chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches, clamminess, vertigo, and arm pain. Treated with Tylenol and Zyrtec.
On 10FEB90 pt devel rash but was afeb w/no URI sx; Subsequently recovered; No further details were provided;
States pain at site with injection.  States the next day she developed a red, splotchy rash to the area. Rash resolved a couple of days later. States then it began to be hot to the touch and hard/swollen. Concerned b/c injection site is now painful to touch for 9 days and no improvement. Difficulty sleeping due to pain in left arm and can't lift that arm past a certain point due to pain. Painful to touch at back of shoulder. Denies any systemic fever. Has been taking Motrin. States she did not have a reaction to the 1st Bexsero.
Nausea, vomiting, diarrhea, arm pain unlike other flu shots before.
axillary lymph node swollen to about the size of tennis ball in right arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 01May2021 at 13:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. It was not reported if the patient received any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 10Apr2021 at 14:00 (at the age of 58-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 02May2021 at 09:00, the patient experienced axillary lymph node swollen to about the size of tennis ball in right arm. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event axillary lymph node swollen to about the size of tennis ball in right arm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
09.18.21 - sciatic pain in both legs & headache about 09.21.21 - pain in hands, wrists,  and all long bones and right knee kept getting worse and more painful.   right knee swelled to 3 times normal size by about 09.26.21 persisted until doctor visits began on 10.19.21 - knee xray and joint fluid drained for lab test follow up visit on 10.25.21 - steroid injection in right knee, xray of wrist 10.26.21 - started oral steroid treatment
Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures.  Patient received the vaccine after a temperature excursion. Storage condition at the time of the excursion was frozen. Temperature was unknown and only manual recording of temperature was done twice a day.  Vials were within unbroken cartons and were of the size 2.5 ml and 5.5 ml.  The vials were returned to the freezer and were still frozen.  Treatment information was not provided.
Patient reported to observation nurse dizziness and tingling sensation in his fingers and right arm. Patient' s vitals noted at 153/102 heart rate 88, Temp 97.7, Res. 20. Patient verbalized anxiety regarding receiving  the vaccine. Patient was offered water and encouraged to relax. Vitals were repeated fifteen minutes later. Blood pressure noted at 171/111, heart rate 88 Res. 22.  The decision was made to contact EMS. Patient was assessed by EMS and vitals  improved at 150/96, Heart rate 76,  Pulse 20. Patient was provided patient teaching should condition worsen. Patient was released and was driven home by his wife.
Severe onset migraine 10/10 pain scale; sweating and chills until following morning, pus-filled blisters: 6 on skin in pelvic area directly above labia, 4 on RIGHT underarm. All blisters extremely painful to the touch.
Red rash that started out about a 2 inch square (about 10 days from when I got the vaccine) that kept growing to wrap around half of my upper arm.  It itched some, and was warm to the touch.  On day  14, after discussion with Dr., he thought it was a skin infection, so prescribed antibiotics (Cephalexin 500 MG Capsules taken 3 times a day), which I started taking on day 14.  By Day 18 the rash has calmed down, not as red or visible,  but still there.  This was for the Moderna vaccine.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 02-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number N025428 and expiry date 19-JUN-2020 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36 to 46 degrees Fahrenheit (°F) (35.9 °F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36°F to 46°F for 10 hours and 25 minutes; and 32°F up to 35°F for 3 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of thirteen reports from the same reporter. Sender's Comments: US-009507513-1811USA008122: US-009507513-1811USA008130: US-009507513-1811USA008124: US-009507513-1811USA008125: US-009507513-1811USA008126: US-009507513-1811USA004452: US-009507513-1811USA008128: US-009507513-1811USA008129: US-009507513-1811USA008121: US-009507513-1811USA008120: US-009507513-1811USA008119: US-009507513-1811USA008123.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age received 1st dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for prevention of meningococcal meningitis. The patient's medical history and concomitant medications were not reported. The patient felt bad on an unspecified date after she was given the first dose that she does not want a second dose. Outcome of the event was unknown.
NECK MUSCLES & UPPER SHOULDERS--SHARP PAIN & AICHE LASTNG FROM10/19/20 EVENING THROUGH 10/24/20.  THEN IMPROVED DURING FOLLOWING 2-3 DAYS. DIFFICULT TO TURN OR TILT HEAD.
Acute respiratory failure with hypoxia - Patient had right and left heart catheterization which showed 65% proximal to mid LAD culprit lesion treated with drug-eluting stent on 11/10/2021. Hypoxia persisted requiring escalation of IV steroids with subsequent improvement. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
doses administered after excursion; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Oct-2022, 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 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.
The patient had Measles titers drawn and they "came back negative".; Patient did not experience any symptoms; This spontaneous report was received from a physician via company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were unknown by reporter.       On an unknown date, the patient was vaccinated with full series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical location of vaccination, lot number, and expiration date were not reporter).         On an unspecified date afterwards, it was performed measles titer drawn test, since the patient expressed concern over recent measles outbreaks, and the result came back negative (measles antibody negative). The patient did not experience any symptoms. She reported was still not recovered as the titers remained negative. It was reported the patient no sought medical attention and any treatment has been provided for the event.  The causality assessment between the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the occurrence of the aforementioned events was not reported.
8/9/21 PMHx most significant for MVP, GERD presenting for chest pain.
The evening of 7/30/18 he became very emotional around 10:00 PM about a situation. This seemed irrelevant to the vaccine at the time. At 8:30 AM he woke with a fever of 102.7, tingling legs, dizzy, joint pain in all limbs, heart racing, headache mainly behind the eyes, ringing of ears. On the way to the ER around 9:00 AM his throat felt like lumps inside. Fever went down about an hour later. Slept most of the day once released from ER. ER Dr. stated it was a reaction to the vaccine. On 8/1 felt better but still some joint aches.
I noticed the day after I received my first dose of the vaccine, when I took off the band aid, that my skin had bubbled at the the injection site on my left arm. The day after that, the bubble of skin turned yellow. This morning my injection site still has a bubble of skin that is now red and looks like it can pop at any time. It has not grown any bigger since the first time I saw it.
Body aches, 102.5 fever, weak, fainted hitting head during fall   Symptoms lasted 24 hrs.  Required complete bed rest   NOTE:  This reaction occured on the 3rd vaccine.  There were no adverse reactions with the 1st and 2nd vaccine.
Redness and swelling noted on the left thigh. The pt was taken to ER and given hydrocortisone for treatment.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT FEMORAL VEIN ACUTE DVT OF LEFT POPLITEAL VEIN
Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, chills, lethargic Narrative:
I am quoting this from my mother as she is currently unable to type due to the shaking and shivering. "It started with red hot places on both arms, and then it moved to my face. 2 1/2 hours later I began getting really nauseated and began shaking/shivering uncontrollably. I then went to urgent care and on the way there my heart was pounding and racing. After I was admitted they told me that I had tachycardia and my blood pressure was high (I do not usually have high blood pressure). They did an EKG at urgent care and noticed small changes. I was then sent to the ER and was given IV Benadryl and oral steroids. I was put on a heart monitor, and they were able to get my heart rate to go down, but a few hours later it jumped back up. At that point I was referred to a cardiologist and given a prescription for steroids, and then I was discharged. I saw the cardiologist 2 days later, during those two days I still experienced red hot spots on my arm, shortness of breath, Tachycardia, and shivering. When I went to the cardiologist, they did another EKG and said I still have tachycardia and did some bloodwork. The results of the bloodwork were normal and the cardiologist diagnosed it as an unspecified delayed severe allergic reaction. I am still experiencing symptoms and still having to use Benadryl and steroids."
A report was received from a health care professional on 10/29/2003 concerning a 34 year old female vaccinee who experienced injection site redness and warmth 15 minutes after vaccination. Chest tightness and itching 30 minutes after vaccination. Fever in the evening of the same day as receiving Fluvirin on 10/21/03. On 10/21/2003, after receiving Fluvirin the vaccinee experienced injection site redness and warmth 15 minutes later, chest tightness and itching extending from the upper arm to the elbow and itching on the face and eyes 30 minutes later and fever of 100 degrees fahrenheit that evening. The injection site redness and warmth resolved on 10/26/2003. the vaccinee recovered on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Update 1, 04/15/2004: A follow up report was received from a health care professional indicating that the redness and itching in the upper arm resolved 15 minutes and the tightness in her chest, itching eyes and itching face resolved after 30 minutes. No follow up pending, all information received. See Ref.: PJP200300945, PJP200300946, PJP200300948.
Forty five  minutes after vaccine brain started feeling like it was speeding, felt buzzy, face started swelling, numbness and tingling in right arm, tiredness, fatigue, unable to stand noise,  loss of voice, out of breath when taking long walks
The first dose I had an irregular. (2 weeks ahead of schedule).  And extremely painful lymph nodes, 2 1/2 weeks after The first dose I had a breast MRI that showed extremely swollen lymph nodes on the left side.   After the second dose, my lymph nodes are completely swollen and painful on the right side. It is only four days out but it is still extremely painful and swollen with some redness
This patient felt weak with shortness of breath, about 5 minutes after the vaccine administration. VSS with good air movement. The patient was given a few sips of soft drink, and 1 tspn of Benadryl. However, the patient still complained of shortness of breath. Epinephrine was given SQ. The patient's symptoms resolved and she was discharged home.
Memory loss; Arm swollen; Inappropriate schedule of product administration; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration), AMNESIA (Memory loss) and PERIPHERAL SWELLING (Arm swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 001Z1Z) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On an unknown date, the patient experienced AMNESIA (Memory loss) and PERIPHERAL SWELLING (Arm swollen). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, AMNESIA (Memory loss) and PERIPHERAL SWELLING (Arm swollen) outcome was unknown.
Information has been received from a physician concerning a child who was vaccinated several years ago with a dose of varicella virus vaccine live. Subsequently, the patient had a breakthrough case. The physician also mentioned who are her children and who experienced similar reactions. Additional information has been requested.
Moderna covid-19 vaccine EUA At time of shot, full body flushing.  At 2:45 next day chills, vomitting, headache.
Menopause; Hot flashes; Mood swings; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of MENOPAUSE (Menopause), HOT FLUSH (Hot flashes), MOOD SWINGS (Mood swings) and NIGHT SWEATS (Night sweats) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced MENOPAUSE (Menopause), HOT FLUSH (Hot flashes), MOOD SWINGS (Mood swings) and NIGHT SWEATS (Night sweats). At the time of the report, MENOPAUSE (Menopause) had not resolved and HOT FLUSH (Hot flashes), MOOD SWINGS (Mood swings) and NIGHT SWEATS (Night sweats) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of MENOPAUSE with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of HOT FLASHES, MOOD SWINGS and NIGHT SWEATS was not provided.  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.
Hospitalization: 9/15/2022 - 9/23/2022 Presentation to the ED: WEAKNESS, SOB.  COVID-19 + date: 9/22/22. Treatment: NO TREATMENT GIVEN AS PATIENT TESTED POSITIVE ON A TRANSFER SCREEN TO FACILITY. Discharge to: Skilled Nursing Facility with Medicar Certification in Anticipation of Skilled Care
Erythema (Pink), warmth, swelling of right upper arm, Event of erythema 17cm from shoulder down toward elbow, indurated circumferentially, swelling lasted 5-6 days. Erythema faded after 2-3 days.
redness; swelling; rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling) and RASH (rash) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 044A2.) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ERYTHEMA (redness), SWELLING (swelling) and RASH (rash). At the time of the report, ERYTHEMA (redness), SWELLING (swelling) and RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter  Treatment medication included IV antibiotics   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR was received Contains no new information