chrisvoncsefalvay/vaers-outcomes huggingface dataset:
0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL; 0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) and DEVICE CONNECTION ISSUE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) and DEVICE CONNECTION ISSUE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL). At the time of the report, UNDERDOSE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) and DEVICE CONNECTION ISSUE (0.25 mL of the Moderna COVID 19 vaccine was given to a patient due to leakage instead of 0.5 mL) had resolved.        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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: This report refers to a case of Underdose and device connection issue for mRNA-1273, lot # unknown  with no associated AEs.
Patient history of Tdap/Td series Patient received Tdap /#1 on 1/18/2023 Patient received Td on/  08/24/2023 RN gave Td on 09/28/2023 - given too soon than the recommended schedule which is 6 months after 2nd dose. No adverse reaction noted from the time the vaccine was given. Patient left without complaints of untoward reaction.
small rashy type pink patches of raised in on my arms, small rashy type pink patches of raised in on my legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (small rashy type pink patches of raised in on my arms, small rashy type pink patches of raised in on my legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced RASH PAPULAR (small rashy type pink patches of raised in on my arms, small rashy type pink patches of raised in on my legs). At the time of the report, RASH PAPULAR (small rashy type pink patches of raised in on my arms, small rashy type pink patches of raised in on my legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Lightheaded and dizzy which came on in pulses and felt in the crown of my head.  Had to sit down and then lay down. Started at 8:00pm on 9/24.  By 9:00 I had pretty severe chills until about midnight.  Also experienced pretty severe nausea.  Took temp, it was 98.5, but I usually run about 97.5 so slightly elevated for me. Both injection sites are sore. I have a slight gooseegg in my right arm when the Moderna bivalent was given. I've also had swollen lymph nodes in my left armpit and under my chin.  I experienced the swollen armpit lymph with my 3rd Moderna shot/booster as well.
Acute widespread urticaria. Tx: Antihistamines < ZYRTEC, BENADRYL.
4AM 23FEB93 woke up screaming; (had 2 doses APAP); hysterical; bathed, gave popsicle, t104 oral; came down to 102 all day 23FEB; by PM nl; seen by MD; attributed to sl congestion & vax;
?Within the first 15 minutes - injection site felt hot (right arm).   ?Within the first hour - right arm felt heavy with some numbness/tingling that lasted less than 10 minutes.   ?3 hours post vaccine - mild arm soreness with ROM, but not to the touch.   ?7 hours post vaccine - I felt very fatigued. I could have gone to bed at 1600. I could barely keep my eyes open.   ?8 hours post vaccine - fatigue was still very much present, moderate arm soreness with ROM and now to the touch. I felt very feverish, but was afebrile.   ?10 hours post vaccine - fatigue was a little better because I had taken an hour nap. Body aches and headache had set in, and I still felt feverish without a fever. I couldn?t stop shivering. I needed to be under multiple blankets with long sleeves, pants and thick socks on to feel even a little bit warm.   ?13.5 hours post vaccine - fatigue and body aches had worsened. It?s a struggle to go from laying to sitting and sitting to standing. I even fell back down to the couch a few times because I didn?t have the strength to stand up all the way. Right arm soreness has progressed enough that lifting up a water bottle was a struggle, and I could not lay on my right side. My temp is now 101.4°.   ?I tossed and turned between 0200-0630 shivering and aching all over. I slept with my entire body (even my head) under the blankets to try to stay warm. My head was throbbing. I got up at 0630 to take some Tylenol and woke up sometime between 0630 and 1030 drenched in sweat, so I?m assuming I had another fever.   ?30.5 hours post vaccine - it?s now January 1st. Body aches/stiffness, headache, fatigue, right arm soreness still very present. Switching any type of body position was a struggle. Temp is 101.2° now. I got out of bed at 1045 and got back in bed at 1200. I stayed in bed until 1845.   ?48 hours post vaccine - slight headache and right arm soreness. Right arm ROM is very doable again. My neck, shoulders and hips are sore, but much better. Fatigue is gone. I?m able to move around fine without any struggle. I still have SOB from March, but I feel like over the last 24 hours it?s worsened a bit.
Dizziness, Headache, Myalgia, Arthralgia,  CoughWheeze, UrticariaPruritus, brief episode tinnitus Narrative:
prolonged (>3 hrs) inconsolable crying p/1st dose of vax;
Severe pain in left arm and back, and numbness in left arm. Pt has treated areas with OTC products for pain but not sucessful in alleviating discomfort. She cannot raise arm due to severe pain.
Trigeminal Neuralgia; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jan2021 at 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high cholesterol, depression and sulfonamide allergy. The patient received unspecified medications within two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 19Jan2021, at 07:00 the patient experienced trigeminal neuralgia. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result trigeminal neuralgia which included treatment with multiple medications. The clinical outcome of the event trigeminal neuralgia was not resolved at the time of the report   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SOB with chest wall pain. Oxygen sat 93% with clear lungs. Chest x-ray clear upper airway with significant cardio meglia. Lasix 20mg IV, ASA, NTG SL. Transported to ER. This report is considered to be an other important medical event (OMIC). Deployed overseas.
I noticed ringing in my ears after the shot. Never went away and intensified after each shot. 2nd shot on 3/5/21. Booster shot on 11/30/21.  I've never had ringing in my ears before so it is very noticeable and aggravating.  I'm hoping it doesn't cause any long term adverse affects on my hearing.
Rapid heart beat fluttering feeling. Tiredness. Emergency room ECG tested negative. Addition ECG and stress testing at a cardiologist revealed an otherwise health heart. ECG and 24 hour heart minor revealed an ?extra heat beat? development never previously experienced.
After the 4th dose of the Moderna vaccination on 01/13/202023 I was completing my water aerobics  class and begin to experience chest pain. I sought care at the emergency clinic. diagnostic  test were ran and diagnosed with a heart attack an emergency stent was placed on two occasions.  I have also  had successful rehabilitation and doing better.
Fever 102, severe chills and vomiting for 8 hours followed by reoccurrence of throat infection that had occurred in August 2020
This spontaneous report as received from a consumer refers to a 39 year old female patient with anemia. The patient had no drug reactions/allergies. On 02-APR-2009 the patient was vaccinated with the secondary dose of VARIVAX (Merck) (lot # unspecified) route, dose and location unspecified. No concomitant medication was reported. On 05-OCT-2013 the patient was tested for an immune response to VARIVAX (Merck) and the blood test showed that the patient did not have an immunity to Varicella. The patient did not specify the date of the first shot. No adverse effect was reported. The patient did not seek medical attention. Additional information has been requested.
Information has been received from a registered nurse concerning a her 16 year old daughter who "sometime in mid-June" was vaccinated subcutaneously in the back of the arm with a first dose of Gardasil. On the same day after vaccination, a PAP smear was performed and was positive for chlamydia for which the patient was treated with Zithromax. On approximately 06-JUL-2007, the patient developed a boil/ carbuncle on the right side of her shaved pubic area at the hair growth line, about 3 inches wide. It was described as a "red, hard, angry looking boil." The patient's mother stated that she learned about the boil at a later date and said her daughter was squeezing the boil which had pus underneath. The patient's mother cleaned the boil with hydrogen peroxide and over the counter antibiotic ointment cream. On 23-JUL-2007, the patient was seen by her pediatric physician and the pus-filled boil was drained and had a yellowish discharge. A wound culture of the boil was obtained and was identified as an MRSA infection. The patient was treated with Septra 1 BID for 10 days. The patient's mother stated that it looked like another boil was underneath the original one. Subsequently, the patient's mother noticed a fire ant or spider bite on the patient's left leg, which was swollen like cellulitis. The patient's mother treated her with over the counter antibiotic and 4 x 4 gauze placed on top. The patient's mother did not think that these infections were related to the vaccine. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Four hours post vax, the pt developed a raised, red wheal area with red edge at injection site that was warm to the touch. Pt instructed to treat with ice and Tylenol. Pt returned to office approximately 2 hours later with large 10 X 12 cm wheal on left upper extremity and injection site. Area remained warm to the touch. Pt denied any respiratory difficulty. Temperature 98 degrees, heart rate 62/min, BP 120/80. Pt treated with Atarax, Prednisone and cool compresses. Pt advised to seek urgent care if any SB, palatal swelling or other acute changes.
age under 18; sore arm for day 1 post vaccine only, completely resolved by day 2
Visit to ED for pain medication - prescribed Hydrocodone 5/325 Return visit to PCP for muscle relaxant - cyclobenzaprine 10 mg TID PT
Patient reports beginning to feel dizzy while sitting to wait 15 minutes post vaccination; patient stood up to ask employee for water then stated he felt dizzy. Patient experienced syncopal episode and employee completed and assisted fall to the floor. Patient did not hit head on floor.  After event patient stated he felt weak, dizzy, diaphoretic, cold, nauseous, and was experiencing a pounding headache after falling. Initial vitals stable at 97% O2, RR 20, HR 70, BP 134/92. Patient reported feeling less dizzy after resting a few minutes and was assisted to sitting up, then sitting in a chair. Patient reported feeling well and almost to baseline at last set of vital signs at 97% O2, RR 16, HR 72, BP 129/90. Patient's wife present to drive him home; patient stated he would seek follow up care with his primary care provider.
This spontaneous report as received from a physician refers to an approximately 4 months old male infant. Medical history and concomitant medication was not provided. On 28-DEC-2012 the patient was vaccinated with ROTATEQ, orally (Lot number was not provided. Product circular #: USPI-OS-V2601212R018). Patient went to the emergency room late November 2012 for an influenza like illness and while there elevated liver enzymes were discovered via a liver function tests. The patient was sent home and recovered from the influenza like illness (date unspecified). In March 2013 (reported as last week) the patient had an electron microscopy of a liver biopsy and an unspecified Mitochondrial disease was discovered. The physician report that the unspecified Mitochondrial disease could have been present at birth. The outcome of mitochondrial disease and elevated liver function tests was reported as not recovered. Mitochondrial disease was determined as life threatening by the reporter. The relatedness for the SAEs was not reported for ROTATEQ. Additional information has been requested.
Participant noted to have pimple size, red bumps on right forearm, no reaction anywhere else at time.
Myalgia, Arthralgia, Fatigue, Injection site soreness Narrative:
Pain, swelling and erythema at injection site that worsened after 24 hours. Was seen in clinic diagnosed with cellulitis by me. Treated with KEFLEX. Patient called back later that day stating erythema had spread beyond outline borders. At which point I directed her to one of our ERs for further eval and possible IV antibiotics. However, ER reports erythema same as I measured. She fully recovered on oral antibiotics.
This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHOIDS THROMBOSED (I developed two external hemorrhoids/ thrombosis) and RASH (I had a rash on my inner thighs which looked like a ringworm) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHOIDS THROMBOSED (I developed two external hemorrhoids/ thrombosis) and RASH (I had a rash on my inner thighs which looked like a ringworm). At the time of the report, HAEMORRHOIDS THROMBOSED (I developed two external hemorrhoids/ thrombosis) and RASH (I had a rash on my inner thighs which looked like a ringworm) had not resolved.            No concomitant medication was reported. The patient reports experiencing development of two external hemorrhoids/thrombosis. The patient developed rash on the inner part of the thigh which looked at a ringworm. The symptoms are ongoing. No treatment medication use was reported. Company comment: This Spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, non-serious and AESI of Haemorrhoids thrombosed, among others. The event occurred on an unknown date after receiving a dose of mRNA-1273 vaccine, exact interval cannot be assessed as event and vaccination dates are not available. The rechallenge was not applicable, as event and vaccination dates are not available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This Spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, non-serious and AESI of Haemorrhoids thrombosed, among others. The event occurred on an unknown date after receiving a dose of mRNA-1273 vaccine, exact interval cannot be assessed as event and vaccination dates are not available. The rechallenge was not applicable, as event and vaccination dates are not available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Less than 24hrs after vaccine client started to experience severe dry mouth, lips sticking to her gums,  swollen lips and tongue, bumps/fine rash to chin, cracks to the corners if her lips, peeling, redness, and itching of lips that lasted for for more than 2 weeks despite treatment with Benadryl, and Prednisone.
Pt was seen by PCP on 18MAR16; at that time she received the TDAp vaccine in her left deltoid and noticed a boil on her arm the following gday. Pt reported she popped it and a clear, yellow tinged D/C came out. Pt then noticed it came back, not as large but she was able to drain the extra fluid. Pt dried out the boil with alcohol and covered it with a band-aid; denied any tenderness with palpation. Upon exam a 1/2 x 1/4 re of induration was noted; no pain or tenderness report with palpation. The area is slightly red with some raised bumps. No warmth noted.
2 days of feeling bad; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (2 days of feeling bad) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and Vitamin D for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (2 days of feeling bad). At the time of the report, FEELING ABNORMAL (2 days of feeling bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.   This case was linked to MOD-2021-343987, MOD-2021-343765 (Patient Link).
sent home by school nurse with 102 fever and glassy eyes.  vaccine administered 6pm 10/20 but computer wouldnt accept time.
Received booster shot on 12/30/2021 and started to have symptoms of bells palsy on 1/26/2022. Went to family doctor and was prescribed medication.
ADMINISTERED 1 VIAL (2.5ML) DOSE IN ERROR; This spontaneous report received from a pharmacist 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 2.5 ml, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced administered 1 vial (2.5ml) dose in error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered 1 vial (2.5ml) dose in error was not reported. This report was non-serious.
Pt noted local erythema approx 12-18 hrs after injection. On 12/19/18 erythema on mid upper arm measured 12 cm by 10 cm. Area warm to touch area well defined. Pt felt fatigued, flushed and subjectively febrile. Placed on prednisone taper.
A report was received from a health care professional on 11/05/2003, concerning a male vaccinee of unknown age who developed oculorespiratory syndrome an unspecified length of time after receiving Fluvirin on an unknown date. The vaccinee is HIV positive. The outcome of the oculorespiratory syndrome was not reported. The reporter has assessed the relationship of the vaccinee to the event as unrelated. Follow up pending.
Almost immediately after vaccine admin. pt. experienced Shortness of Breath, difficulty breathing, and feeling as if throat was closing. Had to take aerosolized breathing treatment, Benadryl with symptoms continuing to escalate. Further treatment was sought through Emergency Room and still persists after 4 days post immunization. Pt. still requiring breathing treatments and Benadryl to hold symptoms at bay. 2/29/08-records received for ED visit 2/8/08. Impression: Allergic reaction. Present with allergic reaction lasting 12 hours, swelling throat, macular rash and urticarial. Pruritis. PE, cough and stridor.
first dose of Shingrix in August of 2020./has not yet received their second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was not recovered/not resolved.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. Limited demographics were obtained. The reporter did not consent to follow up.
Red, swollen arm at injection site - hot to touch, size of baseball. Jaw pain. Muscle weakness/legs gave out in church. Fever/achy. TRMT: Took IBU, used ice pack, went to doctor.
Pt developed 15-20 pox on body reported per mom 2/9/05. Pox gone by 2/2/05.
got a little sick after her 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (got a little sick after her 2nd shot) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got a little sick after her 2nd shot). At the time of the report, ILLNESS (got a little sick after her 2nd shot) outcome was unknown.            Concomitant medications details were not reported.  No treatment information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620750 (Patient Link).