chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time of my first dose of Pfizer Covid vaccine, I was at the end of my menstrual cycle. 8 days following the first dose, I began bleeding again. Unlike a monthly cycle, the bleeding was light in color ?watered-down? and bright red and appeared as a ?fresh wound? vs clotting- type blood during a monthly cycle. The bleeding required sanitary pads and tampons. The bleeding continued for 4 days.  Three weeks after the first dose and two weeks after the start of the aforementioned irregular bleeding , my menstruation cycle began again. The cycle was heavy, with cramping. The cycle lasted 7 days.    I felt it was necessary to report this because my cycle is normally 30-32 days and has been since having children 11 years ago. I do not spot mid cycle and have no instances of an ?early period?. I have not missed a period except in pregnancy. I?m what is considered ?regular?. I do not suffer from anxiety, I?m not afraid of vaccines or needles and have not experienced weight gain or loss. I mention this because I have read these factors could potentially the cause of unusual menstruation related to the COVID vaccine
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 24 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
felt flushed; Elevated heart rate; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked for some recommendations in taking the second dose of the vaccine since she had experienced the side effects- felt flushed and had elevated heart rate on an unspecified date. The outcome of the events was unknown.   Information about the batch/lot number has been requested.
daughter stated the pts left arm is very red, itchy, and swollen about 4 days after getting the vax.  Pt has also has headaches that come and go.  Pt went to CVS and the nurse told her to take Benadryl and cortisone cream.  Pt is only using the cortisone cream and no Benadryl.  Pt still has some itchiness and headaches but is getting better.
Sore Arm; Sleepy most of the day; A spontaneous report was received from a consumer  concerning a 78-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events sore arm/pain in extremity and sleepy most of the day/somnolence.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the anatomical location for prophylaxis of COVID-19 infection. The route of administration was unknown.  On 12 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) in the anatomical location for prophylaxis of COVID-19 infection. The route of administration was unknown.    On an unknown date, the patient experienced sore arm and was sleepy most of the day.  No treatment details were provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event sore arm and was sleepy most of the day were unknown.
having a shingles outbreak; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (having a shingles outbreak) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles (Shingles outbreak in October or November 2020 and then she started to have a couple more ever since.) in 2020. Concomitant products included LORATADINE (CLARITIN [LORATADINE]), IBUPROFEN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HERPES ZOSTER (having a shingles outbreak). The patient was treated with VALACYCLOVIR [VALACICLOVIR] on 17-Dec-2021 for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (having a shingles outbreak) had not resolved.            It was reported that patient was on second day of Valacyclovir.
Per EMS patient's husband reports she was using the push mower in the front yard and suddenly collapsed. EMS brought the patient in with active CPR in progress and the patient was pronounced deceased in the Emergency Department.
NURSE ADMINISTERED 0.2ML IM OF UNDILUTED PFIZER COVID VACCINE FOR AGES 5-11YR. THE PATIENT WAS WITH THEIR FATHER AND WAITED FOR 15 MINUTES IN THE OFFICE AND DIDNT EXPERIENCE ANY ADVERSE REACTIONS. I WAS MADE AWARE AFTER THE PATIENT LEFT THE OFFICE AND CONTACTED BOTH PARENTS. I ADVISED THEM OF WHAT OCCURED ABOVE AND TO MONITOR FOR AND LOCAL OR SYSTMEIC REACTIONS AND SCHEDULED AN APPOINTMENT TO RECHECK THE PATIENT IN 48HRS. PER THE FATHER THE PATIENT WAS DOING WELL AT HOME AND STILL HAD NOT EXPERIENCED ANY ADVERSE REACTIONS. VACCINE ADMINISTRATION AND PREPARTION EDUCATION WAS GIVEN TO ALL STAFF PRESENT THE SAME DAY.
This spontaneous report was received from a registered nurse regarding unspecified patients unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L036823 with expiration date 24-DEC-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 11.5 degrees Fahrenheit for 3 hours and 54 minutes. Data logger was involved. The temperature was back in range. The previous excursions were the following: 15 degrees Fahrenheit during one hour and 20 minutes, 7 degrees Fahrenheit during two hours and 24.1 unspecified degrees during five hours and 41 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
37w6d pregnant during second dose Sore arm Body aches Chills  Fever of 101  For 24 hours
Soreness at injection site, soreness on left side down to hip, much nausea(stomach) , also felt like I was going to vomit, body aches,  head ache and low grade temp until Tuesday 10/26/2021 around 10 am.  This was the Moderna booster shot #3.  I called my Dr's office to check in with the nurse and was advised to report my reactions to the CDC.
Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water,  practiced deep breathing and went back to bed lying on left side. Eventually was able to fall asleep so unsure of total duration.
it is read and itchy; rash on the injection side around 1,5 inches; it is read; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (it is read and itchy), VACCINATION SITE RASH (rash on the injection side around 1,5 inches) and VACCINATION SITE ERYTHEMA (it is read) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder NOS. Concomitant products included AMLODIPINE and CANDESARTAN for Blood pressure, ALOPURINOL for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (it is read and itchy), VACCINATION SITE RASH (rash on the injection side around 1,5 inches) and VACCINATION SITE ERYTHEMA (it is read). At the time of the report, VACCINATION SITE PRURITUS (it is read and itchy), VACCINATION SITE RASH (rash on the injection side around 1,5 inches) and VACCINATION SITE ERYTHEMA (it is read) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included thyroid medication. Treatment medications include a cream for the itchiness.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021 contains updated event outcome to recovered from not recovered
This spontaneous report as received from an 81 year old male consumer refers to himself with no pertinent medical history or drug reactions/allergies. On 15-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported), intramuscularly (dose not reported). Concomitant therapies included metformin, LOTRIL, simvastatin (manufacturer unknown), omeprazole (manufacturer unknown) and aspirin. The patient reports that he developed stomach pains and diarrhea on an unspecified amount of hours afterwards on 15-JUL-2013. The patient reported that he was "certain" that the ZOSTAVAX was administered intramuscularly. He also reported that he did not see the nurse that administered the ZOSTAVAX to him "mix anything" with the ZOSTAVAX so he stated that he was missing a second part to the shot. There was no treatment given for the events. No lab diagnostics studies were performed. At the time of reporting, the outcome of stomach pains and diarrhea was reported as not resolved. The patient did not seek medical attention. Additional information has been requested.
This is a spontaneous report from a non clinical study program from a contactable consumer who reported for her daughter (patient). A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on 25Feb2015 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of unknown, chills/shivering on an unspecified date with outcome of unknown, and shaking on an unspecified date with outcome of unknown. Follow-up (24APR2015): Follow-up attempts completed. No further information expected.
Lt. arm reddened where Tdap was given. Vomited 2x's in the PM on 7/23/07 and vomited 4x's on 7/24/07 in the PM. Also c/o severe H/A and chills. Went to Dr. on 7/24/07 and was advised alternate Tylenol and Aleve of 4 hours. No further tx per Dr.
Had Rhabdomyolysis with swelling from shoulder to wrist of the left arm 19 days after his 2nd Covid vaccine had been given in the same arm. He had done a workout with small weights the day before, his liver enzymes were also increased after 2 days of hospitalizations and hydration the CK dropped to acceptable levels. His arm was also broken at the wrist on the same side 2 months prior to the vaccination. His other arm did the same workout routine and never had swelling or pain.
Received flu shot L deltoid (bandaid applied) became red and warm to touch, itchy and stung, later that day (4"x3" area) used ice and hydrocortisone cream to area and Benadryl one cups-full recovery next day reported some malaise next day.
Patient says her arm started to hurt at injection site about one month after administration.  No redness, or lumps were apparent.  Nothing was unusual for first month after administration.
pt recv vax;pt reported that a "smooth,hot,big size of orange" emerged on eve of shot;pt stated recv previous dose w/ no problems;
stomach ache; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), PAIN (body ache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), PAIN (body ache) and PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), PAIN (body ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient is a nontoxic-appearing 96-year-old female who presents emerged department via EMS for tachycardia.  She has a history of atrial fibrillation on Eliquis as well as metoprolol.  Over the last 2 days she has had some intermittent episodes of elevated heart rates.  This morning it was found to be in the 160s and she was sent to the emergency department.  Patient denies any chest pain just states that she is has some palpitations in her chest.  She does not missed any of her medications.  No syncope. Associated Symptoms: palpitations
12/1/2022 I had loose bowels, bloating and gas. I had an appointment already with my PCP on 12/8/22. He told me maybe the gut bacteria were out of whack. I took a Probiotic for 30 days, but still had the problem, but was better.   Then I had bowels that were like they were locked up. On 2/9/2023 I saw a GI doctor. She ordered a sitz marker test and labs. On 2/13/23 I went back for an x-ray to see if I had passed the markers and I had not passed any. I went back on 2/16/23 and had another x-ray and still had 8 markers let. The doctor ordered LINZESS and my liver enzymes were a little elevated with the bloodwork I had. I started taking the LINZESS. On 3/13/23 I had an appointment with my PCP and felt like the LINZESS was working. I had my routine bloodwork done. The next day they called and said my liver enzymes were extremely high. On 3/20/23 I saw my GI doctor. She ordered more bloodwork. Three different markers were high. She did an MRI with contrast on 3/23/23 which showed no liver mass or no problems. I have an abdominal ultrasound tomorrow. I also have a colonoscopy scheduled.
p/vax pt exp a convuls/sz turned blue needed 02;in 1995 pt had about 19 sz;in 1996 pt had about 28 sz;1997 16 sz plus 7 more sz in a row in the abm;pt also had an abnormality has developmental delayed;gets EEGs all the time;
Right axillary lymphadenopathy still present. Right arm  pain still present.   Bilateral hand rash still present.
Had localized reaction, then with 2 days neck spasms.  Has to manually turn his head so it is midline. Dx: torticollis.
Client presented on 10/18/2018 for Hepatitis B dose#2. The 1st Hepatitis B dose given was HEPLISAV B on 9/13/2018. This nurse reviewed NCIR and the trade name was not listed, therefore, an ENGERIX B was given for the 2nd dose instead of the HEPLISAV B. When the client was informed the date of the next vaccine he said it was a 2 shot series. It was then that I realized I had given a different brand of hepatitis B vaccine. Dynavax company was called for recommendation. Information given was that there is limited Data on the safety & immunogenicity effects when HepB-CpG is interchanged with Hep B vaccines from other manufacturers. When feasible, the same manufacturer's vaccines should be used to complete the series. It is suggested to adhere to a 3 dose scheduling, waiting a minimum of 16 weeks in between dose 1 & 3. The client was called & informed of above & informed of the next dose date.
Positive Ag test; Positive Ag test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 36-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 02Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Apr2022, outcome "unknown" and all described as "Positive Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.   Clinical course: The patient was COVID exposure on 30Apr2022 then 04May mild dizziness fevers and fatigue and Ag test on 05May2022. The patient had covid tested post vaccination.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.       No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Didn´t received second dose / and 1st dose was given during 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   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 were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with US2021151596, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151596:Same reporter.
On day 8 after getting the vaccine,  I had itching and a red patch at the injection site. The patch is approximately  4 inches by 3 inches, oval shape.  It persists on day 9, which is the date of this report, 2/1/21.
Patient was anxious and tachycardic prior to vaccine administration.  This was her second vaccine dose.  She had experienced altered mental status, tachycardia and hypertension after her first dose  so was advised to get her second dose in Urgent Care.  Her BP and HR continued to increase after administration of the second dose.  She was admitted to the Clinical Decision Unit in Urgent Care where her symptoms improved.  She did receive epinephrine, antihistamines and Solumedrol. The patient did have consultation with an allergist after the first dose, who felt that the patient's symptoms were unlikely due to an allergic reaction.
Headache; Chills; swollen lymph nodes under left arm, swolllen neck lymph nodes; fever blisters; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 13:15 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial runs" (unspecified if ongoing); "trigeminal neuralgia" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM; GABAPENTIN; OXCARBAZEPINE; BUPROPION. Past drug history included: Augmentin, reaction(s): "allergies: Augmentin"; Clindomycin, reaction(s): "allergies:clindomycin". Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Phizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose administration date=25Feb2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 25Feb2021, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Phizer,, prev dose brand unknown=False,, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose administration date=24Feb2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 24Feb2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 21Jan2022, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 21Jan2022, outcome "not recovered", described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 21Jan2022, outcome "not recovered", described as "swollen lymph nodes under left arm, swolllen neck lymph nodes"; ORAL HERPES (non-serious) with onset 21Jan2022, outcome "not recovered", described as "fever blisters"; PYREXIA (non-serious) with onset 21Jan2022, outcome "not recovered", described as "Fever". Therapeutic measures were not taken as a result of headache, chills, lymphadenopathy, oral herpes, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event did not require a visit to Emergency Room/Physician Office. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200148630 similar report from same reporter
Information has been received from a physician concerning a 11 year old female who eight to nine years ago, in approximately 1995 was vaccinated with a dose of varicella virus vaccine live. The physician reported that he saw the pt on 01Mar2004 with 500 plus varicella lesions break through. Unspecified medical attention was sought and it was unknown if treatment was required. A product quality complaint was not involved. Additional information was received which indicated that the pt's sister developed breakthrough chickenpox after therapy with varicella virus vaccine live. Additional information has been requested.
10/17/2011 patient reported 10/15 awakened with malaise, body aches, pain (L) deltoid, wheeze. He had received TD vaccine eve 10/13. He noticed red rash and swelling left upper arm with pain at elbow. Today increased heat, redness, tenderness present.