chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3rd dose given instead of booster dose,  gave a Moderna COVID-19 booster dose of 0.5 mL; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (3rd dose given instead of booster dose,  gave a Moderna COVID-19 booster dose of 0.5 mL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (3rd dose given instead of booster dose,  gave a Moderna COVID-19 booster dose of 0.5 mL). At the time of the report, ACCIDENTAL OVERDOSE (3rd dose given instead of booster dose,  gave a Moderna COVID-19 booster dose of 0.5 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
On Friday, around 6:00 pm, February 7, 2020, the patient presented burning, itching and pain in both arms where she was vaccinated. The area was red and swollen.
Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The patient dose of Shingrix in the left arm. The reporter stated that, after vaccination, the patient exerienced injection site pain which resolved in few days. The reporter consented to follow up. For the tolerence of 2nd dose refer case US2019AMR188461. This case has been linked with case US2019187932 reported by same reporter.
light headed; entire arm from neck to elbow was hurting - incredibly painful; hard for her to lift her own arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), PAIN IN EXTREMITY (entire arm from neck to elbow was hurting - incredibly painful) and MOBILITY DECREASED (hard for her to lift her own arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (light headed), PAIN IN EXTREMITY (entire arm from neck to elbow was hurting - incredibly painful) and MOBILITY DECREASED (hard for her to lift her own arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (light headed), PAIN IN EXTREMITY (entire arm from neck to elbow was hurting - incredibly painful) and MOBILITY DECREASED (hard for her to lift her own arm) outcome was unknown. Not Provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
fever, chills, headache on the night the vaccine was given that continued to Wednesday night. The next day following the vaccine administration nausea occurred and on the following day vomiting occurred/
mom phoned office 28FEB97 & stated pt had broken out w/chicken pox;office protocol for varicella reviewed
Pain on forearm; Headache; swelling in axilla and next to collarbone; Fever; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on forearm), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN and METFORMIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and LYMPHADENOPATHY (swelling in axilla and next to collarbone). On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain on forearm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 24-Apr-2021 at an unspecified dose and frequency. On 24-Apr-2021, PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on forearm), HEADACHE (Headache) and LYMPHADENOPATHY (swelling in axilla and next to collarbone) 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.
March 24-26: Pain in left arm March 27-April 2: Mild numbness on left side of upper body - starting at left shoulder blade March 3-Current:  Tenderness/soreness under left armpit area and left breast.  Painful sores/breakout on left side of left breast
Lightheaded /Dizzy; Back pain; Local symptoms; This case was reported by a physician via sales rep and described the occurrence of light headedness in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced light headedness, back pain and local reaction. On an unknown date, the outcome of the light headedness, back pain and local reaction were recovered/resolved.   It was unknown if the reporter considered the light headedness, back pain and local reaction to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Bexsero, the patient complained of lightheaded, dizzy and back pain. The patient went to emergency room and physician gave fluids. The patient also had some local symptoms but not significant. The lightheaded, dizzy and back pain and local reactions resolved in 72 hours. The reporter did not consent to follow up.
Pt broke out in hives treated with Benadryl. No site reaction. No more contact. Presumed recovered.
17NOV95 pt was given vax on 19NOV95 & mom noticed rash skin on pt's back & around & in back of both ears;no other sx noticed;29NOV95 mom states rash disappeared from back,but still present behind ears & in face;
3/7/21 - The day of the vaccination, minimal adverse side effects encountered. Minor soreness at the injection site, as well as general tiredness.   3/8/21 - Day after vaccination - mild soreness in arm, shoulder. Tiredness.   3/9/21 - Day - moderate soreness and pain experienced in the injection arm, shoulder, and back. Body aches, chest aches. Occasional waves of discomfort, similar to nausea but without stomach discomfort. Overall tiredness. Occasional mild headaches. No noticeable fever. Total 1000mg paracetamol taken throughout the day.   3/9/21 - Night - unable to sleep soundly due to moderate pain and aches in upper body, lots of discomfort. 1 dose of Nyquil liquid taken to reduce pain and aid sleep.   3/10/21 - Most pain has gone away, just some mild soreness remains. Still some overall tiredness.   3/11/21 - Side effects appear to have subsided by this day.
Information has been received from a physician concerning a male patient who on 29-MAY-2001 was vaccinated with a first dose of VARIVAX (Merck) (lot # not reported) intramuscularly. On approximately 02-JUN-2001 4-5 days post vaccination the child complained of dizziness, staggering and problems with equilibrium. The physician found fluid in the ear and no fever. The physician gave antibiotic and signs and symptoms subsided. In 2001 the patient recovered. Additional information has been requested.
The vaccine was reconstituted with Sodium Chloride 0.9% instead of the diluent containing adjuvant. The dose was repeated on 5/31/22 per recommendation by the manufacturer.
W/in 24 hrs pt irritable, fever, lethargy; Seen 2nd day pt shocky & moribund; had pneumococcal meningitis by LP;
Myalgias and lassitude starting day 2, 12h after vaccine but resolving in hours; day 3 - asymptomatic; after day 4: symptoms of bronchitis with dry or minimally productive sputum, rales on inspiration and pronounced wheezing, myalgias, dysestheshias (cuteness, scalp), fatigue. After the first 2 days of these symptoms rhinorrhea, signs of otitis media.
Left arm went totally limp with severe pain; like electrical shocks up and down arm muscles. Went to hospital; x-rays done, no breaks. Given pain medication (hydrocodone). See ortho next day. Ortho couldn't explain complete loss of arm use so quickly. Now had rash 3" wide and about 6" long. Full arm swelling plus hand.
chills, nausea, muscle aches, fever overnight. Treated with rest and tylenol
Developed lump on left leg after shots. Looked strange. Approx. 1 week later, refused to walk, severe pain. Tremors from pain. Started walking after 3 weeks of this. Is walking with a lean to the left side. Stumbles a lot. No diagnosis yet.  Follow up 07/22/2002: "Child was admitted to pediatric floor and empirically begun on Rocephin every 12 hours.  Nystatin cream was applied to the perineum, and Rondec DM drops were also given.  The child had a gradual defervescence with improved mouth intake.  On rounds on the 22nd, she was playful and in no distress.  She was changed to by mouth Pediazole and continued to do well.  On rounds on the 23rd, the child was afebrile, lying quietly in bed with mother.  She was taking by mouth well including medications.  It was felt she was ready for discharge."
immunocompromised patient received booster dose instead of full 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of full 3rd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2201200-16) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (was on immunosuppressive medication).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of full 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  The reporter had a question for the patient who had history of an immunocompromised condition and was on immunosuppressive medication, which would have made her eligible to receive a full 3rd dose. Patient did not experience any side effects after receiving the booster dose.   This case was linked to MOD-2022-495993 (Patient Link).
Hives starting around evening time of day of vaccination that continued spreading into the next day. No vomiting or difficulty breathing. No other symptoms.
I had the first shot on March 1st.  My arm was a little swollen and sore for two days, and I was extremely tired, but other than that no adverse reaction.  I received my second shot on  March 19th, my arm again swollen and sore, and I could barely keep my eyes open the rest of the day.  On 3/20/21,  I woke at 8:30, feeling like I had hardly slept at all even though I had slept for 9 hours.  I woke up wheezing,  which led to me coughing and chills but no fever.  The exhaustion I had felt after the first shot, was nothing compared to this.  I thought it would go away, but it didn't.  I also noticed a lot for fluid retention in my lower legs and stomach area.  When I got on the scale, in the 20 days from the 1st shot til the day after the second shot I had gained 20 pounds of fluid.  I was stunned.  I could barely do a simple task, then I would have to sit down to rest for a minute, and would immediately fall asleep for 2 to 3 hours.  I went to my doctor's on 3/22/21.  They did a covid test, it was negative.  The doctor said I was definitely wheezing and gave me the only sample inhaler that they had in stock Anorro to try to open up my airways.  After a week, I was still having the issues, went back to doctor on 3/29/21 This time they perscribed 12 days of taper steroids.  I am on day 4.  I also received a referral to see a pulmonary specialist.  I am still dealing with the exhaustion, wheezing and cough.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 10:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 60.46 for dose administered on 03-APR-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-APR-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-MAR-2021 and beyond use date for the vial was reported as 29-APR-2021. Product moved to clinic on 03-APR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour.  No treatment medications were reported.
Cold; sore arm; sneezed 30-40 times; nose is stuffed up; This is a spontaneous report from a contactable consumer (Patient). An unspecified age of female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Mar2021, the patient experienced Cold, sore arm, sneezed 30-40 times, nose is stuffed up. It was reported that the caller declined stating she just has some questions, and she doesn't care to give out all of her information. The caller had her shot yesterday and she woke up and must have the severe "man cold thing" because she must have sneezed 30-40 times after waking up and her nose is stuffed up.The caller wants to know if it is normal to have a cold after receiving the vaccine. Are they doing anything to improve how sore this vaccine makes your arm? The caller mentions she is holding the phone with her sore arm and is tired of sitting with her phone to her ear.The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
pt recvd vax;heaviness in chest,some diff breathing;14dec94 f/u: also had dry non productive cough,rt side of throat closed up,achiness,conjunctivitis (green discharge from eyes);fever of 102;tx at md's ofc;
After vaccine, pt fainted for a few seconds. Head drooped down. Pt positioned on floor lying down. Called 911 immediately. EMS arrived, monitored vitals, they were normal. BP: 113/78, HR 95/105 Sat 100%.
Anaphylaxis within 1 hour of receiving the vaccine: difficulty breathing, feeling of itchiness and swelling in throat.
Patient states about an hour after Pfizer dose #1, she developed itching on back with one hive - lasted approximately 4 days. Patient estimates the size of hive was around 3cm-5cm. EE states still feels itchy on/off to this day.
The patient woke up with an itchy, red rash located below the injection site. She didn't seem overly concerned but wanted to let us know. She called her physician & has some hydrocortisone cream that she will be applying to the area.
booster; itching all over body; Headache; muscle aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 10:00 (Lot number: 330308D) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm left, administration date 10Nov2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN6199,, prev dose lot unknown=False,, prev dose administration date=025M, ar2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 25Mar2021, when the patient was 52 years old, for COVID-19 immunisation; Bnt162b2 (Prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN5318,, prev dose lot unknown=False,, prev dose administration date=04M, ar2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 04Mar2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: PRURITUS (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "itching all over body"; IMMUNISATION (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "booster"; HEADACHE (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "Headache"; MYALGIA (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "muscle aches"; FATIGUE (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "fatigue". Therapeutic measures were not taken as a result of pruritus, immunisation, headache, myalgia, fatigue.  Additional Information: If other vaccine in four weeks was reported as yes and included Flu, other vaccine 4weeks vaccine date =10Nov2021, other vaccine 4weeks dose number=1, other vaccine 4weeks vaccine location=left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device time stamp: 07Dec2021  Follow-up attempts are completed. No further information is expected
1/13-1/15 sore arm. 1/14 moderate dizziness and nausea. 1/15 light dizziness and queasiness. 1/21 - 1/22 injection site itching. 1/23 injection site redness, moderate dizziness and nausea. 1/24 injection site redness, mild dizziness and queasiness. Injection site redness ended 1/25. Some light, brief, intermittent dizziness 1/25 - current.
Fatigue sore all over chills hot flashes sore throat Feeling of prickly like insulation a red bumps notnclustered just random is on me mostly around the midsection of my body I got this reaction afterb14 days of the 1st shot and was told by Dr probably was related to vaccine but looking back i believe i had this the first time as well it just hasn't gotten as bad yet. He did treat me with oral and topical steriods and antibiotics for ear infection.
Patient called pharmacy describing red arm from elbow to injection site/shoulder. Area swollen, couldn't tell if it was warm to the touch or not. No fever. Had acute diarrhea, not sure if it was related to the vaccine or not.  Arm is sore to move. Symptoms started about an hour after IMZ administered. 24 hours later, patient still symptomatic. Patient stated they had used an icy hot patch to the area after administration when symptoms began. Explained that regular ice packs should be used, patient also taking ibuprofen. Explained description of symptoms over the phone, did not see the reaction in person. Will be following up with primary care physician in the morning. MD not in the office today (it is a holiday).
Developed fever 101.1 and then fine macular rash on extremities. Fever lasted 24 hours, rash faded same interval. No other sequelae. Treated with Tylenol and Claritin
Blotchy, redness @ site of injection that spread to larger area on arm above elbow. Mild itching and soreness with pressure.