chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the vaccine she saw stars for a couple of minutes; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) in a 73-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes). On 18-Feb-2021, VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) had resolved. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.     Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) in a 73-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes). On 18-Feb-2021, VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) had resolved. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.     Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR
1350 - Vagal reaction to injection.  Vitals taken 160/80 P63.  1400- Vitals 125/80 P57 O2 98%  1411 - Repeat vagal reaction. -  EMS called to site.  Pt was bradycardic - alert and never lost consciousness.  History of syncope in past.  Pt has been sating at 97%.  O2 applied at 6L and pt is now sating at 100%.  1415-  EMS arrived on scene, is present and evaluating patient.  Pt continues to sat at 100%.  1420  Pt is refusing transport and signed AMA.  Pt given instructions.
This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 2 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot K024825 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Fifteen minutes after vaccination, patient started feeling warm feeling to Left upper arm and numbness traveled down to hand. Then started feeling headache and warmth to forehead 30 minutes after vaccination. Afebrile, Temp: 97.7F temporally, Applied cold compress to site provided relief to achiness and numbness. VS taken x 2, stable. Released 45 minutes after vaccination to home.
During administration of flu vaccine in my Right shoulder, the plunger stopped before dose fully injected. There was a jolt as the person giving dose pushed harder to give the complete dose and pushed the plunger all the way. She explained what happened and said "Sorry". Within a couple hours, my arm was really aching. I took ibuprofen at home before bed. The next day it felt a little better, but a week out I started developing more pain with range of motion. The last few nights I take ibuprofen before bed and get woken up every time I move. I have to change all my movements to compensate for my shoulder pain with daily activities.
Information has been received from a physician concerning a female with a history of shingles who on 02-OCT-2006 was vaccinated with a 0.65 mL dose of ZOSTAVAX. On 02-OCT-2006 the patient experienced swelling and redness around the injection site and shoulder and neck. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Menstrual cycle started 2 weeks early with severe cramping, heavy flow, and overwhelming fatigue (compared to standard cycle)
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot # L009203, expiration date 17-MAR-2017, lot # L013827, expiration date 21-APR-2017 and lot # reported as L024250, expiration date 30-JUN-2017 which were exposed to temperatures outside of the recommended range. No adverse experienced has been reported This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a 65 year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. It was reported that, on 19-MAY-2017, an unspecified number of doses of ZOSTAVAX (lot # M035695, expiration date 07-NOV-2017), were incorrectly stored at a temperature between 6°F and 14°F, during 1 hour and 15 minutes; and later, on 10-JUN-2017, a dose of the improperly stored ZOSTAVAX was administered to the patient (dose, route and anatomical site of injection were not reported), for prophylaxis. The vaccine was administered along with a sterile diluent, with lot # M024782 and expiration date 23-FEB-2019. The report was because of a data logger and there were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Reddened swollen-hard area L deltoid 9cm x 6 1/2cm induration at center. Injection given 1/21/04. Redness and swelling began afternoon of 1/22/04. Tx with Keflex, f/u apt with MD 1/23/04.
Same day Flu Like symptoms - In bed & needing to urinate, but feeling too wobbly to get up. Made it into bathroom, urinated, felt dizzy, held on to vanity counter - next thing I was aware of I was on the floor - felt throw rug so I knew I was near my bed, but couldn't find it. Around 1 AM (teeth chattering) low grade fever felt light-headed, disoriented, must have passed out; no idea how long. Got back in bed. Felt awful next day - noticed my right hip was sore & discovered a large bruise. No idea what I came in contact with. I reported this incident to Dr. (my PC) via the medical portal. Her response was she was "so sorry". Few weeks later called her office & inquired if this incident was in my medical records - they said no, since I wasn't seen by Doctor. I go to Allergist for Dupixent shots - I explained to Dr. my reaction to covid shot & he advised me to not get another one. Also I discussed this w/ PA, & she gave me this form to submit, saying it needs to be documented. I certainly will not take the risk of another COVID vaccine. Felt sick the next couple days.
Edema and erythema from deltoid distally to elbow. Area all the way down to the elbow was tender to the touch. Patient was sent to ER for medical evaluation.
Bleeding after a week of the vaccination, cramping, and menstrual  period which lasted 5 days.
intractable headache after receiving dose resulting in leaving cheer practice; associated numbness/tingling of arms/hands
Patient had flu shot 11/08/05. Now has 48mm swelling, erythema, and pain at injection site(left arm).  Left arm has red, firm, slightly raised 10x7 cm area on upper arm. Treated with Levaquin 500mg daily for 5 days.  Zyrtec 10mg daily for 5 days. Predisone 40mg one dose.
I received my first vaccine on August 2nd and on August 6th I had Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I received my first vaccine on August 2nd and on August 6th I had Covid) 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 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced COVID-19 (I received my first vaccine on August 2nd and on August 6th I had Covid). On 06-Aug-2021, COVID-19 (I received my first vaccine on August 2nd and on August 6th I had Covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was reported. No Concomitant medication was reported. No lab data was provided. Denied  to be followed by safety
The client developed a rash on the forearm of the vaccination arm (right extremity). The rash was flat, red, not itchy or painful. This rash resolved spontaneously and without interventions.
Rt arm - 2-2 1/2 inch, 4-6 erythema, soreness and redness 4 6 inches.
Patient has pain at site of injection. She has more pain with rotating and pulling movement. It started immediately after the vaccine was administered. No treatment tried. It seems to be worse now. The patient feels that the injection was given too high on the arm. It was very painful when injected.
This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (MYOCARDITIS) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (MYOCARDITIS) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (MYOCARDITIS) outcome was unknown.
SWELLING IN ARM, REDNESS AND WARM TO THE TOUCH. MAY BE CELLULITIS AND PATIENT WILL SEEK MEDICAL TREATMENT
101.4 degrees fever, chills, muscle aches out of ordinary, shaking (from chills). Duration: 9.22-9.24.10 very sore arm at site of shots. Duration - 9.22-9.26.10
Patient had likely syncope. Fainted/felt dizzy after immunization. Patient waited at the pharmacy for 30min until she felt better, then went home.
Stomach was "unsettled" starting day of vaccination. No fever, no N&V or diarrhea, no cramping. "I'm aware that my stomach is there". 1 - 1 1/2 weeks after vaccination c/o feeling like he did with previous cases of Lyme disease (aches, pains, headache). Saw MD, treated for Lyme with Doxy x 21 days (through 3/29/18). No Lyme test done. As of 4/4, still has "unsettled" stomach as described above.
Pain in elbow joints, *severe* pain in neck, inability to sleep: pain is worse when lying down. Administered Advil (4).
ON 1/20/21 @0615 DEVELOPED WEAKNESS, NAUSEA, CHILLS, POOR APPETITE THAT LASTED 24 HOURS
Increasing redness over the injection area starting on 8/15/21 and spreading to 3-7 cm over the right lateral deltoid. Went to ED on 8/16/21. Concern over infection/cellulitis. Given antibiotics and discharged home.
Full body aches, arm pain, 100F fever, neck and headache and sinus pressure.  All subsided after 16 hrs from onset.
Dizziness, Headache, Myalgia, SkinRash, NauseaVomiting, swollen eyes, arm soreness, fatigue Narrative:
Could be completely coincidental, but almost two weeks (4 days prior to her second vaccine) patient started her menstrual cycle for the 2nd time in less than a month.  She has a very regular 28 day cycle and has never had this happen before.
Patient came in to the Annex (vaccination site) requesting bivalent vaccine. Patient was asked for his vaccine card which he stated that he did not have. Patient was then registered. The  nurse proceeded to ask the pre-vaccination questions and then administered the vaccine. After vaccine administration the nurse realized that she had not checked the electronic records. She then realized that the patient had received a Moderna Bivalent in  September 2022.
Information has been received from a physician concerning a 14 year old male with no pertinent medical history, drug reactions or allergies who on 11-JUL-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On 15 AUG 2007, the patient was vaccinated subcutaneously into the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot #"0822U"). There was no concomitant medication. On 16-AUG-2007, the patient developed an injection site reaction described as a 14 X 16 erythematous induration. The patient was started on Augmentin as a precaution for infection (local cellulitis vs reaction to varicella virus vaccine live (Oka/Merck). At the time of reporting the patient was recovering. Unspecified medical attention was sought. There was no product quality complaint. Follow up information was received from an office manager, who indicated under HIPPA she was not permitted to release any patient information without patient authorization. Follow up information from a physician indicated that on 15 AUG 2007 the patient, who had no pertinent medical history, or pre existing allergies was also vaccinated with a second dose of hepatitis A virus vaccine inactivated (Havrix), into the right arm, (Lot # AHAVB184BA). There were no illnesses at the time of vaccination. No further information is expected.
Pt. became faint and lightheaded. Applied cool cloth. Pt. became nauseated. Pt. given ZOFRAN 0.4 mg. Had pt. lay down with feet elevated. Gave pt. water. After approx. 20 min. pt. started feeling better.
Malaise; body aches; Chills; This is a spontaneous report from non-contactable consumer. A 33-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiration date was not provided), via an unspecified route of administration second dose on 07Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 07Jan2021, hours after second dose the patient experienced malaise, body aches, and chills with an outcome of recovering.  No treatment received for the adverse events. Facility where the most recent COVID-19 vaccine was administered at Hospital. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Unknown  Information about lot/batch number has been requested.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevn; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Approx 3-5 min after vaccination patient fainted - no verbal warning - lowered to floor, BP, Pulse done - oxygen given - awoke prior to O2 - awoke on his own - knew his name - weak - after a few minutes of O2 - attempted to sit back up - upright for approx 1 min. then pale again and felt as if going to pass out - lowered to floor - stayed conscious - activated EMS - to hospital.
suspected vaccination failure; It wasn't as severe as the others; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine, 1 year ago from the date of reporting. After receiving Shingles vaccine, the patient had a breakthrough case last month from the date of reporting. The patient stated that, it was not as severe as the others. This case was considered as suspected vaccination failure, since the details laboratory confirmation of herpes zoster was not provided.  This case had been linked with case US2021AMR243453, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243453:same reporter, other episode
Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Itchy unilateral rash for less than 4 weeks. Unknown if antiviral treatment was given.
LUMP AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced lump at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at injection site. This report was non-serious.
1/2 hr post injection, developed flushing rash on deltoids and chest. Given Benadryl 50mg pc-rash resolving in 42 hr next day gone. No resp problems.
Brain fog for the past 2 months.  I cannot focus on anything and I can?t make it through a day without taking a nap.  I?m exhausted all the time
pain in neck and ears; pain on left side of face, back, buttocks, legs,; Injection site hot; injection site became red; Injection site hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in neck and ears), PAIN (pain on left side of face, back, buttocks, legs, ), INJECTION SITE WARMTH (Injection site hot), INJECTION SITE ERYTHEMA (injection site became red) and INJECTION SITE PAIN (Injection site hurting) in a 66-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 reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site hot), INJECTION SITE ERYTHEMA (injection site became red) and INJECTION SITE PAIN (Injection site hurting). On 19-Jan-2021, the patient experienced PAIN (pain on left side of face, back, buttocks, legs, ). On 20-Jan-2021, the patient experienced PAIN (pain in neck and ears). At the time of the report, PAIN (pain in neck and ears) and PAIN (pain on left side of face, back, buttocks, legs, ) outcome was unknown and INJECTION SITE WARMTH (Injection site hot), INJECTION SITE ERYTHEMA (injection site became red) and INJECTION SITE PAIN (Injection site hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
On January 16, one week after my injection (on January 9) my upper arm formed a quarter size reddened area in the injection area. It was slightly warm, hard to touch, itchy, and looked similar to a hive.  It stayed this way until the morning of Tuesday January 19.   The area is only slightly red at the moment, it is now 730pm.  I tried to submit an update to my V-Safe profile but it said I had updated all my health questions.  I did fill out my form on Saturday the 16th prior to my symptoms presenting.
ERRATIC HEARTBEAT AND PULSE, PULSE RATE VARIED; LOOSE BOWELS LIKE WATER, DIARRHEA; TIRED; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included loose bowels. Patient had no gallbladder and no known allergies The patient received covid-19 vaccine ad26.cov2.s by 2 paramedics (suspension for injection, route of admin not reported, batch number: 20SA61A and expiry: Unknown) dose was not reported, 1 total administered on 18-MAY-2021 14:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021 (after the vaccination), the patient felt tired. Patient always had loose bowels, now on 26-MAY-2021, the patient could not make it to the toilet, diarrhea and it came out like water. This had been ongoing for two weeks. On 08-JUN-2021, the patient had erratic heartbeat and on the same day at 12:45 pulse rate had been varied (erratic pulse). Patient could not keep anything in her. It was reported that nurse was in last week and informed loose bowels could be probably due to food. Patient did not had any medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 20-MAY-2021, and had not recovered from erratic heartbeat and pulse, pulse rate varied, and loose bowels like water, diarrhea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Had swelling to his left upper arm which was much greater several days ago. Today has slight swelling and slightly red area 09/14/2010.