chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US024751, is an initial spontaneous report from a consumer (patient) via Claim Management Services received on 23 Nov 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001, expiry date: 31 May 2016) on an unknown date. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, the patient received NEORAL at an unknown dose for an unknown indication. On 06 Nov 2015, the patient had a reaction to the flu vaccine which included nausea, vomiting and fever. The patient experienced severe cough and immune system decreased after receiving the vaccine. The outcome, seriousness and causality of the events were not reported. Follow up report received from a consumer on 07 Jan 2016: Updated suspect drug information (influenza vaccine and NEORAL) and event information (cough and immune system decreased).
One week post vax the pt experienced a varicella like rash with lesions over his body. After 15 days the pt recovered.
PT STATES THAT SHE HAD SEVERE SYNCOPE, HEADACHE AND HYPOTENSION.  PT WENT TO THE HOSPITAL EMERGENCY ROOM.  PT UNDERWENT SCANS, BLOOD TESTS AND OBSERVATION.  ALL TESTES CAME BACK NORMAL.  AFTER A FEW HOURS PT WAS RELEASED WITH NO FOLLOW UP NEEDED.  PT CAME TODAY TO TELL ME ABOUT THE PROBLEM.
Pt developed erythema induration at site of injection w/in 24 hour of admin. followed by axillary tenderness and associated supraclavicular adenopathy.
PATIENT SYMPTOMS: FRIDAY IT STARTED AS TINGLING IN FACE AT 3:00 AND THAT AFTERNOON IT PROGRESSED TO LEFT SIDE OF FACE AND HER SMILE WAS CROOKED.  HER LEFT SIDE OF THE FACE WASN'T MOVING LIKE THE RIGHT SIDE WAS.  PATIENT WENT TO DR ON 3/7/2021 AND DR SAID IT WAS BELLS PALSY.
had COVID 8 months later; had COVID 8 months later; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003919.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "had COVID 8 months later".  Additional information: On 19Oct2022, it was reported that a patient started treatment on 26Feb2021 with Pfizer BioNTech COVID-19 Vaccine (dose 1), 26Mar2021 with Pfizer BioNTech COVID-19 Vaccine (dose 2) and 24Sep2021 with Pfizer BioNTech COVID-19 Vaccine (dose 3) for COVID-19 immunization. It was reported the individual had COVID 8 months later, around 01Jun2022 and had a significant cough and phlegm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient had been experiencing pain and swelling of the right arm starting on 11/11/21.  The patient finally presented to the ER for evaluation of the arm.   The patient developed a DVT of the right axillary, basilic, and radial veins. There was also sub-acute vs chronic thrombus in the right cephalic vein with decreased vascular flow as diagnosed with upper extremity ultrasound.  He reports no injury, or immobilization of the arm.  He has not had any recent surgery.   The only factor which was suspicious as an event precipitating this was the fact that he had the Jannsen vaccine on 9/9/21.   He is otherwise a healthy 42 year old male who takes no prescription medication.   He is fit and active (just trained for a marathon.)  He was started on Eliquis treatment and has reported some improvement in his pain and swelling.
Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients might received doses of VAQTA (dose, route not reported, lot # K002744 with expiration date 19-SEP-2015, lot# J000985 with expiration date 20-AUG-2015, lot# H010106 with expiration date 21-FEB-2015, lot# J011629 with expiration date 20-SEP-2015) that were exposed to temperatures of 0 degree C for 4 hours and 55 minutes. This is one of several reports from the same reporter. Additional information has been requested.
Headache similar to migraine in location and intensity, first day of vaccine and every day since receiving vaccine.  Nausea the day after the vaccine  No appetite every day since receiving vaccine
Heart and chest pain, started about 8-9 hours after injection. Going to sleep, so I cannot continue to monitor until morning.
Rash at injection sight approximately 7 days after injection. I also had an episode of vertigo. Since I've had episodes of vertigo on and off for the past 10 years, this is likely unrelated.
Patient was advised by nurse to mix and match vaccines.  First two vaccines were Moderna and Patient wanted 3rd shot to be Pfizer.  Moderna was accidentally drawn instead while completing patient's vaccination record and Moderna booster was given to patient rather than Pfizer.  No ADRs were observed
Infant had increased apnea,  bradycardia, and desaturation requiring increased respiratory support.
Patient c/o feeling lightheaded approximately 20 minutes after receiving vaccine.  Patient reported that she usually feels like that when her blood sugar is high.  I told her that her blood sugar could also be low and offered her peanut butter crackers and water.  She ate 1 cracker and drank the water. We kept her an additional 15 minutes from her 30 minute wait to observe her.  Her vitals were as follows: 134/77, 71, 18, O2 sat 97% on RA.  She reported a blood sugar reading in the 160s this morning.  I offered to call EMS, but she refused.  Instead, she wanted to call her husband and daughter to come get her.  She said that her daughter would drive her car back home and she would ride with her husband.  Patient was escorted via wheelchair to the car.  She was able to transfer into the car without any difficulties and reported feeling better before leaving.  Patient with history of DM II, HTN, and TIA and reported that she saw her Cardiologist today for a routine visit and her workup was negative. I told her that I would follow up with her in a few days to see how she was doing.  She was agreeable to the plan and verbalized good understanding.
Chest CT done on 7-21-2022 had incidental finding of  paraseptal emphysema.  PFTs done 8-22-2022.   Saw pulmonolgist on 11-8-2022.  FU CT on 11-15-2022 showed mild paraseptal emphysema, no evidence of honeycomging, mild to mod air trapping, paraesophageal lymph nodes measuring up to 1.2 cm.  Additional labs ordered and drawn 11-16-2022 - waiting interpretation, but abnormal results to ANA with Reflex to ENA panel - poistive, Rheumatoid Factor - 59.5 IU.ml, Anti-neutrophilic cytoplasmic antibody - positive, ANA quantitative - 1:80, homogeneous, Anti-neutrophilic cytoplasmic antibody quantitative - 1:1280, Myeloperoxidase Antibody IgG - >8.0 Al . to FU with GI.   PFT challenge test done 11-18-2022, awaiting results
Tired; Splitting headaches; Extreme fatigue; Slight dizziness; This is a spontaneous report from a contactable nurse (patient).A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration, administered in Deltoid Left on 10Feb2021 around at 09:30 as single dose for covid-19 immunization. The patient medical history included covid-19 from 28Nov2020 to an unknown date, ongoing hypertension from Approximately 3 years ago and Controlled by meds, she had 1-1.5 months of severe headaches and post fatigue syndrome. Family Medical History included Patient's son has Asthma, 2 of the patient's aunts had Asthma, patient's mom had cancer and died at age 42 years and patient's dad had lymphoma and died at age 78years. Prior Vaccinations (within 4 weeks) reported as None. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect reported, additional Vaccines Administered on Same Date of the Pfizer Suspect and Relevant Tests reported as None. Nurse (patient) was reported that with COVID-19 she had 1-1.5 months of severe headaches and post fatigue syndrome. She was returned to work on 10Jan2021. She reported that she being tired, so when she got home after the vaccination she took a 2 hour nap; but she had been feeling tired for the last 2 months so she was not surprised by that. By about 20:00 she hit a wall, further described as exhausted. She had onset of splitting headaches again and it was worse when she stands, the extreme fatigue and slight dizziness also around 20:00-21:00 on 10Feb2021. She slept all night from around 20:00 or 21:00 on 10Feb2021-11Feb2021. Patient wanted to know she could take Tylenol after having gotten the Pfizer COVID-19 Vaccine. On 10Feb2021, the patient experienced tired, splitting headaches, extreme fatigue, slight dizziness. The patient was not visited to Emergency Room and Physician Office. The patient was not hospitalized. The causality between the event Tired' and the vaccines was Unknown and between the event Splitting headaches' and Extreme fatigue' was related. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Productive cough; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Productive cough) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two months. In 2021, the patient experienced PRODUCTIVE COUGH (Productive cough). At the time of the report, PRODUCTIVE COUGH (Productive cough) was resolving.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medications were reported.
Day after vaccine- Clementine size bump under left armpit, (swollen lymph node), extreme soreness, and extreme aching up to 1 week. Within 2 weeks of vaccine- began to experience hives and itching all over body, raised red scratch marks last for 30 minutes, itching, and closed throat in the morning (hard to breathe).
Day after shot had sore arm and was tired but those symptoms lasted about 24 hours.   Then 8 days after vaccine I developed a rash about 2 1/2 inches high by 3 inches wide about an inch or so below the injection site on left arm.  The rash is itchy and a little warm to touch.   Contacted allergy Dr. and was told to take an allergy pill.  Am also using cortisone cream.  Rash is a little better after about 24 hours but still there.  Today is 10 days after receiving the vaccine.
CHEST PAIN; SHORTNESS OF BREATH; SWEATING; TACHYCARDIA; DIZZINESS; WEAKNESS; TIREDNESS; Headache; CHILLS; This is a spontaneous report from a contactable pharmacist. A 37-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0196) via an unspecified route of administration in Arm Left on 23Jun2021 17:45 (age at vaccination 37years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history reported as none. The patient had known allergies reported as unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0187) via an unspecified route of administration in Arm Left on 02Jun2021 17:45 (age at vaccina-tion 37years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. On 10Jul2021 13:30 the patient experienced chest pain, shortness of breath, sweating, tachycardia, dizziness, weakness, tiredness, headache, chills. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Fever; Chills; Headache; Tiredness and all of that; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of unspecified age (niece) who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer's niece got the Pfizer-BioNTech COVID-19 Vaccine and did not have difficulty breathing; but did experience fever, chills, headache, tiredness and all of that on an unspecified date. Outcome of the events was unknown.  Information about Lot/batch no has been requested.
devel hives neck chest-under area of inj on 14MAR97-size of fifty cent piece;
Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, via an unspecified route of administration, in the left arm, from 22Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included allergies to penicillin, gluten, chicken eggs (whites & yolks) and cow's milk. Patient was not pregnant. The patient's concomitant medications were not reported.  on 23Dec2020 09:00, after being vaccinated, the patient experienced sore left arm for 2-3 days. The patient underwent lab tests and procedure on unspecified date which included Nasal Swab test/COVID test, yielding negative result. The outcome of event was recovered on Dec2020.  Follow-up attempts are completed. Information on the batch/lot number has been obtained.
missed my period for 3 months, which never happened to me. still experiencing irregular periods and when i get them i have the worst cramps.  this was never the case before. my periods were always on time and never experienced painful cramps like i do not.
Numbness  at  left side of lip . Numbness almost like novicaine feeling at left cheek up towards left eye Tingling at back of the tongue
The entire family had their Pfizer vaccinations in Mar, and all three are positive; The entire family had their Pfizer vaccinations in Mar, and all three are positive; Severe muscle aches; Headache; This is a spontaneous report from a contactable physician. A adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE, and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The physician reported that in the last few days, the physician had four new COVID of patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine. Also, the physician was aware of two other cases in vaccinated patients who were being seen by colleagues. This might be sampling issue, but it was running contrary to the conventional wisdom that most of the cases were in unvaccinated people. A 68-year-old man (patient's father) who had a syncopal episode. He had spread it to his wife and adult daughter (patient) who were also all fully vaccinated. The patient had the same symptoms (severe muscle aches and a headache). The entire family had their Pfizer vaccinations in Mar, and all three were positive. They were more of these vaccinated cases because they were no longer routinely test vaccinated people who were not having typical presentations. It was reported that they had stopped pre-op COVID testing on fully vaccinated asymptomatic people a couple of weeks ago. They were asking if they should be going back to doing that. The reporter wondered if there were a lot more going on in the vaccinated population than they appreciate. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of events were unknown.  Information about lot/batch number has been requested. ; Sender's Comments: Based on known drug safety profile and as patient received  two shots of vaccine on unspecified dates, since there is no information of how many day are gap (19-42)between two shots there is reasonable possibility of drug ineffective for Covid-19.
Swollen lymph nodes under right arm; Hives; Headache; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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 27Mar2021, the patient experienced swollen lymph nodes under right arm, hives, headache, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the event swollen lymph nodes under right arm, hives, headache, chills and fatigue was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient received first dose of moderna on 05/17/2021 and second dose on 06/08/2021. This was sooner than the recommended time frame. No adverse events were reported from the patient.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 3:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 3:28 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 78.11.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 12-Jan-2021, the Excursion time was 08 AM and 09 AM, temperature was 34, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. The vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
got so sick with shot; Initial information received on 29-Nov-2020 regarding an unsolicited valid non-serious case received social media case through agency reported by a consumer (patient).  This case involves patient (unknown demographics) who had the patient got so sick with shot (illness), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date (reported as since few years), (latency unknown) after the initiation of suspect vaccine, the patient got so sick with shot (illness) and thought he was dying. The patient stated do not trust the flu shot.  No relevant laboratory data was reported.  It was unknown if the patient received a corrective treatment. The events outcome was unknown.  There will be no information available on the batch number for this case.
Pain and swelling in the left arm for 5 days. He did yard work after episode.
2/27/2023 I had a high fever, up to 103, fatigue and extreme dizziness. I tested positive for COVID with an at home COVID test. I was prescribed PAXLOVID by my doctor. I began taking it that day. The fever broke and I started to gradually feel better. On 2/28/23 I woke up with my leg swollen, red and hot. I had to go to the emergency room and diagnosed with a skin infection and was given sulfamethoxazole/trimethoprim. I took about five days to feel better from COVID, around the time I finished the PAXLOVID. Five days after that, I had COVID rebound. I had significant congestion, both head and chest. I am still lingering with that.
Uriacara rash onset 12/10 resolved 12:00 no jt or lip swelling no respiratory sign and symptoms.