left side). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the site of injection). On 17-Mar-2021, the patient experienced RASH MACULAR (Moderna Covid vaccine arm (red round blotchy and itchy at the site of injection)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Vaccination site reaction, at a dose of UNK, qd. At the time of the report, BONE PAIN (a shooting pain (very quick) in collar bone on the left side), RASH MACULAR (Moderna Covid vaccine arm (red round blotchy and itchy at the site of injection)) and VACCINATION SITE PRURITUS (itchy at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Redness, swelling, and itching around injection site started day after injection.  Symptoms abated after 6 days.
Pain at site, down arm and lost range of motion in arm. Visit - family Dr. (Wife has same reaction).
This spontaneous case was initially received on 25-Nov-2015. The case report was received from a Non Health Professional and concerns a 14 years old male patient. The patient received AFLURIA on 25-Nov-2015 - 25-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml and received a second dose on 25-Nov-2015- 25-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. On 25-Nov-2015, the patient accidently received two AFLURIA vaccines today. Reporter's assessment: Non-serious.
Nausea, "felt hot", light headed, dizzy, face tingling, elevated heart rate, rash to arm of injection site, soreness to injection site. Stayed for observation. Currently having on and off "hot flashes", and slightly light headed. Other symptoms have resolved.
Nurse inadvertently administered TETANUS and DIPHTHERIA TOXOID IV instead of IM. She realized her mistake before she flushed the line. Poison Center was contacted, they did not have any information on vaccines given IV, recommended to draw back blood from the line, hoping that the dose was never fully administered. Also recommended to monitor for phlebitis and anaphylaxis. Manufacturer-Sanofi Pasteur - was contacted, recommended that they have no clinical trials of the vaccine being given IV, so there are no recommendations regarding adverse events or immunogenicity of an IV dose of the vaccine. Recommended to contact our hospital's on call Infectious Disease specialist. ID was contacted, he recommended watching for fever. The patient is currently stable, experiencing no side effects - no fever, phlebitis, or anaphylaxis currently. We reported the event to the patient and will continue to monitor her while she is in the hospital.
ErythemaMultiform, UrticariaPruritus, delayed onset redness itching at vaccine site Narrative:
Covid shots administered at airport for employees.  I received shot, and within a minute or two- my lips and tongue started to tingle, swell and go numb.  My throat started to swell too.  Had a hard time starting to breathe and took my xopenex inhaler.  I had taken a benadryl beforehand, and ended up taking two more as EMT came over to  help me there at the site.  She kept an eye on me.  My A Fib was speeding up and getting irregular too.  After about half an hour, it stopped getting worse and seemed to level off.  They offered to take me to ER, and had me promise to call 911 if it got bad again.  Still felt bad the rest of the day.  Felt a little better later the next day, and a little better (today is day 3), but still not 100%.  I did contact my doctor to check in
At approximately 09:00 am on the 23rd day of January 2021 my ankles began to itch and I didn't think much of it. I began to scratch it trying it be gentle until I was able to get some hydrocortisone. The rash progressed quickly into what looked like "hives" with pink patches of raised puffy skin, with millions of little raised bumps, and quite a few fluid-filled blisters. By now I am very uncomfortable with my ankles and the tops of my feet are inflamed, the itch is too severe and the hydrocortisone is not working. I scratched my ankles in my sleep and I really tore them up. The infection continued to progress into the next day. Now my ankles are very puffy and swollen, the blisters have popped, they are no longer pink, they are a dark "beet" red-ish purple color and appear to look like cellulitis. At this point, I decided to go to a walk-in clinic and the Dr. was very surprised, very concerned, and beside himself because he had never seen anything like this. (his reaction concerned me) He decided to treat it like Cellulitis and gave me pills that I had to take every four hours for 10 days. It appeared that the medication did nothing they still looked horrible 2 weeks later. I decided to grab some anti-itch vitamin E Neosporin, and self-latch bandage wrap I wrapped them uptight and kept them on for 2 days I did this twice and each time I unwrapped them they looked better and better. Now it's February, 12th and they look and feel better but they are very scared, discolored, and there are dead skin and scabs, my skin feels dried out and wrinkly. I've never experienced anything like this before, I am not allergic to anything, and my skin is good I have clear skin and healthy habits. I have a Dr. appointment with my PC doctor to get some blood work done, I want to make sure that I didn't obtain some type of blood disease or re-accruing situation. I've decided to pass on the 2nd shot, I am not getting anything else like that in my body, we don't know what it is & how it works. I regret putting a substance in my body that was not yet cleared and is pretty much an experimental vaccine.
Patient got flu vaccine 10/17/14 at around 12:45 P.M. He reported having fever, chills, and cold hands and feet around 6 P.M. Then when he woke up Sat AM still had fever and had to take ADVIL. Fever cleared up but still has scratchy throat and cold like symp.
The technician that administered the second vax dose jabbed my shoulder. This is compared to the first dose where the tech smoothly inserted the need into my muscle. Symptoms started in my left arm on the day I received the second injection. Location of symptoms at injection site and in shoulder. I am also experiencing a burning sensation down back of  my arm and over forearm. I am experiencing painful "catching" sensation in shoulder with popping and clicking. Decreased range of motion. I can not raise my left arm above my shoulder without pain. I am having difficulty putting on my seatbelt in my car and looking over my shoulder . Diagnosed on 5/26/21 as SIRVA
shivering; This case was reported by a consumer via interactive digital media and described the occurrence of shivers in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shivers. On an unknown date, the outcome of the shivers was unknown.   It was unknown if the reporter considered the shivers to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had significant shivering in the night following the injection. The reporter wanted to know was it safe for her to receive 2nd dose of Shingrix.
Starting with the first vaccine, Aleutia had symptoms that increased with severity with every vaccine.  Brain fog, heart arrhythmia, skin rashes, but the worst were psychological.  She was always a psychologically healthy person.  She suddenly developed insomnia, episodes of Catalonia, anxiety, intermittent and recurrent fever, panic, and depression states.   By the time she got the booster, she was experiencing psychosis (no prior history of mental illness) and suicidal ideation. . After the booster and starting immediately, she had visual and auditory hallucinations, mood and energy swings, and general delusions, and the suicidal thoughts increased significantly.  She ended up taking her life on November 28 2022. This was absolutely and directly related to the vaccine booster. After the booster, she was never the same again.
12JUN96 in AM pt mom called & stated that pt had gotten a rash all over body;advised mom to have pt checked by a MD;pt was checked here in PM dx urticaria s/p immun given atarax-rx;
No adverse event on patient; Storage in clinical practice; This spontaneous report was received from an office manager concerning to a 11-year-old (also reported as "12-year-old", conflicting information) male patient.  His pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On 18-OCT-2022, the patient was vaccinated with one improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (dose, route of administration, anatomical location, and vaccination scheme were not provided) (Product storage error).   It was reported that the reported vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger) . There were no issues, nor adverse event on patient.  The vaccines were purchased with public and private funds and were administered at private doctor's office/hospital. The medication error occurred in the point of storage in clinical practice.  This was one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:Original case
Been staying with his girlfriends parents and the girlfriends father tested positive for COVID-19.; Has not been feeling well; Little chest congestion; Sore throat; Sinus pressure; Loose bowel but not diarrhea; This is a spontaneous report from a contactable consumer or other non hcp(patient).   A 43-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2020 (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history was and concomitant medications were not reported. The patient previously took BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2020 as DOSE1, SINGLE for covid 19 immunisation. On 14Jul2021, the patient experienced little chest congestion, sore throat, sinus pressure, loose bowel but not diarrhea, been staying with his girlfriends parents and the girlfriends father tested positive for covid-19, has not been feeling well. Reporter and his girlfriend had been staying with his girlfriend's parents and the girlfriend's father tested positive for COVID-19. He has not been feeling well. Reporter had sore throat and a little chest congestion today (sinus pressure, loose bowel but not diarrhea got this from the callback). Reporter got the self swab, and he wants information on the clinical trial in area so he can give them a call and see if he can get in and for someone to come and pick up his swab for the study and the center. The outcome of all the events was unknown. Information about lot/batch number has been requested.
Est DD: 08/07/2021 Patient reported feeling hot and light headed within 5 minutes of receiving injection. Assisted into on the cot. Reports feeling shaky and anxious. States worried because of being pregnant, nausea as well. 1240 BP 147/89 HR  Spo2 99% 1245 BP 126/86 HR 104 Spo2 100% 1255 BP 142/87 HR 96 Spo2 99% ( edge of bed) 1305 All symptoms have subsided. Standing on side of bed. 1310  No further issues . Accompanied out by family member.
Soreness at injection site began around 8:00pm 11/11/2021. Red, raised area (approx dime size), painful to touch causing to be protective of contact with injection site noted 11/12/2021 around 12:00pm. 11/13/2021 8:00am redness, soreness continues. Size of affected area is now quarter size. Will be contacting pharmacy & primary md today during office hours
This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: HANGOVER (non-serious) with onset 2021, outcome "unknown", described as "24 hour hangover like symptoms"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm soreness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
We had a customer pass out after a shot and came too quickly.  He began to fall forward several minutes after the shot and another customer pointed out that he needed assistance.  As I hung up quickly and went to the patient he was coming to and recovered.  I wasn't sure if he bumped his head but did not see any lacerations or signs of obvious severe injury. Store manager was contacted to help assess reporting through Incident reporting process.  His BP was 118/82 after spending a few minutes with him and giving him water.  He had a sweaty forehead and sat with us for a bit. I did offer to call an ambulance and administer Benadryl.  Patient declined.  He mentioned fainting with blood donations in the past, never with vaccines.  We discussed for second shot we will stand nearby ready for fainting again, or receiving the shot at an MD office in prone (lying down) position.  There was no answer to a follow-up phone call the next morning.
Received third dose; Extreme fatigue; Body aches; Chills; Dizzy; Feverish; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 27Nov2021 at 15:00 (Batch/Lot number: 32030BD) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "colitis ulcerative" (unspecified if ongoing), notes: ulcerative colitis; "bronchiolitis obliterans with organizing pneumonia" (unspecified if ongoing), notes: BOOP; "raynaud's syndrome" (unspecified if ongoing); "gallbladder removal" (unspecified if ongoing), notes: no gall bladder and "colectomy" (unspecified if ongoing), notes: no large intestine. Concomitant medications included: VITAMIN D and unspecified multivitamins. Vaccination history included: BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: ER8727, Route of administration: Unspecified), administration date: on an unknown date in Mar2021, when the patient was 42 years old, for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot Number: ER8729, Route of administration: Unspecified), administration date: on an unknown date in Apr2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), PAIN (non-serious), CHILLS (non-serious), DIZZINESS (non-serious), PYREXIA (non-serious); all with onset 27Nov2021, outcome "recovering" and described as ''extreme fatigue, body aches, chills, dizzy and feverish''. Therapeutic measures were not taken as a result of fatigue, pain, chills, dizziness and pyrexia.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Novavax COVID-19 Vaccine, Adjuvanted EUA. Patient states that shortly after receiving vaccine he felt that "needle hit bone or nerve". States that since that night he has had pain in left arm. States he has not seen a physician or been to ER.
Gave pt a tetanus/diphtheria vaccination about 1030 hrs. Pt showed symptoms about 1050 hrs. Pt was given Epi (.3 u SQ left delt) at 1055 hrs. Pt was given Benadryl at 1105 hrs (50mg IM right delt). Pt was given O2 at the time. 1115 hrs pt was given 125 mg solumedrol IM in right glut. 1100 hrs pt was seen by Dr.