chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration on the left arm on 20Mar2021 at 13:00 (at the age of 52-years-old) as a single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included probiotic (MANUFACTURER UNKNOWN), ZYRTEC and multivitamin (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration on the left arm on 27Feb2021 at 13:30 (at the age of 52-years-old) as a single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced fever, chills, headache, body ache, stomach pain, fatigue, tingles in finger tips, sleepy (slept for hours), body sensitive to touch and puffy eyes on 21Mar2021 at 06:00. Treatment was not received for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events fever, chills, headache, body ache, stomach pain, fatigue, tingles in finger tips, sleepy (slept for hours), body sensitive to touch and puffy eyes were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a medical assistant concerning a male child who in August of 2005 was vaccinated with a subcutaneous injection of 0.5 milliliters of varicella virus vaccine live (Oka/Merck) (lot# 647719/0194P). On approximately 10-JUN-2007, the patient developed a varicella rash. It is unknown how may lesions the patient developed or if the patient had any other symptoms. It is also unknown if the patient received 1 or 2 doses in the past. Unspecified medical treatment was sought. No outcome was reported. The facility is requesting a lot check be performed. No product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient concerned a male 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 not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Patient states that she had no issues with her injection site the day of the vaccine.  The next day she did have bruising, a bump at the injection site and warmness around the bump.  She states that it was very painful for about 7 to 10 days and she had trouble with arm mobility.  Those issues had disappeared for a while until about a week ago (31 days post injection), when she started noticing pain again in the injection area.  Last night she noticed a small lump in the injection site and it is tender to palpitation.  The lump was noticed to be smaller than the original bump that she discovered a month ago, but she is still experiencing pain in that area today.
Arthralgias, myalgias, fatigue from 24 hours after vaccination through now. Pt still has symptoms. Last office visit 9/18/07.
AE: patient feeling light headed and dizzy upon vaccine administration. Patient states that she has not eaten anything this morning prior to the vaccine. Patient also states that she feels nervous and sweaty. Treatment: patient was placed on the Trendelenburg position as well as offered water and crackers. after few minutes, patient stated she no longer feels light-headed or dizzy. outcome: Patient was discharged to /Home.
Fever of 102.6, body aches, chills, tiredness, headache, pain at injection site,  coughing.
She started feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She started feeling dizzy) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced DIZZINESS (She started feeling dizzy). At the time of the report, DIZZINESS (She started feeling dizzy) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had started feeling dizzy and it lasted for quite long.  She said that the reaction happened with lot of her medications also.  Concomitant medication including Sleeping Pills was reported.  Treatment  included therapy and exercise .
FLU SYMPTOMS; HURT IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu symptoms, and hurt in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms, and hurt in arm. This report was non-serious.
OB Doctor diagnosed me cervical cancer and positive for HPV multiple strands including 16 and 18.
Right arm soreness and fever x 24 hours. Additionally experienced numbness and tingling of right arm to right fingers, mild pain in finger joints.
Information has been received from a pharmacist concerning a currently 75 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU, lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014127: US-009507513-1611USA014128.
pt devel lt parotid swelling 1 day p/vax;no fever;
Loss of consciousness for approximately 5 sec with quick recovery. Observed in clinic for 30 min with no farther reaction. BP checked and patient checked by MD. MD discussed with father -"syncope can happen after injection observe for recurring symptoms, call clinic promptly or call 911 with emergent concern at home". Taken from Dr's note on incident. Dad referred understanding.
Muscle sore radiating to the left lower body. "It hurt periodically, not constant."
Pt has complaints of fatigue, chills, shortness of breath, cough, and has been symptomatic for the past 5 days. He is admitted to the hospital with COVID, right lower lobe pneumonia, and acute on chronic respiratory failure with hypoxia.
Headache, Arthralgia, Injection site pain and swelling, nasal congestion Narrative:
Patient presented to a clinic owned by another system on 3/11 and received a covid vaccination.  On 3/25 and 4/15 she presented to our clinic stating she had not been previously vaccinated for covid and requested both her first and 2nd dose vaccinations.
felt lazy; felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LAZINESS (felt lazy) and FATIGUE (felt tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LAZINESS (felt lazy) and FATIGUE (felt tired). At the time of the report, LAZINESS (felt lazy) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-046313 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046313:cosslinked
Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Significant discomfort or pain in right arm; Rash on face and neck; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in right arm, on 05Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish, dust mites, cats, cockroach dander, grass, trees, and pollen. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). 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. The most recent COVID-19 vaccine was administered in a hospital. On 05Jan2021, the patient experienced redness and hard lump at injection site, warm to touch (no site reported), significant discomfort or pain in right arm, and rash on face and neck. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
Guillain-Barré syndrome. Started with a very bad headache and one eye ceasing to move, loss of vision followed as well as descending paralyzation. Build up of spinal fluid causing my brain to push against the front of my skull in turn pushing against the back of my eyes affecting my vision and causing permanent damage to my brain and eyes.
Patient had pain and rash from injection of vaccine - itchy red spotted rash - pain/bruise at deltoid. Rash on forearm.
This spontaneous report as received from a nurse refers to a 17 year old female patient. On 16-JUN-1997, 08-AUG-1997 and 26-MAR-1998, the patient was vaccinated with the first, second and third dose of RECOMBIVAX HB respectively (0.5 ml, intramuscular, left arm), (lot # and expiration dates were not provided). Other suspect therapies included the first and second dose of VARIVAX (Merck) (dose, route, lot #, expiration date and dates of vaccinations were not provided). On 07-JAN-2015, the test for Hepatitis B surface antibody was negative. Therefore, a fourth dose of RECOMBIVAX HB was administered on the same date. In addition the nurse also reported that the test for VARIVAX (Merck) failed to seroconvert so another dose of VARIVAX (Merck) 0.5 ml, (subcutaneous, left arm), was given on that same date. No adverse effects reported. At the time of the report the outcome of Hepatitis B surface antibody negative and seroconversion test negative was unknown. Additional information has been requested.
developed 3 inch diameter raised, hard, red lump at injection site that was hot to the touch and very painful - condition persists after 2 days
Tightness in chest, loss of appetite, anxiety, night sweats, uneasy feeling, all mainly before bed.  tightness in chest and anxiety continue.  Breathing exercises help.
Patient had never received flu vaccine prior to today and had never had a previous reaction to a vaccine before. Patient instructed to stay in my location for 15 minutes after injection per policy. Patient administered vaccine at 7:42am in right arm and walked over to an area behind my work table to sit on a couch (about 10 feet). Patient fainted/passed out at 7:48 am while seated on couch. No injury occurred at any time. Patient reports feeling "like he was falling asleep really fast" and had a head rush prior to fainting. Upon becoming aware of his surroundings, he remained jittery and had feelings of anxiety. He reported no issues with breathing or constriction of airway. Patient had very little to eat for breakfast one hour prior and so we gave his a little orange juice orally at 7:55am. At 8:00 am patient vomited x2 while still seated. Heart rate was steady at 68 bpm and respiratory rate of 16. Lips were pale as was skin. Patient's hands were shaking but he was talking and describing his symptoms. At 8:15 am, patient laid down with his legs elevated on the couch. He felt this made him feel worse again and so he sat back up at 8:25 am. Patient continued to improve over the course of the next 40 minutes and reported feeling 90% or better and could return to work. He was advised to remain with another person for the duration of his day if he was able to stay at work. If he felt like he needed to go home, he was instructed to only go home if he was with another person and to have that person drive him. I will follow-up with him in the afternoon.
Flu like symptoms such as shaking, chills, and fatigue. The same thing happened with the first dose.
Subject was given three injectable vaccines for pre-departure travel on 2/28/2007.  Within one hour of injections, sudden symptoms of "tingling fingers", "racing heart", rapid breathing, nausea began.  Over 24 hours, symptoms worsened to vomiting at intervals.  Denies hives, itching, swelling or difficulty breathing. After 24 hours, symptoms subsided but subject was very weak.  Client was seen again on 10/30/07 wherein these symtpoms were discussed.  Client was given Influenza and hep A vaccinations on 10/30/2007 and observed for 15 mintues with no side effects observevd.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 66-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 an unknown indication.    No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-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) Discontinued. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Redness developed and continued to spread approximately 5 inches below injection site up to her shoulder.
At 2:58 pm, Pt. reported feeling light headed and her vision getting blurred. Pt was alert and oriented X4, BP=137/82, hHR=88 , RR=22. Pt. was laid on a flat surface, legs were raised, cold ice pack applied at the back of the neck, slow deep breaths were encouraged and performed.  at 3:02 pt reported symptoms had subsided, pt. was offer room temperature water and observed further for 20 minutes. At 3:39 pt. was d/c home in a stable state with mom.
Possible adm of vial 1 was given to pt. , not discovered until after 5 doses were administered from box. unable to determine which pt. did not get mixed dose
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with VAQTA (lot # L008665, expiration date 10-FEB-2017; lot# K012457, expiration date 04-JUN-2017; lot# L004743, expiration date 01-JUN-2017); (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
persistent paresthesias lt shoulder & forearm x 7-9 days;rx NSAID, soma;
p/vax pt noted itching rt upper arm medial aspect above antecubital site late afternoon;this AM 7.5 x 8.3cm area of redness, swelling & warm to touch;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 3:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 3:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.61.  Concomitant product was not provided by the reporter.  Vial underwent temperature excursion with temperature of 35 at 08 AM, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. Vaccine BUD date was 26-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken 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.  It was reported that the patient was 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 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Red arm, very warm site, pain in arm, then splotchy itchy arms and neck continuing for over a week.  On week 2 now of continuing symptoms.  Puffy face.
I received my second dose of the moderna vaccine 4/15/21. On 4/18/21, I noticed I had some hives on my trunk and neck/jaw area. I am still having flare-ups today but am able to manage them with benadryl and hydrocortisone cream.
Pt came into the clinic requesting dose #1 .  He was acting nervous & claustraphic (not wanting to be inside).   I did not check the state system to see whether or not he had received prior doses before administering the vaccine today.  It wasn't until afterwards that it was determined that he had received Phizer on 2/8/21 & 3/1/21.    He received the 3 rd dose today.   He was feeling fine when he left the clinic after observation.
This spontaneous report was received from a physician assistant via a company representative concerning 42 year old male patient. Approximately on an unknown date in April 2013 (reported as about 6 months ago), the patient was vaccinated with a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in 2013, after the vaccination, the patient developed a measles rash with koplik spots and a fever. On an unknown date prior to vaccination, titers were performed that showed the patient did not have immunity against measles, mumps and rubella. The patient sought medical attention (called physician office). It was unspecified if any treatment was given or if any lab test were performed after the vaccination. The outcome of the events was unknown. The relatedness for a measles rash with koplik spots and a fever was unknown for MMR II. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 17-OCT-2017, the patient was inadvertently vaccinated with PROQUAD injection, via subcutaneous route, lot # reported as M044032 with expiration date on 03-JUL-2019 (dose was not reported) and not the intended M-M-R II. No adverse effects were reported. Lot number M044032 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
Uncontrollable eye twitching/ blinking of both eyes. No outcome as of yet, looking for answers...