chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tiredness; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 17:00 (Lot number: EWO171) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Vitamins, notes: She was just taking vitamins in past. Vaccination history included: Bnt162b2 (Lot number: ER8729, Dose: 1, first vaccine was around 5 , Anatomical location: Left arm), administration date: 13Apr2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 04May2021, outcome "not recovered", described as "nauseous"; FATIGUE (non-serious) with onset 05May2021, outcome "not recovered", described as "tiredness". Therapeutic measures were taken as a result of nausea.  Additional information: Patient was at high risk for COVID. She was just taking vitamins in past. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Reporter stated her mom, Witheld, has been feeling nauseous and tiredness since Tuesday since she got the second dose of the vaccine, she received the second dose of the vaccine on 04May2021 and wanted to know how long she will feel this way. Other products and patient history reported as no. Investigation assessment reported as no. She also asks mother and then translates for questions that she does not know the answer to. Reporter is calling about the Pfizer Covid-19 Vaccine. Reporter states that she is translating for her mom because her mom made a comment that there is no Spanish Speaking representative. Patient received the vaccine on 04May2021 and that same day she started feeling nauseous. The tiredness was the next day. Both are a little bit less but still there. Reporter states no medications or medical conditions, she was just taking vitamins. Reporter does not provide any additional details. Treatment reported as pills for nauseous-ness. Time the vaccination was given reported as first vaccine was around 5 and the second one was around 5 pm. History of all previous immunization with the Pfizer vaccine considered as suspect reported as those two are the only ones she received. All vaccines administered on same date with the Pfizer vaccine considered as suspect reported as none. Adverse was not resulted in physician office and emergency room. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as none. AEs following prior vaccinations reported as none. Family Medical History Relevant to AEs reported as none. Relevant Tests reported as none. Reporter states there is nothing additional to add to the report, but that her mother wants to know if nausea and tiredness are a common thing and how long it will last.  No follow-up attempts are possible. No further information is expected.
A report has been received from a PSS via physician concerning a two child and this report was for first patient. No information regarding medical history and concomitant medicines was provided. The reporter called to report adverse event that was reported to her by pediatrician HCP. HCP reported that he had two patients who received FLUMIST quadrivalent (intranasal), 0.2 milliliters and developed severe nose bleed later that same day. One of the patients was seen the following day and the reporter reported that the childs mucosal tissue in the nares was inflamed and irritated. No specified date for FLUMIST for either child was given but a time frame of a week or two was given. The reporter reported that one patient got a severe nose bleed that night she got the FLUMIST and the other patient got a severe nose bleed five days later after getting the FLUMIST. The action taken to suspect drug was unknown. The outcome of the events of developed severe nose bleed and mucosal tissue in the nares was inflamed and irritated was unknown. The report was considered to be non-serious by company physician.
urinary tract infection; cancelled her original second dose appointment since on medication and is now scheduled for second dose on 27 April.; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection), PRODUCT DOSE OMISSION ISSUE (cancelled her original second dose appointment since on medication and is now scheduled for second dose on 27 April.) and PAIN IN EXTREMITY (Sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-positive) in November 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection), PRODUCT DOSE OMISSION ISSUE (cancelled her original second dose appointment since on medication and is now scheduled for second dose on 27 April.) and PAIN IN EXTREMITY (Sore arm). The patient was treated with NITROFURANTOIN (MACROBID [NITROFURANTOIN]) for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary tract infection), PRODUCT DOSE OMISSION ISSUE (cancelled her original second dose appointment since on medication and is now scheduled for second dose on 27 April.) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing was delayed on an unknown date.       No concomitant medications were reported.   The patient cancelled her second dose vaccine appointment as she was on antibiotic therapy and was scheduled for 27-Apr-2021.
On approximately 05/28/2015 (3 weeks post vaccination) my son developed red raised papules on neck and hand. The papule on his hand measured approximately 2 cm wide. This was accompanied by low grade fevers and vomiting. He has a history of developing these same type of red raised papules with prior vaccinations.
Pt informed nurse that her lips felt "numb" directly after receiving vaccine. Pt stated that one week later she developed pain and numbness toleft side of her face starting from behind her ear,  then also started behind her right ear. On 4/4/2021 Pt went to the ER as pain and numbness had not gone away and was dx with Bells Palsy. Pt was started on antibiotics, steroids , and Ibuprofen. On 4/7/2021 Pt went to see PCP at gateway, He informed pt to go home and continue medication regime. Then pt states pain became worse because ibuprofen is no longer working. 4/15/2021 @1755, pt was advised to f/u with PCP  tomorrow, or to go to urgent care/ER if symtoms do not improve in the next 24 hours. Pt/Spouse verbalized understanding.
COVID; again covid; COVID; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4296985-00 (Agency).  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), intramuscular (Batch/Lot number: unknown) till Oct2021 at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "COVID"; COVID-19 (medically significant) with onset Feb2022, outcome "not recovered", described as "again covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive; (Feb2022) positive. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporters causality for Humira (adalimumab) for the event(s) of covid, again covid with Humira (adalimumab) was no reasonable possibility. The reporters causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) for the events of COVID-19 and recurrent COVID-19 was not reported  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect drug cannot be denied for the reported events.
Pt had been seizure free for one year while on Lamictal. On night of 4/24/00 she stood up from sitting position and fell to floor and had seizure which lasted for 1 or 2 minutes.
started getting a headache around 7 pm on 04/06/2021, fell asleep for a few hours and woke up to drink water. Very dehydrated. Woke up every couple hours to drink fluids, ended up sleeping a total of 16 hours. 8:30 pm - 12:45 pm. Very nauseous and didn?t eat at all on 04/07/2021. Still currently 04/08/2021 and I still have a headache, somewhat nauseous and slept 13 hours last night (7:30 pm- 8:30 am)
Pain, Numbness and loss of feeling from right neck, right shoulder, arm elbow and index and middle fingers.  Started 2/1/21 worsened until this report  2/5/2021.  Seeing neurologist  2/6/2021.  Treatment rest and inactivity.  Unknown outcome at this time.
headache; tired; fever; shivering; shoulder is tender; This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th December 2019, less than a day after receiving Shingrix, the patient experienced headache, tiredness, fever, shivering and shoulder pain. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the tiredness, fever, shivering and shoulder pain were unknown.   It was unknown if the reporter considered the headache, tiredness, fever, shivering and shoulder pain to be related to Shingrix.  Additional details were provided as follows:  The patient exprienced headache, tiredness, fever, shivering and shoulder pain after receiving 1st dose of Shingrix. The headache was getting less intense. The reporter asked if the 2nd shot will produce side effects too. Consent to follow up was denied.
On 10/9/2014 at 1000, asymptomatic. Received the flu shot, higher dose as I am 79 years old. At 1600, both eyes became reddened, swollen and painful. Developed a cough, experienced chills, lethargy, hands became swollen and painful (for 48 hours).
I was completely fine for 7 days after the shot, then on the 8th day I started to get a red rash on the site of the shot on my left upper arm, swollen, and the muscles going up to my shoulder and neck started to swell and painful (painful to lift my arm up).  For the past 2 days the swelling and rash has doubled in size (grown to 3.5inches in diameter), fatigue, nausea, dizziness.
Pt. reports feelings of warmth/flushed, itching in face. No reports of difficulty breathing, no acute distress noted. Skin appears normal for ethnicity, however patients mother reports "her face is red". Patient was due to exit the clinic @ 1145, however kept and monitored until 1205. No difficulty breathing, no worsening of complaints, however reports continued facial itching. Patient and family advised to follow up with PCP and seek emergency treatment if symptoms continue/worsen.
EPILEPSY, UNSPECIFIED CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Rash is red and look liked scratches and spread out all over the body; Rash is red and look liked scratches and spread out all over the body; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash is red and look liked scratches and spread out all over the body), RASH (Rash is red and look liked scratches and spread out all over the body), PYREXIA (fever) and CHILLS (chills) in a 35-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Rash is red and look liked scratches and spread out all over the body), RASH (Rash is red and look liked scratches and spread out all over the body), PYREXIA (fever) and CHILLS (chills). At the time of the report, RASH ERYTHEMATOUS (Rash is red and look liked scratches and spread out all over the body) and RASH (Rash is red and look liked scratches and spread out all over the body) had not resolved and PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Patient had blood work and other test done but so far cause of the rash is unknown. 11 days after receiving the booster dose and experienced a rash all over the body. Patient had the rash for two weeks now and reported the rash is red and looks liked scratches and spread out all over the body. Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-404755, MOD-2021-404744 (Patient Link).
ER visit for weakness, vomiting, elevated blood sugars, dehydration 9/6/2021
her husband had fever and chills; her husband had fever and chills; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (her husband had fever and chills) and CHILLS (her husband had fever and chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome and Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (her husband had fever and chills) and CHILLS (her husband had fever and chills). At the time of the report, PYREXIA (her husband had fever and chills) and CHILLS (her husband had fever and chills) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Patient was given first GARDASIL 9 vaccination. Approximately 3 minutes after receiving injection, patient stated she was light headed. She was already seated on the exam table and was assisted to a supine position. Patient loss consciousness for approximately 60 seconds. A cool wash cloth was placed on her forehead, ice packs were placed behind  and around her neck, and her blood pressure was taken. Her blood pressure was 118/75. Patient stayed in the supine position for about additional minutes. Patient was assisted into a sitting position for another 5 minutes. At this time she states she is feeling much better. She is given some cold water to drink. She is assisted to her family car by her mom and this nurse. Patient is driven home by mother.
patient received the expired vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021 at 11:36 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021 at 11:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.). On 18-Nov-2021 at 11:36 AM, EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that upon delivery of each vaccine order (021B21A- feb-2021  and 021B21A- MAR-2021. the vaccines were placed into the freezer the same day they were delivered. The vial from the freezer was removed and was put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow-up received contains patient demographics.
VASCULITIS AFTER BEING INOCULATED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vasculitis after being inoculated. Laboratory data (dates unspecified) included: Blood test a finding in blood, had vasculitis. The doctors do not know what it was, there was a suspicion that it was something plastic or metal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vasculitis after being inoculated was not reported. This report was non-serious. This case, from the same reporter is linked to 20220732360.
No Adverse Event; 3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022; 3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022), INCORRECT DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022) and NO ADVERSE EVENT (No Adverse Event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 063B22A, 025D21A, 016B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 28-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022) and INCORRECT DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022), INCORRECT DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022) 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 EXTRA DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022) and INCORRECT DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022).    No concomitant medications were reported. The patient was given an extra fourth dose on 28-Sep-2022.  No treatment medications were reported.
On the evening of 12/15/00 the patient had a fever of 103, alert and oriented times three. On 12/16/00, Saturday AM the patient woke up with swollen right arm and rash all over her body. She was taken to the ER. The patient was treated for an ear infection and bronchitis. Calamine lotion to the rash, no mention of allergic reaction, temperature 97.
high blood pressure; Diarrhea; Cough; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach), HYPERTENSION (high blood pressure) and DIARRHOEA (Diarrhea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Mantle cell lymphoma.    Concurrent medical conditions included Blood pressure. Concomitant products included RAMIPRIL (ALTACE) for Blood pressure, RITUXIMAB (RITUXAN) for an unknown indication.   On 23-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced HYPERTENSION (high blood pressure). At the time of the report, COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach), HYPERTENSION (high blood pressure) and DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amylase: elevated. On an unknown date, Blood pressure measurement: High. On an unknown date, Lipase: increased. On an unknown date, SARS-CoV-2 test: Negative.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The events of elevated lipase level, cough, upset stomach and diarrhea was not Provided. The reporter's causality for the events of elevated amylase level and high blood pressure with Imbruvica (ibrutinib) was a reasonable possibility.  Treatment drug was not reported.  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.
Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP
positive for Covid; positive for Covid; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients. This is the first of two reports. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 16Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that both patient and his wife got their first Pfizer covid vaccine on 16Mar2021. They had not been feeling well for two weeks and on 31Mar2021, they both tested positive for Covid. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374570 same reporter/ drug/ event, different patient