chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The prospective pregnancy report, has been received from a nurse practitioner referring to a 18 year old female patient without pertinent medical history or drug reactions/allergies. On 08-SEP-2015, the patient was vaccinated with her second dose of (Oka/Merck) VARIVAX (Lot#, expiration date, dose and route were unknown) and GARDASIL (Lot#, expiration date, dose and route were unknown) both. There was no concomitant therapy taken. The reporter stated that after the patient received the vaccines, on the same day, a urine screening was done for pregnancy which showed a positive result. The patient became pregnant with last menstrual period (LMP) of 26-AUG-2015 and estimated delivery date (EDD) of 01-JUL-2016. Initial exposure to (Oka/Merck) VARIVAX and GARDASIL was at 2 weeks. The pregnancy outcome was outcome pending. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored with VARIVAX, injection, lot # L017146, expiry date 13-MAY-2017 and lot # L035127, expiry date 14-SEP-2017 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same source. Follow up information has been received on 12-DEC-2016 that all telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Reporter and narrative were updated.; Sender's Comments:  US-009507513-1611USA000865:,MERCK 1610USA014127:Mfr number.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted immediately after injection. Immunizer (RN) administered epinephrine and the patient arose from her fainting state with no issues. Patient stated that she always faints from every needle stick (did not inform the immunizer beforehand). Patient was monitored for 30 minutes before leaving.
So I had the booster by Pfizer; So I had the booster by Pfizer; Arrhythmia aggravation; arrhythmia /It is still extremely high; intense heat/got very hot all over; diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on 27Aug2021 (age at vaccination was 84 years) as DOSE 3, SINGLE for COVID-19 immunisation. The patient's medical history included arrhythmia (had no effect on shot one or shot two). The patient's concomitant medications included rivaroxaban (XARELTO) 15 mg for indication blood thinner and metoprolol 25 mg one tablet a day (two medication for her heart and both never affected her heart rate). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date in Jan2021 as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date a DOSE 2, SINGLE; both for COVID-19 immunisation. After the first and second shot, she had no stress, no headache, and had no reaction to shot one or shot two. She had no fatigue also after second shot. The patient stated that, in Aug2021 (from the minute she took the shot) her arrhythmia which she had no problem with shot one or shot two her arrhythmia, her heart rate it was jumped up to a very dangerous level and it continued to the day of reporting. In Aug2021, she had no chills, what she had was intense heat, it was sort of like the closest thing she could describe it as, it was like when women have like they have menopause, a woman got very hot all over specially in the top part of the bottom in the top part of the body; burning up, there were no chills, there was just intense heat and she had diarrhea and nothing else. She did absolutely nothing, had no treatment whatsoever there was nothing what she was going to do with heat. She stated burning up was okay and the fact that her heart, she has to go and see her cardiologist and she do not know what they are going to do about her heart to bring it back down to its normal level. She had been checking heart rate in Aug2021 (for the last three days) and it was been consistently high, it was still extremely high, and it has to be gone back to its normal beat. The patient underwent lab test and procedure on unspecified date in 2021 (three week ago) included antibody test and resulted into antibody was fine. The outcome of events was arrhythmia aggravation was not recovered; intense heat/got very hot all over and diarrhea was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
patient received a dose of Tenivac on 2nd of November 2020 that had expired on the 23rd of October2020, No AE; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves patient (demographics unknown) who was administered an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number not reported and expiration date: 23-OCT-2020) via unknown route in an unknown administration site for prophylactic vaccination on 2nd November 2020 (Expired product administered).  Medical history, past medical treatment(s), medical treatment(s), concomitant medication (s), vaccination(s) and family history were not reported.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number to be requested for this case.
Big bump (1.25"x1/2") on the Injection Site after booster; Hot to the touch Injection Site  (97.9 F) after booster; Hard bump (1.25"x1/2") on the Injection Site after booster; Red on the Injection Site after booster/Redness spreading; Inflamed Injection Site after booster/Throbbing Injection Site after booster; Itching Injection Site after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE WARMTH (Hot to the touch Injection Site  (97.9 F) after booster), VACCINATION SITE INDURATION (Hard bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE ERYTHEMA (Red on the Injection Site after booster/Redness spreading) and VACCINATION SITE INFLAMMATION (Inflamed Injection Site after booster/Throbbing Injection Site after booster) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 027A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history report information was reported.  Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) from 29-Sep-2021 to an unknown date for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE MASS (Big bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE WARMTH (Hot to the touch Injection Site  (97.9 F) after booster), VACCINATION SITE INDURATION (Hard bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE ERYTHEMA (Red on the Injection Site after booster/Redness spreading), VACCINATION SITE INFLAMMATION (Inflamed Injection Site after booster/Throbbing Injection Site after booster) and VACCINATION SITE PRURITUS (Itching Injection Site after booster). At the time of the report, VACCINATION SITE MASS (Big bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE WARMTH (Hot to the touch Injection Site  (97.9 F) after booster), VACCINATION SITE INDURATION (Hard bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE ERYTHEMA (Red on the Injection Site after booster/Redness spreading), VACCINATION SITE INFLAMMATION (Inflamed Injection Site after booster/Throbbing Injection Site after booster) and VACCINATION SITE PRURITUS (Itching Injection Site after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.9 fahrenheit (normal) 97.9 Fahrenheit.         Treatment medications was not reported.
vision problems in the right eye; her right eye is really swollen; red eye; hard to see; peripheral vision is obstructed; blotches in eye; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision problems in the right eye), EYE SWELLING (her right eye is really swollen), OCULAR HYPERAEMIA (red eye), VISION BLURRED (hard to see) and VISUAL FIELD DEFECT (peripheral vision is obstructed) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DULOXETINE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced VISUAL IMPAIRMENT (vision problems in the right eye), EYE SWELLING (her right eye is really swollen), OCULAR HYPERAEMIA (red eye), VISION BLURRED (hard to see), VISUAL FIELD DEFECT (peripheral vision is obstructed) and VITREOUS FLOATERS (blotches in eye). At the time of the report, VISUAL IMPAIRMENT (vision problems in the right eye), EYE SWELLING (her right eye is really swollen), OCULAR HYPERAEMIA (red eye), VISION BLURRED (hard to see), VISUAL FIELD DEFECT (peripheral vision is obstructed) and VITREOUS FLOATERS (blotches in eye) outcome was unknown.            Concomitant product also includes Birth control medication.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090307 (E2B Linked Report); Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090307:1st dose
fever, soreness to arm, red and swollen area distal to site of injection, aching body
Tiredness, dizziness, fever, brain fog, headache (not migraine), severe chills
Nausea, fever of 101.4,  headache, soreness in arm of insertion site. Treated with Tylenol. Resolved within 24 hours.
This spontaneous report as received from a certified medical assistant refers to four patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, injection, lot # L019297, expiration date 18-AUG-2017 (dose and route of administration were not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 f for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Per RN- At 1350 client stated "Slight numbness and tingling in both arms". No redness or swelling at injection site. At 1355, a coke was provided and tolerated well. At 1359, BP in left arm was 176/94, HR- 74, Lungs clear, Respirations- 20. At 1415, Numbness decreased to only in hands. At 1418, BP- 173/89, HR-71, Respirations- 18, Lungs clear, Client escorted to car by EMT.
Pain in right arm starting 3 days after vaccination. Still complains of shoulder pain and pain with certain motion today 8/30/18 pain worse in the evening/night.
I had a sore throat, nasal congestion, cough, and fatigue. I tested positive for COVID-19 at home. I spoke to my doctor and they prescribed me PAXLOVID.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot# K016129, expiration date 23-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
urticaria/erythema multiforme;began about 15MAR & is cont @ least through 27MAr
Spot on arm where I got the vaccine probably 4 days ago is continuing to increase in size and is red, swollen and hard; it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction; purple and red; continuing to increase in size and it is red and swollen and hard now; Made me really, really sick like bedridden for 2 days; Spot on arm where I got the vaccine probably 4 days ago is continuing to increase in size and is red, swollen and hard; This is a spontaneous report from a contactable Other HCP (patient). An unknown age and gender patient received BNT162B2 (lot# unknown) on Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient stated, "I just have a question, my Pfizer COVID Vaccine made me really, really sick like bedridden for 2 days which I am finding out is probably normal. But the spot on my arm where I got the vaccine, it was probably 4 days ago that I got it and it's continuing to increase in size and it is red and swollen and hard now. Like I am a Nurse Practitioner, this is not like a normal injection site reaction, it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction, should I be concerned, do I need to go to the hospital?" Outcome of the event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
My inner thigh had a horrible cramping that hurt so badly I passed out for over 5 hours and was completely soaked in sweat upon awakening in my living room floor. My thigh today 10/02 is still very sore to the touch and feels as if it will start cramping if I exert the muscle too much. If I had not been home alone I would have gone to the emergency room for help but I was afraid to drive myself and did not feel an EMS needed to be called. Muscle weakness in that leg has me limping today.
hives; This is a spontaneous report received from a contactable other health care professional, the patient. A 40-year-old female patient received first dose of BNT162B2 (BNT162B2) (Lot/batch no: = EN6208) via an unknown route of administration on 14Mar2021 at 11:30am for COVID-19 immunisation. Medical history and past drug history were not reported for the patient. The patient received Lo Lo Estrin FE Birth Control, QD within 2 weeks of vaccination. Allergy to Vicodin was reported. 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 and since the vaccination, the patient has not been tested for COVID-19. The patient's Lab Tests were not reported.  Patient experienced hives all over my low, mid and upper back as well as back of neck. The patient described the hives as raised, warm and painful to the touch similar to a severe sun burn.  The patient could not lay or apply pressure to the area. After 48 hours the hives first began to subside. No therapeutic measures included the use of a handheld massager on her back and neck, the same areas where hives developed. The clinical outcome for the event was reported as recovering/ resolving. No follow-up attempts are needed. No further information is expected.
ulcerative colitis; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).  This female patient of an unspecified received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at SINGLE DOSE for COVID-19 immunization. Medical history included she was allergic to sulfa. The patient's concomitant medications were not reported. She had ulcerative colitis and asked if that would impact anything. Outcome of the event was unkonwn.  Information on the lot/batch number has been requested.
Pt recv vax on 12/15/98; on 12/18/98 pt exp fever (105), irritability, rigidness, immobile
Moderna COVID-19 Vaccine EUA. Swollen lips and face, painful hives all over body on all limbs. March 20th, 2021, 10AM. Began itching 03/19/21 around 11pm.
Since the middle of September after my vaccination, I had woke up from nausea and threw up everything I had eaten before which was primarily undigested. The nausea and vomiting has continued since and the only thing that I can keep down is an English muffin. During the time in the hospital I projectile vomited. Last night I was woke up multiple times throughout the night, having the need to vomit., in which I did. So far today I have kept down my English muffin. When I went to see the internist, he stated he had seen this with Moderna vaccinations, however it is typically only a short term.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 25U/0.5 ml injection (lot#K005323, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified), lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Upper airway swelling; nasal plus sinus congestion; nasal plus sinus congestion; Rhinorrhea; acute sinusitis/sinusitis symptoms; This is a spontaneous report from a contactable physician. A 59-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 09Feb2021 (lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included asthma and takes inhalers as needed and environmental allergy and takes antihistamine both on unknown dates. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT); albuterol [salbutamol] (manufacturer unknown) and cetirizine hydrochloride (ZYRTEC), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 19Jan2021 for COVID-19 immunization and experienced sinus infection, dizziness, right ear aching, headache, pain in jaw, swelling of bottom lip, rhinorrhea and upper airway swelling. The patient experienced upper airway swelling and nasal plus sinus congestion on an unknown date in 2021. The patient also had rhinorrhea and acute sinusitis/sinusitis symptoms in 2021 which were treated with antibiotics. The events did not require a visit to the emergency department or hospitalization. The patient did not have anaphylaxis. The patient did not have any bilateral wheeze/bronchospasm, respiratory distress, dry cough, hoarse voice, difficulty breathing (without wheeze or stridor), sensation of throat closure or sneezing. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy) and RASH (rash on legs that looked like measles it is now spreading to neck) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced RASH PRURITIC (itchy) and RASH (rash on legs that looked like measles it is now spreading to neck). At the time of the report, RASH PRURITIC (itchy) and RASH (rash on legs that looked like measles it is now spreading to neck) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications provided. Treatment included diphenhydramine. Action taken with mRNA-1273 in response to the events was not applicable.
Immediately after vaccination, patient became very hot, pale and lethargic. We administered cold rag, checked patient temperature, gave cold water and monitored patient  for about 10 minutes.  Color returned and he began talking again.
This spontaneous report was received from certified medical assistant referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 30-NOV-2015 the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (Lot # 1014427, expiration date 09-MAR-2018) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.