chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness in arms and legs; shortness of breath; she felt terrible; achiness; energy level is just no energy; chills; could not walk across the room; This is a spontaneous report received from a contactable consumer (patient). An 81-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder upper arm from 13Mar2021 02:00 to 13Mar2021 02:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No family history. No additional vaccines administered on same date. No Prior Vaccinations within 4 weeks. Patient received 1st dose of the Pfizer COVID vaccine on 13Mar2021 and experienced side effects on 31Mar2021. She mentioned that she could not walk across the room (2021) due to shortness of breath that began 31Mar2021 and was ongoing and about the same, her temperature was not high, down by 1 which would then be the onset of her chills (2021) which would come and go, just like a roller coaster, she felt terrible, had achiness, could not decide what to eat, and would feel better for 2-3 hours but felt bad right away. She mentioned that she felt just terrible and that all she wanted to do was die. Patient had whole body aching that was off and on since 31Mar2021 and not it finally diminished starting yesterday; she had weakness in her arms and legs that began not right away but on 04Apr2021 and was better; her energy level was just no energy and it started on 31Mar2021 and ran through 05Apr2021 and thank goodness the energy finally came back and she is finished now with that and feeling better since yesterday; she felt better but that only lasts 2-3 hours and she felt bad again and the chills start in again. She mentioned that she took acetaminophen and ibuprofen for the achiness, whenever needed. Patient stated she had no treatment, no visit to the HCP or emergency room and just took acetaminophen and ibuprofen and did not know when the took them but it was just in that timeframe. This morning, she had Gatorade to regain electrolytes and felt energized. As of calling, she was finally been feeling better and ally symptoms have decreased. AEs did not require a visit to ER or MD office. Outcome of shortness of breath was not recovered, outcome of achiness and weakness in arms and legs was recovering; outcome of other events was unknown. No investigation assessment.  No follow-up attempts are needed. No further information expected.
The colitis has been controlled with Simponi for 5 years/had a flare up with rectal bleeding; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received dose 1 of bnt162b2 (covid 19 VCCINE; manufacturer not reported), via an unspecified route of administration, administered in left arm on 22Mar2021 11:15 (Batch/Lot Number: EP6955 6023162) as SINGLE DOSE for covid-19 immunization. Medical history included hemophilia B and ulcerative colitis. The colitis has been controlled with Simponi for 5 years. The patient also had sulfa allergy since an unspecified date. 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. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included multivitamins taken for an unspecified indication, start and stop date were not reported; and golimumab (SIMPONI) taken for an unspecified indication, start and stop date were not reported.  On 24Mar2021 22:30, the patient had a flare up with rectal bleeding had a flare up with rectal bleeding. He had to infuse with factor (BENEFIX) overnight and also take prednisone he had on hand. He will see the GI doctor tomorrow. The outcome of event was unknown. The reporter considered the event as serious, life threatening.   Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Information has been received from a Registered Nurse concerning a 14 month old male child who on 09-APR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine inadvertently instead of PREVNAR. This was reported as human error. No adverse event reported. The outcome was unknown. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given 7 days past beyond use date of 23-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given 7 days past beyond use date of 23-Jun-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given 7 days past beyond use date of 23-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given 7 days past beyond use date of 23-Jun-2022). No concomitant medications were reported. It was reported that vaccine was given 7 days past beyond use date of 23-Jun-2022. The moderna was contacted and the lot was analyzed. It was stated that as per moderna this lot was still active and patient was not needed to be revaccinated. No treatment medications were reported.
About 6 hours after vaccination woke up and had to go to urinate, felt heart racing, aching as if it was going to get the flu. Also felt like someone hit him in the shoulder with a sledge hammer and couldn't put weight on the left shoulder. In the next couple of hours had to go urinate multiple times--8 times; felt incontinent, also achy and weaklike flu-like symptoms. Patient did not have fever and did not take any medicine. Next day, went to work, ate something light and drank water because felt dehydrated. Patient worked a full day, during the day felt nauseous, weak, thirsty, and spaced out/disoriented. Patient almost had to stop working because he felt so nauseous but symptoms subsided by the end of the day. Left shoulder and arm was sore and uncomfortable. Patient took 3 Advil but did not seem to help that much. Patient's vision was a bit blurry because noticed glasses were not enough. Patient did not feel worse than in the morning so was hesitant to call doctor on Friday. On Friday ate light, drank more water because felt dehydrated, felt better but still queasy/lightheaded, and had soreness on shoulder; went to sleep early--around 5:15pm. Patient slept until next morning on and off until 8:30am. On Saturday ate and went about the day but still felt off; took 3 Advil and no improvement. Saturday went to bed early again since had to work on Sunday. On Sunday, felt a little better, arm was sore, felt queasy/unsettled but felt better; patient did not take Advil that day. By Monday there was improvement but still felt soreness on left shoulder but mostly back to normal.    Today, almost 2 weeks later patient is feeling back to normal. After first dose of SHINGRIX, had soreness on shoulder but nothing that stands out as unusual.
2 DAYS AFTER VACCINE, LEFT THIGH WAS RED AND SWOLLEN TIMES 1 DAY. MOM GAVE TYLENOL AND COOL COMPRESS
Pt had localized soreness and edema at injection site 1 day after receiving shot. Pt reported splotchy redness and warmth to face and left arm (injection site). Pt also reports fever of 100.3F for 3-4 hours with fatigue, body aches, chills, nausea and decreased appetite X 1 day. Pt c/o seeing spots after getting out of bed 3 days after shot.
Upset stomach; lower abdominal cramps; back ache; Pain at the injection site; tireness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 09Apr2021 at 10:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously took Epinephrine (MANUFACTURER UNKNOWN) started on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 06:30 the patient experienced upset stomach, lower abdominal cramps, back ache, pain at the injection site and tiredness. No therapeutic measures were taken as a result of the reported 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 the events upset stomach, lower abdominal cramps, back ache, pain at the injection site and tiredness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Up to 60 hours after the booster, I got a major headache like my head was cracking; uncontrolled chills; extreme fatigue; unable to do anything. Then I had 3 weeks of fatigue, constipation and light headedness. I still am having problems getting motivated. Not back to normal 21 day later.
SIDS; well visit; no illness @ time of exam; @ sitter's found around noon cold & blue; CPR started & taken to ER: autopsy results consistent w/SIDS:
The patient had vaccination, 3 days after her injection she noted a rash in her lower extremities, severe abdominal pain, and diarrhea followed. She saw an immunologist on 11/07/00. The doctor did a skin test  ( had throat swelling). Diagnosed with hypersensitivity vasculitis from the Flu vaccine. Recurrence more rash in the upper abdominal area, pain, diarrhea on 11/09/00. Finally the patient was admitted on 11/11/00 for 3 days.
presented in ER w/t39.9 R; mom reported having immun earlier in the day 5APR95; mom reported slept most of the day & had dec appetite; denied nausea/vomiting; taking fluids; diarrhea stool x1; orange in color;
Individual was given Johnson & Johnson COVID-19 Vaccination at age 16 years and 10 months when it is currently licensed for use in individuals ages 18 and older.
I began having hives 11 days after receiving the booster.  The hives have not improved very much to date but seem to be getting better.
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown. The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
After two weeks notice swelling on Face, Lips , After couple days swelling on Tongue and Finger  Break out of Hives like Ulticaria
CHEST PAIN; MIGRAINES; STOMACH PAIN; DIARRHEA; SWELLING IN BOTH LEGS; BLURRED VISION; CHILLS; PAIN IN BOTH LEGS; TIRED FEELING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection (twice), and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AZ1A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced chest pain. On 10-MAY-2021, the subject experienced migraines. On 10-MAY-2021, the subject experienced stomach pain. On 10-MAY-2021, the subject experienced diarrhea. On 10-MAY-2021, the subject experienced swelling in both legs. On 10-MAY-2021, the subject experienced blurred vision. On 10-MAY-2021, the subject experienced chills. On 10-MAY-2021, the subject experienced pain in both legs. On 10-MAY-2021, the subject experienced tired feeling. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, migraines, stomach pain, diarrhea, blurred vision, chills, pain in both legs, tired feeling, and nausea on 10-MAY-2021, was recovering from swelling in both legs, and the outcome of headache was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
On 8/8/08 pt received TDAP and Varicella in right arm.  Varicella was given IM instead of SQ.  Noted 20 X 30 mm nodule with redness, edema, warm to touch to both sites.  I notifed immunization organization of the incident.  Dr. ordered Tylenol, ice, and Benadryl for treatment.
Attempting to confirm which COVID 19 vaccine was given (Moderna or Pfizer). They did not send the record when they sent the patient to General ER the next am.  Did not answer the phone.
This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 26-JUL-2017, the patient was vaccinated with a dose of PROQUAD for prophylaxis, which was outside of the recommendations in the vaccine prescribing information (inappropriate schedule of drug administration). No adverse effects were reported. This is one of the two reports received from the same reporter (MARRS# 1707USA011306). Additional information has been requested. Sender's Comments: US-009507513-1707USA011306.
L deltoid red, swollen, tender x 2 days DX: Cellulitis Treatment: Z-max 200mg, Cool compresses
This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneous (lot # and expiration date were not provided). The doses were exposed to temperatures of -9.5 degrees C for 1 hour and 43 minutes, and then were administered. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
felt faint; felt faint and ill; This case was reported by a consumer via call center representative and described the occurrence of felt faint in a 61-year-old female patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th March 2021, the patient received Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. On 10th March 2021, less than a day after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced felt faint (serious criteria GSK medically significant) and feeling unwell. On an unknown date, the outcome of the felt faint and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the felt faint and feeling unwell to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. After being vaccinated the patient felt faint and ill. The patient was transported to the emergency department (ED). Symptoms have since resolved. The reporter did not consent to follow-up.
The day after receiving vaccine, a sore dime-sized red raised area developed.  Each day the area has increased. Today the area is about the size of a slice of bread, red, slightly raised and tender to touch; The day after receiving vaccine, a sore dime-sized red raised area developed.  Each day the area has increased. Today the area is about the size of a slice of bread, red, slightly raised and tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 16:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included ovarian cancer, thyroidectomy and wasp bites. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), rucaparib camsylate (RUBRACA), warfarin sodium (COUMADIN), exemestane (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 04Feb2021 at 16:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation and received cefaclor (CECLOR) and  chlorhexidine topical scrub (MANUFACTURER UNKNOWN); both on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 12:00, the day after receiving vaccination, the patient experienced a sore dime-sized red raised area developed. Each day the area had increased and at the day of reporting (Today) the area was about the size of a slice of bread, red, slightly raised and tender to touch. It looks similar to a response to wasp bites she had several years ago. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events a sore dime-sized red raised area and the area was about the size of a slice of bread, red, slightly raised and tender to touch was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Approximately 30 minutes after receiving vaccine dose #1 patient described tight feeling in throat and appeard to have slight red area to chest. No difficulty breathing- EMS at location and performed a full assessment.
Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest and fluids, acetaminophen started at 0400 am on 1/6 symptoms started to resolve by 2000 (8pm) on 1/6
itchiness and redness at site of injection; Redness at site of injection; Pain at injection site for 5 days; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness and redness at site of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection), VACCINATION SITE PAIN (Pain at injection site for 5 days) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A27A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals (Has anaphylactic (6 days out) after deep injections lidocaine.). Concomitant products included METOPROLOL, CLONIDINE and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site for 5 days) and HEADACHE (headache). On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness and redness at site of injection) and VACCINATION SITE ERYTHEMA (Redness at site of injection). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and DIPHENHYDRAMINE (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchiness and redness at site of injection) had not resolved, VACCINATION SITE ERYTHEMA (Redness at site of injection) and HEADACHE (headache) outcome was unknown and VACCINATION SITE PAIN (Pain at injection site for 5 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
2 days after vaccination, pt developed right sided chest pain, swelling  and tenderness. It resolved after 4-5 days and he thought he was better. Then two weeks after the vaccination he developed tiredness, and cough, that lasted for several weeks until pt presented to hospital on 8/17/21. He was admitted for full cardiac workup due to extensive cardiac hx, and elevated cardiac enzymes.
The pt experienced blisters, rash, hives to the left leg and left arm which were also red, warm to the touch. Mom states some new redness and swelling at the site. Not anything like the present reaction. Treated with Benadryl.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 79-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 29-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Fever with seizures, rash occurred apprx 9 days after immunizations given. Symptoms resolved completely. No treatment.