chrisvoncsefalvay/vaers-outcomes huggingface dataset:
menstrual spotting that started on 22Oct21/ didn't stop until my period finished on 04Nov21; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Oct2021 02:30 (Lot number: RF2593) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Yes, sulfa, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: RF2589), administration date: 01Oct2021, when the patient was 27 years old, for COVID-19 Immunization, reaction(s): "my period started a few hours after receiving the first dose, usually it takes 2 days after I stop taking the pill (birth control) for my period to start.". The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 22Oct2021, outcome "recovered", described as "menstrual spotting that started on 22Oct21/ didn't stop until my period finished on 04Nov21". The event "menstrual spotting that started on 22oct21/ didn't stop until my period finished on 04nov21" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of intermenstrual bleeding. Additional Information: Other vaccine within 4 weeks was reported as none. Other medications in two weeks was reported as prescribed medicines.The patient had COVID prior vaccination and COVID tested post vaccination was reported as none. The patient stated that, on 01Oct21 her period started a few hours after receiving the first dose, usually it takes 2 days after she stop taking the pill (birth control) for her period to start. She stopped taking her pill for that month on Friday 01Oct21 and her period stopped on 07Oct21. After her second dose she had menstrual spotting that started on 22Oct21, a few hours after receiving her second dose, and didn't stop until her period finished on 04Nov21. She was still taking the pill during that week she was spotting, and it was a medium amount of spotting during that week. She had a doctors appointment on 28Oct21 and mentioned it then, but nothing came about from it.  No follow-up attempts are possible. No further information is expected.
March 5: day after vaccine arm was extremely sore, red patch about size of nickel and hot to touch. 7 days after vaccine.-Vaccine site became red ,swollen and itchingabout the size of a quarter
Patient had vasovagal reaction about 2 minutes after receiving the shot. 911 call paramedics did not send pt to hospital because she was recovering when they got there.
The day after receiving my booster, I noticed/felt a lump under my right collar bone. I looked in the mirror and noticed it was very visible. It was squishy and painful to touch. It is still painful today. It runs through my shoulder, up my neck to my ear and my face. I was up at 2:30AM today in pain and I haven't been able to go back to sleep. I went to Hospital ER and they provided me with Mobic (which I cannot take) and Toradol. I was told that I can use voltarin gel until my follow up appointment.
The facility does not have Vaxelis on hand and may decide to use Pentacel for the second dose in the series; This non-serious spontaneous safety report with reference number # 2022SA128494 was received by a partner on 11-APR-2022 and forwarded to agency on 12-APR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event "the facility does not have Vaxelis on hand and may decide to use Pentacel for the second dose in the series" is assessed as not applicable due to the nature of the event.  No further information is expected since consent to follow-up was not provided.
Pt c/o body aches, abdominal pain, and diarrhea. She reports she took diclofenac which only helped for a little while but her symptoms returned. She reports her abdominal pain is throughout all 4 quadrants and diarrhea. She reports her pain as a 10/10, and says it is a pain that she has never felt before. She says she also has chills, weakness, and feels feint.
inquired about recent pain meds being taken on 10/30/2020 and 11/2/2020 patient said that she had reaction to vaccination on 10/18/2020 pain and swelling at injection site that was unresolved. ask daughter about reaction when she can and picked up medication on 11/02/2020 and she said that her mom had told her later that she was having pain and swelling at site of pneumovax injection( did not say how many days later) asked daughter if she had put ice packs on it  she said she told her mom to put cold and warm compresses on it ( again not sure when this occured) she said she thought she may be having allergic reaction. 10/30/20 dr did give patient cephalexin and tramadol for reaction but not sure if cellulitis or precautionary on cephalexin.
1st dose on 12/2020, never received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details reported were as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received the second dose 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired if the patient needed to restart the series or get the second dose of Shingrix. The reporter unable to provide vaccine and the patient details.  The reporter did not consent to follow-up.
COVID infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (COVID infection) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        Concurrent medical conditions included Cirrhosis liver.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (COVID infection) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. Related        For mRNA-1273 (Spikevax) (Unknown), the reporter considered COVID-19 (COVID infection) to be related.    Concomitant and treatment medications were not reported. Study was carried between July 18, 2021 and February 11, 2022, when B.1.617.2 (Delta) and B.1.1.529 (Omicron) were the predominant variants.  Author stated that the findings support the third dose of mRNA vaccine among patients with cirrhosis.  Company Comment: This is a literature non-study case concerning an adult patient of unknown gender with medical history of liver cirrhosis, who had fatal outcome with unexpected, serious event of COVID-19, 207 days after receiving the second dose of mRNA-1273 vaccine. The patient had compensated cirrhosis and was treated with remdesivir and dexamethasone at the time of infection but died following critical COVID-19. It is unknown if an autopsy was performed. Medical history of liver cirrhosis could be contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a literature non-study case concerning an adult patient of unknown gender with medical history of liver cirrhosis, who had fatal outcome with unexpected, serious event of COVID-19, 207 days after receiving the second dose of mRNA-1273 vaccine. The patient had compensated cirrhosis and was treated with remdesivir and dexamethasone at the time of infection but died following critical COVID-19. It is unknown if an autopsy was performed. Medical history of liver cirrhosis could be contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of Death
Patient became dizzy, feeling like she might faint within 5 minutes of administration. Nausea and 1 episode of vomiting followed at 15 minutes after administartion.
Tired. Headache. Muscle ache. Joint pain. Unusual behavior. Nausea. Diarrhea. Fast heartbeat. Dizziness. Weakness. Tired and fatigue for 2 days. Nausea and diarrhea for 7 days. Weakness and unusual behavior for 4 days. Fast heartbeat 2 days. Dizziness 2 days. Headache and muscle and joint 5 to 6 days.
Tiny Red bumps that were itching and burning; Tiny red bumps that were itching and burning; Rash on forearms and crease of elbow as well as chest; Bump on back right side of neck; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (Tiny Red bumps that were itching and burning), SKIN BURNING SENSATION (Tiny red bumps that were itching and burning), RASH (Rash on forearms and crease of elbow as well as chest) and RASH (Bump on back right side of neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAPULE (Tiny Red bumps that were itching and burning), SKIN BURNING SENSATION (Tiny red bumps that were itching and burning), RASH (Rash on forearms and crease of elbow as well as chest) and RASH (Bump on back right side of neck). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) at an unspecified dose and frequency. At the time of the report, PAPULE (Tiny Red bumps that were itching and burning), SKIN BURNING SENSATION (Tiny red bumps that were itching and burning), RASH (Rash on forearms and crease of elbow as well as chest) and RASH (Bump on back right side of neck) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Soreness and pain near injection site, cough, headaches, a bit of fatigue, congestion
Parotid gland swelling; This is a spontaneous report from a contactable physician, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), nifedipine (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), vitamin d nos (MANUFACTURER UNKNOWN) and curcuma longa (TURMERIC) all for an unknown indication on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 10:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. 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 14Apr2021 at 00:00, the patient experienced parotid gland swelling. The event did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event parotid gland swelling was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 10-JUL-2012, the patient completed the 3 dose series of GARDASIL for prophylaxis (strength, dose, route, frequency, lot # and expiration date were not reported). 18-DEC-2017, the patient was vaccinated with GARDASIL 9 4th dose, lot # N021571, expiration date 29-APR-2020, for prophylaxis (strength, dose and frequency were not reported).
PT. IS 64 YR OLD. ADMINISTERED FLUZONE HD INSTEAD OF AGE APPROPRIATE FLU VACCINE
Patient starting getting itchy about 5 to 10 minutes after administration.  Gave patient 25 mg diphenhydramine, cold compresses.  Patient wanted to use her EpiPen so her husband administered her EpiPen.  She started to feel better. She refused me calling 911, but did have her husband bring her to emergency room.
Red itchy spot on back/ red itchy area by wrist; Itchy spot on back/ red itchy area by wrist; This case was reported by a nurse via call center representative and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date unknown) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included food allergy and drug allergy.   On 23rd August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, 35 days after receiving Shingrix, the patient experienced localized erythema and localized itching. On an unknown date, the outcome of the localized erythema and localized itching were recovering/resolving.   It was unknown if the reporter considered the localized erythema and localized itching to be related to Shingrix.  Additional details were provided as follows: The patient was a registered nurse and reported adverse event experienced by herself. Three weeks before the reporting date, she developed a red, itchy spot on her back and wrist The patient did not consent to follow-up and refused to provide any additional details, declined any future follow up or communication regarding this. For tolerance of 2nd dose of Shingrix, refer case US2019188850. There was a discrepancy in the reported outcomes of the events localized erythema and localized itching. In XML, outcome was mentioned as recovering/resolving and in system, it was reported as not recovered. However outcome of these events is captured as per system. Also, there was a discrepancy in the reported vaccination date of 2nd dose of Shingrix, in the 1st part of source document, the date was mentioned as 23-AUG-2019 and in the 2nd part of source document the date was mentioned as September 2019. We kept it as per source document part 1 after making clarification to Hub.
Large rash over upper left arm over injection site on April 8th. Vaccine on March 31
Started with eyelid reaction to makeup (eyeliner) that has no turned into eyelid dermatitis x 5 days and then both forearm dermatitis x 3 days. Benadryl (oral and ointment) and Claritin (oral) have been tried with no improvement. Will be trying steroid cream on forearms.
Extremely soar arm. The next 24 hours convulsion like shakes. Lethargic 48 hours
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Jun2023 at 12:00 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left 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), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Raynauds syndrome" (unspecified if ongoing); "Known allergies: Sulfa medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 27Jul2023 to 01Aug2023.  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.
Pt is complaining of left upper arm pain/shoulder pain which began shortly after vaccine administration on 10/3 and has worsened over time.
About 20 hours after injection, in addition to sore arm, my brain felt foggy.  I work on the computer could not remember what to do next as I searched for needed files.  At the end of the day, I signed off my computer but needed to think about how to turn off the monitor.  The next day was better, but by the 3rd day out I became very sensitive to sound.  On the 4th morning the brain fog got much worse, my head hurt and I felt like I was moving through life in slow motion.  This continued for two whole days and I could not sleep at night due to the intensity of my headache.  All of this could have been a migraine which I had in the past, but never to this extent.  Past migraines were visual in nature and only lasted about an hour.  By the 5th day, I started to feel normal, with the occasional headache or wave of nausea.
On day 8 after the shot I got a small rash on my left arm.  By day 10 the rash has grown.  Now today it's up on my shoulder as well as the muscle part of the upper arm.
12 days after, at and around injection site warm, swollen with several raised nodules and itchy.
needle came apart while vaccine was being administered; Another dose was administered on opposite arm from first shot in both patients as indicated in invalid dose SRL; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT COMPLAINT (needle came apart while vaccine was being administered) and INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in invalid dose SRL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT COMPLAINT (needle came apart while vaccine was being administered) and INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in invalid dose SRL). On 24-Apr-2021, PRODUCT COMPLAINT (needle came apart while vaccine was being administered) and INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in invalid dose SRL) had resolved. Not Provided      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 medication was not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-089574 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089574:
I felt tired and tightness in the chest, headache, low-grade fever of 100.7F, body fatigue, heavy cough like I was coughing up a lung, and body chills and aches. My ribs were hurting for several days from my heavy cough. I took a rapid at-home COVID-19 test on 12/12/2022-12/14/2022 each of those days which all came back negative. However, my symptoms kept worsening so I took another test on 12/15/2022 which finally came back positive. I contacted my physician when I was positive, but my symptoms were slowly going away finally. I couldn't get an appointment until Monday, 12/19/2022 virtually for a telehealth appointment; but, by then my symptoms were practically gone. Before my telehealth appointment, I took acetaminophen, DAYQUIL and NYQUIL with cough drops to help with my symptoms. Right now, I feel fine with a lingering cough, but I'm fine now.
Nine days post vax, the patient developed a macular red rash. The rash has persisted for 3 days.
Injection site tenderness; Injection site pain; Initial information was received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves 17 years old female patient who experienced injection site tenderness and injection site pain after receiving vaccine influenza quadrival a-b vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphenhydramine hydrochloride (MENNA).  On 28-Nov-2022, the patient received a dose of 05 ml suspect influenza quadrival a-b vaccine Suspension for injection with frequency: Total (lot: U7684BB and expiry date: 30-Jun-2023) via intramuscular route in the left arm for Immunization (Immunisation).  On 29-Nov-2022 the patient developed a non-serious event of injection site pain and injection site tenderness (injection site pain) 1 day following the administration of influenza quadrival a-b vaccine.  It was reported, "MA reporting that a patient received the product FLUZONE QIV NP 2 days ago and is now back today at the clinic complaining of pain and tenderness in the area. MA said the patient was provided a splint for their arm and was advised to apply an ice pack but the patient is still in pain."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (Injection site tenderness, Injection site pain).  At time of reporting, the outcome was Not Recovered for the event injection site tenderness and injection site pain.
Received my Pfizer booster at 2pm on Thursday, started having intense intermittent chills and hot flashes around midnight through the morning. When I woke up, I felt as though taking a shower would help and when I was in the shower, I felt as though I was going to pass out and quickly rushed to the toilet and vomitted. I had intense chills, fatigue, hot flashes, loss of appetite, and a minor headache on Friday. At around 3pm on Friday, I started to develop joint pains in my hips and knees making it almost impossible to walk up a flight of stairs. I still had chills on Friday night, into Saturday morning. My joint pain has almost subsided nearly 4 days later, but I developed lymphedema (swelling of lymph nodes) in the armpit of the injection side (right arm). This has continued since Saturday evening and is ongoing. I am also still feeling fatigued.