chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe fatigue; Chills; Headache; Swollen lymph node on the left side of my neck; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 07May2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included quetiapine (MANUFACTURER UNKNOWN) 50 mg , cetirizine hydrochloride (WAL ZYR) 10 mg and famotidine (MANUFACTURER UNKNOWN) 40 mg; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GR8731) via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously received aspartame (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 08May2021 at 08:00, the patient experienced severe fatigue, chills, headache and swollen lymph node on the left side of her neck. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fatigue, chills, headache and swollen lymph node on the left side of her neck were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Experienced body aches; Tired; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 20Apr2021 at 16:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included controlled hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) 5 mg by mouth (PO) four times in a day (QD) and losartan (MANUFACTURER UNKNOWN) 50 mg by mouth (PO) four times in a day (QD) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 30Mar2021 at 15:45 as a single dose for COVID-19 immunisation. On 21Apr2021 at 06:00, next morning following second dose the patient experienced body aches and was tired. This lasted for approximately 6 hours, by that evening was back to base line. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches and was tired recovered on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient stated that in total 5 of them caught COVID-19 after cruise.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742650, US-MODERNATX, INC.-MOD-2023-742698.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2023: Upon on internal review 12-Oct-2023, significant correction was done to retain and process this case in the database as previously this case was incorrectly deleted. Hence deletion action item closed for this case and now case processed as valid case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742650:Same reporter, Different Patient US-MODERNATX, INC.-MOD-2023-742698:Same reporter, Different Patient
Information has been received from a registered nurse concerning a 65 year old female who was vaccinated on an unspecified date with a dose of Zostavax. Subsequently the patient developed a red and itchy injection site rash. The patient sought medical attention and was instructed to apply ice. The patient's symptoms resolved within 24 hours of onset. No further information was provided. There was no product quality complaint involved. Follow-up information has been received. The patient stated that she did not have a reaction and refused to fill out paperwork. No additional information is available.
Numbness in the left arm and left hand for about 2.5 days. Severity lessened as days progressed
feels really dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 12:30 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose, Upper left arm), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 25Mar2021, outcome "recovering", described as "feels really dizzy". Therapeutic measures were not taken as a result of dizziness. Additional information: It was reported that the patient was taking several pills a day and has been doing it for years but nothing relevant to dizziness. Patient wanted to know the event was a normal reaction with the vaccine. Patient had no other additional administered vaccines, no prior vaccinations within 4 weeks, and no family medical history relevant to adverse event  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse via vendor refers to a 2 patients of unknown age and gender. On 04-DEC-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (dose and route of administration were not provided). PNEUMOVAX 23 was found to be supported with in-house stability data. No adverse symptoms. Additional information has been requested.
Pt received Fluogen within 30 min experienced coma & Hypoglycemia; Blood sugar 20 mg/100 ml; No other reports of this nature on the lot.
swollen arm, red.  I had it sprouted and very hard.  with itching and pain
Sore arm, tiredness, and after I had my physical last month in October 2021, the doctor discovered that a part of my heart has enlarged.
Customer asserts that she experienced great pain as I administered a flu vaccine to her shoulder socket. She claims that she mentioned the pain to me and I told her to take Tylenol. I have been informed that this customer is currently seeking medical attention for weakness and numbness in her hand and has residual nerve damage from the flu shot that I admnistered.
Extreme rapid heart rate that caused intense heart palpitations, breathing issues that required inhaler use, insomnia & horrible nightmares
Large redness, painful are on L arm at injection site. Rx with steroids, Benadryl and antibiotics.
Severe runny nose, much like a allergy attack.  comes and goes several times a day.
Patient fainted a few moments after administering FLUCELVAX QUADRIVALENT vaccine. Patient has a history of seizures, but has been receiving the vaccine every year according to mother of the patient. Ambulance was called and they confirmed the patient's blood pressure dropped and will monitor her in the ambulance to make sure she is ok. Mom of the patient insisted on not going to the hospital.
Patient received Fluvirin in right arm on 9/13/10.  She began experiencing "pain" in right shoulder area "2-3 weeks" after immunization.  When questioned, patient described pain more as a stiffness in shoulder area and not a radiating type pain.  She states occurs approxiamtely 2-3 days per week.  Patient counseled to contact physician, and that issue may not be related to immunization, but would complete adverse event paperwork.
This spontaneous report as received from a pharmacist refers to himself. The pharmacist reports that some of the ZOSTAVAX (Lot# H019998, EXP January 2014) leaked on his own skin, when he was going to give it to a patient on an unknown date. No adverse effects occurred. Product quality complaint (PQC) was involved. It was unknown if the patient had sought medical attention. Additional information is not expected.
Pt recvd 2nd dose of vax & subsequently exp pain in arm that lasted for 1 day; applied ice pack to inject site;
Patient complained about throat tightness. Patient was closely monitored with vital signs taking. No medication administered
redness at injection site and upper arm/redness of upper arm; Swelling at injection site and upper arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in the right deltoid and experienced swelling, redness at injection site and upper arm. The reporter asked, how to processed with 2nd dose of Shingrix. The patient information was gathered.
0.5 ml dose given instead of the 0.25 ml. It was a  booster dose so it should have been 0.25ml.
Received MMRV, Hepatitis B, PCV, 2-3 days later developed diffuse varicella rash with fever, lethargy, pruritus. Went to ER and on 3/5/16 physician's office on 3/7/16. Placed on acyclovir.
The patient presented for admission with a new onset seizure as well as abdominal pain.  +Home test 2/25/22, prescribed Paxlovid by PCP.  The patient had a ct scan of the abdomen which showed only constipation and GI signed off.  The patient also had a ct scan of the brain and a MRI of the brain which showed no acute changes.  The patient also had an EEG as well with no seizure activity seen.  The patient was cleared for discharge by Neurology and the patient was directed not to drive for 6 months.     Admitted 2/26/22 - 2/27/22.  Moderna 2/16/21, 3/16/21 & 12/3/21
patients face developed blotchy red rash with erythema around mmr injection site, with hives on right arm and right leg. chest clear no oral/ facial/ tongue swelling noted.
cyst like boil appeared on back shoulder blade right side, then right upper arm then left upper arm and left above elbow
Vial was initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 and administered on 10-Mar-2022; Administered 3 vaccines beyond the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 3 vaccines beyond the beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 and administered on 10-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 3 vaccines beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 and administered on 10-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 3 vaccines beyond the beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 and administered on 10-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Vial did not undergo any temperature excursions.  No treatment medications were provided.   This case was linked to MOD-2022-566621 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Follow-up contains no new information.
booster dose was given to a 17 year old. only approved for 18 years and older. no adverse event reported so far.
83 y/o female, PMHx of arthritis, COPD, CAD, DM, GAD, HTN, hypercholestermia, and a pacemaker, admitted for weakness on 10/1/21. Pt does also have dementia. Pt presented with O2 sat of 87% and with an associated cough. Chest x-ray shows bilateral, patchy infiltrates. Pt treated with Decadron, aspirin, Lovenox, and breathing treatments. Also treated with Vancomycin and Zosyn for bacteremia. Pt was discharged with Home Health on 10/4/21.
1st attempt to administer dose intradermally was unsuccessful. No wheal produced. 2nd dose was administered approximately 2 inches away from previous site which produced a wheal.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not provided. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lots # K026532 exp date 06-MAY-2017, L042257 exp date 17-AUG-2018, M001811 exp date 04-NOV-2018 and M020101 exp date 07-MAR-2019) (dose and route not reported) for prophylaxis. The vaccines were exposed to 33.8 Fahrenheit degrees for 1 hour 25 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. As of 06-FEB-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001950: US-009507513-1612USA001951: US-009507513-1612USA001952: US-009507513-1611USA009104.
tested positive for the COVID-19 Virus on 27Mar2021; This is a spontaneous report received from a contactable consumer (husband). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) at 51 years old as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history was none. There were no additional vaccines administered on same date of the pfizer suspect. Prior Vaccinations (within 4 weeks) was none. Concomitant medications were not reported. The patient wife tested positive for the COVID-19 Virus on 27Mar2021, and on 02Apr2021, his wife had the monoclonal antibodies to treat the COVID-19 Virus. The patient did not receive her second COVID-19 Vaccine dose at this time. She had a really bad experience with the COVID-19 Virus. Reporter clarified the patient spent the day in the hospital Emergency Room, and was not admitted to the hospital. The husband wanted to get to the bottom of this, and get his wife fully vaccinated. The patient went to the Emergency Room on the morning on 27Mar2021, and was in the Emergency Room at the hospital all day. The doctors got the patient breathing, saying the doctors did whatever they do. She was discharged home from the hospital Emergency Room late in the day on 27Mar2021. On 02Apr2021, the patient had the monoclonal antibodies given to her. She received only one treatment of the monoclonal antibodies, and recovered completely from the COVID-19 Virus. The patient had no side effects from her first COVID-19 Vaccine dose. Diagnosed with COVID-19 Virus required a visit to Emergency Room and Physician Office. The outcome was recovered.   Information on the lot/batch number has been requested.
Vomiting; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Aches) in a 54-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Aches). At the time of the report, VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Aches) outcome was unknown.            Concomitant medications were not reported.  The treatment information was nit provided.   This case was linked to MOD-2021-362105 (Patient Link).
NECK PAIN; BODY ACHES; BURNING SKIN; POSSIBLE SINUS INFECTION; POSSIBLE DOUBLE EAR INFECTION; FAST HEART RATE; SHORTNESS OF BREATH; SPLITTING HEADACHE; FATIGUE; DIZZINESS; VISION CHANGES; POOR SLEEP; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasovagal syncope, postural orthostatic tachycardia syndrome, atypical asthma, ehlers-danlos syndrome, attention deficit hyperactivity disorder, hallucinations, and no allergies or reactions to previous vaccination. The patient experienced drug allergy when treated with hydrocodone for drug used for unknown indication, and drug allergy when treated with salbutamol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, treatment medications included: levosalbutamol. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced vision changes. On 10-MAR-2021, the subject experienced poor sleep. Laboratory data included: Blood pressure (NR: not provided) 102/60 mmHg, and Pulse rate (NR: not provided) 72 pm. Treatment medications included: paracetamol. On 10-MAR-2021 22:00, the subject experienced splitting headache. On 10-MAR-2021 22:00, the subject experienced fatigue. On 10-MAR-2021 23:30, the subject experienced fast heart rate. On 10-MAR-2021 23:30, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced possible sinus infection. On 11-MAR-2021, the subject experienced possible double ear infection. On 11-MAR-2021, the subject experienced burning skin. On 11-MAR-2021 03:00, the subject experienced neck pain. On 11-MAR-2021 03:00, the subject experienced body aches. On 11-MAR-2021 07:45, treatment medications included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and splitting headache on 11-MAR-2021, and dizziness, and vision changes on 10-MAR-2021, was recovering from fatigue, burning skin, and possible double ear infection, had not recovered from fast heart rate, possible sinus infection, body aches, and neck pain, and the outcome of poor sleep was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
After receiving the first covid vaccine I started having terrible stomach pain after eating certain foods and violent vomiting. The stomach pain felt as strong as appendicitis. After several bouts of this I did a good elimination process and found that I could no longer tolerate stabilizers or thickener additives such as xantham gum, guar gum, carrageenan etc.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.
Vaccine given on 10/22/18 at 145 pm. Patient began with erythema and pain to left deltoid area at 4 pm. She took "2" VISTARIL at 6 pm without symptom improvement. She took "2" VISTARIL again at 2 am on 10/23/18 without symptom improvement. Site is erythematous, warm, tender, hived. Cold compress and BENADRYL 50 mg given by mouth. Patient then went to the ER with her mother.
Patient had Vasovagal reaction. V/S 130/70 MMhG, o2 sat @97% on room air, pulse 60 bpm. Patient's family member requested for ambulance, endorsed to AMR with V/S 130/70 MMHG, Pulse 75, o2 sat @97% on RA. Denied any respiratory discomfort.
Sore throat,  congestion and headache 3-4 days after vaccine was given - Mom states this occurred each time GARDASIL was given.
Immediately after injection, a small hard lump formed at injection site. Had patient sit for ~20min, patient started to feel a little dizzy, unsure whether it is from the vaccine itself or nervousness from the lump. Lump softened in ~20min but was still there, patient was feeling okay after some rest and went home. Patient did not want ambulance to be called.
Sour tinge in mouth; Tingling arms or fingers; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 36-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "Sour tinge in mouth"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling arms or fingers".  Additional Information: The patient had sour tinge in mouth immediately and tingling arms or fingers following vaccination. The patient was asking if should receive second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.