chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized itching at the injection site after the first dose; Swelling at the injection site after the first dose; Redness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Aug2021 11:30 (Lot number: FC3180, Expiration Date: Oct2021) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Hpv vaccine. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 09Aug2021, outcome "recovered" (Aug2021), described as "Localized itching at the injection site after the first dose "; VACCINATION SITE SWELLING (non-serious) with onset 09Aug2021, outcome "recovered" (Aug2021), described as "Swelling at the injection site after the first dose "; VACCINATION SITE ERYTHEMA (non-serious) with onset 09Aug2021, outcome "recovered" (Aug2021), described as "Redness at the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pruritus, vaccination site swelling, vaccination site erythema.  Additional information: Reporter states that a patient reported that they had localized itching, swelling, and redness at the injection site after the first dose. Report is not related to a study or programme. Reporter assessed causality, with event as yes. Reporter stated its unknown whether patient had laboratory tests.   No follow-up attempts are possible. No further information is expected.
Temp 103. Lowers to 101 after Motrin then back up in 1-2 hours to 103 Chills Bad Headache Sore arm
Pt called call center 5/6/2021 regarding of covid vaccine side effects.  Pt denies emergency s/sx. Pt stated pt got 2nd covid vaccine Pfizer at clinic 5/5/2021 and pt got pain on right shoulder pain(joint pain) on the vaccination site. Noted no emergency covid vaccine side effects. Noted no side effects of covid vaccine at 1st covid vaccination per pt. visit made for consultation on 5/6/21
Red hard lump around injection site, size of two quarters side by side. Hot to the touch.
Temperature Excursion Product Administered; Initial Report Received on 07-Apr-2022  An administrative manager from a Hospital reported that a 62 year-old male (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization involved in a temperature excursion.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 04-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05 and serial number 659541770826) intramuscularly in the left deltoid from a registered nurse. The patient received the vaccine that was involved in a temperature excursion, which was 0.8 degrees Celsius for 31 hours and 12 minutes from 30-Mar-2022 through 04-Apr-2022.  No additional information was reported. It was reported that the patient did not experience adverse reactions.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
I had the 2nd vaccine at 10 am and by 8:30 I was started to feel adverse effects like flu symptoms and tiredness. I had fallen asleep earlier but then started feeling ill and achy at 8:30.  I had a very sore arm which I did not have from the first vaccine.  Then I got very chilled and shaky, increased body aches, nausea and some stomach distress in the bowel region.  I was very miserable, but I did not want to take a Tylenol or other aid for nausea as I wasn't sure I was allowed to do that.  I spent hours just moaning and running to the toilet. I felt just malaise and being out of it and tired.  I finally fell asleep after 3 am when the nausea eased up.  I did not vomit but wished I was able to do so.  My neck also got stiffer but no headache.  I felt better in the morning but still had the stiffness in the neck and some light nausea.  I was also very tired as if my body had fought a war.  I pretty much rested the whole day and ate mild food. I also called the pharmacy and they said I could take Tylenol which I did. It helped relieve the stiffness.  Today is the 8th of July and I am better, but still not 100% yet.  I'm still more tired than usual and a bit off, but much better.
having similar side effect to her own; Injection arm hurts reported on blog; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having similar side effect to her own) and VACCINATION SITE PAIN (Injection arm hurts reported on blog) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having similar side effect to her own) and VACCINATION SITE PAIN (Injection arm hurts reported on blog). At the time of the report, VACCINATION COMPLICATION (having similar side effect to her own) and VACCINATION SITE PAIN (Injection arm hurts reported on blog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.
Within 24 hours, high fever 103.6 lasting more than 12 hours. 2 days out of work to recover. Persistent HA for now nearly 8 weeks. Neurologist suspects mild chemical meningitis.
Pt hospitalized 4/9/22 with acute kidney failure, anemia, throbocytopenia, hypoxia, transaminase elevations.    Self limiting
Received anthrax vaccine 06 Apr 03, was seen in Clinic on 11 MAR 04, because of a rash, neck, joint, and shoulder pain. Slowly improving over time. Family history of atopy.
Pt called 6 days after administration complaining of swelling in arm. Golf ball size swelling at injection site.
5/10/03 - Left arm (upper) red, swollen, warm to touch - neosporin to site wrap in plastic wrap several hours - continue with Motrin or Tylenol. 5/11/03 - about the same; same tx. 5/12/03 "back to normal" per mom.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX QUADRIVALENT 2017-2018 season for an unknown indication. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown  if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist said that they had been giving SHINGRIX vaccine (refer case US2018158121) and in general they had observed more soreness at the injection site than what they normally saw with the flu shot. No particular patient's information was associated with this report. This case has been linked with case US2018158125 reported by the same reporter.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 27-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA008566: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Approximately a few weeks after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: Scratchy throat, Runny nose, Cough, Sinus Infection. I took Allertex and Tylenol for treatment and after consulting with my doctor, I was prescribed with PAXLOVID for 5 days and I am currently on my 2nd day of taking it. So far, I felt so much better than before but unsure whether it's because of time or the effect of PAXLOVID.
Initial report received from nurse on 16 Dec 2009: One dose of FLUVIRIN (batch no. 1008142P) was administered to a 3-year-old boy on 14 Dec 2009. No adverse effect was reported.
Patient states that over the last few days she has been feeling well, with no fever or chills, shortness of breath, cough, abdominal pain, dysuria, aches or pains out of the ordinary, diarrhea.  She has been eating normally and has started no other new medications.  She did recently return from a visit to family out of state.  She otherwise went to a local pharmacy for a "booster" immunization against COVID-19.  Due to the episode last May, she received the Moderna COVID-19 immunization yesterday.  That happened around noon.  Into the evening the patient started to feel somewhat chilled, and blood pressure was running a bit lower.  Later her daughter checked on her around 10:00 and the patient was febrile, lethargic and hypotensive.  Daughter states the patient was unable to ambulate, thus EMS was contacted and she was brought to the ER by ambulance
Customer received a flu shot on Jan 27, 2019. She claims that the pharmacist was too busy running around doing several things and was not focused on her when administering the vaccine. She said the shot was painful and she experienced soreness around the injection site for several weeks. She also says that after she received the shot she began experiencing constant numbness in her arm and especially her left hand. This numbness is still an issue for her and she is scheduled to see a neurologist next month. She mentioned that she was documenting our conversation. She did not  specifically say, but it seems she will be looking for compensation.
The pt became very pale after receiving vax. The pt's feet were elevated above head and level. Color started to get better. Child became responsive and looking at mother, the child then became pale again and circumoral cyanosis. Feet were elevated again and 911 called. Color got better but still pale, color changed again increased pallor and experienced cyanosis under nose to chin.  Elevated feet again and color slowly returned to normal.
Day 1:  severe joint/muscle pain in injection arm and neck for 2 days with intense headache Day 2 - TFN:  throbbing headaches two weeks after:  went to dr after I almost passed out from throbbing head pain in head after gym workout,  bottom blood pressure was high for the first time in my life, usually in the high 60's. 10/28:  had follow up dr appt about high bottom blood pressure that has continued to stay high.  Ranges from mid 80s- to high 90's,  dr put me of blood pressure medication.  headaches have gotten better but still experience temple pressure.
blood clots; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated several months ago her husband (patient) developed blood clots that he thought might be related to his Pfizer vaccine. He went to the hospital and was told that his condition was not related to his vaccination. The event outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
No adverse event; The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.; Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2022 at 3:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours). No concomitant medication was reported. On 19-JUL-2022 the vial was initially stored in the refrigerator. On 15-AUG-2022 at 2:30PM vial was first punctured and for 25 hours the vial was exposed to room temperature before being administered on 16-AUG-2022 at 3:15 PM. No treatment medication was reported.
I experienced slight fever (100.4), dry cough and sore throat and COVID HOME TEST POSITIVE. Made an appointment and met with APRN, RN. An additional POC SARS COV ANTIGEN test to confirm the positive result. Result - Positive.  Then prescribed Paxlovid for five days morning and evening. I took the first dose the evening of 6/30/2022. Slight fever (99.0) continued for 7/1/2022 and 7/2/2022. Cough diminished and then, later, reappeared - more intense 7/11-12/2022 not sore, with hoarseness but now diminished. Self-administered Mucinex and Fluticasone Propionate nasal spray the last 4 days. Symptoms diminished but linger.
sz w/in 2-3 hrs p/administration of DTP #3 w/fever 103;
moderate vertigo; chest tightness; slight wheezing; forehead tightness; mild facial swelling; had flushing on my lower arms with small unraised red spots; had flushing on my lower arms with small unraised red spots; suspected mast cell activation syndrome; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 at 08:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included Basedow's disease from an unknown date and unknown if ongoing , anaphylactic reaction from an unknown date and unknown if ongoing , mast cell activation syndrome from an unknown date and unknown if ongoing , penicillin allergy from an unknown date and unknown if ongoing , sulfanomide allergy from an unknown date and unknown if ongoing , beans and legumes allergy from an unknown date and unknown if ongoing , and pollen allergy from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOXYL) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Apr2021, at 08:45 AM, the patient experienced suspected mast cell activation syndrome (medically significant), and flushing on my lower arms with small unraised red spots (rash macular and flushing). At 9:15 am, the patient experienced forehead tightness, mild facial swelling. At 20:15 (8:15pm), the patient experienced chest tightness, and slight wheezing. On 11Apr2021, at 08:45 AM, the patient developed moderate vertigo. The patient stated, "about 15 min after the injection I had flushing on my lower arms with small unraised red spots.  About an hour after I experienced forehead tightness and mild facial swelling.  I pre treated with Benadryl and Pepcid due to suspected Mast Cell Activation Syndrome.  I have had 4 previous anaphylaxis reactions to foods and this didn't feel the same.  I took more Benadryl about an hour and a half after the injection, and the tightness and forearm symptoms dissipated.  12 hours after the injection I developed chest tightness and slight wheezing.  I took Zyrtec and Pepcid with minimal improvement.  24 hours after injection I developed moderate vertigo". The patient was recovering from the events, forehead tightness and flushing on my lower arms with small unraised red spots, but had not recovered from the other events.
POTENTIAL CLOTS; HIGH BLOOD PRESSURE; This spontaneous report received from a consumer via media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported administered 1 in total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced high blood pressure, and potential clots "My mother had a dangerously high blood pressure and potential clots for a month after her JnJ jab". Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure and potential clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220208979, 20220208988 and 20220208918.; Sender's Comments: V0.20220208980-covid-19 vaccine ad26.cov2.s -Potential clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
COVID Breakthrough Case Pfizer Dose 1 4/22/21 (ER8731) Pfizer Dose 2 5/14/21 (EW0168) COVID Positive 11/15/21  11/21/21: Patient is a 59 year old female who presented to ED via EMS with complaints of shortness of breath that began yesterday. On arrival of EMS the patient was saturating on room air at 66%, DuoNeb was administered, she was placed on 15 L non-rebreather with improvement in oxygen saturation to 96%. Pt began having headaches and fatigue one week ago. Two days later she developed chills, decreased appetite, nausea and a cough. She was tested at Urgent Care and notified two days later, on Wednesday that she was positive. Yesterday she started becoming short of breath and "hot." She became very weak to the point where her husband had to walk her to the restroom. She denies any abdominal pain, vomiting or diarrhea. Denies chest pain. She is fully vaccinated against Covid-19. She denies any history of asthma or tobacco use. She has a past medical history of anxiety/depression and neuromyelitis optica. She is followed by Dr. with neurology for her autoimmune disease, she received her first Rituxan infusion back in July.  On arrival to ED the patient febrile 101, tachycardic 123 and hypoxic on 15 L non-rebreather at 86%.  She was placed on high-flow nasal cannula 40L with 70 FiO2.  Laboratory findings were significant for hyponatremia 133. Transaminitis AST 54. D-dimer 1.63.  C reactive 24.0. Chest x-ray showed extensive bilateral pneumonia.  CT chest negative for PE.  Extensive bilateral patchy consolidated pneumonia.  Patient received ceftriaxone and Decadron in ED. She received NS 1 L in ED.  12/1/21: Acute hypoxic respiratory failure status post intubation on 11/23/2021  Severe bilateral COVID-19 pneumonia, vaccinated status  Superimposed bacterial pneumonia  Hypotension concerning for septic and hemorrhagic shock requiring multiple vasopressors  Acute blood loss anemia secondary to GI bleeding status post PRBC transfusion Upper gastrointestinal bleeding status post endoscopy on 11/29/2021  Acute kidney injury likely due to hypoperfusion Severely elevated liver function enzymes likely due to shock liver Elevated serum inflammatory markers secondary to infection  Hyponatremia  Morbid obesity  Anxiety/depression  Neuromyelitis optica, chronic. Patient passed away on 12/01/2021 at 14:07  Patient was made DNR status and was started on comfort measures per family's request
This spontaneous report was received from a healthcare professional and refers to multiple unspecified patients with unknown demographics. Information about the patients' pertinent medical history, drug reactions, allergies and concomitant medications was not reported. On an unspecified date in 2016 (reported as from 01-MAR-2016 through 08-MAY-2016), the patients were vaccinated with doses of improperly stored GARDASIL 9, lot # L044475 with expiration date 12-MAY-2017, (dose and route of administration were not reported). No adverse effects were reported. The vaccine experienced the following temperature excursion: 7.2 F, on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported dizziness / lightheadedness, nauseated, and tingling in both hands about 5 minutes post injection.  After sitting and having water patient reported feeling back to normal after approximately 15 minutes