chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm is sore; her neck is swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2 ; lot number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's arm was sore and neck was swollen after taking first dose in Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 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 EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 13th of 40 adult patients. No concomitant medication was reported. No treatment information was reported.
Vaccine given 4/27 patient came 4/30 to let us know of swelling, redness and pain radiating towards the arm and breast area. Pt went to primary doctor and was told to take OTC ibuprofen.
Within 12 hours of receiving vaccine, there was extreme pain in left arm which radiated down to my hand. Since the vaccine, I have limited mobility in that arm and pain when with motion. I waited to seek treatment as I hoped it was getting better but seemed to plateau and increase in pain level. I went to my primary care who referred me to a physiatrist.   His treatment plan is pending an EMG.
Slight swelling, tenderness, and warmth at injection site.  Chills. Slight fever. Breathing issues
On 9/1/18 I developed what looks like poison ivy on my right hand. Blisters, redness, itching occurred. This spread to my abdomen and to my left hand developing blisters, redness and itching. It lasted 10 days before I contacted Dr. to get a Rx for Steroid treatment. I don't know if it is poison ivy OR related to the SHINGRIX vaccination. I am worried about getting the second dose. Please advise.
Vaccine given on 2/22/02 with increased erythematous/induration around the site with it covering most of the upper left arm from shoulder to above the elbow on 2/24/02. Better with decreased swelling and redness on 2/25/02 with oral antihistamine and Benadryl.
No adverse event, she was inadvertently given old version as a booster rather than the new bivalent version.  She was revaccinated with new version
Case number PHHY2016US006986, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 605762) website on 18 Jan 2015. This report refers to a 57 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 173989) intramuscularly into left arm on 21 Oct 2015. On the same day after vaccination, patient experienced congestion, diaphoresis, flushing, tongue tingling, joint discomfort, dyspnea. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of respiratory tract congestion, flushing, paraesthesia oral and dyspnoea were upgraded based on information available in source document. Quality assurance (QA) department confirmed that, the reported batch number 173989 is not valid batch number for FLUVIRIN. Hence, investigation could not be performed. Follow up information received from Quality assurance (QA) department on 29 Jan 2016: Added QA comment.
After patient received vaccine in the morning, patient started experiencing chest pain, headaches, and numbness in left arm that same evening. Patient scheduled appointment to see her primary care provider on  September 22, 2021. From this appointment due to her chest pain they immediately referred patient to cardiology for screening and evaluation.
Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I began experiencing both partial loss/diminution of my ability to smell, AND a phantom smell combining putrid/sweet/burnt. I lost taste as well (e.g. got stomach upset from eating what someone told me later was a very spicy food, which I had not perceived at the time).   During my bout with Covid in December I had lost all smell abruptly and then regained it abruptly. No partial smell and no phantom smell. This is different, as both of those are occurring. Seven weeks later,  the phantom smell is not as prominent and my own ability to smell real things is stronger -- but both improvements are moderate at best.   No treatment.
On the 28th, she did not notice or pay attention until Saturday evening with itching.  On Sunday it was severely inflamed, and she called the doctor on Monday and was informed to put ice packs on it.  She also took a 1/2 Benadryl that day but has not taken anything due to the lethargy from the medicine. This morning she measured it and it is extends from the shoulder down 6" and about 4" around the arm.   It has not gotten any larger, she marked it and it has stayed inside the circle, and is not as inflamed today.  She did call her doctor and they gave her the instructions to mark.  It itches, and has been putting ice packs on it.
Information has been received from a consumer concerning his niece who on 18-JUN-2007 was vaccinated with the first dose of Gardasil. On 19-JUN-2007, the patient experienced severe abdominal cramping "in the stomach area." The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report previously submitted on 07/16/2007 Initial and follow-up information has been received from a healthcare professional and a consumer concerning a 15 year old female who on 18-JUN-2007 was vaccinated in the left deltoid with the first dose of GARDASIL (lot #657868/0523U). On 19-JUN-2007, 24 hours post-vaccination, the patient experienced severe abdominal cramping in the stomach area, it was reported that the patient experienced the severe abdominal cramping on day two of her menstrual cycle. The patient sought unspecified medical attention. Subsequently, the patient recovered. No additional information is expected.
Swollen (Rt) leg after vaccines - 2 days after 4x cm swollen (Lt) leg after vaccines - 2 days after 7 x 7 cm not walking "painful", fever 101.0
10am Saturday-shot About 1pm Saturday-extreme fatigue and slept 7pm-woke up with chills, body aches, fever b/w 101-103, headache 9pm-Went to bed w/same symptoms but debilitating constant headache that felt like knife stabbing me in the brain. Could not sleep due to extreme relentless head pain 9am Sunday-Painful headache and fatigue continued all day and could not do anything 10am Monday-symptoms subsided
Information has been received from a physician concerning a 12 year old male who on 06-AUG-1998 and on 06-JUN-2001 was vaccinated with the first dose and second doses of MMR II, respectively. On 04-DEC-2009 the patient experienced left mumps. On 07-DEC-2009 the patient was diagnosed with mumps. At the time of the report, the patient's outcome was unknown, this case was non-serious. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a 55 year old female patient. There was no pertinent medical history. The patient's medical history included rash after use of an unspecified strength of AVELOX tablets. On 26-NOV-2013, the patient was vaccinated with ZOSTAVAX lot # H021712 expiry date 06-MAR-2014 (dose and route not reported). There was no concomitant medication. On 28-NOV-2013, the patient experienced an injection site reaction. The site was red, hot, painful and spread down to the patients elbow. Patient visited the physician's office and began treatment with amoxicillin due to "cellulitis versus immunization reaction". No lab diagnostics performed. There was no rash to obtain samples from. The outcome of the events was reported as not recovered. Additional information has been requested.
Felt fatigued; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Felt fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced FATIGUE (Felt fatigued). At the time of the report, FATIGUE (Felt fatigued) outcome was unknown.            Patient reported that she did not test positive for Covid. Concomitant information was not reported.  Treatment information was not reported.  The action taken with mRNA-1273 with the event was considered as not applicable.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 29-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 29-Apr-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) 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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    On 27-Jul-2022, the patient received first dose of Monovalent Moderna Covid-19 vaccine (Batch/Lot number: AR9237B and Dose/volume: 25 micrograms).  Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna monovalent was reported as Mono and bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
I have neck pain/heaviness as if someone is standing on my neck. At times it's so heavy I have to put my head down or prop it against something. It comes and goes randomly but at least once or twice a day lasting anywhere from 10 minutes to 2 hours. I take ibuprofen if it lasts longer than 20-30 minutes. It makes it difficult to work, causes me to have a headache and upper back pain. I never had any problems prior to getting the vaccine. It's been 10 months and still happening. I went to my doctor but she is perplexed as to what to do. No one knows what to do about it!
A couple hours to a day after I received the vaccine I came down with a skin condition called granuloma annulare. I went to see my PCP who was not well versed in skin conditions. I went to see the dermatologist who is currently treating my condition. She prescribed Triamcinolone Acetonide 0.1% Cream that helped the spot but move it reappeared in a different area of the body. She has now added a once a week light treatment to my medical routine.
Whelps all over entire body-spreading throat itchy and difficult to breathe - responded to BENADRYL given 6/21/15 by parent.
This spontaneous report was received from a nurse (also reporter as healthcare worker) refers to unspecified number of patients of unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date an unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K020214, expiration date 25-MAR-2016). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
She also has all over body soreness as if she has been exercising; ear pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear pain) and MYALGIA (She also has all over body soreness as if she has been exercising) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic pain.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced EAR PAIN (ear pain). On 06-May-2021, the patient experienced MYALGIA (She also has all over body soreness as if she has been exercising). At the time of the report, EAR PAIN (ear pain) had resolved and MYALGIA (She also has all over body soreness as if she has been exercising) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she has been taking pain medications for chronic pain. Treatment included Pain medications for ear pain.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative; (09Dec2022) Positive; (15Dec2022) Negative; (21Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
1 hr: site pain and swelling ; 12 hrs later dizziness; 16 hrs later nausea, fever (101.4), increased pain, chills, headache over 5 hr period; 24 hrs later headache , site pain and swelling  persist; fatigue (perhaps due to restless sleep), 2nd night fever, headache , restlessness; day 2, swelling subsides sore to the touch, dull headache.  First night confirmed the vaccine is the way to go to avoid these symptoms and the virus
Bruise at injection site, large red rash below injection that is hot to the touch and painful
lethargic; sore right arm; tired; entire body ached; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargic), VACCINATION SITE PAIN (sore right arm), FATIGUE (tired) and MYALGIA (entire body ached) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced LETHARGY (lethargic), VACCINATION SITE PAIN (sore right arm), FATIGUE (tired) and MYALGIA (entire body ached). At the time of the report, LETHARGY (lethargic), VACCINATION SITE PAIN (sore right arm), FATIGUE (tired) and MYALGIA (entire body ached) outcome was unknown.      Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-666268, MOD-2022-666297, MOD-2022-666332 (Patient Link).
Muscular pain, especially lower back.  Pain first noticed upon waking at 5:45am.  Took 3 ibuprofen in morning and 3 again mid afternoon.  Fatigue - around 3pm. Slept for 3 hours. Chills at night.  Covered up. Pain much improved the following day.
Patient fainted momentarily after she received the vaccine. Patient was okay afterward. She sat in the pharmacy for few minutes before leaving. Patient suffer no injury.
I95.9 HYPOTENSION 4/17/2023 EXTRAHEPATIC OBSTRUCTIVE BILIARY DISEASE R57.1 HYPOVOLEMIC SHOCK 4/9/2023 EXTRAHEPATIC OBSTRUCTIVE BILIARY DISEASE
Violent shakes; disoriented; skin was hot to touch; fever of 104; Sore shoulder; Nausea; Diarrhea; Frequent urination (7 times last night; Very bad stomach cramp; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violent shakes), POLLAKIURIA (Frequent urination (7 times last night), ABDOMINAL PAIN UPPER (Very bad stomach cramp), DISORIENTATION (disoriented) and DIARRHOEA (Diarrhea) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced POLLAKIURIA (Frequent urination (7 times last night), ABDOMINAL PAIN UPPER (Very bad stomach cramp), DIARRHOEA (Diarrhea), ARTHRALGIA (Sore shoulder) and NAUSEA (Nausea). On an unknown date, the patient experienced TREMOR (Violent shakes), DISORIENTATION (disoriented), SKIN WARM (skin was hot to touch) and PYREXIA (fever of 104). On 26-Feb-2021, POLLAKIURIA (Frequent urination (7 times last night), ABDOMINAL PAIN UPPER (Very bad stomach cramp), DIARRHOEA (Diarrhea), ARTHRALGIA (Sore shoulder) and NAUSEA (Nausea) had resolved. At the time of the report, TREMOR (Violent shakes), DISORIENTATION (disoriented) and PYREXIA (fever of 104) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included Anti-diarrheal drugs and Antacids. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: :Details of AEs were updated and consumer agreed to fill out ADR form
Rectangular red and puffy underneath injection site of Pneumovax 23 beginning 2 inches below injection site and ending 1 inch above the elbow crease. Slightly warm to the touch.
On October 25, 2021 I woke up for work at 7 AM with left hand numbness/tingling that radiated down to underside of my elbow. I could feel sensation but it was decreased. I went to work and then at approximately 12 PM I began having left-sided facial numbness/tingling. I also began having some chest tightness on the left side only. My coworker noticed that I began having difficulty saying words. Not that my speech was slurred, just that I seemed to be having an issue with word recall and was experiencing some confusion. At this point, my coworker (a certified EMT) recognized I may be having a medical emergency and drove me to the ER.   Once at the ER, the medical team began working me up for stroke vs TIA vs heart attack among other things. The tests performed are listed in Item# 19. While in the ER being worked up, the doctor noticed I had a left-sided facial droop around 12:30-12:45 PM. I was given prednisone and sent for more imaging. All imaging was determined to be negative. I was discharged around 5:45 PM with a prescription for Valtrex and Medrol dosepak. The diagnosis assigned to me was ?with left-sided ulnar arm dysesthesias and Bell?s Palsy?, although my medical team did say it was ?atypical? because my other symptoms did not fit the profile for Bell?s Palsy.   I did not sleep very well the night of October 25. When I woke up in the morning on October 26, my symptoms had resolved. After October 27, my symptoms were transient, but not as severe as Oct 25 until  November 2. On the morning of November 2, I woke up with left hand and arm numbness/tingling. The left side of my face began to feel numb with tingling around midday. In the evening, my family noticed I had a slight left-sided facial droop. By the evening, only my left thumb, left armpit, left forearm and left chin were still feeling numb/tingly. I did not seek medical care during this episode.  The course of treatment for the Medrol dosepak (4 MG tablet) began on October 26 and ended on November 1. The Valtrex (1 G tablet) was 1 PO TID beginning October 26 and ending on November 1.