chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the first covid vaccine on 1/4/21 and the 2nd on 1/25/21.  On Feb 22nd I started having heavy vaginal bleeding and severe stomach cramps.  These continued for 9 days and then I went to the Emergency department because I felt like my HGB was low.  They checked it and it was 11.3 and did an abd US that showed my endometrium was thick.  They recommended follow up with GYN and a biopsy.  I continued to have significant bleeding and cramps until the next week when I called the nurse line and they set me up with a virtual visit with GYN provider.  She started me on progesterone and scheduled a hysteroscopy and D & C for the following week.  The progesterone slowed the bleeding down but I continued to experience abd cramps.  I had the D & C and after getting home started to have heavy bleeding and bad cramps again.  The following week I called the GYN provider and she had me come in for another Abd US and checked my HGB which was 9.3.  She also checked for infection and other labs which were all within nml range.  The pathology from my D & C was neg and the GYN really was not worried that is was anything other than a period but was surprised that it was lasting so long.  She gave me TXA and after 5 days on that the bleeding has now stopped but I am still having bad cramps in my lower abd and a lot of bloating.  Also having lots of jolting pains in lower abd.  I have never had  periods that were anything like this and never really had bad cramps like this before.
Pt called on 10-19-18 in the morning stating that she was feeling "paralysis" "feels like my arm is hanging" of the R arm (site of administration). Which started today on 10-19-18 in the morning after she woke up. I asked if the patient had any other major symptoms. She denied of having any inflammation/swelling near the site of the administration and also denied of having fever. I further advised the patient to seek further treatment by visiting her PCP or visiting a nearby Urgent Care Facility for further examination and clearance and to rule out any other cause of "paralysis" of the R arm. I also advised the patient to follow up with us in next 24-48 hours to see how she was feeling and the status of her complaint. We will also follow-up with the patient in the next 24-48 hours.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number 9KT7T, expiry date 13th March 2021) for prophylaxis. On 18th December 2018, the patient received SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX.  Additional details were reported as follows: The patient experienced injection site reaction, which was red and warm. The events were recovering but it was unsure how soon after vaccination the patient developed the reaction. The patient was able to perform daily activities like swimming and yoga. The reporter had consented to follow up.
I am 1 + years menopausal. But 1 week after vaccination, i started a menstrual cycle that?s lasted 5.5 WEEKS.  Solid, consistent, not spotting. After 2nd vaccine, april 7, it became intensely  heavy bleeding. Ended up at doctor?s for numerous tests including  ultrasound, bloodwork, and extremely painful uterine biopsy.
Early menstruel cycle at day 23 and late up to 10 days every month after that and continue to be irregular. I also experienced changes in my breast tissues, and have a recent mammogram for proof.
Pt recvd vax & exp shingles lt arm, chest & upper back;  treatment DPH, Lidex, Medrol;
"Covid Arm". Swollen, red itchy rash; "Covid Arm". Swollen, red itchy rash; "Covid Arm". Swollen, red itchy rash; This is a spontaneous report from a Non-contactable Consumer or other non-HCP. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Feb2021 at 17:45 (Lot Number: EL9269), as DOSE 2, SINGLE for covid-19 immunisation. The patient had no other medical history. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included Simvastatin and Levothyroxine sodium (LEVOTHYROXINE), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 08:30 AM (Lot Number: EL9262), as single for covid-19 immunisation. On 17Feb2021 at 07:00 AM, the patient experienced "covid arm", swollen, red itchy rash. No treatment was received to treat the events. The patient outcome of the events was resolving at the time of this report.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
STRUGGLE TO OPEN EYES; SICK FOR 3 DAYS; SLEPT FOR 3 DAYS FULL; NAUSEA WHEN SEE FOOD; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced struggle to open eyes, sick for 3 days, slept for 3 days full, nausea when see food, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from sick for 3 days, and slept for 3 days full, and the outcome of headache, struggle to open eyes and nausea when see food was not reported. This report was non-serious.
This case was reported by a healthcare professional and described the occurrence of transient global amnesia in a 63-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 16 June 2011 the subject received 2nd dose of TWINRIX at 1.0 ml. At an unspecified time after vaccination with TWINRIX, the subject experienced transient global amnesia. At the time of reporting the event was unresolved. The healthcare professional considered the event was probably related to vaccination with TWINRIX.
the patient inadvertently received both  VARIVAX and PROQUAD in the same day.; also notes that the patient is above 12 years of age (17 years old); No symptomatic AE reported; This spontaneous report has been received from a registered nurse and refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 01-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, 0.5 milliliter (ml) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection 0.5 ml (dose number, frequency, route of administration vaccination scheme, anatomical location lot number and expiration date were not provided for both vaccines), administered for prophylaxis, on the same date (accidental overdose). Additionally, the patient was above 12 years of age (product administered to patient of inappropriate age).  No symptomatic adverse event (AE) reported.
Body aches, after both vaccines; Very tired after both vaccines; Headache after first vaccine; Left arm soreness, after both vaccines; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Could not sleep on left side, after both vaccines; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for Injection Batch/Lot Number: EW0172), via an unspecified route of administration, administered in arm left on 03May2021 15:30 (at the age of 67-year-old), as single dose for COVID-19 immunisation. Medical history included covid-19 from an unspecified date in Jan2021. The patient concomitant medications were not reported. On 03May2021, the patient experienced left arm soreness, after both vaccines, swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. caller reports these events together, could not sleep on left side, after both vaccines, on 04May2021 body aches, after both vaccines, very tired after both vaccines, headache after first vaccine. Patient was not administered with Additional Vaccines on Same Date of the Pfizer Suspect. The patient under-went lab tests and procedures which included sars-cov-2 test positive: positive on Jan2021. Out-come of the events Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together, Left arm soreness, after both vaccines was resolved on an unspecified date in 2021, Headache after first vaccine was resolved on 04May2021, Body aches, after both vaccines, very tired after both vaccines was resolved on 24May2021, could not sleep on left side, after both vaccines was resolved on 26May2021.  Agency Communication: Multiple reclarifications made with patient in adverse event section, to clarify if events occurred after the first or second vaccine, or with both vaccines.  For events occurring with both vaccines, patient reports start date as when event occurred after first vaccine and end date, as the date event ended after the second vaccine.
other zoster related conditions; shingles; Information has been received from a lawyer and refers to a patient of unknown age and gender. The patients concurrent conditions and historical conditions were not reported. On or about 11-AUG-2016,  the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a pharmacist at pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and other zosterrelated conditions.As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The evenst were considered to be related to zoster vaccine live (ZOSTAVAX).
Fever, clonic tonic seizure. Vaccine administered in the morning; symptoms occurred that evening.  Nurse follow up on 08/30/04 states: "Complete."
Erythema, swelling, tenderness and heat over R upper arm; Afebrile.
as dose 3 (booster), single; Severe chest discomfort; cold chills; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old male patient third dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 32030bd, Expiry date: unknown), via an unspecified route of administration, administered in left arm on an unspecified date as dose 3 (booster), single for covid-19 immunisation at Pharmacy or Drug store. Medical history included heart bypass, diabetes mellitus, cholesterol, blood pressure. The concomitant medications were not reported. No other vaccine received in four weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Er8727, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 17Mar2021 at 17:00 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Er8727, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 07Apr2021 at 17:00 as dose 2, single both for covid-19 immunisation at Pharmacy or Drug store. Known allergies to Vancomycin was reported. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination. The patient had not been tested for COVID-19 post vaccination. On an unspecified date the patient received DOSE 3 (booster) and experienced severe chest discomfort on 13Nov2021 at 14:00 and cold chills on 13Nov2021 approximately at 21:00. Patient took nitro to relieve some discomfort. No treatment was taken for cold chills. The outcome of the event severe chest discomfort and cold chills was resolving.  Follow-up attempts are completed. No further information is expected.
Arm still hurts; that could be part of this problem propylene glycol; Diarrhea/I havent been able to keep any food in my system; really bad aching; Extreme lethargy; headache; cant sleep; rash; sick from the vaccine; fever; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 and its ingredient propylene glycol (as reported) dose 2 via an unspecified route of administration, in upper left arm on 25Mar2021 (Lot Number: ET8733) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, high blood sugar, high cholesterol from an unknown date. Concomitant medication(s) included rosuvastatin calcium (CRESTOR); levothyroxine sodium (THYROXINE); olmesartan (OLMESARTAN) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccination included dose 1 of bnt162b2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 09:15 (Lot Number: EN6206) as SINGLE DOSE for covid-19 immunisation, and experienced feeling achy and tired, headache, bad diarrhea, fever, could not sleep, sick. The patient preciously received codeine and experienced allergy. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had been really sick from the vaccine. She took it (first dose) on the 5th and felt fine on the 5th but on 6th she started feeling achy and tired with a headache, the day after that she started getting very bad diarrhea and she started running a fever and that lasted about 10 days. On the 25th she went back for second dose and she felt fine on the 25th but on the 26th up until last Wednesday (31Mar2021) she ran a fever a low fever of 115degrees, terrible diarrhea, really bad aching, extreme lethargy, headache, could not sleep, couldn't sleep on the other one either but now she really could not sleep and she got a rash running from her ear across her face down her neck and her arm still hurts and today is April 8th. She has not been able to keep any food in her system like she said last Wednesday (31Mar2021) when the fever finally quit and now she stop having the diarrhea and she had to take Pepto Bismol (treatment) and even that just helped very much. She does not know she think that a more complete sheet should be given of what the ingredients were and what the possible reactions would be because on the initial sheet that all put out, it does not list like glycol she forget it. She wanted a more complete information about all the ingredient because she knew there is one in there that could be part of this problem propylene glycol and on the first sheet it does not list propylene glycol. The outcome of the events sick from the vaccine, that could be part of this problem propylene glycol was unknown, of the event arm still hurts was not recovered, of the other events was recovered with sequelae, the event fever was recovered with sequelae on 31Mar2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route, lot# and expiration date were not reported). On an unknown date, the patient experienced fainting. The physician seen the patient afterwards because of the adverse event. The outcome of the adverse event and the causality between the adverse event and GARDASIL 9 were not provided. This is one of two reports from the same source. Additional information has been requested.
Father states localized edema, redness, warm to touch and pain to injection site not relieved with ibuprofen or cold compresses. Seen at ER. Dx with cellulitis and placed on po antibiotics.
BrEN; This spontaneous case was reported by an other health care professional and describes the occurrence of BRENNER TUMOUR (BrEN) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced BRENNER TUMOUR (BrEN). At the time of the report, BRENNER TUMOUR (BrEN) 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 CONCOMINANT,TREATMENT MEDICATIONS WERE USED. LAB DATA WAS NOT GIVEN   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No specific follow-up information recorded.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. Since 11-OCT-2015, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (lot # L001329 and expiration date 13-JAN-2017, exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
days 1 and 2- arm and extreme armpit pain. Armpit pain continued for 7 days. day 3 - congestion, runny nose, all over aches and pain began.  Day 14 congestion/runny nose continue. No fever.
Initial misuse report received from a healthcare professional on 05 February 2014. This case is invalid as individual patient identifiable were not reported. Gave only DTaP-IPV from PENTACEL to a patient (No information was provided regarding the patient) on an unspecified date. No adverse event was reported. List of documents held by sender: none.
This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: Unknown. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He received his last shot on Nov2021 and he was diagnosed with Covid infection on Friday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The caller stated that, he received his last shot on Nov2021 and he was diagnosed with Covid infection on Friday and he believed that this could had been prevented. It was ridiculous that second dose was not given to front liners. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.
Mid of night 1, 3/27 sore arm started and very flush and solid red on neck and chest. Laid ice packs off and on and was better. 3/28 tonsil area glands (don't have tonsils or adenoids) hard, fatigue started but could still do some things. Night of 28th bad cough and lethargic, took cough meds and slept hard.  29-31 fatigue and slept, some coughing, flushed, and foggy. 4/1 night injection arm started itching and feeling on fire, mild headache, but fatigue lifted and could get things done around the house. 4/2 bad fatigue, dull headache, joint and muscle aches in neck/shoulders, hands, and hips took Tylenol first thing in am and at noon, no relief.  4/3 arm has non stop itched, burned, and swollen, still have headache and feels a bit worse, neck and joint aches, and off and on flush. Ice pack on arm. Just took pain reliever and laying back in bed.
Red inflamed area on right upper thigh where immunization was given.  4 cm X 6 cm.
Patient was given the Zostavax in the right tricep on 1/28/08 and on 1/29/08, she woke with approx 50 shingles-like lesions on her right buttocks. Patient was seen by a physician on 1/29/08 who confirmed non-injection site like zoster-like rash.
2.5 WEEKS AFTER THE FIRST SHOT, I HAVE A SORE ARM NEAR THE INJECTION SITE.   **I HAVE HAD PERIODIC BUT CONSIDERABLE MUSCLE STIFFNESS/SORENESS. LIKE I HAD JUST STARTED LIFTING WEIGHTS AGAIN AND OVER-DID IT ON THE FIRST DAY. STARTED ABOUT A WEEK AGO. MUSCLE SORENESS, WAS/IS HEAD TO TOE.   THEN TODAY IS WHEN THE INJECTION SITE MUSCLE BECAME SORE.
Patient given expired medication, manufacturer contacted, vaccine maintained the activity necessary to  protect against Covid-19 virus at time of administration.