chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received Moderna Covid vaccine on day 21 of my menstrual cycle (2/8/21).  I was supposed to begin my period five days later, 2/13/21.  The start of my period was delayed by eight days, finally starting 2/21/21.  I track my period with an app so I know that this is highly unusual.  I'm 47 so I was assuming perimenopause could be playing a role in my delayed period until I discovered that there are many others reporting the same issue.  It's not a big deal to have a delayed period, it just would have been nice to know that it's a normal potential side effect.
Second Dose administered at day 20; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown  with no associated AEs.
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during his 1st year of life from 1/99 through 2000 and each time he received a multi-dose vaccine. The alleged results of these vaccinations are that the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. In addition, it is alleged that the pt has sustained further neurological insult from other vaccines, including MMRII, which does not contain thimerosal, but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, permanent injuries, severe autism, neurological disorders and the exacerbation of the neurological disorders were considered to be "Other Important Medical Events". No further information is available.
Client arrived at ER 06/01/12 at approximately 4:45pm for a vesicular rash to his feet, legs, arms, back and abdomen since 05/30/12; pulling at ears and vomiting x1 on 06/01/12 and fever of 100.1 on 05/30/12.  Dr. diagnosed client with varicella and client was discharged from ER at 5:50pm with instructions to follow-up with his physician as needed.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case pertains to the 87th patient of the total 190 patients.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Patient received a moderna vaccine and later had COVID.; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Patient received a moderna vaccine and later had COVID.) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.  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 COVID-19 (Patient received a moderna vaccine and later had COVID.). At the time of the report, COVID-19 (Patient received a moderna vaccine and later had COVID.) outcome was unknown.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  Patient's age was reported between 35 to 45 years. No concomitant medications were reported. No treatment medication were reported.  Company comment: This spontaneous case concerns an adult male patient of unknown age with no reported medical history, who experienced an unexpected, non-serious AESI COVID-19 after receiving a dose of mRNA-1273 vaccine. Exact latency of the event relative to vaccination cannot be determined with an unknown event's onset date and vaccine administration date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns an adult male patient of unknown age with no reported medical history, who experienced an unexpected, non-serious AESI COVID-19 after receiving a dose of mRNA-1273 vaccine. Exact latency of the event relative to vaccination cannot be determined with an unknown event's onset date and vaccine administration date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed per medical judgement.
Apprx. 10 min after receiving the flu vaccine in her left arm, pt c/o itching. Her injection site was hot, red apprx. 8cm around site. No other c/o. No respiratory distress, N+ V. R 18-20 P72/80. Ice pack to site. Tylenol tab 500mg /tab. Benadryl 50mg-po observed for 30 mins.
Pt. received VZV shot in La on 11-5-12. Came back to clinic on 11-7-12 c/o swelling & redness. She was seen by RN and encouraged to put cool compress several x daily and explained this is one of the side effects, and encouraged to see an M.D. if worsening occurs. 11-8-12 at 2:45PM mom states "It was still red this AM but not any worse".
whole-body hurts; can hardly move arm; has a temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole-body hurts), PAIN IN EXTREMITY (can hardly move arm) and PYREXIA (has a temperature) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020. Concurrent medical conditions included Drug allergy (Codeine (nausea)).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (whole-body hurts), PAIN IN EXTREMITY (can hardly move arm) and PYREXIA (has a temperature). At the time of the report, PAIN (whole-body hurts), PAIN IN EXTREMITY (can hardly move arm) and PYREXIA (has a temperature) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Got Td on Thursday, 08/10/2006 left arm, on Friday 08/11/2006 started with red arm swelling warm to touch, Saturday 08/12/2006, with nausea, shortness of breath, fever, chills, had an antibiotic called in on Sunday 08/13/2006 had appointment in office 08/14/2006 still had redness with swelling to most of her upper arm, no fever, no shortness of breath.
Patient began having symptoms 7 days after vaccination:  chest pain, shortness of breath, feeling like a lump in the throat.  Over several days symptoms worsened, and included upper back pain and some pain in the upper left arm.  Patient went to urgent care clinic on the morning of March 15, where staff decided to send patient by ambulance to the hospital.   She was admitted to the hospital and diagnosed with having 5 blood clots in her lungs. She was discharged March 16 in the evening on Eliquis 5mg twice a day. She states the hospital did not know what caused the blood clots, and were aware she had been vaccinated recently.  She has not had a doctor visit in years, but is now established with a primary care physician for follow-up care.   The second Moderna dose was given today 3/31/21.
Myalgia. Acetaminophen 2 tab once, sodium chloride 125 ml other, ceftriaxone 1 gm once
pt recvd 2nd & 3rd doses of Engerix-B & exp no medical problems or reactions; titer test results indicated no antibody conversion;
A rash started forming around my neck  starting around 9pm on 6/14. Went to bed and woke up around 2:45am with hives all across my body. Went back to sleep and rash had spread further when I wome up the morning of 6/15.
Myopericarditis - elevated troponins and CKMB, global ST segment changes on ECG
Rash on chest with a burning sensation, bruise on lower leg, applied hydrocortisone on rash. Leg still showing some bruising, Rash is mostly gone now, but burning sensation is still there.
Systemic: pale-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Mild, Additional Details: Pt vision went dark within a few minutes after vaccine. Pt HR 40s, O2 93%, temp 97.1 and pt looking pale. UTA BP as pt is autistic teenager and was agitated and trying to leave during visit. Pt mother present and helped calm patient. 911 called due to vision change and low heart rate. EMS arrived and pt HR back up and no longer pale. EMS reassessed pt, per pharmacy on NP return, pt/guardian refused ER transport and condition stabilized. Pt vision returned. Further EMS services declined.
one friend got COVID after the shot and has passed away; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine and got COVID after the shot and has died/COVID-19.  The patient's medical history was not provided. Concomitant product use was not provided by reporter.    On an unknown date the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    Reporter mentioned that her friend got COVID after the shot and has died. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the event death is not applicable.   The patient died on an unknown date. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: A case of death of female patient of an unknown age who developed COVI on an unknown date post mRNA-1273 (vaccination (lot   unknown) and died.  Very limited information regarding this event/s has been provided at this time.  However, based on the known etiology of COVID and the established profile of mRNA-1273, the event is assessed as unlikely related to mRNA-1273 administration. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Quarter-size knot painful to the touch; Swollen lymph node above left collar bone.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 20:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to penicillin. Concomitant medications included citalopram 25mg (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. 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 04Apr2021 at 06:00, the patient experienced swollen lymph node above left collar bone and quarter-size knot which was painful to the touch. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph node above left collar bone and quarter-size knot painful to the touch was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient blacked out and fell on his side to the ground about 5-10 minutes after the shot.  911 was called but pt declined EMT or Emergency services. He said he felt better after we gave him some orange juice.
Left arm pain from site of injection, shooting down lateral arm to lateral elbow, lasting a few seconds at a time, several times a day, every day.  Comes and goes on its own.
Went at 0917. PT went to the ED for chest tightness and tach.  Treatment: IV/LR 1L 0825. 0917 Asprin 324MG.  Procedures: CT, ECG, LABS.  Outcome: PT was admitted to MSU
erythema, tenderness, pain to rt deltoid area s/p Td vax on 16JUL98 measuring 10-11cm x 7-8cm examined by MD;placed on ATB;
Extreme chills starting around 9:00 PM, no fever  Around 11:00 PM, extreme vomiting  Around 11:45 PM vomiting again
High fever (103), extreme fatigue, migraine, body aches, night sweats, large red circle with tenderness on arm near injection site, bruising at injection site
LITTLE NUMBNESS IN LEFT THIGH/NUMBNESS IN UPPER PART OF BACK; ARMS WHERE VACCINE WAS APPLIED TINGLING/HAND OF THE SAME ARM TINGLING WHEN LYING DOWN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number and expiry unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced little numbness in left thigh/numbness in upper part of back. On MAY-2021, the subject experienced arms where vaccine was applied tingling/hand of the same arm tingling when lying down. The action taken with covid-19 vaccine was not applicable. The outcome of the little numbness in left thigh/numbness in upper part of back and arms where vaccine was applied tingling/hand of the same arm tingling when lying down was not reported. This report was non-serious.
Hot round red spot on upper right arm beginning the day after the injection and continuing through today Feb 28 2021
This spontaneous report was received from a 56 year old female patient regarding on herself with migraine headaches and none drug allergies, who on 15-OCT-2013, was vaccinated with a dose of ZOSTAVAX (Lot no. J004266, exp. 12-JUL-2014), subcutaneous in the left arm for vaccination. Concomitant therapies included TOPAMAX. On 15-OCT-2013 the patient developed swelling, redness and warmth at the injection site 1 hour after administration of ZOSTAVAX. On 17-OCT-2013, the patient developed multiple fever blisters on her lip. The patient was evaluated by her unspecified physician who prescribed two courses of antiviral medication. On approximately 29-OCT-2013 (reported as 'within two weeks") injection site reaction resolved. The patient added that the corners of her mouth were cracked. The patient tried ABREVA and "lactinex". No lab diagnostic studies were performed. At the time of the report the patient had not recovered from fever blisters on her lip. Relationship between multiple fever blisters on her lip, swelling, redness, warmth of injection site and therapy ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report was received from a physician via a company representative referring to a 16 year old female patient. The patient had not medical history nor concurrent conditions. In approximately 2017 (reported as "within the last few weeks"), the patient was vaccinated with a dose of GARDASIL 9, 0.5 ml (lot # and expire date were not reported) for prevention of HPV. Concomitantly the patient was vaccinated with a dose of MENACTRA. In approximately 2017 (reported as "within the last few weeks"), as the patient was leaving the office, she passed out and made some tonic clonic movements, as a result, the patient had some abrasions (skin abrasion) from the fall. The outcome of the patient regarding the events of tonic clonic movements, skin abrasion and passed out was reported as recovered/resolved, on an unspecified day in 2017. The patient's mother told to the doctor that she was planning to take her to see a neurologist about this adverse events, but it was unknown if the patient had seen the neurologist at this time. The patient did not received any treatment for the adverse events. No causality assessment was provided by the physician. Upon internal review tonic clonic movements and passed out were considered to be a medically significant events. Additional information has been requested.
Following Tdap vaccine patient developed "twitching "over the left index finger initially and then generalized to the entire arm/arm also had become swollen/ seen in the emergency room they felt it was nerve irritation discharged with Codeine and local heat compresses/ when seen in student health the twitching and pins and needles had resolved still with some pain
Shot was given at the top back side of left arm & was very painful as it was administered. The next day my whole arm was sore. Even now, 4 mths. later I have lost strength in that arm, arm pain & mobility difficulty.
Patient presented to the clinic with redness, swelling, warmth (Lg. Hive) to L upper arm.  Picture was taken and sent to our dermatology dept. to determine further treatment plan.
On my shoulder there is a large bump; circle around it; It's reddish and inflamed; itchy/The middle is solid, itchy around; Next morning developed a bump on her shoulder. It is red, swollen, and itchy; It's warm to the touch; This is a spontaneous report from a contactable consumer or other non health care professional (patient herself). A female patient (Age: 77 units: Unspecified) received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that, she had her first dose of the Pfizer vaccine on (Saturday) 06Feb2021 afternoon in her shoulder. She had an interesting reaction that appeared, next morning 07Feb2021 developed a large bump on her shoulder, circle around it. It was pretty reddish/red, inflamed, hot, swollen, and itchy. It was a little bigger, about 2.5 inches to 3 inches in diameter. It was at injection site. The middle was solid, itchy around. It was warm to the touch. It was around 2.5-4 inches. She wanted to know if the needle went in all the way. She didn't feel the vaccine, but she was pretty tough. She wanted to know if it was normal for people to get the rash and bump and asked for the second dose any contraindications on taking it. Investigation Assessment was not Provided. The outcome of the events was unknown.  Description of complaint: Had a bump that was itchy and red after COVID-19 Vaccine. Concerned needle didn't go in deep enough. Caller declined to complete report. Full details not obtained. Product strength and count size dispensed and Additional lot numbers Not provided. sample of the product available to be returned, if requested as Not provided. Packaging sealed and intact was Not provided. From mail trail received in response to query sent regarding confirmation correct PRD involved in this report: Query: Please help to confirm correct PRD of attached report since "09Feb2021" provided in the source, but SRD is 08Feb2021in the processed ICSR screen. (Screen shot attached). Response: PRD is 08Feb2021(see below). Nurse is currently sending dates over to hospital format. If you have any questions around this, please contact your BT support or digital team for further information.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient was given a COVID PFIZER vaccine that has been stores outside temperature excursion allowed. (2 weeks in freezer + 1 week thawed). Patient has no adverse events and was notified 6/21/22. No issues identified.
MODERNA BRAND WAS INADVERTENTLY ADMINISTERED TO A 13 YEAR OLD.  NO ADVERSE REACTION PER MOTHER.
One hour after vaccination with Hep B, developed redness of face, lips, throat with sensation of tingling, swelling tongue, lips, throat. Given Benadryl.
PATIENT RECEIVED INJECTION WHILE STANDING, STATED THAT SHE FELT LIKE SHE WAS FLOATING, AND WAS LOWERED TO THE FLOOR BY A FAMILY FRIEND.
Redness and mild swelling at injection site. Patient said that redness had moved down the outer bicep to about 1 inch above elbow over the course of 48 hours.
I had mild pain radiating in my arm within 2 minutes of the vaccine.  1-2 hours later I developed unusual and intermittent pain on the volar surface of my wrist.  8 hours after the vaccine I developed chills, severe fatigue, myalgias, loss of appetite, and a fever up to 101.  I was bedridden for 36 hours and then the symptoms gradually subsided by day 3.  I then developed a sense of chest tightness intermittently for the next 4 days usually at night.  I did not have chest pain, but had tachypnea at times with a respiratory rate up to 22/min. At day 7 this resolved.