chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold like symptoms. It is more in her nostrils than chest area. It's like she has gotten a cold. She does not have a lot of mucus. She has nasal symptoms. Cold like symptoms. It is more in her nostrils than chest area. It's like she has gotten a cold. She does not have a lot of mucus. She has nasal symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (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: Bnt162b2 (dose 1, single), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), NASAL DISCOMFORT (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Cold like symptoms. It is more in her nostrils than chest area. It's like she has gotten a cold. She does not have a lot of mucus. She has nasal symptoms.".  Additional information: She received her second dose of the covid vaccine at hospital. She received her second shot on Monday morning and later she had a cold like symptoms. She thought it was like allergies. She knew that the Covid vaccine was new, and Pfizer might not know that much. Beings that it was in a three day period of receiving her second dose of the Covid vaccine, she wanted to know if it is okay to take a cold decongestant/antihistamine or a cold tablet/capsule for her symptoms. She was just trying to see if it would hurt the injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
p/vax pt exp a whole body rash; hives & itching; tx w/steroids & benadryl
PFIZER-BIONTECH COVID-19 VACCINE EUA.  ADMINISTRATION ERROR:  It has been discovered that patient received 2nd dose of Covid-19 vaccine too early. The 1st and 2nd doses are recorded to be given 4 days apart at 2 different Vaccine Clinics. The Nursing Home Employee received the 1st dose on 7/24/21 at an Outside Clinic. On 7/28/21, the employee received a dose at a Mobile nursing facility where he works. Screening form stated no prior doses received.  Immprint, state immunization database, was checked for previous doses but none found on the day of screening.  Prior dose had possibly not been uploaded at that time.  No adverse events have been reported.
Pediatric patient was administered 0.2mL Adult Pfizer BioNTech  Covid19 Vaccine  . Patient completed 15 minute observation with no adverse reaction. Consulted with Provider about vaccine administration medication error provider informed patients parents per CDC there are no contraindications.
V-Fib, cardiac arrest Narrative:  First COVID vaccine administered 2/25/21 with no noted reaction. Patient received his second COVID vaccine 3/21/21 at 1203. Notes in electronic medical record indicate in the morning of 3/22/21 he arrived at a hospital with ER this morning in V-Fib/cardiac arrest. Unclear of potential treatment that was administered at outside facility. Time of Death was about 1330 on 3/22/21.
Patient inadvertently received the Fluad vaccine for patients over 65 despite being <65 years of age.  Patient reported feeling pain at injection site the following morning (11/11/2023) as well as fatigue, and muscle aches/stiffness. She took ibuprofen that morning and took another dose of ibuprofen at noon which resolved her symptoms.
Metal taste; A spontaneous report was received from a consumer concerning a female patient who experienced a metal taste (dysgeusia).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reported having a metal taste in her mouth that is ongoing and doesn't stop. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, metal taste, was considered not recovered.; Reporter's Comments: This case concerns a female of unknown age who had a nonserious unexpected event of dysgeusia.  Event onset occurred 2 days after the first dose of mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the dysgeusia, a causal relationship cannot be excluded.
his temperature 102°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (his temperature 102°F) 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 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (his temperature 102°F). At the time of the report, PYREXIA (his temperature 102°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 102°f (High) 102 degree Fahrenheit.         No concomitant medications were reported. No treatment details were reported.
No adverse event occurred. Injection of Pfizer vaccine was administered on 09-21-2022, the BUD label on the vaccine packaging read 09-23-2022. However, the expiration date as per the MFR was 08-31-2022, MFR was contacted, so far no adverse events to report. Currently awaiting instructions to determine if whether or not an additional dose is required for protection against COVID-19.
Patient developed a rash on her face and her trunks, the next morning it had spread into a total body rash.  It looked like she had the measles all over her body.  It lasted for a day, then the next day the trunk faded, the following day the arms improved.  When she gets hot, you can still see a little residual on her face and arms/legs.
This spontaneous report as received from a physician assistant refers to a male patient of unknown age. On unspecified date in July 2013 the patient was vaccinated with the first dose of GARDASIL (strength, dose and lot# unknown) injection. On 07-OCT-2014 (also reported as today) the patient was vaccinated with the second dose of GARDASIL (strength, dose and lot# unknown) injection. No adverse effect reported. Additional information has been requested.
Encounters an allergen, in my case mold, the vaccine appears to attack the allergen.; Hay fever,; But within 2 days I developed a fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) for Covid-19 Immunization. The patient's concomitant medications were not reported. On an unspecified date the patient were encounters an allergen, in this patient case mold, the vaccine appears to attack the allergen, hay fever, but within 2 days patient developed a fever. Patient recently received your vaccination shots. Patient had found an interesting reaction that occurs. When a vaccinated person encounters an allergen, in patient case mold, the vaccine appears to attack the allergen. patient encountered mold days after patient 2nd shot. patient reaction started as hay fever, which is normal, but within 2 days patient developed a fever. It's as if the vaccine was trying to rid patient of the allergen by attacking it. Patient a friend who has had the same reaction but with cotton wood trees pollen. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient died after receiving the Spikevax injection; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died after receiving the Spikevax injection) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 1 out of 16.   This case was linked to US-MODERNATX, INC.-MOD-2023-734806, US-MODERNATX, INC.-MOD-2023-734808, US-MODERNATX, INC.-MOD-2023-734811, US-MODERNATX, INC.-MOD-2023-734820, US-MODERNATX, INC.-MOD-2023-734823, US-MODERNATX, INC.-MOD-2023-734833, US-MODERNATX, INC.-MOD-2023-734834 (E2B Linked Report).; Reporter's Comments: This spontaneous case concerns patient of unknown gender and age, with no medical history reported, who died an unknown time after a dose of mRNA-1273 (seriousness assessment reported as fatal). Cause of death was not reported. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734820:Patient 8 US-MODERNATX, INC.-MOD-2023-734834:Patient 14 US-MODERNATX, INC.-MOD-2023-734833:Patient 13 US-MODERNATX, INC.-MOD-2023-734811:Patient 4 US-MODERNATX, INC.-MOD-2023-734806:Patient 2 US-MODERNATX, INC.-MOD-2023-734808:Patient 3 US-MODERNATX, INC.-MOD-2023-734823:Patient 9; Reported Cause(s) of Death: Unknown cause of death
A spontaneous report had been received from a Physician concerning a 4 year old, male patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient had been receiving  FLUMIST Quadrivalent  started on an unknown date. The patient stated the he got in the clinic a part of the dose to one nostril and local bleeding started. Action taken with FLUMIST Quadrivalent was unknown. The outcome of the event of local bleeding was unknown. The reporter assessed the event of local nasal bleeding to be non-serious.
Information has been received from a health department administrator concerning a female in her "early twenties" who was vaccinated on an unspecified date with a "second dose" of GARDASIL (lot # not reported). The administrator reported that the patient received the second dose of HPV rL1 6 11 16 18 VLP vacine (yeast) and later the same day, the patient called to report that she was experiencing numbness on one side of her face. The administrator also reported that the patient was advised to go the emergency room. The patient was not admitted to the hospital. The patient's outcome was not reported. Additional information has been requested.
Caller took the vaccine on January the 13th and 12:30 pm and within an hour she started to have symptoms. Symptoms: Spotting, chills, fever of 101, extreme fatigue, stayed in bed for 3 days, has not felt right since that day and has blood in her urine and is having period pains.
I usually don?t get periods because I?m on the depo shot and this also happened to me after I got my second shot. My period has been going for 3 weeks now and will come out of no where with horrible cramps and passing clots and goes back and forth from very light flow to open the flood gates flow. Very uncomfortable and last time it did not return to normal until after I got my next depo birth control shot.
red swollen site of 4 cm at injection site with redness spreading to elbow, warm to touch
Face swelling; This is a spontaneous report from a contactable consumer, the patient. A 30-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 16May2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had no allergies to food, medications or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 at 12:00 (at the age of 30-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 COVID vaccine. On 16May2021 at 19:00, the patient experienced the event face swelling. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event.  The clinical outcome of the event face swelling was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had severe immediate pain as the vaccine was injected on 9/21/20. I informed the nurse it was the most painful injection I've ever received. During the next 3 days my entire left arm was very painful to touch or move. Since then I have continued pain in my left shoulder and it is difficult and more painful when I raise my left arm up or perform any range of motion.
Pt experienced syncope in his chair in the post-vaccine waiting area, fell out of his chair, and hit his head on the ground. Upon assessing the patient, he did not know where he was, but he did know his own name, pt appeared pale and was trembling. Paramedics were called for further assistance and took pt to hospital.
Extremely itchy eyes, scalp, body. Very itchy hives on several area of my body randomly appearing on different areas all times of the day and night. At night it is worst. Dermographia that Itches and causes hives. It wakes me up during the night.  Zyrtec does not help, Benadryl does not help, Claritin helped a little but not enough. My Doctor prescribed hydroxyzine HCl 10mg tonight will be my first time taking it. I also received a referral for an allergist. I'm awaiting approval.
face swelled up really bad to where she could not open her eyes; allergic reaction; Fever; pain and aches; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in arm left on 03May2021 (at age of 32 years old) (lot number: ER8735, it also reported "the second dose lot number was either ER8735 or ER8235"), time the vaccination was given was between 15:00 and 15:30, as single dose for covid-19 immunisation. Patient's medical history was reported as no. Other products was reported as no. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Apr2021 (at age of 32 years old) (lot number: ER8N30) as single dose for covid-19 immunisation. Family medical history relevant to events was no. No relevant tests. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced face swelled up really bad to where she could not open her eyes on 05May2021, fever on 04May2021, pain and aches on 04May2021. The patient stated she was calling to make a report on the second shot since she had an allergic reaction. The patient clarified the second shot she was referring to was the COVID 19 vaccine. The patient stated the symptoms she had was the first day she had fever, aches, and pain then the next day her face swelled up really bad to where she could not open her eyes. The patient stated she went to urgent care and at urgent care she was given a steroid shot and then she took a steroid and allergy medication and also diphenhydramine hydrochloride (BENADRYL). The events did not require a visit to emergency room. When asked if went to physician office, the patient stated she went to urgent care for events fever, aches, pain, face swelled up really bad to where she could not open her eyes. History of all previous immunization with the Pfizer vaccine considered as suspect was no. Additional administered vaccines was no. The outcome for allergic reaction was recovered on 09May2021, for face swelled up really bad to where she could not open her eyes was recovered on 09May2021, for fever was recovered on 05May2021, for pain and aches was recovered on 07May2021.
devel malaise p/vax 10 days later noted swelling of ankles assoc w/redness & warmth, t101 max; devel rash around lt ankle, then knees & elbows started hurting; dx arthus react to flu vax;
Patient got a 0.5ml dose of Moderna's COVID19 vaccine 21 days after receiving the booster dose (0.25ml) of Moderna. Patient did not experience any adverse events as of 02/06/22
Information has been received regarding a case in litigation from a lawyer, a elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 68 years of age, the patient was administered the ZOSTAVAX by a healthcare provider. On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Patient woke up with 2 in by 1 in warm, raised, itchy knot. Over the course of the day it has increased to 3 in x 4 in.
beginning about 16hr p/vax pt had irritability, high pitched crying for  up to an hr @ a time inconsolable w/no fever, cont intermittently w/abn crying for 3 days;
Headache by mid afternoon. Sick in bed that evening with fever, shaking chills, and severe body aches. Fever broke during night. Next morning felt tired and weak.
3/4, admitted 3 days after covid vaccine. Presented to ED with complaint of weakness, onset 1 wk ago. Endorses fatigue, leg swelling, ankle swelling, fluid retention.  Last EF was 6 and "he feels like that same feeling now". On Eliquis and 4mg of Bumex 2x daily. Acute exacerbation of CHF (congestive heart failure) patient with known severe heart failure and ejection fraction of 24% presented with shortness of breath,profound edema, 11 pound weight gain.  Respiratory PCR negative. IV Lasix 40 twice daily-continue with Lasix 40 p.o. twice daily at home. Metolazone 2.5 once a day as needed weight in excess of 235 pounds. Patient continues on Toprol-XL and spironolactone.  Spironolactone was raised to 25 twice daily to try to help manage his potassium fluctuations.
Left upper outer arm with redness, swelling, erythemic papules and one blister - size 9mm diameter x 3mm raised. BENADRYL, ice packs prn.
Headache soreness with localized rash at injection site, muscle pain to right side of neck, shoulder and upper back Narrative:
PATIENT PASSED OUT IN THE ARMCHAIR IN THE OBSERVATION AREA OF THE PHARMACY A FEW MINUTES AFTER RECEIVING THE FIRST DOSE OF THE MODERNA VACCINE. 911 WAS CALLED IMMEDIATELY. PATIENT CAME ROUND AFTER A COUPLE OF MINUTES AND SAID HE FELT LIKE THROWING UP BUT HE DID NOT THROW UP. HE WAS SWEATING AND WAS GIVEN SOME TISSUES. HE SAID HE DID NOT NEED AN AMBULANCE AND LEFT JUST AS EMS ARRIVED.
No additional AEs were reported; Patient received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 03-MAR-2022, the patient was vaccinated with an improperly  stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot # U026664, expiration date: 24-FEB-2023 and/or lot# 1741817 with expiration date: 30-JUL-2022) administered for prophylaxis by oral route (strength, and route of administration were not provided) as well as the patient received another improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #U026217, expiration date: 02-NOV-2023) administered for prophylaxis (strength, and route of administration were not provided).  The administered doses experienced a temperature excursion of 34.3 Fahrenheit (°F) during a time frame of 55 minutes. No previous temperature excursions were reported.   No additional adverse events were reported.
Received Tdap vaccine in the hospital afteer delivering baby on 12/10/10. Blood pressure began to elevate 2 days later before my release and stayed high for over a month. I also experienced partial paralysis of the right side of face and lips and tongue on 12/18/11. Suspected Bells Palsy and was confirmed at the ER the following day 12/19/11. Was prescribed steroids and antiviral medicine. Slowly I regained feeling and motion. Shortly after that I developed a breast abscess from the steroids and lowered immune system. This resulted in having to have it drained surgically.
Recent admission for COVID pneumonia and left lower extremity DVT at Medical Center was brought into another medical center due to lethargy and concern for aspiration. Patient with severe dementia and is unable to provide any additional history.  Reports that she was admitted at the hospital for antibiotics and discharged with 3 days of cefdinir. She was diagnosed with COVID pneumonia. She was also found to have a left lower extremity DVT but not treated with any anticoagulation due to history of subdural hematoma which had to be drained in September of last year. After discharge patient was doing much belter and In her usual state of health. However, began to have more difficulty breathing and has been lethargic.  Pt was admitted at the hospital for further evaluation. Pt was noticed to have acute hypoxic respiratory failure likely secondary to COVID pneumonia vs. aspiration pneumonia. For the rest of her medical condition, home medication resumed. Pt's condition declined during the hospitalization. Pt was placed on IV steroids, breathing treatment, high amount of oxygen/ vapotherm. Palliative care was consulted. Per daughter who Is the POA, pt was placed on comfort care. Patient expired on January 16, 2022 at 2:15.
Information has been received from a registered nurse concerning an 8 year old female with vesicoureteric reflux and no drug reactions/allergies who on 19-OCT-1998 was vaccinated with a dose of Varivax. There was no illness at the time of vaccination. There was no concomitant medication. On 06-APR-2006 the patient experienced a rash on her right neck, extremities, and body. It was noted that the rash started on her neck and spread to her extremities. Twenty to twenty-five vesicular lesions were noted.  She was seen in the office on 07-APR-2006 with no fever and less then 50 lesions (with some lesions crusted over). She was treated with Benadryl. It was noted that one and a half weeks prior to onset of symptoms, the patient was exposed to an aunt who had shingles. There were no lab diagnostic studies performed. The outcome was reported as recovering. There was no product quality complaint. Follow up information indicated that the patient recovered on 08-APR-2006. It was also noted that the patient was exposed to shingles 1.5 weeks prior to onset. No additional information is expected.