chrisvoncsefalvay/vaers-outcomes huggingface dataset:
oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) .  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30  at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No  COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't  received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day.  I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask.  I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems.   I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering.  Information on lot/batch number has been requested.
Redness of 5 inch circle with lump on left arm.  Lasted about 5 days
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  Treatment information was not provided.
A non-serious, spontaneous report of gave FLUMIST to a 65-year-old female patient was received from a nurse, subsequent to FLUMIST. Medical history and concomitant medications were not reported. On an unknown date, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Fast heartbeat; Body aches; Headache; Fever/high temperature; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Fast heartbeat), MYALGIA (Body aches), PYREXIA (Fever/high temperature) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Fever/high temperature). On 18-May-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). On an unknown date, the patient experienced HEART RATE INCREASED (Fast heartbeat). The patient was treated with OSELTAMIVIR at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 14-May-2021, PYREXIA (Fever/high temperature) outcome was unknown. On 22-May-2021, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown. At the time of the report, HEART RATE INCREASED (Fast heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Influenza: (Negative) negative. On 20-May-2021, SARS-CoV-2 test: (Negative) negative.         No concomitant medications were not provided.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended for Document Attachment
This spontaneous report as received from a current 48 year old female consumer refers to herself. The patient's medical history included "Surgical menopause, degenerative disc disease, autoimmune thyroid". In the unspecified past, the patient was vaccinated with PNEUMOVAX23 (manufacturer/brand not specified by consumer), (lot#, expiry date, dose, frequency and indication not reported) several times, and developed pneumonia at an unspecified time post vaccination in "2009 or 2010". The patient stated this vaccination was suggested by her unspecified rheumatologist. On 04-FEB-2014, the patient developed shingles (captured in the case 1402USA008849). This is one of several reports received from the same patient. Additional information has been requested.
Patient was fine with the first dose that she received on 04/02/2021. Patient received Botox two weeks later, and one week after that underwent a procedure to get polyps removed. Then patient received second dose of Moderna vaccine. The day before her second dose, she thought she had a pimple around her eye. Two days after second dose it broke out into shingles. The second dose of Moderna vaccine was administered on 05/06/2021 and patient underwent anesthesia 05/04/2021. The patient's symptoms started on 05/04/2021 with itching of the left scalp and a pimple on the left eyebrow.
pt. recvd. vax @ 15 months & developed measles @ 3 yrs. of age.
Injection site pain, swollen Lymph node under arm on the side on vaccination. Started the day after vaccination.
Patient reported that the opposite side to injection, near his rib, felt sharp/pinching pain after receiving immunizaiton, also redness/pus in small spot on opposite rib side to where vaccination was received.
Information has been received from a physician concerning a 63 year old female patient with allergic reaction to tetracycline and CEREFOLIN NAC, deep cleaning and periodontal issues who "sometime" in July 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The physician reported that in July 2008, the patient felt tingling, numbness and pain on the left side of her tongue and gum area. The physician also reported that the patient experienced oral pain in the left side of inside mouth. The upper left near gums and tongue and upper area got tingly and numbness with some pain. The patient got blisters in mouth that came and went. The patient got "oral neuropathy" (also reported as jaw neuropathy). The physician stated that the patient went to an oral pathologist, ears, nose and throat (ENT) and an oral surgeon, no specific diagnosis was reported. It was reported that a prescription drug treatment for experience was required (unspecified). At the time of the report, the patient had not recovered. It was reported that the patient was still being treated. The patient's oral neuropathy tingling, numbness and pain on the left side of her tongue and gum area and blisters in mouth were considered to be disabling by the physician. Additional information has been requested.
about 45 min after shot, face began tingling and then felt numb. numbness continued for about 24 hoursn
felt faintish after 2nd bivalent booster vaccine; had pain in legs after 1st bivalent booster vaccine; had pain in chest after 1st bivalent booster vaccine; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (felt faintish after 2nd bivalent booster vaccine), PAIN IN EXTREMITY (had pain in legs after 1st bivalent booster vaccine) and CHEST PAIN (had pain in chest after 1st bivalent booster vaccine) in a female patient of an unknown age 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 third 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, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt faintish after 2nd bivalent booster vaccine), PAIN IN EXTREMITY (had pain in legs after 1st bivalent booster vaccine) and CHEST PAIN (had pain in chest after 1st bivalent booster vaccine). At the time of the report, DIZZINESS (felt faintish after 2nd bivalent booster vaccine), PAIN IN EXTREMITY (had pain in legs after 1st bivalent booster vaccine) and CHEST PAIN (had pain in chest after 1st bivalent booster vaccine) had resolved.        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.   Concomitant drugs were not reported.  It was reported that patient received Moderna monovalent vaccine as dose 1 and dose2. It was reported that patient had experienced different side effects after taking vaccine which took several days to overcome.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-024164 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024164:Monovalent Product
I started having numbess and tingling episodes radiating down left arm from bicep to fingertips, lasts 10-20 seconds up to several minutes.
Extreme muscle aches all over and in joints.  Tylenol and Advil not helping, used tramadol and muscle relaxer.
Ataxia developed within 30minutes of receiving the dose. Bounced off the walls walking from car to house. No significant vertigo, just could not walk straight. Took ibuprofen and  water and went to bed . Symptoms improved greatly after a couple hours rest. Thereafter I just had a couple days of fatigue.
deep aching pains in both upper arms,& both upper legs w/muscle wasting x 2 days post vax;
Initial and follow-up information has been received from the Merck pregnancy registry from a registered nurse and a physician concerning a 34 year old female with drug hypersensitivity to codeine with a history of dilation and curettage procedure done in February, who on 29-MAR-2007 was vaccinated IM with a first dose of Gardasil (lot # 654885/1424F). On 04-Jun-2007 was vaccinated IM with a second dose of Gardasil (lot # 654885/1424F). Concomitant therapy included NEXIUM, ASTELIN, NASONEX, KLONOPIN, "FECON", and antimicrobial (unspecified). ON 25-JUN-2007 and 26-JUN-2007 the patient reported that the beta-human chorionic gonadotropin test (unspecified) were positive. On 05-JUL-2007 and 09-JUL-2007 the patient came into the office for blood work. The 09-JUL-2007 blood work reported that the patient was four to five week pregnant. The patient's last menstrual period was approximately 31-MAY-2007 and the delivery date was 06-MAR-2008. The physician reported that the baby's heart tunnels are present. Subsequently the patient experienced some bleeding during pregnancy. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from the Merck pregnancy registry form a registered nurse and a physician concerning a 34 year old female with drug hypersensitivty to codeine with a history of dilation and curettage procedure done in Febraury who on 29-MAR-2007 was vaccinated IM with a first dose of GARDASIL (lot # 654885/1424F). On 04-Jun-2007 was vaccinated IM with a second dose of GARDASIL (lot # 654889/1424F). Concomitant therapy inclued NEXIUM, ASTELIN, NASONEX, KLONOPIN, FECOM, and antimicrobial (unspecified). On 25-JUN-2007 and 26-JUN-2007 the patient reported that the beta-human chorionic gonadotropin test (unspecified) were positive. On 05-JUL-2007 and 09-JUL-2007 the patient came into the office for blood work. The 09-JUL-2007 blood work reported that the patient was four to five weeks pregnant. The patient's last menstural period was approximately 31-MAY-2007 and the delivery date was 06-MAR-2008. The physician reported that the baby's heart tunnels are present. Subsequently the patient experienced some bleeding during pregnancy. Follow up information was received from the nurse on 27-MAR-2008. The patient did not receive her prenatal care at their office. The name of the provider was not available. No additional information was provided.
Itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional intervention
Case previously recorded as MA2009-4792. Report received on 23 NOV 2009 via agency, from a healthcare professional the following information: A 4-year-old male patient was vaccinated i.m. only with 0.25 ml FLUVIRIN, batch no. unknown on 20 NOV 2009. No adverse event was reported. No further information available. Company assessment: No serious criterion given. Causality: not applicable. Expectedness assessment according to foreign agency: Given 0.25 ml FLUVIRIN is unexpected. No change in benefit-risk-ratio. No measures necessary. Agency no: NA09-008705.
Patient became lightheaded and had a sycopal episode shortly after. Events began 5 minutes after vaccine was administered
I soon I took the 2 Moderna  of covi19 my arm got very red and yesterday was grow  on red and black a lot pain burn and hurt
Symptoms began about 12 hours after my 2nd vaccine. I had body pain, cold sweats, headache, nausea, dizziness, fatigue, and injection site soreness. Most of these symptoms passed after 36 hours. Mild headache has lingered past 48 hours.
At 8 PM on May 1, the day of the vaccination. I experienced loss of vision in my right eye. The loss was the top half of the eye and symptoms were similar to retinal TIA.  Loss of vision was complete in the top half and lasted for several minutes. It resolved eventually but I went to emergency room at the request of my eye doctor.
Moderna COVID?19 Vaccine: Left arm rash slightly below injection site, 9 days after 1st Dose. Raised circular rash, itching and warm. I am using  Cortizone 10 Maximum Strength cream to relieve itching
This spontaneous report was received from a 34, year old female patient, who was also a licensed practical nurse, concerning herself. The patient's current conditions included allergy to shellfish. Concomitant medications included ZYRTEC. The patient had no pertinent medical history. The nurse reported she received two doses of (Wistar ra 27-3) virus vaccine, live HSA M-M-R II. The first (Wistar ra 27-3) virus vaccine, live HSA M-M-R II was administered for prophylaxis on 28-OCT-1983, and the second (Wistar ra 27-3) virus vaccine, live HSA M-M-R II was administered also for prophylaxis on 13-FEB-2001 (lot number and expiration date were not reported for any of the aforementioned doses). On 27-JAN-2017, the patient had titers drawn, to verify immunity for nursing school, and the result showed low titers for Mumps and Rubella. At the time of this report, it was unknown if the patient recovered from the events. Causality assessment was not provided.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported. No treatment medications were provided.
Patient requested the Pfizer vaccine but due to a misunderstanding, received a flu shot. She was also given a Covid vaccine after discovered the mistake.
Patient had mild fever (100.8-100.7 F), shooting pains all over body that lasted on-off through the night, tenderness in armpit, stiff neck
Feeling extremely anxious; Patient recently received a booster vaccine, however she should have got a second dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: (005570).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2 (bivalent), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "Feeling extremely anxious"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Patient recently received a booster vaccine, however she should have got a second dose". Additional information: The patient's spouse was writing to inquire about the potential health risks associated with failure of COVID-19 vaccination. His wife (patient) recently received a booster vaccine, however she should have got a second dose. As a result, she was feeling extremely anxious about the potential health consequences of this failure of vaccination. The spouse was kindly requesting for assistance in providing information about any potential health damage that may result from failure in vaccination of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Spontaneous nose bleed, with large clotting, bleeding lasted approximately 45 minutes total, while the heavy bleeding was about 20 of the 45 minutes.
Pt woke up on 1/16/18 with redness and swelling at the injection site. The redness was the size of 2 half dollars per mom. Nurse discussed signs/symptoms of infection. Advised to apply cold compress prn and call back with new/worsening symptoms.
Tingling, numbness in left arm and heart area; shortness of breath; abnormal heartbeat all on a daily basis since about a week or 2 after the second vaccination shot.
Felt like skin, head to toe was "on fire" and mild hives (burning- similar to past reactions with things) - I took 50mg benadryl [I have an epi pen but chose to try benadryl first as my symptoms were only skin and I was breathing fine (pulse ox was 98 which is normal for me);  also had racing heart  and was only a little above my norm of 80's -90's, but did not feel PVCs or irregularity, aches, chills, fatigue, eye pain, severe headache on weds night night and thursday; drove 2 hrs home to cabin for new years the next day on thursday (new years eve) (I am working for COVID - epidemiologist, retired nurse), aches, cold/chills/severe headache remained (took 1000 of tylenol in the morning and then before going to bed that night); in bed at 2000pm because I was so tired and felt "sick." the next day I had no symptoms when I woke up. My arm was not even hardly sore in the two days that I did not feel bad; I could feel the injection but it was not painful like previous vaccines that I had received.  Before the vaccine I called my ex housemate who is a trauma nurse practitioner and she advised me to take tylenol and not aspirin after I get the vaccine; I did not administer 1000mg tylenol and benadryl (50mg) to myself until bedtime that even after my symptoms began)
Patient stated that she felt like her hands were tingling, swelling and turning red at approx 13 minutes post vaccination. Upon assessment, left hand was visibly red and puffy.  Patient also stated headache and tingling in her lips. No swelling visible in lips but due to complaints, patient was given IM Benadryl 50mg at 9:38 am and put under monitoring. Vitals taken and all within normal limit. Pulse 77, Respirations 16, Blood Pressure 125/83, o2 sat 97 at 9:51am.  Redness and swelling of upper arm 1 inch below injection to hand noted at this time. After keeping patient to 10:20am, no additional swelling noted and patient beginning to feel better. Was wheeled out in wheelchair by  , RN with instruction to go to ED if symptoms return or get worse. Advised patient to call her primary care to discuss event and if he suggests second dose. Patient voiced understanding.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. "About 4 years ago", in approximately 2010, the patient was vaccinated with the first and second dose of GARDASIL (strength, dose, route and lot # not reported). On 03-OCT-2014 the patient was vaccinated with the third dose of GARDASIL (strength, dose, route and lot # not reported). No adverse effect reported. Additional information has been requested.