chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After taking the vaccine my periods are way more heavy, way more painful, and super irregular; After taking the vaccine my periods are way more heavy, way more painful, and super irregular; After taking the vaccine my periods are way more heavy, way more painful, and super irregular; dealing with extreme fatigue the week before my cycle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 (Lot number: EW0168) at the age of 42 years as dose 1, single and administered in arm left, administration date 04Jun2021 (Lot number: EW0168) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset 21May2021, outcome "unknown" and all described as "After taking the vaccine my periods are way more heavy, way more painful, and super irregular"; FATIGUE (non-serious) with onset 21May2021, outcome "unknown", described as "dealing with extreme fatigue the week before my cycle". Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, menstruation irregular, fatigue.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Patient had been taking levothyroxine for hypothyroidism for almost 3 years now. In her 43 years of life she would had rather suffered through COVID then to deal with this monthly. And it's not getting any better.   No follow-up attempts are possible. No further information is expected.
SEVERE side effects: visible swelling in arm below injection site for 30 minutes, agonizing burning pain through entire arm from shoulder to fingertips for about 6-8 hours, finally settled to dull aching pain. Extreme fatigue, barely able to get to bathroom or out of bed. Feverish and with headache, Tylenol somewhat relieved headache and fever but not arm pain. Fatigue has continued since date of vaccination, as only starting to recede somewhat, but not fully, on 6th day. Still very weak and shaky if standing for longer than a very few minutes. Unable to do basic household cleaning and need assistance for bathing and basic hygiene. Will not be receiving second dose, side effects way too severe to go through twice.
Rheumatoid arthritis flare up; Drug Allergy; This spontaneous case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and DRUG HYPERSENSITIVITY (Drug Allergy). The patient was treated with METHOTREXATE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and DRUG HYPERSENSITIVITY (Drug Allergy) 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.   Concomitant medications was not provided by the reporter.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Pediatric Pfizer bivalent booster vaccine was administered without diluting with diluent. Higher than intended dose was administered.
0.25 mL of expired doses were given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (0.25 mL of expired doses were given) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Janssen (LOT: 1808609) on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (0.25 mL of expired doses were given). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (0.25 mL of expired doses were given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received and stated that patient felt fine and with no side effects.
Developed a rash on my body, starting with chest first, than shoulders, following belly, arms and upper legs. It shows little spots and it is very itchy; developed a rash on my body, starting with chest first, than shoulders, following belly, arms and upper legs. It shows little spots and it is very itchy; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534) via an unspecified route of administration in right arm on 19Mar2021 12:15 AM as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included allergies of latex and walnuts (from an unknown date and unknown if ongoing). Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM), ibuprofen (ADVIL 12 HOUR), vitamin B complex (VITAMIN B) and magnesium (MAGNESIUM) taken for an unspecified indication (start and stop date were not reported). Patient also received first dose of bnt162b2 (Batch/lot number EP7534) in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 (five days after second Pfizer vaccine), patient developed rash on the body, starting with chest first, then shoulders, following belly, arms and upper legs. It showed little spots and it was very itchy. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was steroids and hydroxyzine 25 mg four times per day:  The clinical outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Starting at 11:30pm and lasting for 48 hours- nausea, headaches, chills,  fatigue,  runny nose,  severe muscle aches.  After 48 hours and still happening  headaches, brain fog, fatigue
pt recv vax 4JAN96&4JAN96 the pt exp rash&fever of 101;5JAN96 rash consisted of red,flat blotches;No further details were provided;
Pt. called facility to report that her arm was swollen, tender, and painful to touch. Pt. was instructed to alternate hot and cold compressions to her arm and to elevate the arm as much as possible. Also instructed pt. to take pain medications if available and to contact for further instruction or to report if the swelling has decreased.  If staff is unavailable to visit the nearest emergency room.
Injection painful when given, felt as if the needle hit a nerve. Left upper arm/bicep area red, painful, warm to touch; swollen for a few days to a week, then pain in the bicep area and in the humerus for weeks - achy/throbbing.
After about 30-40 min, I started to notice a quickening in my chest.  It felt like heart palpitations.  This sensation continued for a few days following the vaccine.  I noticed 3 days following, while on a walk my heart rate was in a "peak zone" on my tracker for over 30 minutes.  That evening, I did feel chest discomfort - and I was not sure if it was from heart burn or not.  This all has resolved, and only lasted about 4 days in total.  I am due for my 2nd shot on 3/4, and I am not sure if I should go or not?
Injection site was very sore and painful to touch. The worst pain was about 12 hours after the shot and lasted a few hours. About 12 hours after the shot I developed a low fever accompanied by chills that lasted approximately 24 hours. I was very fatigued and tired for about 48 hours. I treated the injection site pain and fever with acetaminophen, which did seem to help a bit.
Redness 6cm x 7cm, mild swelling, soreness, fever. Treated with Tylenol or Motrin PRN.
I received the Pfizer Bivalent COVID-19 booster on 10/18/2022. On 12/4/2022, I began sneezing; aside from the sneezing, I felt fine, though. I went to a family holiday celebration that day. I didn't think that sneezing was a symptom of COVID-19, so I didn't test myself that day. I also didn't sneeze that often. I probably sneezed twice while I was at the celebration and maybe three times at home, so it's as if the sneezing was constant. On 12/5/2022, I still had sneezing. I had some home antigen tests, so I took one, and the result was positive. I notified the other celebrants I had seen the day before, and ultimately, none of them ever tested positive for COVID-19. I contacted my doctor on 12/5/2022, and I was prescribed PAXLOVID. I began taking it that day. After I started the PAXLOVID, I actually felt sicker, but I think it was due to the medication rather than the virus. I had nausea, vomiting, and diarrhea, plus I also passed out on one occasion. I attribute those symptoms to the medication rather than COVID-19, though, because those symptoms didn't develop until after I started the medication. The worst day was 12/7/2022, and by the time 12/9/2022 rolled around, I felt like I was recovering. At the time of this writing, I feel that I have completely recovered and have no residual symptoms.
He was given a second dose of monovalent booster, when he was supposed to receive bivalent.
Pfizer Bivalent 6m-4y vaccine given after the beyond use date of 06/06/23.  No signs or symptoms reported at this time. Pfizer contacted and had no recommended action. Consulting with provider and reviewing CDC guidelines.   Lot: GP4345 Fridge exp: 06/06/23 Manufacturing exp: 04/30/23
For about 3 days there were soreness in my arms. Then there were a pain for about a week. Now a little weakness when I lift something or have my arm a certain way.
Chills; Fuzzy feeling in my head; Body aches; Temperature 101 D farenheight; Rash on front of my body; Fatigue; Red ring around my belly button; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight) and RASH (Rash on front of my body) in a 77-year-old female 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 26-Feb-2021, the patient experienced CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight), RASH (Rash on front of my body), FATIGUE (Fatigue) and ERYTHEMA (Red ring around my belly button). At the time of the report, CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight), RASH (Rash on front of my body), FATIGUE (Fatigue) and ERYTHEMA (Red ring around my belly button) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
12:45 Post vaccination reports feeling some  generalized  "numbness" to face, denies any additional complaints or associated symptoms, NAD, no respiratory complaints; medical monitoring, vitals assessed: BP 130/90 P80 O2 sat 96%. Reports "feels better", released from facility w/self.
clammy, light headed, mild nausea Narrative:  Had reaction while in clinic after 2nd dosage. After the vaccination, describes that he feels like he had a sudden increase in fatigue (clammy, lightheaded, mild nausea) that lasted for about 5 minutes. Not associated with flushing tachycardia, palpitations, shortness of breath, increased oral secretions, difficulty swallowing, syncope, sense of impending doom, stridor, angioedema, pruritus, urticaria, confusion, vomiting or abdominal cramps. Then developed what was described as a left sided dry throat. VS were WNL, exam benign other than some tenderness to palpation over the anterior right side of his throat w/o associated swelling/warmth/erythema/palpated thyroid abnormality. Water provided, no difficulty swallowing observed. He had not eaten lunch yet and was on his way afterwards. He was observed him for 30 minutes with precautions related to further care needs provided.
Mom stated she developed a generalized rash with itching and hives in the evening after receiving the influenza vaccination on 11-1-2005.  Had gone directly to "work out" after receiving the vaccine and informed mom of rash after returning home.  Mom reported that she called a nurse friend who told her to give Benadryl and to call Public Health the next day to report reaction.  Mom gave Benadryl 50 mg at approximately 7 p.m. and again at 11 p.m. on 11-1-2005. Mom reported that she was completely improved by the next morning.  Public Health informed mom that she might be allergic to one of the components of the vaccine and that she should notify her physician about this reaction and to check with her physician before receiving any future influenza vaccinations. Mom reported that she is not known to be allergic to eggs and eats them all the time.
Report on admission: History of Present Illness:  65-year-old male brought to ED for evaluation of generalized weakness, patient cannot hold himself up this morning.  He was diagnosed with COVID about a week ago.  He does not seem to be having any respiratory distress, chest x-ray is clear, oxygen saturation 97% on room air.  No signs of COVID-pneumonia, no hypoxia.  His serum glucose was only 46, D50 IV was ordered.  He looks dry clinically, his mucous membranes are dry, he is hypotensive, but renal function is essentially normal.  BUN is elevated at 42, but creatinine and GFR normal.  Lactate is elevated at 2.5, but he is not febrile and white blood cell count is normal.  Blood cultures were collected, was covered with initial doses of IV Zosyn and vancomycin pending blood culture results.  Urinalysis was has been ordered, urine specimen has not yet been collected by nursing.  Has elevated liver enzymes, AST 278, ALT 332.  Has had mildly elevated liver enzymes in the past.  Could potentially have some mild transaminitis secondary to the COVID infection.  Clinically he is not jaundiced, does not appear to be having any abdominal pain, abdomen nontender.  IV fluids started, blood pressure has improved to the upper 90s to over 100 systolic.  EKG shows no acute injury pattern, troponin negative, no evidence of acute myocardial infarction, cardiogenic shock.  CODE STATUS is comfort care.  We have tried to reach the patient's guardian/power of attorney to discuss what level of care they wish to be provided, but at this point have not heard back.  I discussed the case with Dr.'s PA, who accepted admission on Dr. service   On admission, patient with acute on chronic transaminitis likely elevated in the setting of COVID.  Home statin and Tylenol on hold.  Blood cultures no growth to date.  Decadron continued on admission.  Guardian interested in possible hospice services and instructed to pursue this outpatient with primary PCP.  Patient discharged back to group home in stable condition.
TOOK TWO UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-438) on 15-Feb-2019. The report describes a 48-year-old adult female consumer who "took two unrefrigerated doses". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  It was reported that the consumer picked up Vivotif on 10-Feb-2019 and left it unrefrigerated. She then took two unrefrigerated dose on 12-Feb-2019 and 14-Feb-2019, respectively.  The action taken with Vivotif with respect to the event "took two unrefrigerated doses" was not applicable.  The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable
Left arm soreness. Left arm redness from deltoid injection site down to elbow Narrative:
12/20/21 presenting today for Cough (temp 100.6. patient currently being treated for breast cancer. ) and Covid-19 Positive Review of Systems  Constitutional: Positive for chills, fatigue and fever. Negative for activity change and appetite change.  HENT: Positive for rhinorrhea. Negative for congestion, ear pain and sore throat.   Respiratory: Positive for cough. Negative for shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for nausea and vomiting.  Musculoskeletal: Positive for myalgias.  Neurological: Positive for headaches.
There was a marked flare of symptoms in a pre-existing inflammatory condition (RIGHT shoulder bursitis) in an area remote from the vaccination site (LEFT deltoid). The flare began 24 hours after injection and subsided 72 hours after vaccination. Symptoms went from "2" (on a scale of 10) to 10, then returned to "2".  The patient's wife, also an MD, also noted an identically timed flare of her own pre-existing inflammatory state with the same time frame.
This spontaneous report was received from an approximately 11 year old female patient, reporting on herself. The patient did not have pertinent medical history and had a drug allergy/reaction to BENADRYL. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. It was reported that the patient received her last GARDASIL on 10-DEC-2014. By the time of the reporting, she had not recovered from the events. The reporter did not assess the causal relationship between GARDASIL and the events. Upon internal review, chronic fatigue syndrome, head swelled in certain areas and got hot, migraine, and passed out were considered to be disabling events.
This case was reported by a pharmacist via call center representative and described the occurrence of local reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured adult as per vaccine indication. The pharmacist stated that he noticed that the patients who received SHINGRIX often get localized reactions on their arms but closer to the elbow. The pharmacist did not have specific patient and vaccine information and he made a general comment on what he had been noticing. This case has been linked to the US2018146919, reported by the same reporter.
Breakthrough case admission after 3 vaccines Pfizer 4/8/21 Lot# Ew0150;  Pfizer 4/29/21 Lot# Ew0164;  Pfizer 12/29/21 Lot# FL3197
Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given  for Janssen vaccine instead of 0.5 ml.  No adverse consequences reported.
Information has been received from a licensed practical nurse concerning a 3 year old female who on 10/01/1999 was vaccinated with the first dose of varicella virus vaccine live. Concomitant vaccination the same day included a first dose of MMR. In the end of January 2002, the pt developed chicken pox which lasted for 5 days. Subsequently in February 2002, the pt recovered from the chicken pox. No further info is expected.
Case previously recorded as MA2009-4398.  Initial case report received from a nurse, via agency on 16 NOV 2009.  A 3 year-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009, an off-label indication.  No adverse event was reported.  Vaccination in children younger than 4 year-old is an off-label use and unexpected for FLUVIRIN (2009/2010).  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.