chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prior to receiving my first vaccine, I had gone into peri-menopause, skipping menstrual periods for months at a time and when I would have them, they were pretty light and short (~3 days). In late April 2021, I began having menorrhagia, debilitatingly heavy menstrual periods, where I haven't been able to leave the house for the first 3 days, using overnight pads and changing them every 1-2 hours, bleeding through tampons and pads together onto clothes. I had this happen once in my early 20s so just thought it was something that would pass, but it's been this way since, following my first vaccine. I hadn't put it together (to report) until recently when I started having conversations with friends about it who are also having/had similar issues. I read an article on a website that encouraged reporting this to vaers, so I'm doing that now. Has been difficult to get in to see a doctor about it due to a health care shortage in our area where I moved last year, but I have an appointment in November to see a gynecologist.
arm is hot to touch; A spontaneous report was received from a consumer concerning a 92 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm is hot to touch/feeling hot.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   The patient received their second of two planned doses of mRNA-1273 (Batch number: 010MZ0A) on 12 Mar 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.    The patient received the second dose of Moderna COVID-19 vaccine on 12 Mar 2021. The patients report that the arm is hot to touch. Treatment information of the events was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the arm is hot to touch was not reported.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. Nurse noted that patient was administered the first dose in the VARIVAX (Merck) (strength, formulation, lot#, dose/frequency, route were unspecified) vaccination series on 22-MAR-2013. On 21-MAY-2013, the patient was inadvertently administered ZOSTAVAX (subcutaneous, strength, formulation, lot#, dose/frequency and duration were unspecified) instead of VARIVAX (Merck) for the second dose in the VARIVAX (Merck) vaccination series. No adverse effect reported. Patient present status was reported as other: no known adverse effect. Outcome was unknown. Additional information has been requested.
Headaches, dizziness, sore throat, head pain more on right side, both eyes pressure (soreness), right eye lid dropped for a few minutes I couldn't lift it, only the right eye heavily twitching, nose pressure pain, inner ear pain (more on right side), teeth and gum soreness, neck pain, chest pain (pressure).  Two severe days ( February 28th and March 1st) and then it gradually got better by end of two weeks.  I'm 96% back to normal today.  Still having occasional slight pains in head, ear, nose and throat.  Advil and Tylenol help.
A small droplet came out during administration; A small droplet came out during administration; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A small droplet came out during administration) and PRODUCT ADMINISTRATION ERROR (A small droplet came out during administration) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (A small droplet came out during administration) and PRODUCT ADMINISTRATION ERROR (A small droplet came out during administration). At the time of the report, ACCIDENTAL UNDERDOSE (A small droplet came out during administration) and PRODUCT ADMINISTRATION ERROR (A small droplet came out during administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was a pharmacist stated that when a provider was administering 0.25ml booster dose of the Moderna COVID-19 vaccine to the patient, a small droplet came out but the majority of it was administered.  No Concomitant product use was reported. No treatment information was provided.   Reporter did not allow further contact
My arm was never really sore after injection and I assumed I had no reactions.  However, exactly one week after the covid injection my left arm, at the shots location, it started it itch, became slightly red like a rash and was a bit hard and swollen.  During the week after the injection a few days later I started to get hot and clammy and a bit weak feeling several times a day  (age is 72) which I had not experienced before.  I've also begun to have headaches almost daily and just feel quite physically and mentally off since that week.
PT WAS HAVING JOINT PAIN,BONE ACHE AND RASH (LOCAL SITE REACTION "SIZE OF BASEBALL") ON THE UPPER RIGHT ARM. PT. ALSO EXPERIENCEED EXTREME FATIGUE.  SYMPTOMS ARE CURRENTLY DISTRESSING PT. (EMPHASIS ON FATIGUE)  Per follow-up: Still having right shoulder pain and a white pimple erupted at injectin site. Itching is present on and around the pimple.
Pt presents with redness, blistery rash. Varicella -like rash
Ct. states that he had nosebleed for one month following administration of intranasal influenza vaccine.
@ 1528 Patient receives Pfiz 5 - 11 y/o  Covid-19 after receiving clearance from vaccine director for administration since the patient was on xolair treatment regimen for Asthma. 1545: Patient complaints of tightness of chest with on site provider confirming wheezing w/o any further systemic symptoms. 1600: patient provided with albuterol followed by administration of epinephrine 0.3mg 1:1000 after patient states no sign of relief of symptoms. 1614: on-site EMS decide transportation to emergency room after receiving clarification of vaccine director since the patient denies improvement of symptoms.
Patient had a syncopal episode after receiving vaccine. there is a history of anxiety over needles per family on scene.
This spontaneous report was received from a physician via a company representative and refers to an approximately 12 year old female patient with migraine. Patient's medical history was not reported. On an unknown date, the patient had received first dose of GARDASIL 9. Patient received the second dose on 02-OCT-2015. On 08-APR-2016, the patient received her third dose of GARDASIL 9 (0.5 ml, lot #L026602, expiry date 19-OCT-2017). Concomitant therapies included naproxen. On unknown date, in approximately April 2016, the patient experienced swelling in her knees, elbows, ankles and also had some swelling in her lips following the third dose of GARDASIL 9. Patient also complained of lethargy and her migraine had worsened. Patient sought medical attention-she had a follow up visit with the physician on 04-APR-2016 because of the adverse events, following the third vaccination. The patient was given prednisone for a 2 weeks as treatment. No product quality complain (PQC) was involved. At the time of reporting, the outcome of the events was reported as recovering. The reporter did not assess the relatedness of the events with GARDASIL 9. The reporter considered the events to be serious due to disability. Additional information has been requested.
Information has been received from a licensed practical nurse concerning an 80 year old female who on Oct 20 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). Subsequently, she experienced an injection site reaction. It was noted that hospitalization was not required. The patient was treated with fexofenadine hydrochloride (Allegra) and hydrocortisone (Hytone) (1% lotion). No product quality complaint involved. No further information is available.
This spontaneous report as received from company representative who was reported by a healthcare worker refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with first dose of GARDASIL injection (lot number, dose and route of administration was not reported). On an unknown date the patient experienced lightheaded, fainted and hit her head on the wall in the physician office after receiving GARDASIL. No laboratory details were provided. The patient was not treated for the reported events. The patient recovered from the reported events on unspecified date. The reported events were not considered as hospitalisation, cancer, life-threatening, disability or overdose.  No product quality complaint (PQC) was filed. No further information was available. Additional information is not expected as permission was not given to contact the health care provider.
PATIENT REPORTS RECEIVING VACCINATION AT APPROXIMATELY 830AM. SHE WAS BUSY THROUGHOUT THE DAY BUT ONCE SHE RETURNED TO HER OFFICE AROUND 120 PM, SHE STARTED TO NOTICE HER ARM IN WHICH SHE RECEIVED HER VACCINE WAS PAINFUL AND SHE WAS UNABLE TO "LIFT IT UP". SHE ALSO NOTICED HER TONGUE BEGAN TO FEEL "WIERD AND TINGLY". SHE THEN REALIZED HER TONGUE WAS PUSHED UP AGAINST HER TEETH AND COULD SEE A VISIBLE TOOTH MARK ON HER TONGUE. SHE ALSO REPORTS THAT HER BRAIN FELT "FOGGY" DURING THIS TIME". ADDITIONALLY, SHE REPORTS THAT ONSENT OF ALL HER SYMPTOMS PRESENTED PROGRESSIVELY. SHE RECIEVED IM BENADRYL ONSITE PRIOR TO TRANSFER TO THE EMERGENCY ROOM FOR EVALUATION. AT THE EMERGENCY ROOM SHE WAS GIVEN THREE MEDICATIONS, SHE RECALLS ONE WAS A STERIOD AND BELIEVES ATLEAST ONE WAS AN ANTIHISTAMINE. HOWEVER, SHE IS NOT COMPELTELY CERTAIN WHAT THE OTHER MEDICATIONS WERE. SHE REPORTED IMPROVEMENT OF SYMPTOMS WITH MEDICATION. SHE WAS PRESCRIBED BENADRYL AND A MEDROL DOSE PAK AT TIME OF DISCHARGE. SHE WAS NOT ADMITTED TO THE HOSPITAL.
Vaccine was administered on Saturday 8/3/19; patient states about 36 hours following vaccine, patient began shaking severely. Went to ER, shaking subsided within about 5 hours. Was kept for observance for 2 days at hospital, Patient reports all tests came back normal.
Chicken pox; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In 2019, the patient received a dose of Shingrix and developed a mild case of chicken pox. The patient was asked about the follow up vaccination.
immediately during getting the injection i was told it would "burn" . instead of burning it felt like i was being punched with knife in my arm.  i kinda screamed a bit in fact.  in the car after that i kept moving my arm around as i was told that would help disperse the vaccine faster in my body, but 30 minutes later i felt queezy, tired and was in EXTREME pain.  i took tylenol about 4 hours later and when i got home that night the pain was SO SEVERE that i went to bed at 8:30 without dinner.  i took another tylenol and thru the night i kept waking up with SO MUCH PAIN at the site of the injection i took more tylenol (about 4 times) . today it is only slightly, every to slightly better but i am experiencing flu like symptoms. tired, body aches, etc.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Reaction similar to stevens Johnson" (unspecified if ongoing), notes: Reaction similar to stevens Johnson syndrome (experienced 10 years ago with lamictal). Concomitant medication(s) included: MUCINEX, start date: 06Jun2022; SUDAFED 12 HOUR, start date: 06Jun2022. Past drug history included: Lamictal, reaction(s): "Allergy", notes: known allergies: Lamictal. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid 09Jun2022 to 10Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine leaked , less dose given, Vaccine came in contact with skin/needle must be loose or defective; inadequate dose; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Vaccine leaked , less dose given, Vaccine came in contact with skin/needle must be loose or defective) and UNDERDOSE (inadequate dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hyperlipidemia on 17-Dec-2018. Concomitant products included SIMVASTATIN and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Vaccine leaked , less dose given, Vaccine came in contact with skin/needle must be loose or defective) and UNDERDOSE (inadequate dose). At the time of the report, DEVICE CONNECTION ISSUE (Vaccine leaked , less dose given, Vaccine came in contact with skin/needle must be loose or defective) and UNDERDOSE (inadequate dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Vaccine Adverse event reporting form appended. Concomitants added. patient information updated.
On 5-15-13, patient received GARDASIL #1 and Hep A #1 vaccines. Beginning later that day, he experienced "difficulty breathing". No wheeze or distress, no interruption of usual activities. No hives, no fever. In May, child has also had hx of environmental allergies. Parents did not seek care. Pt expressed reluctance to receive 2nd dose of GARDASIL due to sx following his 1st dose.
Pt states while waiting the 15 min post vaccine, he felt that he was getting sleepy/drowzy
On 03/01/2023 - Hib vaccine given first in right deltoid, then Hep. A given in left deltoid. After Hep. A was given, patient reported to writer/vaccinator that she "felt that one." Writer/vaccinator stated to patient that the Hep. A vaccine is 1.0ml, compared to the Hib vaccine which is 0.5ml, which may be attributing to the immediate sensation felt. Patient stated she was feeling well and was escorted to the waiting room by writer/vaccinator. On 03/02/2023 - Patient called agency and reported that she is having pain in her left shoulder and is having trouble moving her left arm out to the side. Patient stated she was in contact with her primary care doctor, who will be prescribing a steroid for her. It was explained to patient that a report will be sent in regarding these side effects, and agency will be following up with her - Patient stated understanding.
Approximately 12 hours post vax area around puncture site became swollen, warm and red. Used warm compresses. Still a problem next morning. Exam done by MD 24 hours post injection. Dx as local reaction to vax. Arm did not improve and patient saw private MD, dx cellulitis placed on Amoxicillin. 1/11/01 Arm improved. Pt incidentally developed pneumonia in both lungs and pancreatitis in the early post vax period.
Pt C/O feeling really sick, vomiting, fatigue the day after the shot was given. There is a 2.5 -3 inch red spot at the site of the injection-arm is sore.
Itchiness on her left arm; Skin went dark; Skin went red; Swollen left arm; A report was received from a physician concerning a 76 year old female patient who was participating in a trial and developed itchiness on her left arm, swelling on her left arm, skin went dark and red on her left arm, and swollen left arm.   The patient's medical history, as provided by the reporter, included heart disease and pacemaker placement. No relevant concomitant medications were reported.   On 29 Dec 2020, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot : 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021 the patient began experiencing reactions on her left arm including itchiness, swelling, dark and red skin, and swelling. The events were treated with prednisone.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of itchiness on her left arm, swelling on her left arm, skin went dark and red on her left arm and swollen left arm were not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever; severe Body aches; head ache; unexplained odd discomfort in uterus and Fallopian tubes; High Blood pressure; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 6199), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:30 (at the age of 73-year-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included High BP from an unknown date and unknown if ongoing, gout from an unknown date and unknown if ongoing, Penicillin (Drug hypersensitivity) from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: 9269), via an unspecified route of administration on 10Feb2021 at 13:30 (at the age of 73-year-old) administered in Left arm as single dose for COVID-19 immunisation. It was reported that other vaccine not administered in four weeks. It was reported that Other medications was taken in two weeks. It was reported that it was unknown If patient had covid prior vaccination. Covid tested post vaccination was No. The patient experienced Fever, severe Body aches, headache and unexplained odd discomfort in uterus and Fallopian tubes and High Blood pressure on 04Mar2021 09:00. The patient did not received treatment for the event. The outcome of all event was Recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained
Originally mild symptoms of severe localized pain in left shoulder where I recieved vaccine as well as raised, red, swollen lump covering upper arm and shoulder.  Severe muscle aches increasing in effect and area currently on Day 9 have spread to whole left side of torso and neck hindering breathing and inability to sleep.  In addition sharp movement pains in effected area that almost seem more like nerve pain more than muscle.  Have felt some numbness in left arm and left area of chest but no paralasis as of yet.
Fatigue, Dizziness, elevated temperature, hot flashes TeleDoc consultation Rest, ibuprofen pen, no work x 5 days Symptoms persist however severity has decreased
Left thigh is red and swollen all around thigh and slightly past knee. Treatment: Tylenol dosing and cool compresses.
fine papular rash to legs & abdo; 2 cm area erythema to rt buttocks; 4cm area erythema to lt buttocks;
rash on upper torso an extremities of right arm and left arm breast and back  Taking on the duplicate form of the hives red itchy patches raised in the middle
The patient got a shingles shot and pneumonia at the same time in the same arm; The pain was awful for about 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm) and PNEUMOCOCCAL VACCINE (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: The pain was awful for about 3 days) and wrong technique in product usage process (Verbatim: The patient got a shingles shot and pneumonia at the same time in the same arm). The outcome of the injection site pain was resolved (duration 3 days) and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case was received from the patient via interactive digital media. The patient got a shingles shot and pneumonia at the same time in the same arm, oh what a mistake. The follow-up could not be possible as no contact details were available. The patient got a shingles shot and pneumonia at the same time in the same arm, which led to wrong technique in product usage process.
The patient recieved and expired dose of M-M-R II; No known adverse effects; This spontaneous report was received from a other healthcare professional regarding and anonymized patient. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not reported.   On 02-MAY-2019, the patient received an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M- R II) (expired product administered), subcutaneous, lot number N024696, expiration date 07-APR-2019, for prophylaxis. No known adverse effects reported.
Redness and sight soreness around injection site 8 days after vaccination.  Experienced soreness for about 1 to 2 days right after vaccination, then nothing else until today.
This case was reported by a other health professionals via call center representative and described the occurrence of erythema in a adult patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and pharmaceutical product complaint. On an unknown date, the outcome of the erythema and pharmaceutical product complaint were unknown. The reporter considered the erythema to be probably related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a pharmacy buyer. On 15th September 2015 or after (exact date of administration unknown), the patient received FLUARIX QUADRIVALENT on an unknown arm. The patient experienced localized redness around injection site and on arm. This is one of the five cases reported by the same reporter (see cases US2015133740, US2015133746, US2015133760 and US2015433773). The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. At the time of reporting, any further details were not known by the reporter.