chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Janssen COVID vaccine on 4/7/21, Pfizer COVID vaccine on 10/25/21 and 4/11/22, and Pfizer Bivalent COVID booster vaccine on 10/21/22. On 4/6/23, patient admitted to our inpatient facility (med/surg unit) with COVID-19 pneumonia with resulting acute hypoxic respiratory failure and thrombocytopenia. Patient discharged home on 4/10/23.
3/19/2021 Fever, 100.2,chills, muscle pain,headache, fatigue, rash, blistery hives at injection site, itching varies other places on body  3/22/2021 Symptoms subsided.
Right after getting the vaccine about 7pm on 11/6/19 , the patient's head went backwards and he slipped out of the chair. He seemed to pass out for a minute then he woke up. He spoke. His mother said he fainted after getting HPV  vaccine at  age 11.  We called 911. After paramedics examined him, he walked out of the store himself. They tested blood sugar, blood pressure among others. Mom said he had not eaten since lunch time about noon. He said he was ok and his mother declined the paramedic's offer to take him to the hospital. He walked out of the store with his family.
Sneezing; Runny nose; Sore throat; Phlegm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Mar2021 at 15:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 50 mg from an unknown date for an unspecified indication, ethinylestradiol; norgestimate (ORTHO TRI-CYCLEN) from an unknown date for birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced cold-like effects for 6 days now: sneezing, runny nose, sore throat, phlegm, and fatigue. Patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 01Apr2021, the patient underwent PCR oral swab test and the result was negative. The clinical outcome of the events sneezing, runny nose, sore throat, phlegm, fatigue was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
WIDESPREAD RASH THAT STARTED AT INJECTION SITE THEN  SPREAD TO BOTH ARMS THEN OVER ENTIRE BODY OVER A PERIOD OF 4 DAYS ALONG WITH EXCESSIVE FATIGUE. TOOK IBUPROFEN AND ZYRTEC AND OATMEAL BATHS UNTIL IT RESOLVED ON 11/2/2021.
Patient received her first dose of Pfizer vaccine in left deltoid. After waiting approximately 1 min in the waiting area, patient became dizzy. Patient was then brought to our observation area on the stretcher. Water and icepack provided for patient. Vital signs taken. BP 95/61 Sp02 98%. Patient is alert and oriented x 4. Some SOB noted. No swelling of throat noted. No difficulty swallowing. Patient responding to questions appropriately. Patient stated she previously has enlarged tonsils. Vital signs retaken approx. 10 min later and Bp was then 118/79 Sp02 97%. Patient verbalizing throat "closing and opening". Patient verbalized being "nervous". Benadryl 25mg administered via IM in patients right deltoid. Patient still verbalizing throat opening and closing with no additional swelling or enclosement noted. 911 called at 1700. Paramedics arrived into clinic at 1712. After discussing options with with patient via paramedic, patient stated will leave clinic and was made aware to contact emergency services if anything /or other symptoms progresses. Patient then left clinic walking independently accompanied by patients husband.
Asthma attack about 4 hours later and had to take prednisone to control. Asthma lasted 36 hours. Fever of 102 started about 8 hours later and lasted about 60 hours. Sharp pains all over the body, vomiting and nausea for about 48 hours. Extreme fatigue for about 60 hours.
Patient reports anaphylactic reaction (shortness of breath, redness, hives, red eyes, swollen tongue, trouble breathing).
Patient present today 9/25/17 with information about his allergic reaction symptoms after receiving flu vaccine on 9/19/17 in clinic. After flu vaccine, one day later became sick w/cold S/S and sore throat and next day presented with a rash all over his body. He went to clinic and was seen and treated for possible allergic reaction. He was treated and sent home. Today he continues with itchy rash and will be going to his primary physician. Rash red, itchy and generalized.
Total body skin reaction of hives and fever (101.5-102) 3-4 days after vaccine. No respiratory distress.
immediately felt a sharp burning pain down arm as injection was done.  I pulled away and was told that sometimes tetnus injections did this.  I have not been able to laterally raise arm since.  Have continued to have burning down arm and limited movement since injection.
sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2020 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Shingles vaccine (Shingles vaccine several years ago.), for immunization; Bnt162b2 (DOSE 1, SINGLE), administration date: Apr2020, for COVID-19 Immunization. The following information was reported: SINUSITIS (non-serious), outcome "recovering", described as "sinus infection". They gave her steroids and antibiotics for the Sinus Infection. Therapeutic measures were taken as a result of sinusitis. The lot number for bnt162b2 was not provided and will be requested during follow up.
Received Moderna Bivalent dose on 09/13/2023 - No adverse advent experienced.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age.    On 10-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M042785 in the left deltoid for prophylaxis. On AUG-2017 the patient experienced pyrexia, dizziness, chills and pain. The outcome of dizziness, chills, pyrexia and pain was reported as not recovered/not resolved.
Second dose of the vaccine after 3 weeks from the first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine after 3 weeks from the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 16-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine after 3 weeks from the first shot). On 16-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine after 3 weeks from the first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Developed malaise, headache and 10 red itchy spots on neck, side of cheek, upper arm on same side where vaccine was given, cheeks, back and legs.
Required code to be called and short MICU admission for observation, including neurology and psychiatry services. Seizures & PNEA (Psychogenic Non-Epileptic Attack)
Our pharmacy facility went onsite the patient's residence to administer influenza vaccinations and COVID boosters. The patient received both the COVID Pfizer Bivalent Booster and the FluAd Quadrivalent vaccinations. It is reported that very soon after receiving both shots he began to experience pain, the patient did not think much of it since some pain can be expected after vaccination. However in the following 2-3 days the pain continued to intensify to a state of severe and unbearable pain.  When the pain got to a point of not being able to function normally he went to see a provider and was put on low dose steroids and pain medication. The medications seemed to help for a day but then the pain got even worse still so the patient went to the Emergency Room at the hospital where he was diagnosed with Polymyalgia rheumatica (PMR). (approximately 2 weeks after vaccination)  The patient is experiencing some relief with high dose prednisone, however in the question below I am considering the patient "not recovered" because at his age being on high dose steroids is not ideal, so I would not consider him "recovered" until we know he is able to be without pain after the steroid treatment is completed.  The patient got so bad that palliative care was discussed, but it does seem that with the treatments he may turn the corner.
Painful menstruation cycle directly after (4days earlier than I should?ve received it), longer than usual menstruation  cycle (8 days instead of 4 days), and different texture (thicker and sticky)
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided. A vial was punctured 30 times at the clinic. 10 patients who were administered the vaccine were affected. No treatment medication details was provided.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of PEDVAXHIB (dosing details were not reported) (incorrect product storage). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperature the vaccine were exposed were above the range and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reported. Additional information has been requested.
12 yoF with recent covid infection who presented for symptoms as stated below that began 1 day following 2nd Pfizer vaccination.  Myocarditis, pericarditis with chest pain few days after vaccination. Received IVIG and methylprednisolone. Started on aspirin. Chest pain improved prior to discharge with troponin downtrending.   Headache and lymphadenopathy starting 1 day after vaccination. Headache persisted for two weeks before improvement. Received numerous pain analgesics.
From correspondence received on 11/28/01, it was reported that a 43 year old female patient received a Fluzone SV '01-'02 vaccination administered approx. one month ago (Oct,2001). Within 48 hours, the patient developed a rash and pruritus on her back and spread over entire body. patient was seen by two dermatologists- unresolved.
Had a fever and headache and vision problems on day after Moderna Shot.  1 week later started to feel exhausted and lethargic and depressed.
Patient is experiencing no side effects, adverse events, or outcomes. Patient has received the Moderna Monovalent COVID-19 vaccine rather than the Moderna Bivalent COVID-19 vaccine. As per patient, pharmacist administered the shot and asked the patient if it was her fifth shot, patient confirmed it was but unaware that it was not the bivalent shot.
A report was received from a healthcare professional on 10/20/2003 concerning a female vaccinee in her 50's who experienced an injection site reaction with redness, pain, swelling, and itchiness 1 day after receiving Fluvirin on 10/17/2003. ON 10/18/2003 the vaccinee experienced an injection site reaction with redness, pain, swelling, and itchiness.  The swelling was 1.5cm by 1.5cm and the redness was 7cm by 7cm.  The vaccinee had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment. Update 1, 02 December 2003 Follow up information received from a healthcare professional indicated that the vaccinee who experienced severe swelling, redness and pain at the injection site, recovered within 1 week.
2" erythematous rolling patches with central clearing, warm non tender no indurations. BL deltoid.
Dizziness, Myalgia, Diarrhea, NauseaVomiting, chills body aches Narrative:
06/22/2021 @ 1000 Patient was given J&J vaccine.  1010: Patient had seizure under a min. Patient was placed on side lying position and safety measures  1015: VS WNL 102/72 68 HR. Patient was still confused but alert.  1025: Patient was transferred by EMS. Injection site was free from itching, redness, patient denies any respiratory problems, or history of seizures.
This spontaneous report was received from a registered nurse refers to 6 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 20-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot# N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004061, 1806USA004062, 1806USA004063, 806USA004064 and 1806USA004065).
Diffuse arthralgias started immediately after injection (ongoing over 3 weeks now). Still symptomatic.
Initial report received from a health care professional on 16 September 2010. A 35-year-old male patient, with a medical history of seizure disorder, no illness at the time of vaccination and an allergy to ULTRAM, received on 27 August 2010 at 3:05 PM an injection (route and site unknown) of ADACEL, lot number not available. The patient was taking KEPPRA and another unidentified medication. The patient was seen in the Emergency Room (ER) on 27 August 2010 for a laceration and given ADACEL. On the evening of 27 August 2010, the patient developed swelling of his arms and feet. On 28 August 2010, the patient called 911 to report shortness of breath and weakness. He was taken to the ER where he was diagnosed with renal liver failure, hepatitis and hyper-potassium. The outcome was reported as unknown. Documents held by sender: None.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 MALIGNANT PLEURAL EFFUSION
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported.On unspecified dates the patients were administered improperly stored PEDVAXHIB (unknown strength and route). Concomitant medications were not reported. There was no known adverse effect. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
nauseous; mild headache; Feeling mentally fuzzy; low grade fever 101.3/temp was down to 100.7; severe chills, teeth were chatter very loud; Feeling joint aches and pain; sleepy; could not get warm; This is a spontaneous report from a contactable pharmacist. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), dose 1 intramuscular, administered in Arm Left on 18Mar2021 15:15 (at the age of 50-years-old) as DOSE 1, SINGLE and dose 2 intramuscular, administered in Arm Left on 09Apr2021 15:15 (at the age of 50-years-old) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included hypertension. Allergies to medications, food, or other products: no known allergies (NKA). Concomitant medication(s) included hydrochlorothiazide, atorvastatin calcium (LIPITOR), verapamil and ezetimibe (ZETIA). The patient did not receive any other vaccines within 4 weeks prior to the COVID 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 09Apr2021, the patient woke up around 4 am with severe chills, teeth were chatter very loud. Temperature at 8 am low grade fever 101.3. Took Tylenol and was feeling better by 10 am. The chills started again around 1 pm, temperature was down to 100.7. Patient took two Advils (2 x 200 mg) around 1pm. The patient had feeling joint aches and pain, mild headache, sleepy and could not get warm. The patient was feeling mentally fuzzy, nauseous and headache as of 6 pm. As a treatment the patient received Tylenol and Advil. The outcome of the events was not recovered.  No Follow-up attempts are needed. No further information is expected.
I woke up with a swollen lymph node in the L side of my neck. I also had a red flat rash at the site of my vaccination. The rash lasted 3 days, started out diffuse and flat at the site, then made a circle, then progressed to a ring, then half a ring, then was gone. It itched if my clothing  touched it, but no other time.
I received 2 initial does plus 1 booster shot of the Pfizer vaccine. This Moderna vaccine was my 2nd booster shot. Chills, fatigue, muscle aches and diarrhea on 1st day after vaccination., mostly resolved by day 2. Painful sore on roof of mouth on 2nd day after vaccination, still unresolved.
Short-term: flu-like symptoms including chills, nausea, muscle aches, weakness, headache. Long term effects: delayed menstruation & insomnia, but fewer migraines.
Patient came in with a local reaction to the injection. Left arm revealed a large black section where the injection was given, with redness on the outside and further out, was yellow. Patient did not have any pain, but the area did have minimal swelling. The discoloration was of most concern to her. She said it was better, but reaction started after the injection was originally given. Patient was recommended to seek attention from a medical doctor as soon as possible.
Subjective fevers, chills, nausea, chest tightness that are improving with time and Tylenol
Very difficult breathing. Nasal passages became inflamed or swollen and could not breath easily through nose. When walking had to take deep breaths through mouth, heart pumped harder, etc.
Moderate pain at injection site, limited arm motion, treated with Ibuprofen and heat compress.
12 hrs later   Fever above 100 and child?s abs diarrhea  and leg cramping for 36 hrs   Terrible worse than first shot      Both were bad though
Vaccine manufacture expiration date was 8/31/22. Vaccine was administered to patient on 9/22/22 after expiration. No adverse reaction reported by patient.
Sore arm, then next day real bad nausea with vomiting feeling, sweating on and off, tired
An itchy round rash at the injection site - it started 8 days after the injection. This is my first dose. Google tells me this is sometimes called "COVID arm". (I assume it will go away.)
I smell what smells like cigarettes smoke when no-one else can. multiple times a day, different time, settings, and locations. a few days of this are logged waiting for my PCM to make a decision on next step.
This case was received from a health professional on 25 July 2007. A 46-year-old male patient with no reported medical history received an intramuscular right deltoid injection of DECAVAC (lot number U1956AA), right deltoid injection of MENACTRA (lot number U2377BA) and left deltoid injection of PNEUMO (Merck, lot number 1005F) on 24 July 2007. Approximately ten hours later, on 25 July 2007, the patient began experiencing fever, chills, and body aches. Outcome was not provided. A corrective version was created to change the preferred term for body aches from "generalized aching" to "generalized muscle aches". No new information has been added to the case. Follow-up information was received from the health professional on 02 November 2007. The patient was prescribed ibuprofen, and the events resolved on 26 July 2007. Per the reporter, the patient did not keep a follow-up appointment.
Nursing staff gave the patient the wrong Covid-19 vaccine ( Moderna ) .  Nursing staff gave a pediatric Moderna (6mos-5yrs) to a 51 y/o  adult patient.  Staff had called the patient and  informed them of this medical error.  Patient came back to the  clinic  on the same day to received the right vaccine and dosage for their age group.
mild facial swelling lt eye & upper lip; pt put on DPH & given Pedrapred;
COVID-19 unknown manufacturer EUA: patient presents to emergency department (ED) one day after receiving vaccination reporting suprapublic swelling and pain and difficulty urinating that started shortly after vaccination. Two weeks prior to vaccination underwent abdominoplasty and abdominal/submetal liposuction and three days prior to vaccination had drains removed. Vital signs within normal ranges. Patient addmitted for management of fluid collection and antimicrobials, drain placement, and observation.
The patient refers that three days after vaccination (Pfizer) he began experiencing vasovagal episodes, nausea, vomiting, diarrhea, and panic attacks. The next day he began experiencing severe fatigue, and a week later he noticed severe pitting edema and swelling of bilateral lower extremities, up to the level of the knee. Now, in January, he refers he is experiencing rectal hemorrhage, severe chest pain, and pain in his left arm (contralateral to that of vaccination).  The patient visited his primary doctor who suggested it was associated to vaccination event, and recommended he fill out a report. Recommendation by us was to visit a specialist, and undergo further more exhaustive and comprehensive testing, before reaching such a conclussion.
There was no adverse reaction.  This patient received an extraneous dose of Moderna after already having received two Pfizer doses.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient has a history of fainting with medical procedures. We called 911  Paramedic responded observed patient took patient's blood pressure waited 15 minutes told patient he should not drive. Patient said he was fine declined medical transport said he was OK to walk home.