chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on her face; This is a spontaneous report from a contactable healthcare professional (physician assistant). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration, on 24Dec2020 as a single dose (reported as 0.3) for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced hives on her face in Dec2020, which was reported as medically significant. It was reported that within 24 hours of vaccination, the patient had hives for 48 hours. The event was reported as a moderate systemic reaction. The clinical outcome of hives on her face was recovered in Dec2020.; Sender's Comments: Based on the compatible time association, the event hives on her face is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness  Treatment: Benadryl Outcome: Recovered in 2 hours
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Since 24-FEB-2015, the unspecified patients were vaccinated with VAQTA that were improperly stored. No adverse effects were reported. The healthcare worker stated that the patient, lot and actual dates of administration were not available. The dates of administration range from 24-FEB-2015 to present 15-JUL-2015. No product quality complaint (PQC) was reported for VAQTA. This is one of the several reports from the same reporter. Additional information has been requested.
pt devel sz & fever 2 days p/vax;pt has had intractable sz since that time;
I fall asleep constantly; have no energy; I have brain fog / I feel as though I have been injected with poison; slight headche; fatigue / tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (I fall asleep constantly), ASTHENIA (have no energy), FEELING ABNORMAL (I have brain fog / I feel as though I have been injected with poison), HEADACHE (slight headche) and FATIGUE (fatigue / tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (allergic to Sulfa).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 04-May-2021, the patient experienced SOMNOLENCE (I fall asleep constantly), ASTHENIA (have no energy), FEELING ABNORMAL (I have brain fog / I feel as though I have been injected with poison), HEADACHE (slight headche) and FATIGUE (fatigue / tired). At the time of the report, SOMNOLENCE (I fall asleep constantly), ASTHENIA (have no energy), FEELING ABNORMAL (I have brain fog / I feel as though I have been injected with poison), HEADACHE (slight headche) and FATIGUE (fatigue / tired) had not resolved.            No concomitant or treatment medication has been reported.   This case was linked to MOD-2021-079362 (Patient Link).
This case was reported by a consumer (subject) and described the occurrence of falling asleep suddenly in a 61-year-old female subject who was vaccinated with Influenza quadrivalent vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included osteoporosis spine. Concurrent medications included OPANA ER, Oxymorphone and NEURONTIN. On 14 October 2013 at 16:00 the subject received a dose of Influenza quadrivalent vaccine unspecified (unknown details, left arm). The subject did know which GSK quadrivalent vaccine for influenza she received. On the morning of 16 October 2013, 2 days after vaccination with Influenza quadrivalent vaccine unspecified, the subject experienced pain around injection site. The subject stated that "the pain at injection site has spread down near her elbow, then up to her shoulder, and then into her neck." In October 2013, at an unknown time after vaccination with Influenza quadrivalent vaccine unspecified, the subject experienced falling asleep suddenly (described as "spontaneously falls asleep", headache-daily and intolerance to sun (without any cutaneous reaction) (described as "cannot stand to be in the sunlight"), and injection site movement impairment (described as "cannot hardly use that arm"). The subject reported "having headaches almost every day". She remarked that "she has been poisoned." The subject reported that "if she sleeps on her arm it hurts so bad that she cannot hardly use that arm." The subject did not clarify what she meant by "cannot stand to be in the sunlight." The subject reported experiencing "all of these symptoms every day." In the subject's opinion, the events were disabling. This case was assessed as medically serious by GSK. The subject considered the events to be disabling. At the time of reporting the events were worse. At the time of reporting, the subject had an appointment planned with her physician.
This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 24Apr2021 at 11:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included systemic lupus erythematosus (SLE). The patient previously took cephalexin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the 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 medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 03Apr2021 at 11:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 08:00, the patient experienced high pulse 190 upon marginal exercise, around 90 resting and low pulse 50/85, lasting about 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 25Apr2021, the patient underwent lab tests and procedures which included pulse rate and the results were 190 (units unspecified), 90 (units unspecified) and 50/85 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events, high pulse 190 upon marginal exercise, around 90 resting and low pulse 50/85 were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Eleven days after vaccines, pt. developed fever and had a seizure at home. Parents took pt. to hospital - fever recorded at 101.5F. Bloodwork was normal. Rapid flu swab was negative. No URI symptoms. Developed rash 2 days after seizure.
Rash on chin and arms and itching, stomach cramps,diarrhea. Patient took benadryl and the reaction lessened.
inflammation @ inj site persisting for wk;redness, swelling, pain, tenderness, induration lasting more than 16 days;
Almost immediately experienced flu like symptoms combined with body aches/soreness/stiffness in the shoulders, upper arms, girdle groin area, wrists and fingers.
Infanrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 16-JUN-2023, the patient received Infanrix. On 16-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-JUN-2023 Medical assistant called to report an expired dose of Infanrix was administered to a patient. The vaccine Administration facility was the same as primary reporter. Consent to follow up via email agreed.
The evening I received the 2nd dose of Moderna (1/24) I started having a headache followed by fever, chills,  arm soreness, and fatigue. Monday, 1/25, I no longer had headache but fever, chills, arm soreness, and fatigue was still present.  I felt so cold I had on long sleeves and multiple blankets. I took tylenol for my symptoms. This latest until Tuesday morning  (1/26) when I awoke when all of my symptoms were gone other than my arm in discomfort. When I looked into the mirror I saw  a red welty rash on my arm. I  continued to take tylenol and iced my arm. I called my primary care doctor. I later received a message from her office to take tylenol and ice arm and come in to be seen if my arm did not improve. Later on in the evening the size of the rash continued to grow and get angry red. I felt great pain. I ended up going to the ER to get it looked it. I was given a rx for keflex to treat my arm for potential cellulitis of the arm but also noted that what I was experiencing was likely a localized reaction to the injection itself per the discharge summary. That evening I circled the rash so I could keep track of its growth. It did slightly grow the next day (1/27).  I followed up with my primary care doctor today (1/28) as I was instructed by my ER discharge summary to follow up in 3 days and she only had availability 2 days later.  The rash appears to finally have stopped growing but it still present. It does appear to have faded some. I was advised to take Claritin or Allegra and use calamine lotion.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients might have been vaccinated with PROQUAD lot# M038228, expiration date 06-MAR-2018; lot# M049123, expiration date 13-JUN-2018; lot# N008825, expiration date 12-SEP-2018; lot# M035689, expiration date 06-FEB-2018; lot# M041509, expiration date 09-APR-2018 (strength, dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 Fahrenheit degrees and 46 Fahrenheit degrees with the range of 30.4 Fahrenheit degrees for 16 hours. Digital data logger was used to capture temperature excursions. There were no previous temperature excursions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA005417.
Fussiness, loss of appetite, large blotchy spots, later identified as Erythema Multiforme Minor
Patient received first dose of Moderna COVID-19 vaccine on 21MAY2021 and as of 30JUL2021 had still not received the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received first dose of Moderna COVID-19 vaccine on 21MAY2021 and as of 30JUL2021 had still not received the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received first dose of Moderna COVID-19 vaccine on 21MAY2021 and as of 30JUL2021 had still not received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received first dose of Moderna COVID-19 vaccine on 21MAY2021 and as of 30JUL2021 had still not received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
This was the Booster of 0.25ml Moderna.  Head ache, overall body aches, chills. and a little nausea for about 2 1/2 days.  Although not as bad as after original 2nd dose last given on 05/05/2021.
Thrombosis Development After mRNA COVID-19 Vaccine Administration: A Case Series; This is a literature report.  A 40-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, 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: THROMBOSIS (medically significant), outcome "unknown", described as "Thrombosis Development After mRNA COVID-19 Vaccine Administration: A Case Series". The patient underwent the following laboratory tests and procedures: White blood cell count: 12.9 x103, notes: 12.9 x103 uL (Ref: 4.4-11.0 x103 uL); Computerised tomogram head: showed no signs of an acute bleed; Magnetic resonance imaging: bilateral thalamic ischemic infarcts; Echocardiogram: showed an intracardiac shunt with patent foramen o; Angiogram: multiple pulmonary emboli in the right lung; Ultrasound testes: a right brachial vein deep vein thrombosis. Therapeutic measures were taken as a result of thrombosis.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202300137572 Same article/drug/event or different patient;
hives around neck; rash around neck; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number HL2CM, expiry date 21st January 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were recovered/resolved.   It was unknown if the reporter considered the hives and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient reported that 3 days after first dose of Shingrix the patient experience hives and rash around neck and resolved on its own. The Vaers details were updated. The reporter consented to follow up.
took both of my Moderna shots 14 days apart; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who experienced took both of my Moderna shots 14 days apart.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On unknown date, approximately fourteen days prior to the first dose, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On unknown date, the patient reported he took both Moderna shots 14 days apart and he never had any reaction. Treatment information was not provided.    The action taken with the drug in response to the event is not applicable.  The outcome of the event took both of my Moderna shots 14 days apart was unknown.; Reporter's Comments: The reporter refers to a case of inappropriate schedule of product administration for mRNA-1273 vaccine, batch number not provided, with no associated AEs. Causality of this event is not applicable.
Breaking out in sweats; Muscles cramping up in legs/Muscles cramping up in stomach; Chills; Vomiting real bad/Vomiting a lot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Breaking out in sweats), MUSCLE SPASMS (Muscles cramping up in legs/Muscles cramping up in stomach), CHILLS (Chills) and VOMITING (Vomiting real bad/Vomiting a lot) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F214) for COVID-19 vaccination.    Co-suspect product included non-company product ELECTROLYTES NOS for Dehydration.    No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ELECTROLYTES NOS (unknown route) at an unspecified dose. On 10-Sep-2021 at 4:30 AM, the patient experienced HYPERHIDROSIS (Breaking out in sweats), MUSCLE SPASMS (Muscles cramping up in legs/Muscles cramping up in stomach), CHILLS (Chills) and VOMITING (Vomiting real bad/Vomiting a lot). The patient was treated with VITAMIN D NOS at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Breaking out in sweats), MUSCLE SPASMS (Muscles cramping up in legs/Muscles cramping up in stomach), CHILLS (Chills) and VOMITING (Vomiting real bad/Vomiting a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is on no concomitant medication reported by reporter.
4 day p/vax pt exp chills, fever (not measured), h/a, myalgias, soreness @ the inject site, abdominal distress, fatigue;
Approximately 3 months after receiving the first Covid vaccine, I developed a rash on the top of my left foot.  It spread to the calves of both legs.  It was diagnosed by a dermatologist with a biopsy as granuloma annulare.
Patient signed up for a Shingrix Vaccine, and the vaccine given was a 4th Booster Shot, indicated for persons >50 yrs old. Patientsa last 'Booster' was provided 1/2022. Greater than 5 months prior, so on time for COVID series.
sore arm; she's feeling nauseous (slightly queasy, come and go); This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiry date: unknown) via unspecified route of administration on 19Feb2021 as DOSE 2, SINGLE for COVID-19. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiry date: unknown) via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19. It was reported that the patient clarified she had her second shot on 19Feb2021 and this morning (01Mar2021) she was feeling slightly nauseated. She suspects it was not connected. Caller asks the call handler as a nurse in her professional opinion, could it be related to the vaccine this long after. The caller states the only reaction she had to the vaccine was a sore arm. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt received diphtheria/tetanus booster and developed erythema at injection site (4.7cm x 3.5 cm) no induration; warm to touch.
Employee  received second dose of COVID Moderna  vaccine on 12/17/21 prior HX COVID positive on 12/8/20 ,came to work on 12/18/21 @ 12:08 pm c/o dizziness ,headache   and  ,numbness to both hand and feet. Employee awake ,alert and oriented  able to follow verbal commands well. Blood sugar on scene 84 mg % with BP :140/80  , HR :74 /mt and 02 Sat's 96% Employee was triaged by RN and send out to outside hospital via AMR for further  eval and treat @ 1233 pm .
PT CALLED COMPLAINING OF BODY ACHES AND HEADACHE, TOLD TO TAKE ADVIL OR TYLENOL FOR DISCOMFORT. LIE DOWN AND REST. PT STATED IF DIDN'T FEEL BETTER WOULD PROBABLY GO TO EMERGENCY ROOM
shortness of breath, cough, low grade fever for 72 hours, tachycardia, nausea,  overwhelming sense of impending doom, weakness, fatigue,  runny nose, headache
Pt. got hive from shoulder to elbow after flu shot. No previous reactions to other imms.
Pt recv vax on unknown day (5/98 or 6/98);  post vax pt exp serum sickness w/ joint swelling & pain; anxiety, concentration difficulties, fatigue & neuropsychiatric rx; tx=Nordazepam
(L) arm pain. Redness on elbow bilateral. Tx below 12 pres. antibiotic and hydro cort.
7/28/2021: Ocular migraine lasted approximately 30 minutes. 7/29/2021: Ocular migraine lasted approximately 60 minutes followed by a migraine headache, which I never experienced previously. 7/29/2021: Seen by eye doctor and advised it was not my eyes. It was recommended to see a neurologist if it happens again. 11/6/2021: Ocular migraine lasted approximately 15 minutes. 11/8/2021: Ocular migraine lasted approximately 15 minutes and I had a headache for the remainder of the day. 12/6/2021: Headache all day. 12/30/2021: Headache developed at 1:00 pm and lasted the remainder of the day. 01/11/2022: Ocular migraine  lasted approximately 2 hours.
Felt like having a cold around 25 or 26 Jan; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt like having a cold around 25 or 26 Jan) and COVID-19 (Tested positive for Covid) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J2oA) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced FEELING COLD (Felt like having a cold around 25 or 26 Jan). At the time of the report, FEELING COLD (Felt like having a cold around 25 or 26 Jan) and COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, COVID-19: positive (Positive) tested positive for Covid on 28 Jan 2021.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment was given.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event- feeling cold , a causal relationship cannot be excluded. Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.