chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes under my left arm; Aches in my breasts; Stinging in the nipple on my left breast; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single and administered in arm left, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin allergy; "Type 2 diabetes mellitus" (unspecified if ongoing), notes: Type 2 diabetes. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "unknown", described as "Swollen lymph nodes under my left arm"; BREAST PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Aches in my breasts"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Stinging in the nipple on my left breast". The events "swollen lymph nodes under my left arm", "aches in my breasts" and "stinging in the nipple on my left breast" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, breast pain, pain.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021, the patient experienced swollen lymph nodes under left arm, aches in breasts, mainly in the left one, since about a week after the first shot. A couple of weeks before the report, patient started feeling a stinging in the nipple on her left breast in addition to the swollen lymph nodes and achiness, etc. it has now been five weeks exactly since the second shot. Patient had read that this was a normal side effect but was concerned when it persisted. She went to see a doctor today who said it is likely a vaccine side effect and she worked with a woman who still has swollen lymph nodes three months after getting the vaccine. The doctor could feel the swollen lymph node under her arm. The adverse event resulted in doctor or other healthcare professional office or clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash all over upper-left arm. In subsequent days, customer reports pain in left hand. Recommended customer go to MD office to have arm and hand evaluated.
03/23/21: Patient presented and was admitted through ED for chest pain associated with shortness of breath which is worsening from yesterday.  Patient also complains of diaphoresis.  Shortness of breath worse with sitting straight up and better with lying on his side.  In ER patient was found to have blood pressure 119/84 temperature 97.4 heart rate of 101 bpm saturation on 6 L and can supplement therapy via nasal cannula. PMH significant of COPD on 2 L nasal cannula at home.   Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
This case was received from a health professional on 21 April 2008.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  A 19-year-old female patient, with no known allergies, received a second intramuscular injection of Imovax Rabies (lot number A0239-2) on 21 April 2008.  The dose was given as part of a pre-exposure series, and no adverse effects had been reported following dose one.  Approximately 45 minutes after vaccination, the patient developed tachycardia (112 beats per minute), chest discomfort described as "fluttering", and shaking of the arms and legs.  At the time of the report, the event had been ongoing for approximately one and one-half to two hours.  The patient had a history of acne, and was taking Minocycline concomitantly.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back) and RASH (2 days later rash came all over body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Thyroid disorder and Anxiety. Concomitant products included DIAZEPAM (VALIUM) for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Fibromyalgia, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, CALCIUM and ZINC for an unknown indication.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back), RASH (2 days later rash came all over body), PYREXIA (100 F temperature) and FATIGUE (Fatigue which was pretty overwhelming,fatigue for a full day). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back), RASH (2 days later rash came all over body), PYREXIA (100 F temperature) and FATIGUE (Fatigue which was pretty overwhelming,fatigue for a full day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) reports temperature of 100 degrees F (her normal temperature is 97 to 97.7 F).         Patient reports that she has a genetic defect called MThfr compound heterozygous. It means sometimes she methylates, or absorb medications very quickly, and there were other times where she absorbs medications very slowly.   Patient mentioned that she asked her doctor about receiving the flu vaccine, and her doctor told her to wait a bit to receive it. She mentioned she will wait until December to receive it because of her condition and the vaccines.   This case was linked to MOD-2021-329852, MOD-2021-329866 (Patient Link).
Fatigue; Headache; Muscle pain; Joint pain; Nausea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
muscle pain; joint pain; tiredness; feeling unwell; a little bit of dizziness; losing strength in her hands; fingers are swollen up; achiness and pain are more pronounced than usually; This is a spontaneous report from a contactable other hcp. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported), dose 2 via an unspecified route of administration on 14Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, losing strength in her hands, fingers are swollen up, achiness and pain are more pronounced than usually. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 18Mar2021 and the second dose on 14Apr2021, about 2 and a half weeks ago or 3 she started experieinced side-effects, she had this side-effects in the past also and they include: muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, she's also losing strength in her hands because her fingers are swollen up. She states that this time the achiness and pain are more pronounced than usually. She would like to know if this could possibly be side-effects from the vaccine. She would like to know what are the recommendations. She would like to know how far after vaccination the side-effects were reported (onset). She would like to know how long this side-effects can last. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sudden knee stiffness, joint pain and swelling. Later determined to be sudden onset of RA. Symptoms started 3/15/2021 diagnosis 5/6/201.
Pt had 3-4 hr period of pale appearance & lethary/hyporespons & had low grade fever 101.5;
Headache, Myalgia, NauseaVomiting, left arm injection site pain, chills, fatique, Narrative:
Sudden coughing, shortness of breath, and wheezing approximately 3 hours after receiving vaccine. The following day fatigue, less coughing, slight achiness which resolved by evening.
Cellulitis (Left Deltoid) Area of reaction increased from 3 inches to 8 inches. Patient went to urgent care and was prescribed Keflex. Patient will follow-up with pediatrician.
Bell's, Palsy, Treatment with steroid pack and anti viral pills  Loss of muscle control left side of face  symptoms began 6/16/2021 , no previous history of Bell's palsy
On March 26,2001, my 18 month son had a bad reaction to his vaccination. He ran 103.5 for several days, his legs blew up, he was lethargic, listless, high pitched screaming, loss of balance, (virus?) lasted 1 week.
pt recvd vax 22JUN93 & family member reported on 23JUN93 arm became red, swollen & painful;
Delayed hypersensitivity to TD vac, 5 x 4.5 cm erythematous, warm, edematous area left deltoid, applied neosporin ontment and gave Zyrtec 10 mgs one per day for five days.
After I got the shot, I got home and my arm was hurting real bad and swelled up then my neck started hurting. By Friday/Saturday, I had to skip the dose of my metrotxate per my rheumatoid doctor. I started getting nauseated and had diarrhea and took some medicine for both and Tylenol for the pain. Over night I had a really bad headache and got up and couldn't hardly walk cause everything was hurting, dizzy and really sick. I had chicken soup and had pain in my stomach and my feet started hurting because I have neuropathy in them. As the went on I kept getting sicker and sicker. I took the regular flu shot 3 weeks earlier and got sick. All the vaccines make me sick but the doctor said I had to get them because I have a weak immune system. But I wasn't sick at all when I got the 3rd shot. Even with the 1st dose, I got really sick after the vaccine for a whole month. My muscles was weak and I had pain in my back and everything. I went to my rheumatoid doctor and told her how sick I was from the shot. Every time I take the vaccine it makes my acid reflux really worse. My acid reflux has never been this bad before.
Swollen lymph nodes in right arm pit; Fever; Chills; Fatigue; Full body aches; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8731) via an unspecified route of administration in the right arm on 21Apr2021 at 08:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included reflux and sulfa allergy which causes nausea. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) and desogestrel/ethinylestradiol (APRI); both were from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8730) via an unspecified route of administration in the right arm on 31Mar2021 at 08:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 20:30, symptoms started 12 hours after second vaccination, for 12-16 hours the patient had fever, chills, fatigue and full body aches. On 22Apr2021, next day the patient woke up with swollen lymph nodes in right arm pit that continue today (at the time of this report) and fatigue was continuing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, fatigue, full body aches and swollen lymph nodes in right arm pit was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
2-3 hours after vaccination he started to develop muscle aches, dry cough, red sore eyes, fatigue these signs and symptoms lasted 3 days.
This study case was received on 27 February 2013 from the investigator in a trial. A female subject (age and birth date not reported) with no relevant past medical history, developed possible myopericarditis two days after she received the following vaccines on 07 April 2011: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported); and concomitantly, an injection of TYPHOID VACCINE, manufacturer unknown, (lot number, route, site and side not reported) and an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported). On 09 April 2011, two days post vaccination the subject developed possible myopericarditis of moderate severity. The subject reported onset of chest tightness and palpations felt in neck and chest bilaterally while lying down two days post vaccination, with no known triggering or exacerbating factors. The subject self-referred to Urgent Care and subject reported labs, electrocardiogram (ECG) there were normal; and diagnosis (dx) was "awareness of own heart beat". Study ECG and Troponin were reported as normal. According to investigator, there was low suspicion for myopercarditis. No treatments were prescribed. The stop date of adverse event and outcome were reported as recovered/resolved on 10 April 2011. According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
On 2/26/21 patient had tingling and numbness in legs. Legs wouldn't move. Patient fell. provider not contacted 3/27/21 called 911, patient had maybe had seizure couldn't talk. Patient had EEG,MRI and CAT scan- all came back negative for stroke or seizure.
ErythemaMultiform & MUSCLE PAIN; INJECTION SITE PAIN  CEPHALEXIN 1 TAB QID TAKE 1 CAPSULE ORALLY EVERY 6 HOURS
Less than 24 hours after my second dose of the vaccine, I woke up feeling extremely nauseous.  Shortly after waking, I was walking out of my bedroom and passed out.  For several minutes I was unresponsive, my body was rigid and I was not able to breath.  My husband had to call 911 and was about to start chest compressions when I came to.
Tested positive for COVID-19; Tested positive for COVID-19; Received dose 3 on 09Jan2022; This is a spontaneous report received from a contactable consumer via regulatory authority. A 14 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 09Jan2022,at 16:30 (Batch/Lot number: unknown) at the age of 14 years as dose 3 (booster), single, administered in arm left, administration date 16Jun2021, at 09:00 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 26May2021 08:45 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included topical ezcema from an unknown date. There were no known allergies. Concomitant medications included:  dupilumab (DUPIXENT). Prior to vaccination, the patient was mot diagnosed with COVID-19. The patient received dose 3 on 09Jan2022. The patient tested positive for COVID-19 on 25Jan2022, at 21:30. The patient underwent the following laboratory tests and procedures, which included  a positive COVID-19 test on 25Jan2022. Therapeutic measures were not taken as a result of covid-19, vaccination failure. The clinical outcome of received dose 3 on 09Jan2022 was unknown. The outcome of tested positive for COVID-19 was not recovered.   The lot number for BNT162B2 was not provided and will be requested during follow up.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in refrigerator on 17-Nov-2021.  Vial did not undergone to any temperature excursion.  No adverse event was reported.  No treatment medications were reported.
Coughing, heavy snot accumulation, sore through getting worse through 10/5/2013 and slowly alleviating after that.  Treatment: aspirin, hot tea.
PT RECEIVED HIS FIRST DOSE OF THE PFIZER COVID VACCINE  ON 4/23/21, PT RECEIVED THE JOHNSON & JOHNSON COVID VACCINE ON 5/5/21
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 02-MAR-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
The second dose was given on 5-14-2021 And should be given on 5-21-2021
Sedation, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, fatigue, pain and swelling at the injection site.
10-15 minutes post immunization. Patient lost consciousness in the waiting area falling backwards. He was sent to our urgent care center. CT revealed fracture of right occiput and cervical vertebrae 1.
This case was reported by a physician via sales rep and described the occurrence of varicella-like rash in a 80-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown. It was unknown if the reporter considered the varicella-like rash to be related to SHINGRIX. Additional details were reported as follows: The physician reported that the patient experienced rash in random spots that resembled chicken pox after receiving the SHINGRIX.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19), HOT FLUSH (Hot flash), COUGH (Cough), HEADACHE (Headache) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced NAUSEA (Nausea). On 12-Jan-2021, the patient experienced HOT FLUSH (Hot flash), COUGH (Cough), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid. On 13-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, COVID-19 (Diagnosed with COVID-19), HOT FLUSH (Hot flash), COUGH (Cough), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: additional information received; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
No adverse event; a 0.5ml bivalent booster dose instead of his primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 0.5ml bivalent booster dose instead of his primary series) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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) .5 milliliter. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (a 0.5ml bivalent booster dose instead of his primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 0.5ml bivalent booster dose instead of his primary series) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (a 0.5ml bivalent booster dose instead of his primary series).    No concomitant medication details was reported. No treatment medication details was reported.
Information has been received from a female patient who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not provided). Subsequently the patient experienced redness at the injection site. No further information is available.
3 days later after receiving vaccine developed redness, pain, on 10/4/16 was seen in our office given KEFLEX 500 mg TID for 7 days and BENADRYL. Called patient on 10/6 patient says is much better.