chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MENSTRUAL BLEEDING; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included period ceased. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced menstrual bleeding. The action taken with covid-19 vaccine was not applicable. The outcome of menstrual bleeding was not reported. This report was non-serious. This case, from the same reporter is linked to 20210621127.
The child developed swollen tonsils in the week post-vaccination. The tonsils grew in size to about the size of a large grape. No previous tonsillar issues. The tonsils enlarged to the point that speech was affected and the child developed sleep apnea. Pediatrician advised a "wait and see" approach for the abnormal enlargement, believing it to be a normal immune response to the vaccination. The tonsils remained enlarged and required surgery and speech therapy.
This spontaneous prospective pregnancy report as received from a registered nurse, refers to a 19 year old female patient with no pertinent medical history and no drug reactions or allergies. On 23-FEB-2009 the patient was vaccinated with the first dose of GARDASIL (lot number was not reported) 0.5 ml, intramuscular and on 15-JUN-2009 the patient was vaccinated with the second dose of GARDASIL (lot number was not reported) 0.5 ml, intramuscular. On 13-AUG-2013 pregnant patient was vaccinated with the third dose of GARDASIL (lot # H021861, expiration date: 09-OCT-2015), 0.5 ml, intramuscular. The patient did not use any concomitant medications. On 13-AUG-2013 the patient had a positive urine pregnancy test. The patient became pregnant with last menstrual period (LMP) of 12-JUL-2013 and estimated delivery date (EDD) of 18-APR-2014. Initial exposure to GARDASIL was at 4 weeks. The pregnancy outcome was pending. The outcome of events was unknown. Additional information has been requested.
After the vaccine I had 102.5 fever for three days. Body aches, chills, nausea, headache, vision problems. I now go to the eye doctor and I have been told I have blister on my retina most likely from a stressor to my body which is caused by the vaccine.
Had recurrent fever blisters lips  beginning two days after shot - had 5 more bout os fever blisters next 10 weeks Had Ocular Migraine 1 week after - went to eye doctor Had UTI 2 weeks after the shot for 8 weeks went to 3 urgent care doctor and there was no bacteria and they could find nothing wrong
Following vax pt developed mild swelling @ inject site w/blotchy erythema; rxn remained w/in 15cm of inject site; tx unspecified prescription therapy; pt recovered;
1:50 p.m. vaccine given.  9:30 p.m. began feeling feverish.  Severe chills, sweating, and aching until 7:00 a.m. next day (3/26).  101 degree fever persisted from 7:00 a.m. to 4:00 p.m. on 3/26, decreased to 100.4 degrees in the evening of 3/26, aching continued all day on 3/26.  Chills and sweating all night again, 3/26 to 3/27.  Temperature decreased to 99.3 degrees on 3/27, but continued feeling achy.  Large swollen and painful lymph node in left armpit from 7:00 a.m. on 3/26 to present.
Onset 9/5/12 fever, chills, malaise, body aches, diarrhea 9/7/12 started KEFLEX for redness at (L) arm injection site. 9/10/12 afebrile, redness at site faded, back to work.
After 1st and 2nd dose of Pfizer covid shot had breakthrough mentraul bleeding within 5 days of each shot. Have menstruation 3 times in 1 month
mom noticed rash yesterday 6/30/2021 brought pt into the office 7/1/2021 10 pox on body coming out as being examined
Shortness of breath, wheezing, chest tightness starting Friday evening 1/29/2022.  No prior h/o asthma.  No prior reaction to primary Pfizer Covid-19 vaccination series.  Seen in clinic 1/31/2022 and given nebulizer treatment with albuterol.
After receiving the immunization patient became unconscious, unresponsive, diaphoretic, incontinent and was drooling from the mouth. The patient did not respond to verbal or physical stimuli and his pulse was weak. Due to the patients position it is unknown if the patient was breathing or not. At this point epinephrine was administered into the patients left thigh. Within a 2-5 minutes the patient regained consciousness. He was alert and oriented at this time.  His blood sugar was testing using his continuous glucose monitoring system and was 191.  911 was called and the paramedics took the patient to the hospital.
pt recv flu vax & 6 wk later devel Bell's Palsy, affecting the lt side of the face; pt's otolaryngologist began tx 13JAN95 w/decreasing doses of Pred;
had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; This is a spontaneous report from a contactable Other Health Professional reported that a 35-year-old female  patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient experienced a reaction of bells palsy with mild symptoms 5 minutes of receiving Covid vaccine. "facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better, patient was vaccinated 10 days ago on 21Dec2020.  Patient was treated with 60mg of Prednisone for 5 days which was started today." Question is regarding the 2nd dose of Covid vaccine, whether or not she should have it.  The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. .; Sender's Comments: There is a positive chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Unknown age male soldier developed a local reaction, including swelling that extended to his hand after the first dose of Anthrax. The subject's entire arm and shoulder were painful. Symptoms resolved in 6 days and subject received the second dose without incident.
Right arm swollen and injection site increase in local temperature. Treatment tylenol and Benadryl 8cc q 4 (deg) PRN.
confused/ feels befuddled / difficult to focus; head in a fog; loss of peripheral vision; can not drive/start a task and unable to finish it; distracted; pressure at the top of my spine; trouble concentrating/trouble reading my laptop; very tired; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), CONFUSIONAL STATE (confused/ feels befuddled / difficult to focus), FEELING ABNORMAL (head in a fog), VISUAL FIELD DEFECT (loss of peripheral vision) and MOBILITY DECREASED (can not drive/start a task and unable to finish it) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). On 08-Jun-2021, the patient experienced CONFUSIONAL STATE (confused/ feels befuddled / difficult to focus), FEELING ABNORMAL (head in a fog), VISUAL FIELD DEFECT (loss of peripheral vision), MOBILITY DECREASED (can not drive/start a task and unable to finish it), DISTRACTIBILITY (distracted), SPINAL PAIN (pressure at the top of my spine), DISTURBANCE IN ATTENTION (trouble concentrating/trouble reading my laptop) and FATIGUE (very tired). On 08-Jun-2021, PAIN IN EXTREMITY (sore left arm) had resolved. At the time of the report, CONFUSIONAL STATE (confused/ feels befuddled / difficult to focus), FEELING ABNORMAL (head in a fog), VISUAL FIELD DEFECT (loss of peripheral vision), MOBILITY DECREASED (can not drive/start a task and unable to finish it), DISTRACTIBILITY (distracted), SPINAL PAIN (pressure at the top of my spine), DISTURBANCE IN ATTENTION (trouble concentrating/trouble reading my laptop) and FATIGUE (very tired) 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 medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant FU - Events outcome updated.
1 week after vaccine  symptoms began of fever, runny nose, headache, and diarrhea; currently diarrhea persists and runny nose, and worried about Guillian Barre syndrome, very tired. Trying to stay hydrated, went over 20 times (diarrhea today). Saw Dr on 7/9/21 and called for another appt. today and they instructed her to call here. Encouraged her to get in and see Dr again asap for ongoing diarrhea symptom.
Vomiting - 5:30am, 6:30am, 7:30am, 8:30am, & 9:30am on Friday 7/15. One episode of vomiting Sunday 7/17 at 8:30am.
Small bruise at injection site, swelling and pain around injection site. Red rash that has grown to about 3 inches over the past three days at injection site. Rash is warm to touch and mildly itchy.
My throat started closing within 30 minutes. I had difficulty swallowing. It was similar to an anaphylactic reaction I get to nuts. It lasted about three hours.
patient received injections of Quadracel and a separate extra dose of Ipol on the same day, no AE; Initial information received on 19-Feb-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This was reported that a four year old patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5656AA, Exp. Date 31-Aug-2021) and IPV (VERO) [IPOL] (lot P1A25, Exp. Date 02-May-2020) via intramuscular route in the right arm for prophylactic vaccination on 18-Feb-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination on 18-Feb-2020.  It was an actual medication error case due to extra dose administered.  It was reported that patient received injections of Quadracel and a separate extra dose of Ipol on the same day.  At the time of reporting, no adverse event was reported.  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 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.
It?s been 7 days since vaccine and am still experiencing the following symptoms: severe headache, severe fatigue, body aches.  I previously that week I had a slight headache.  About 1 hour after the vaccine , I developed a bad head ache, extreme fatigue, body aches and slept 20 hours a day for 3 days ,and continued to have all the above symptoms at time of filling out this form but less severe.
Sore joints and muscles; Sore joints and muscles; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 at 16:00 (Batch/Lot Number: ER2613)  (at the age of 63-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergies: penicillin. The patient had no COVID prior to vaccination. Patient had no other vaccines in within 4 weeks prior to COVID vaccine. Concomitant medication included sertraline taken for an unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6199) on 15Mar2021 at 16:00 (at the age of 63-years-old) in the left arm for COVID-19 immunisation. In Apr2021, patient reported sore joints and muscles. The events appeared the week of second injection and then went away and reappeared on  05May2021 and is continuing. It was unknown if treatment was given to the patient. Patient had not tested for COVID post vaccination. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 02-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Chest pain, had a difficult time breathing,headache,developed a fever,hives, redness through out certain part of the body, body pain/soar patient could feel the pain to the bone, weakness,high blood pressure, and fast heart beat
9 mins post vaccination pt states that she is having "pressure" on her chest.  VS WNL.  Nothing remarkable upon assessment. Vitals: 119/80, 86, 20, 99% Pt stable and released from the vaccination site
After receiving my first dose, I had shortness of breath, racing heart, felt dizzy. I went to the doctor in 05/2021; by that time, I had shortness of breath, dizziness, extreme fatigue, and racing heart. My doctor put me on a two week heart monitor and diagnosed me with atrial fibrillation. On 01/04/2022, I had a cardiac ablation. Even after the procedure, I was still having the same symptoms, but worse. They put me back on the heart monitor again and diagnosed me with SVT (Supraventricular tachycardia) and had over 3,000 episodes in a two-week span, the longest episode lasting 5 minutes. They changed my prescriptions and told me it could take up to 3 months for the ablation to take place and show changes. They put me on Eliquis and other blood thinners. I had to have a vascular surgery, and they had to take me off the blood thinners.
That night, I started to feel very faint. I developed a small cough and a fever. I decided to take Nyquil and went to sleep. I had a virtual visit with my doctor and she suggested that I continue with the Nyquil 2x a day.
Underage before the 5/12/21 approval for Pfizer vaccine  Suspected falsification of DOB ? unable to contact guardian DOB in system has recently been changed to 01/22/XXXX, originally was listed as 01/22/XXXX
COVID 19; COVID 19; brand other=Moderna bivalent, brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 11Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "crohn's disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Drug allergies:Aspirin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Oct2022, outcome "unknown", described as "brand other=Moderna bivalent, brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tinnitus (left ear, same side of injection). Constant whistling sound exacerbated by noise.
Day after Maderna Covid-19 vaccine #1 I had severe flu like symptoms.  Heavy/tight chest, bad headache all day long, chills, aches, nausea. I finally took Tylenol at 2pm and it worked wonders. I was still sick but was able to relax and sleep. Felt like mild flu after Tylenol. Next day (2 days after vaccine) felt much much better. Still have slight weakness like after being sick and some light headedness but feel like I should be back to 100% tmw.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M002418, expiration date 12-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
falling down; severe joint pain; fatigue; headache; Severe pain; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FALL (falling down), PAIN (Severe pain), ARTHRALGIA (severe joint pain) and FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN (Severe pain), FATIGUE (fatigue) and HEADACHE (headache). On 30-Mar-2021, the patient experienced FALL (falling down) and ARTHRALGIA (severe joint pain). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), FALL (falling down), PAIN (Severe pain), ARTHRALGIA (severe joint pain), FATIGUE (fatigue) and HEADACHE (headache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: The patient information, vaccine lot number and additional event were updated.
producing a lot of gas in stomach and chest; does not want to eat; indigestion; producing a lot of gas in stomach and chest; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (indigestion), CHEST DISCOMFORT (producing a lot of gas in stomach and chest), FLATULENCE (producing a lot of gas in stomach and chest) and DECREASED APPETITE (does not want to eat) in a 64-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.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DYSPEPSIA (indigestion), CHEST DISCOMFORT (producing a lot of gas in stomach and chest) and DECREASED APPETITE (does not want to eat). On an unknown date, the patient experienced FLATULENCE (producing a lot of gas in stomach and chest). At the time of the report, DYSPEPSIA (indigestion), CHEST DISCOMFORT (producing a lot of gas in stomach and chest) and DECREASED APPETITE (does not want to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and treatment medications were reported.
Left arm pain,  currently still experiencing; tinnitus both ears, left greater that right (still ongoing); metallic taste in mouth, immediately after injection (lasted 2 hours)
Difficulty breathing, sweats, feeling dizzy and like I was going to pass out (vision went dark a few times), nausea. Oral liquid antihistamine administered. Recovered within 20 minutes.
Patient confirmed she had  no history of severe allergic reaction to a prior vaccine or any of the ingredients in the Moderna vaccine prior to vaccination which was performed 1/7/2021 without complications and she was observed for 15 minutes post vaccination without any adverse reaction.  Her husband reported that she was well until the evening following her vaccination (1/08/2021) at which time she became agitated.  The following day she became very fatigued and unresponsive, taking only sips of water.  The only medical attention they sought at this time was a home health hospice nurse as the patient had been on hospice.  Her condition spontaneously improved without treatment after 3 days and 6 days after her vaccination she was at her normal baseline.
Edema, erythema, and warmth at site of injection, as well as pain and tenderness.