chrisvoncsefalvay/vaers-outcomes huggingface dataset:
missed their menstrual cycle after their second shot of their COVID 19 vaccine.; This is a spontaneous report from a contactable consumer and a contactable nurse (one of which is a colleague). This nurse reported for three adolescent female patients. This is the first one of three reports. An adolescent female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation.  It was unknown whether the patient was diagnosed with covid prior to vaccination or was tested for COVID-19 post vaccination. The patient missed her menstrual cycle after their second shot of their covid 19 vaccine. It was unknown if the patient receives any treatment in response to the event. The outcome of event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100930370 Same reporter/drug/AE, different patient;US-PFIZER INC-202100930371 Same reporter/drug/AE, different patient
my hand now are hurting like I have arthritis or something/causes the hurt and they just ache my wrist and my hands like hurt so bad like/ hands felt so bad; They were numb, my toes went numb; my toes went numb and that was for few days; I can't even hardly sleep at night.; my hands causes the hurt, they just ache my wrist and my hands like hurt so bad like; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 26May2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient hands were hurting like a patient had arthritis or something. Patient wonder that was the side effect of the vaccine, toes were not numb anymore, they were numb, toes went numb, patient did not had diabetes, any neuropathy or anything like that, toes went numb and that was for few days and gone, after like 2 days patient hands cause the hurt and they just ache, wrist and hands like hurt so bad like, patient did not even hardly sleep at night, patient can barely sleep. Hands felt so bad. Patient never had a problem with any sort off arthritis or anything like. The outcome event toes went numb was recovered and for other it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
immunocompromised patient given 0.25 as a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 as a third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 as a third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 as a third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Pharmacist called and indicated that they had a patient that they got the Moderna two dose primary series (0.5 milliliter) and then a Moderna booster dose (0.25 milliliter). The patient told the pharmacist that they were immunocompromised and wanted a fourth dose. The pharmacist also indicated that they needed an answer fast because the patient was there. The context and the details of why the 0.25 milliliter dose given were not described in details.   Reporter did not allow further contact
Patient wife reported that patient had itching at injection site, localized tenderness, erythema at injection site, and swelling at injection site. Said this occurred earlier but reported to us at 8:50PM.
red, itching rash on her face and scalp / rash is on her face in the area where she wears a face mask; red, itching rash on her face and scalp / rash is on her face in the area where she wears a face mask; muscle pains that she described as cramps in her calf muscles; cramp in calf muscle; This case was reported by a consumer and described the occurrence of itchy rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included muscle pain and cramps calf.   On 12th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced itchy rash, red rash, muscle pain and cramps calf. On an unknown date, the outcome of the itchy rash, red rash, muscle pain and cramps calf were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash and cramps calf to be related to Shingrix. The reporter considered the muscle pain to be unrelated to Shingrix.  Additional details provided were as follows: The patient received the first dose and later and experienced red and itching rash on her face and scalp the patient reported muscle pains that she described as cramps in her calf muscles. She had experienced these events prior to receiving Shingrix. It was unclear how long after the injection these symptoms were noted. The patient had planned to consult with a dermatologist soon. The reporter did not consented to follow up. The reporter does not feel muscle pain was related to Shingrix vaccine.
Received first dose and 10 days later suffered from feeling like I was underwater in left ear.  Went to doctor for ear cleaning.  Removed wax and feeling continued.  Received second dose and severe hearing issues in left ear within 4 days.  Now seeing ears nose and throat person tomorrow.
On an unspecified date, the patient received an unspecified flu vaccine (manufacturer and batch number not provided) and unspecified pneumococcal vaccine (manufacturer and batch number not provided). On an unspecified date, the patient developed an allergic reaction to an unspecified pneumococcal vaccine and unspecified flu vaccine. The outcome was reported as recovered (as the patient was "fine"). Company comments: Seriousness: Non-serious. Listedness: Listed. Causality: Unassessable.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016 (reported as between "18-JUL-2016 and 04-AUG-2016"), the patients were vaccinated with improperly stored doses of VARIVAX lot # M000756 with expiration date: 06-JAN-2018 and lot # M006731 with expiration date: 09-FEB-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of - 10.8 degrees Celsius for 35 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
Swelling 7-17-14 at 5pm; redness 7-17-14; hot 7-17-14.
Seriousness criteria: Important medical event. Initial unsolicited report received from nurse on 19-Apr-2018. This case involves female patient (age and gender not reported) who was vaccinated with a dose of IPV (batch number: N1G51), DTAP (batch number: C5180AA), VARICELLA VACCINE (LIVE) (batch number: N029634), MMR (batch number: N023153) and HEPATITIS A VACCINE (Batch number: N030286) (expiration date, dose, route was not reported for all vaccines) in leg (on record it says 2 shots on left leg and 3 on right leg but was told that it was wrong. They are not sure which shots were given on which leg) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient left leg had three puncture wounds. One was a given a little high up, two puncture wounds on right leg. On an unspecified date, following the vaccination, the higher puncture on left leg had swelling and was raised, a little warm to the touch which indicate of cellulitis 2 degree. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none. Sender's Comments: This is a poorly documented case in which patient was given 5 parenteral vaccinations on the thighs simultaneously, one of them being Polio vaccine. One of the 5 vaccination sites developed Cellulitis. It is not known as to which vaccine corresponds to which puncture site. The time to onset is not reported, neither is the etiology of the cellulitis confirmed by lab tests. Based upon the reported information, it is not possible to comment on the role of any particular vaccine in this case.
Severe headache, lasted about 1 week Chills, lasted about 1 day Fatigue, lasted about 1 day Tinnitus, constant ringing, started 3/25/21 and has shown no improvement. As of today I have had this symptom for 3 weeks. It remains unchanged as of right now.
This spontaneous report was received from a physician via company representative regarding a 12 years old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 27-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 in the left deltoid, lot# N026812 and 22-JUN-2020 expiration date, for prophylaxis (strength and frequency were not reported). Then, on 02-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 in the right deltoid, lot# N026812 and 22-JUN-2020  expiration date for prophylaxis (strength and frequency were not reported). On 03-JUL-2018, the parent of the patient contacted the physician and reported that the patient's right shoulder up to his neck was swollen and he had pain (pain and swelling). The patient's was seen in the physician's office and was treated with ibuprofen (manufacturer unknown) and ice. On 04-JUL-2018, the patient's pain increased and the patient was experiencing diarrhea with a fever of 101 (pyrexia), then patient was instructed to bring the patient to an unspecified emergency room. In the unspecified emergency room an unspecified labs and sonogram were performed. The sonogram showed the lymph nodes were swollen on the right side (lymphadenopathy), but there was no drainage. In the emergency room the patient was treated with clindamycin (manufacturer unknown). Additionally, unspecified cultures were made and came back negative. The patient was discharged on 04-JUL-2018 and put on oral clindamycin for 3 days. On 09-JUL-2018, the patient returned to physician's office with no fever, decreased swelling and slight discomfort when moving the right arm. On 12-JUL-2018, the patient had recovered from the events.
During a review of the Department of Health internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Immediate and constant asthma attacks from lung swelling; Body aches; Lethargy; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 13Apr2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypoglycaemia, high cholesterol and lung swelling. The patient had allergies to eggs, shellfish, molds, radish and sulfa antibiotics. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included birth control (unspecified) started from an unknown date for unspecified indication, atorvastatin (MANUFACTURER UNKNOWN) started from an unknown date for unspecified indication, cetirizine hydrochloride (ZYRTEC) started from an unknown date for unspecified indication, montelukast sodium (MONT) started from an unknown date for unspecified indication and fluticasone propionate (FLONASE) started from an unknown date for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 13:30, the patient experienced immediate and constant asthma attacks from lung swelling, body aches and lethargy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events- immediate and constant asthma attacks from lung swelling, body aches and lethargy were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient fainted approximately 5 minutes after receiving vaccine. Returned to normal approximately 30 seconds  after elevating feet, providing ice packs.
Swelling, warmth, redness, beneath site of vax, began 48 hours post vax in right arm.
Pt developed dizziness, headache and muscle aches, immediately, post vax, lasting about 24 hours.
The Volunteer was vaccinated one week before his due date.  Called 2/12/2021 arm sore, same side effects as first, just tired.
Swelling, redness and itching at the injection and upper (L) arm. Pt. used hydrocortisone to help w/itching.
Leg swelled up around injection site, warm to the touch, red splotchy rash was given DPT Tox, seemed to help.
Patient was given a TDap vaccination October 8 at the 30 week pregnancy checkup. Baby was due December 14, and gave birth December 21. There were no pregnancy complications. Injection was given high on the shoulder. Patient had no pain or injury to the shoulder prior to injection.  A few hours after the injection the pain was debilitating and patient was unable to lift the right arm at the shoulder. Examination and blood tests showed no signs of infection. Patient was unable to move their arm at the shoulder for approximately two weeks. Patient started attending physical therapy at two weeks and condition slowly began to improve though still exhibited loss of motor control and pain. An MRI showed ?nonspecific mild edema of the supraspinatus muscle" and "mild right subacromial/subdeltoid bursitis" though physical therapist observed worse symptoms than what MRI showed. As of March 12, condition is still improving though patient still has not recovered full active range of motion.
With the first two doses, my lymph nodes in the axillary area swelled up for several months on the side of the vaccinated arm.  The third vaccine had the worse adverse effects. My lymph nodes in my neck swelled up like a baseball on the left side, my scalp broke out into a severe case of folliculitis, and I lost my hearing in my left ear.  The neck swelling took three months to go away.  The folliculitis took four months.  And I am still dealing with the hearing loss in the left ear.
Within about 12 hrs of receiving immunization, her arm developed large red raised area that was painful & itchy. Also formed blisters it was so taut. Grew to 13.5 x 8 cm by time it was seen 2 days later. No trouble breathing/swallowing, no other rashes.
Product temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 11-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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 information was reported.   This case was linked to MOD-2021-421651 (Patient Link).
arm soreness; can not physically lift her arm up; Hives; Chills; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A female patient of an unspecified age received bnt162b2 PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported on an unspecified date, she knew that arm soreness was normal after the vaccine, but she could not physically lift her arm up, it had to stay by her waist. She could not pick it up and she was also experiencing hives and chills. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
I feel out of sorts, a  disorientation feeling. I feel as if I'm coming off or a post serious flu with high temperature. A feverish feeling coupled with arm ache where the shot enter my arm
Headache, fever,  weakness, flu like symptoms so severe that I did not eat for 30 hours and slept the entire time.  Heart pain for a couple hours 24 hours after the shot.
Patient received 1st Covid vaccine on left deltoid muscle. Patient advise the need to wait 15 minutes for any adverse reaction. Patient verbalized understanding. Once patient was in the waiting room, she stated to the staff in the business office, she felt nauseated and dizziness and sat on the waiting floor per patient. provider was made aware. Patient was brought to patient room and was laid down on examination room Per patient she has history of fainting in the past but recently been fine. Vital sign as follow at 01:13 PM BP 128/67 HR 40 RR 16 SPO2 98%, vital sign repeated at 01:25 BP 131/72 HR 40 SPo2 96% RR 16 Per patient heart rate is always in the low side.  Provider was made aware. At 01:36 patient stated she felt better, and vital sign take BP 136/75 HR 41 RR 16 Spo2 96%. At 01:41 vital sign as follow BP 128/74 HR 46 Spo2 97% RR16. Vaccination record card and Fact sheet for vaccine provided to patient. Patient monitor for 30 minutes no adverse reaction noted. Patient left clinic stable with steady gait.
Dizziness; Chills; fever of 102; first  dose on August 2018 /  6 months after the vaccine was not available; This case was reported by a consumer and described the occurrence of dizziness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st vaccine on an unknown date, many years before reporting day).   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced dizziness, chills, fever and product supply issue. On an unknown date, the outcome of the dizziness, chills, fever and product supply issue were unknown.   It was unknown if the reporter considered the dizziness, chills and fever to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not applicable for 2nd dose of vaccine. The patient reported that she got her first Shingrix vaccine dose and had a severe reactions. The patient reported fever of 102 degrees Fahrenheit, chills and dizziness that did not let her get out of bed. The patient reported that about 6 months after the vaccine was not available and she reported that her Healthcare professional stated to forget of getting the vaccine, which led to product supply issue. The reporter stated that this healthcare professional was a new doctor and not the one that she had when she got her vaccine. The reporter consented to follow up.
Received flu injection 10/10/2007 Skin eruption occured five days later starting with right shoulder and extending over trunk area. Saw PA and then was seeen by Dr.  Received steroids and said MD called it a drug eruption. Person is on Attenolol,Norvasc, HCTZ, K+,Evista,Lasix,Zedia with no prior problems
Patient states she had a bad asthma attack, She became dizzy and heart rate was very elevated along  with shortness of breath. She then came in and was treated, she is responding well to the steroids.
Swelling/redness on R lower part of upper arm. pt states 0 discomfort.
AFTER REVIEWING PRE-VACCINATION CHECK LIST, DISCUSSED WITH PATIENT ALLERGY TO PENICILLIN AND INQUIRED INTO DETAILS OF FLU VACCINE REACTION.  PATIENT DISCUSSED BOTH "ALLERGY/REACTIONS" WITH PHYSICIAN AND HE ADVISED PATIENT TO GO AHEAD WITH VACCINE.  PATIENT NOTIFIED OF 30 MINUTE WAIT TIME.  THE JANSSEN COVID VACCINE WAS ADMINISTERED IM AT 2:05 PM.   5 MINUTES LATER WHILE DISCUSSING SIDE EFFECTS THE PATIENT EXPERIENCED  LIGHT HEADNESS, FOLLOWED BY DIZZINESS,  THEN  NAUSEA. PATIENT PLACED HEAD DOWN TO KNEES  BUT UPON RAISING HER HEAD THE SYMPTOMS RETURNED, ALONG WITH SWEATING AND A HEADACHE.   PATIENT ASKED TO LAY DOWN ON CARPETED FLOOR AND  , 911 WAS CALLED.  A PHYSICIAN IN OUR MEDICAL BUILDING NOTICED AND ASSISTED BY CHECKING BLOOD PRESSURE (122/77) AND PULSE WHICH WAS STRONG AND REGULAR..  HE REMAINED AT HER SIDE UNTIL THE  FIRESTATION MEDICS ARRIVED FOLLOWED BY EMS.  BY THIS TIME .  PATIENT SAID THIS TYPE OF REACTION HAS OCCURRED BEFORE AND LASTS 30  MINUTES WITH A FULL  RECOVERY.  PATIENT WAS  PUT INTO A CHAIR TO SIT UPRIGHT, THEN ALLOWED TO WALK AROUND UNASSISTED.  EMS GAVE PATIENT OPTIONS OF GOING TO THE ED TO BE EXAMINED, OR RELEASED TO HER HUSBAND.  SHE CHOSE THE LATTER OPTION AND LEFT VIA CAR. AT 3:45 PM
She got Prevnar 13 immunization on 12/6/19. Her whole upper arm got swollen, red and got worse on 12/13/19.
Extreme soreness at site of injection. Significant weakness in both legs.  Achiness in both legs, particularly from knees down.
Sore arm immediately and on-going, headache, fever, chills, joint and muscle aches the next day into 10/29/21. All but fever continue. Strong shoulder and back pain 10/31/21
Shortneas of breathe. Headache. Dizziness. Heaviness in chest. Exhaustion.    Rescue inhaler, Tylenol, water, rest
Patient states that she was feeling fine during and day vaccination was given. Later on the next day she felt the injection site was warm to touch and was risen. It was red and swollen. Took BENADRYL to ease the swelling and redness.