chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my first vaccine I didn?t get my period. My cycle was regular since I was taking birth control. I don?t remember the exact timeline but I went from having very heavy regular periods to having mild spotting after a few months of no period. I think it took a couple months for my period to come back, I  don?t exactly remember. After my booster shot I again stopped having my period. I stopped taking birth control in august I think?  Since then I have only had my period twice and it?s been almost a year. My main concern is that my periods were very regular and the symptoms were always the same up until I started getting vaccinated for COVID. I know birth control can affect your cycle when you stop taking it, but I have gotten it a few times and this irregularly started after my vaccines.
Initial report received on 19 September 2013 from a non-health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported) on September 2013. Patient had swelling, large raised bump, and redness. One patient had an area approx. 1.5 inches x .5 inches in other direction. Several complain of pain and itching. One person stated that they had trouble raising their arm. List of documents held by sender: none.
FLUCELVAX administered, approx. 15 min later pt. complained about nausea, lightheadedness. I put pt. in safe area on floor. He recovered within 10 min. without further issues.
had shot in lt arm & 2wk later reports 50 cent size bruise black & blue;2wk p/vax h/a daily by eyes using ASA w/relief;sore throat for past week daily-not real bad;had lower back ache past week;later stated h/a started 13APR97;
pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain on the injection site). At the time of the report, VACCINATION SITE PAIN (pain on the injection site) 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. No concomitant and treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
no adverse event reported---no reaction verified with patient 5/23/19--vaccination was administered intramuscularly vs subcutaneously as recommended but per merck vaccination should be effective and no additional measures necessary
This female subject was enrolled in the prophylactic open study 107682 (HPV-018). On 02 April 2007, the subject received the 1st dose of HPV 16 and 18 (IM left upper deltoid), the dose of Aventis Pasteur's Menactra (IM, right lower deltoid) and the dose of Boostrix (IM right upper deltoid). On 08 May 2007 and 14 November 2007, the subject received the 2nd and 3rd dose of HPV  (IM left upper deltoid). On 25 November 2007, 11 days after the 3rd of HPV 16-18, seven months after the 1st dose of Boostrix and seven months after the 1st dose of Menactra, this 13-year-old subject developed febrile rash. The subject was hospitalised. The subject was treated with adrenaline, diphenhydramine hydrochloride and corticosteroid. The event was unresolved at time of reporting. The investigator considered there was no reasonable possibility that the febrile rash may have been caused by Boostrix or Menactra but the investigator considered that there was a reasonable possibility that the febrile rash may have been caused by HPV 16-18. Investigator Comments: On 21 November 2007, the subject stated she had headache, muscle pain and weakness. On 25 November 2007, the rash started on legs during the evening. On 26 November 2007, the subject came to clinic with a rash covering most of her body. Given Epinephrine and told to take Benadryl. Return to clinic on 27 November 2007 in AM. On 27 November 2007, the rash was worse, subject had temperature of 39.4 C and general malaise. She was sent to hospital ER for evaluation where she was admitted. Per mother, the subject was given a steroids IV and discharged with Prednisone and Motrin. Information received on 28 November 2007 following a phone call with her grandmother; the subject had a temperature of 38.6 C yesterday afternoon. She stated that she was admitted for 3 days of treatment. The doctors there felt it was related to the HPV vaccine. The subject was feeling better and the rash has decreased. On 28 November 2007, the subject was going to be discharged in this afternoon. She stated that the ER doctor diagnosed "serum sickness".
11-9-05 Gave pneumo shot at clinic. Pt called at 4:30 - started getting a sore arm about 1 hour after shot was very sore now - suggested Ibuprofen and Benadryl. She stated she had some hydrocodone and may try those. 11-11-05 called pt to check on her states did go to the ER got a Medrol dosage. Swelling was down some. Shoulder to elbow was involved and red as a beet. Is able to lift arm a bit now. Hydro did help her get some sleep. Has appointment with PCP on 11-14. She did have a flu shot (at Safeway) 4 days earlier in the same arm. 11-16 called headache, 11-17 called headache, 11-18 7:35 just fine, just about all back to normal, color back to normal
This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right deltoid (shoulder) on 04Mar2021 11:20 (Lot Number: EN6199) (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. Medical history was none and there were no concomitant medications. Patient had no family medical history relevant to adverse event. The patient did not receive any prior vaccinations within 4 weeks and no other vaccines were administered on same date of the Pfizer suspect. The patient stated that the nose bleeding started right after she got the shot on 04Mar2021 11:20, but she had to sit for 30 minutes after her shot. While sitting there because of the mask on her nose and mouth she felt moisture and thought it was a runny nose by going inside from cold weather. She remembered handing the ladies a card and saw a rusty spot on it and saw it on the plastic gloves she was wearing and didn't remember that being on there when she entered the building. The whole time she was sitting there for 30 minutes, her nose was bleeding, but it was not visible because her mask was black. She completed the 30 minutes and at least 3 ladies had talked to her and didn't see it because of color of the mask. When she got outside and was driving away and took off her mask she realized, her nose was bleeding. She was still bleeding from right nostril at the time of reporting. As treatment she first pinched bridge of nose but didn't think she was doing it right, so she started packing cotton balls in her nose and she had been packing it and putting new packing in. She stated that it had improved but still bleeding some just not as heavily. The patient stated that she did have nose bleeds but not this morning before the shot and she doesn't have one every day, only if she hits it on occasion but this just happened with the shot. The events did not require visit to the emergency room and physician office. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, NauseaVomiting, Localized pain; slurred speech, chills, fatigue Narrative:
Delayed reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction) 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 were not reported. Treatment information was not provided.
(PM) arm ache radiating to back and neck cold sweat, n/v, flu like symptoms. Patient's husband will contact MD on 10/5/11.
Patient received first dose on 4/19, second dose administered today 5/3 which is too soon
Initially severe left hand pain/swelling, transitioned to right hand pain/swelling, back to left hand pain and swelling, improved 4 days later but not resolved.
This spontaneous report was received from a certified medical assistant refers to a 74 year old male patient with no pertinent medical history or drug reactions/allergies. On 04-OCT-2013 the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX23 (lot# J005067, expiration date 17-JAN-2015), intramuscularly. The reporter stated that the patient developed swelling of the left arm where the PNEUMOVAX23 was administered and the patient was unable to walk or talk on 05-OCT-2013. She stated that the patient went to a hospital on 05-OCT-2013 and was diagnosed with cellulitis of the left upper arm. He was sent home from the hospital on the same day and prescribed an unspecified amount of KEFLEX. The reporter stated that the patient was currently in the physician's office as a follow-up. She stated that his arm was still red but the patient was able to walk and talk as well as he was able to drive himself to the physician's office. The outcome of cellulitis of the left upper arm was reported as recovering/resolving. The outcome of patient was unable to walk or talk was reported as recovered/resolved. It was unspecified whether laboratory diagnostic studies were performed. The patient sought medical attention for the events. Causality was not reported. Upon internal review the event 'unable to talk' has been considered as medically significant. Additional information has been requested.
Seizure-generalized, associated with rectal temp 103.2. 28 hours after vaccinations.
within 15-20 minutes of vaccine, my face got flushed and then neck and upper chest can red and itchy.  I had already left pharmacy so I went to Urgent Care.  They gave me a liquid steriod to drink, benedryl and one Claritin and watched me for 30 minutes and told me to follow up w/ my primary care doctor.  I made appointment w/ PPO doctor.  She advised me to get allergy tested for vaccine componments.  Had allergy testing done on 3/23/21 and tested negative (no reaction) to all Covid vaccine components.  He advised to go ahead and get second vaccine and gave me rx for epi-pen just in case.   Primary doctor also recommended I get the 2nd vaccine but in a clinical (not retail) setting.    On 4/9/21, I went to Clinic to get second vaccine.  I told the RN about previous experience and she got the PA on staff at clinic.  They would not give me the 2nd vaccine and said they were not equipped to handle a more severe reaction.  PA advised second vaccine, which adds maybe 15% more coverage,  may not be needed as first one has provided me with good coverage.  They advised to follow up w/ my doctor and to see about going to a hospital to receive second vaccine, if I decided I wanted it.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Redness, arm swelling, shortness of breath 2 - 3 hours after vaccination
I had an intense reaction to my second Moderna dose on March 10 which included fever, joint aches, chills, fatigue, lethargy and headaches.  I developed ringing in my ears (Tinnitus)  that I noticed about a week after injection.  It grew in loudness, intensity and pitch throughout the rest of March and into April.  I also had a feeling of fullness in my ears and head.  It interfered with my sleep and activities.  I saw a general practitioner initially, then an audiologist, and finally an ENT doctor.  My general practitioner prescribed prednisone (5 day burst) which helped very much, but the ringing would come back (though not as loud) after the course of steroids.  I did another 5 day burst of Prednisone with similar outcome.  Audiology showed slight bilateral high frequency hearing loss.  My ENT prescribed a 19 day tapered dose of Prednisone which helped the most and brought the level of ringing down to a more manageable level.  Now it is 4 months later and the ringing is still present bilaterally.  It is not as loud as it was initially when I first developed it.
Large localized reaction left upper arm - itchy, redness does not appear to be infected. Large area 5x5.5 in. Small area 1.5x1.25 in.
Fever/ chills, severe pain and swelling of arm, uncontrollable shaking - seizures.
Per mom, patient developed fever 101 @ home around 10pm 1/31/09- given dose of TYLENOL- shortly after pt had jerking + shaking, eyes rolled backwards for approx 4-5 min. transported to ED via ambulance, temp on arrival 102 rectally.
residents moved while being administered the vaccine and only half the volume of the vaccine in the PFS went into the patient, with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male patient who reported one of residents moved while being administered the vaccine and only half the volume of the vaccine in the pfs went into the patient, with no reported adverse event while receiving influenza quadrival A-B high dose HV vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (dose, formulation, strength, lot number and expiry date not reported) via unknown route in unknown administration site one of residents moved while being administered the vaccine and only half the volume of the vaccine in the pfs went into the patient, with no reported adverse event (incorrect dose administered) (unknown latency).  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Lot number: EN6798), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm, on 02Feb2021 as dose 1, single (Lot number: EL9266), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
Pt vaccinated with TD c/o numbness of hand & feet 24-48 hrs after vaccination, decreased sensation in both feet  (to pinprick), developed polyneuropathy & required mechanical ventilation, developed respiratory distress, suffered CR arrest.
Swollen armpit on left side filled with liquid; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10May2021 at 08:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously took doxycycline hydrochloride (DOXY) on an unknown date for unspecified indication and experienced the event rash(She think the rash was a known AE from the other med she took simultaneously). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021 the patient experienced swollen armpit on left side filled with liquid and the patient was aware of this known adverse event. She just want you to have the right percentage. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as the result of events. The clinical outcome of the event swollen armpit on left side filled with liquid was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
exhaustion - couldn't move from the couch for over 24 hours; Joint pain in both hips & left knee; sinus pressure; This is a spontaneous report from a contactable consumer. A 46-years-old non pregnant female patient received first dose of BNT162B2 (COMIRNATY, formulation solution for injection, Lot Number: EL9267), via an unspecified route of administration, in left arm on 12Feb2021 09:45 as single dose for covid-19 immunisation. It was reported that patient was covid prior vaccination. The patient had sulphur allergies. The patient's concomitant medications were not reported. On 13Feb2021 12:30 the patient experienced exhaustion couldn't move from the couch for over 24 hours, joint pain in both hips and left knee and sinus. The patient did not received treatment for the events. The patient was not covid tested post vaccination. The patient did not received other vaccine in fourweeks. The outcome of the events was not recovered.
It was diagnosed as cellulitis; area gradually became swollen and red; area gradually became swollen and red; right buttock area; This case was reported by a consumer and described the occurrence of injection site cellulitis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, several hours after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown and the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on her right buttock area which led to vaccine administered at inappropriate site. Few hours later, the patient experienced area gradually became swollen and red and the swelling was the size of a softball. The patient was diagnosed with cellulitis and treated with antibiotics in emergency room visit. A CT scan was performed and an abscess was ruled out. The patient recoverd after week and half . The patient felt it was important to note that she is a natural red head and it has been proven that red heads can react strangely to medications. The reporter consented to follow up. No further information was available.
Moderna Covid-19 Vaccine EUA  Redness and swelling in left arm, itching at injection site. Kept track by outlining and it went from 5 cm on day 2 to 9 cm on day 3. Diagnosed with cellulitis at injection site as well. Treatment of steroid shot, antibiotics, ice and Benadryl.
Tetanus booster administered in left deltoid on 7/5/2004. Her most recent booster before this was said to be in the late 1980s per the patient. She called doctors office and came in to evaluated on 7/14/04. She exhibited a localized, reddened, painful, swollen area on the left deltoid, approximately 10cmx5cm. Patient denied fever or shortness of breath. Pt was given an injection of 80mg depomedrol in office on 7/14/04.