chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; dose of VAQTA was administered after its labeled expiry date; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.       On 02-MAR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T017179, expiration date 26-OCT-2021 for prophylaxis (dose #, exact dose, route of administration and anatomical location were not provided) (expired vaccine used).The vaccine did not experience any temperature excursions. The reporter provided the non-supported disclaimer based on the post expiry memo. No additional adverse event reported (no adverse event).
metallic taste in my mouth; got very light headed; tingly; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in my mouth), DIZZINESS (got very light headed) and PARAESTHESIA (tingly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced DYSGEUSIA (metallic taste in my mouth), DIZZINESS (got very light headed) and PARAESTHESIA (tingly). At the time of the report, DYSGEUSIA (metallic taste in my mouth), DIZZINESS (got very light headed) and PARAESTHESIA (tingly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
FEVER 100.3 KNEE SWOLLEN, TENDER, ERYTHEMA, PAINFUL TO EXTEND, PAINFUL TO AMBULATE THAT OCCURRED 2 DAYS AFTER VACCINE IN THAT THIGH. XRAY SHOWED SWELLING BUT NO BONY ABNORMALITY. BLOOD CULTURE NEGATIVE.
Left upper arm stated to get red, swollen and hot. Started at the vaccine administered area but spread and grew all around the arm. Per hospital it created a cellulitis.
Patient received Janssen vaccine on 3/26/21.  States she had a headache on day one of receiving vaccine and progressive neuro symptoms afterwards.  Went to UC 4/14/21 with facial drooping, left side weakness.  Sent to ED and airlifted to hospital.
pt recv vax 22MAY96 & pt was exposed to wild-type varicella;6JAN97 pt devel an atypical case of breakthrough chicken pox consisting of less than 50 lesions that were mildly itchy;sx required a visit to MD on 6JAN97;
Experiencing like runny bowel movement; diarrhea; This is a spontaneous report from a contactable consumer (parent). A male patient (reporter's son) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 13Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Caller wanted to know about side effect from the second dose of Pfizer vaccine and wondering if this was happening because of the vaccine. On an unspecified date in Jul2021, the patient experienced experiencing like runny bowel movement, diarrhea. The outcomes of events were unknown.  Information on lot/Batch number has been requested.
Developed cellulitis and associated axillary lymphadenopathy over left deltoid area on Day seven after vaccine.. Also developed herpes labialis 3 days after vaccine
Hives started to appear on neck, chest, abdomen, back, legs, & arms.
felt so cold; became sick; kidney pain; very weak; headache; kind of tired; vomited which smelled like rotten eggs; body aches; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 043A21A /045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak), HEADACHE (headache), FATIGUE (kind of tired), VOMITING (vomited which smelled like rotten eggs), MYALGIA (body aches) and ARTHRALGIA (joints hurt). At the time of the report, NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak), HEADACHE (headache), VOMITING (vomited which smelled like rotten eggs), MYALGIA (body aches) and ARTHRALGIA (joints hurt) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Patient went to doctor says this may last a week. Patient had missed two days of work.  Action taken with mRNA-1273 in response to the events was not Applicable
Digestive upset; symptoms of muscle aches; Chills; Intense headache; Fever peaking at 100.2; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ZR8734) via an unspecified route of administration in the left arm on 06Apr2021 at 17:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included ethinylestradiol; levonorgestrel (ASHLYNA) from an unknown date for birth control. senegalia Senegal; ascorbic acid; betacarotene; calcium carbonate; calcium pantothenate; calcium silicate; cellulose microcrystalline; colecalciferol; croscarmellose sodium; cyanocobalamin; dextrin; dl-alpha tocopheryl acetate; ferrous fumarate; folic acid; gelatin; glucose; hypromellose; lecithin; macrogol; magnesium oxide; magnesium stearate; nicotinamide; pyridoxine hydrochloride; retinol acetate; riboflavin; silicon dioxide; starch; thiamine mononitrate; titanium dioxide; zinc oxide (ONE-A-DAY WOMEN'S) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 15Mar2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. 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 07Apr2021 at 07:00 the patient experienced the symptoms of muscle aches, chills, digestive upset, intense headache, and fever peaking at 100.2 (UNSPECIFIED UNITS). The patient did not receive any treatment for the 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 stomach upset, muscle ache, chills, headache, fever was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient reported having reaction to flu shot in past so was being monitored closer. Upon her completion of 30 min observation, patient felt lump on throat, slight pain to touch on upper chest, slight headache, some redness to chest area and arms. Patient came prepared and took 25mg of chewable Benadryl at 10:13am, two minutes after symptoms began. 20 minutes later lump on throat was gone and redness to skin had disappeared. Symptoms resolved, patient was monitored for an extra 15min, asymptomatic upon leaving, had husband waiting outside to drive her home. Patient has EpiPen and understands if any sx return, chest pain, trouble breathing, should go to ED.
Nephrolithiasis - CT abdomen/pelvis showed: Stable 0.7 cm right mid ureteral calculus with associated moderate-severe right hydronephrosis and proximal ureterectasis. PROCEDURES PERFORMED:   1.   Cystoscopy.    2.   Retrograde pyelogram.    3.   RIGHT ureteral stent placement (6-Fr, 28 cm) UA was grossly positive and he was treated with ceftriaxone.  Electrolyte abnormalities were repleted as appropriate. Nephrology was on board.  Due to persistently depressed renal function, patient was commenced on dialysis. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Red blotches on neck, itching, dizzy, arm "flaming red," trouble breathing, blisters on lips, eyes swollen.
Information has been received from a physician concerning a 20 week old male who on 07-FEB-2007 was vaccinated with a second dose of Rotateq. Approximately three weeks later, on 27-FEB-2007, the patient experienced three days of severe diarrhea and fever. Subsequently, on 12-MAR-2007 and 13-MAR-2007, the patient's mother brought the patient to the office because the child was experiencing fever, vomiting, and diarrhea. Also the patient's "stool was very foul smelling." Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a 79 year old male patient. The patient's concurrent conditions included drug reactions/allergies to penicillin. The patient had no pertinent medical history. On 07-DEC-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous, lot # L032399 with expiration date 26-NOV-2016. The patient was not taking concomitant medication. The reporter stated that, on 14-DEC-2015, the patient developed an itchy rash on the right side of his waist which spread to the left side and then his face. The patient was administered prednisone (manufacturer unknown) on 14-DEC-2015. No lab diagnostics studies were performed. The outcome of rash pruritic was reported as recovered, on an unspecified date. The reporter did not assess the relatedness between rash pruritic and ZOSTAVAX. Additional information has been requested.
Temp up to 100.3; Body aches; Nausea; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 12Jan2021 11:00 at a single dose on right arm for COVID-19 immunization. Medical history included Hypothyroidism and allergies to Latex, Cephlosporins, Kiwi. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 22Dec2020 11:00 AM at a single dose on right arm for COVID-19 immunization. The patient experienced common listed side effects, Temp up to 100.3, Body aches; Not Listed as common, Nausea on 13Jan2021 16:30. No treatment received for the events. The outcome of the events was recovering. The events were considered as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was the Nursing Home/Senior Living Facility. 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 has not been tested for COVID-19.
This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 05-FEB-2018 the patient was vaccinated with improperly stored PROQUAD lot # N020620, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 127 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
3 weeks after receiving the vaccine, the patient got COVID and was very sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (3 weeks after receiving the vaccine, the patient got COVID and was very sick) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (3 weeks after receiving the vaccine, the patient got COVID and was very sick). At the time of the report, COVID-19 (3 weeks after receiving the vaccine, the patient got COVID and was very sick) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that her daughter in law's mother received a COVID-19 vaccine recently. The reporter was not sure if the patient received the Pfizer or Spikevax vaccine. However, 3 weeks after receiving the vaccine, the patient got COVID and was very sick. Patient experienced loss of taste and smell, tiredness, fatigue, and weakness as symptoms.  No treatment medications were reported.
C/O itching and redness at the site. First noticed several days after the injection was administered.
Severe headache into week 4 - Rizatriptan 10mg, But/Apap/Caf
Initial unsolicited report received from a Nurse on 12-Mar-2015. A female patient (age not provided), who had no medical history and no concomitant medications were taken, had received a dose of FLUZONE vaccine via intradermal route (dose details, batch number, expiry date and site of administration not provided) on 10-Jul-2013 and 0.5 ml first dose of PNEUMOVAX 23 via subcutaneous route (batch number: K019386, expiry date: 09-Jun-2016, site of administration was not provided) on 18-Jan-2015 around 13:00 hours. On an unspecified date, the patient developed redness at the injection site due to eggs being in the FLUZONE vaccine. On 18-Jan-2015 at 16:00 hours after vaccination, the patient developed swelling and redness at the injection site which extended to a 6 inch area. It was reported that "by the end of yesterday" the patient developed fever and chills. The fever was as high as 100.2 degree Fahrenheit. The swelling and redness at the injection site extended "yesterday" to a 6 inch area. Laboratory investigations were not performed and the patient received corrective treatment which was not specified. At the time of this report, the patient had recovered from the event: redness at the injection site, after administration of FLUZONE vaccine on an unspecified date. The patient had not recovered from the events: fever, chills, swelling and redness at the injection site which extended to a 6 inch area. It was reported that the patient sought medical attention. Documents held by sender: none. Follow up information received from a healthcare professional on 13 April 2015: No new information received, however events details were changed as per previous version source document.
Flu symptoms. Fever. Chills. Aches. Headache.  Nauseous
This is a spontaneous report from a physician and a 56 year old female pt who received the 1st and 2nd dose of Lymerix on 4/30/99 and 6/4/99, respectively. In early July, 1999, one month after 2nd dose of Lymerix and 64 days after 1st dose, the pt developed a swollen lymph node in her left armpit. At approximately the same time, the pt had poison ivy exposure to her left hand. The pt indicated that a surgeon was possibly going to operate on the swollen lymph node. The most recent information, received on 8/31/99, reported the condition of the pt is unknown.
Pt describes becoming pale, shaky,nauseated "like I had the flu"". Pt stated she felt the flu vaccine caused her blood sugar to drop and for her to have.  Follow up: had dizziness, body ache and pain in right arm.  Prescription for Phenergan.  Seen at work next day, feeling better.
Other complications following immunization, not elsewhere classified, sequela on 2021-01-05.
Rash, ErythemaMultiform, left axilla tender, no nodules Narrative:
Mother brought child into the clinic 2 days, post vax. His right upper arm was bright red, warm to the touch and hard with a small bump noted. Mom stated she has been giving him Tylenol. Instructed her to take him to the hospital; gave her directions. Mother took child to ER and they admitted him to the hospital, have him an IV and administered antibiotics. He stayed overnight. Talked with mother on 8/6/01 and child's right arm looks very good.
doses administered from vaccine stored in unmonitored freezer temperatures; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures). At the time of the report, PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The reporter stated that for 13 nonconsecutive days the maximum temperature ranged from -12 to -14 for an unknown period of time. The vaccine was utilized by 2/6/21.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up contains non-significant information includes reporter contact details.
Cellulitis - vs allergic reaction after PNEUMOVAX and influenza vaccine. Start KEFLEX tomorrow. BENADRYL PO (warned of sedation and urinary retention). Return tomorrow for recheck, sooner if worsening.
The day following the vaccine I started feeling pressure in my ears. It increased as my head moved and interfered with my ability to hear anything. I'm used to plenty of tinnitus but this was much louder and I don't usually have the pressure.
As reported to me by Patient On 6-29-2021 patient had a stroke on 6-30-2021 sister came to get him and took him to Hospital in city  Stroke on left and has affected his right side of body.  He is still recovering. His Blood was very high. However, he has never been to see a physician so no baseline Blood Pressure.
PATIENT INITIALLY PRESENTED WITH LARGE BRUISE APPROXIMATELY 2 INCHES IN DIAMETER, AND COMPLAINED OF SORENESS AND "FEVER" AT INJECTION SITE ABOUT 2 DAYS AFTER RECEIVING VACCINE.  I INSTRUCTED PATIENT TO CONTINUE TO MONITOR.  WITHIN A FEW DAYS, THE BRUISE WAS GONE , BUT AN INDENTION IN THE SKIN REMAINED AT THE SITE.
Patient called the clinic to report aches and pain at the injection site of TD vaccine. The patient started taking Motrin and Tylenol for the aches and pain and was advised by the physician to come in the clinic if she experiences any fever. Follow 12/05/06 patient recovered.
Adverse reaction from the Moderna vaccine; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an adverse reaction from the Moderna vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced an adverse reaction from the Moderna vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, an adverse reaction from the Moderna vaccine was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of VAQTA (L018499; expiry: 25-FEB-2017, L028666; 04-NOV-2016 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind12 yr molars); Slept a lot so far; injection arm very sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283), intramuscular on 13Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. The patient medical history was not reported. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]), colecalciferol (D3), estradiol (ESTROGEN), progesterone, "bioidenticle" and multivitamin, reported as "Other medications in two weeks: Multi vitamin, vitamin E, D3, bioidenticle estrogen/progesterone"). The patient previously took iodine, metronidazole (FLAGYL), doxycycline and telithromycin (KETEK) and experienced allergies to all. No other vaccine in four weeks. Facility type vaccine was hospital. The patient received the first dose on 23Dec2020 04:45 PM (lot number: EL0140), intramuscular on the right arm and patient felt slightly light headed. Within 5 minutes right (Rt) hand got red & hot, numb, heat in Rt arm and Rt side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. Patient took benadryl. Next few days was reported as "v fatigued & on p.m. of 24th it hurt to open my mouth (gland by Rt ear felt swollen). I got a line of inflammation in my Rt inside cheek & a tissue mound that has not gone away". On 14Jan2021 (reported as today), the patient experienced chills, dizzy, body aches, fever 99.5, fatigue, joint aches, injection arm very sore (started yesterday on 13Jan2021), jaw hurts more on right (Rt) side (lower behind12 yr molars). Patient took Tylenol and slept a lot so far. No treatment was received (If treatment AE: No) - pending clarification. Outcome of the events was recovering.  Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination.
I had a stroke. Assumed blood clot traveled from my leg, up through a hole that was discovered in my heart (PFO) and to my brain.