chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effect reported.; a patient was administered a second dose of VARIVAX at an extended interval after the first dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, previous drug reactions and drug allergies were not reported. Concomitant therapies included sterile diluent.  On 01-MAY-2018, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On 23-AUG-2019, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously, lot # S010296, expiration date not reported, but upon internal validation established as 03-APR-2021 (strength, dose and frequency, were not reported); as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
PATIENT FELT WARM AND WAS FLUSH-MENTIONED PAIN BEGINNING IN THROAT
Immed following vax, pt stood up; slumped to floor; striking chin & rt eyebrow on table; became rigid; minimal convuls motion then alert & responsive; episode lasted about 30 sec;
Subjective Patient is a 36 y.o. female who was seen today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience warmth of left arm and chest. Red rash present on left forearm. Later she developed tingling of left arm.  She denied difficulty breathing, difficulty swallowing, lightheadedness and dizziness.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms, respiratory distress and skin changes.     ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing, dizziness and headaches    Warmth of left arm with tingling:     Previous Reactions: Flu shot made her really sick in the past with respiratory issues. She has had a tetanus shot in the last 3 years though and she handled it well without any symptoms.     Objective    Vitals Vitals:   03/05/21 1202 03/05/21 1238 03/05/21 1305 BP: (!) 139/100 (!) 134/112 126/86 Pulse: 80   92 SpO2: 99%   99%      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses:          Radial pulses are 2+ on the right side and 2+ on the left side.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Musculoskeletal:     Comments: Equal hand grip in bilateral arms. No weakness noted.   Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.     Findings: Rash (lower arm and near injection site) present. No erythema.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: antihistamines, water and pepcid and Tylenol. Applied ice to left arm near injection site where warmth was noted. Redness of lower and upper arm resolved with time. Follow up response to treatment: good. Symptoms resolved upon discharge and BP improved. She still had some warmth of right arm after being observed for 1.5 hours. She did not have any rashes, swelling, burning or weakness of left arm. Discussed with patient continuing to ice left arm near injection site. If she experiences any redness, swelling, burning or worsening symptoms this weekend she is to seek medical care. Pt understands and agreed to plan.  Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash)  3/5/2021 1:05 PM
Headache Runny nose, sore throat, L jaw pain L swollen, lymph nodes, vaccination site pain Narrative:  unknown
t102, & mom reports jerking; pt taken to ER; MD states it was not a sz;
The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022; No adverse event; Moderna dose administered to patient 2 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient 2 days after beyond use date), PRODUCT STORAGE ERROR (The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient 2 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient 2 days after beyond use date), PRODUCT STORAGE ERROR (The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient 2 days after beyond use date) and PRODUCT STORAGE ERROR (The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022).    No concomitant drug was reported. The patient had not reported and adverse reactions at that time. No treatment drug was reported.
I got the flu worse with the shot than without it.  I feel more work needs to be done with it before it is administered.  Every year it is the same problem.
About 7 hours after the vaccine, I started to feel draggy and awful.  I became very cold, so I piled on blankets.  I couldn't get warm all night and I felt terrible.  If I hadn't had the vaccine the day before, I would have thought I was getting Covid.  It was scary.  The next morning I took some Advil, and I started to feel human againm but tired and weak.  By 2:30 that afternoon, my stomach was gurgling and I had gas and diarreah.  The cold and now at times hot symptoms returned. The injection site is very sore.  That is the only side effect I thought I was going to experience.  This is awful.  I'm not sure I will go back for the second dose.
On 1/19/02 in the PM, "broke out with hive-type itch, rash on abdomen "hip to hip" progressed to entire body. Self Rx'd with Benadryl 1% cortisone cream. Reports rash is still there on 01/23/02 but getting better. Felt "fever-like". No temperature taken."
Approx 5 minutes large hive like skin eruption, left arm after getting Varicella 0.5cc SC,
exposure via breast feeding; A spontaneous report was received from a nurse concerning a 31-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) who would like to enroll in a Breast Feeding Study.   The patient's medical history, was not provided by the reporter. No Concomitant medications were reported.  On 08 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot number:  011J20A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.   The patient would like to enroll in a breastfeeding study after receiving the Moderna COVID-19 vaccine.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event was nor recovered.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
It could have been my right arm but not sure. The next day arm hurt/muscle ache a little and that's all. In middle of Jun 13, 2021 for COVID, I did a lot of sneezing and coughing continuously, A week after, I lost my taste and smell. The worst was the fatigue for a good month and my energy came back slow. I couldn't move for 3 days and went to the ER. Something odd, I lost a lot of hair after COVID. Tons of hair loss for a good month and my smell hasn't come back 100 percent.
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, 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 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the freezer.  Multiple patients received vaccine  that underwent a temperature excursion in the freezer. Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not reported any adverse event.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-676622 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-676622:Same reporter
Pt received initial Shingrix vaccine at approximately 4:05. Approximately 20 minutes later at check out, she developed sensation of throat closing and tongue swelling.   She was alert and able to speak but complained of sensation of tongue swelling and feeling like she couldn't swallow. She was placed in wheelchair, given 2L O2 via NC and 50mg of Benadryl IM. SpO2 was 98%, pulse 89. She quickly noted improvement in symptoms. On exam, there was never visible edema/swelling of tongue, uvula, or posterior Oropharynx. Lungs remained cleared without wheezing. Pt remained able to talk the entire time. After 15 minutes, Supplemental O2 was stopped and SpO2 remained 98%, pulse 86. Patient was observed for 80 minutes. She was able to drink water without difficulty.
Temp 102.2.  Chills, Malaise, Headache for approximately 36 hrs.  Vaccine received at 11:30 am Friday, June 27.  Body aches started that evening and I could not move much at all on Sat d/t body aches, fatigue, and headaches.  Fever Sat evening even w/Tylenol Q 4-6 hr was 101.9.  Fvr finally broke Sat night with only low grade temps and fatigue on Sun.
The patient experienced nausea, fever, vomiting, runny nose, skin rash, and 10 spots with varicella appearance when seen in the office on 07/17/2001. The patient returned for an office visit on 07/18/2001 with crying and otitis media. There are no new skin rash spots.
Arm had shooting pains at injection site; experienced 12 hours straight of constant chills and terrible nausea; experienced 12 hours straight of constant chills and terrible nausea; Slept on and off all day the day after shot.; Night of shot felt as if someone was standing on center of my chest; Booster; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30145BA), dose 3 via an unspecified route of administration, administered in Arm Right on 10Nov2021 09:00 as dose 3 (booster), single for covid-19 immunisation (at the age of 72-years-old). Medical history included, high cholesterol, pre-diabetic, drug hypersensitivity from an unknown date and allergic to some meds but never vaccinations. Concomitant medication included simvastatin. Historical Vaccine included BNT162B2 (lot number:EN6201) as dose 1 on 17Feb2021 and BNT162B2 (lot number:EN6204) as dose 2 on 08Mar2021 for COVID-19 immunization. Both the vaccination was done at the age of 71-years-old. After both the doses the patient had soreness in arm. On 10Nov2021 at 18:00, the patient experienced arm had shooting pains at injection site, experienced 12 hours straight of constant chills and terrible nausea, slept on and off all day the day after shot, night of shot felt as if someone was standing on center of my chest. The event chills was on and off for another six hours as well as some nausea. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 57 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 23-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
stuffy nose and feels like she has to sneeze all the time, but can't; Tested positive for COVID-19; I lost my sense of taste; I lost my sense of smell; Body aches; Joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19), AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches) and ARTHRALGIA (Joint pain). On 04-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On 07-Jan-2021, the patient experienced NASAL CONGESTION (stuffy nose and feels like she has to sneeze all the time, but can't). At the time of the report, COVID-19 (Tested positive for COVID-19), AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches), ARTHRALGIA (Joint pain) and NASAL CONGESTION (stuffy nose and feels like she has to sneeze all the time, but can't) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
I administered an expired MMR vaccine on 12/6/21. The vaccine vials expired on 12/4/21 and the diluent vials were fine, they expire on October 2022. I notified the patient and prescriber
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      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 relevant concomitant medications were reported. Treatment information was not provided.
Lower pain on left side of the rib cage within 5 minutes of injection, felt a heavy pain in chest that same night. Following days sensitivity at the sternum,  with dull achy pain on the left side of the chest. Some days felt heart stabbing and heart palpitations. Felt less pain when standing up vs laying down. Various days later woke up with rapid heart beat  and chest pain, had another incident a week an a half later( nighttime)followed by Left arm pain and a locked jaw, with hands that were really cold. This pain lasted for 3 weeks.  Months later in late August( not sure if it?s related) ,body aches in the lower back and whole midsection of the body including testicular pain. Sudden weight loss of 15 lbs in 2 weeks  Pain lasted 3 -4 months.
Pt received vaccine at the pharmacy, no trouble during administration, pt walked out of counseling room to waiting area chairs, during the 15 minute wait period, pt mother stated child fainted and seized. Upon observation child was pale and could not get up off the ground, but allergic reaction suspected therefore no epipen was administered. 911 was called, firefighters arrived at the scene, took blood pressure, blood sugar and heart rate and attempted to sit child up, symptoms occurred again, child fainted again, was placed back in lying position on the ground. Ambulance rescue was called and paramedics were trying to have child sit up for the third time and began to lose consciousness again, moved child to the stretcher and taking child to the hospital for further evaluation.
This spontaneous report was received from a non medical healthcare worker refers to an unspecified patient of unknown age and gender. No pertinent medical history was reported. on an unknown date in March 2015, the patient was vaccinated with improperly stored dose of GARDASIL (lot # K007828 and expiration date 02-MAR-2017) (dose and route were not reported). No adverse events were reported. This is one of the two reports from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. In September 2016, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis. The patient inadvertently received the second dose of ZOSTAVAX in September 2016. The doses of the vaccine were reconstituted with sterile diluent (MERCK STERILE DILUENT). The patient experienced no adverse event. Additional information has been requested.
2 Pts recd a series of Hepatitis B vax doses; PTs did not respond; 2 Engerix-B booster doses were given to each PT MAY91 & JUN91;
Facial paralysis on the left side of the face. Numbness on the left side of the face. Pressure under the left ear, eye, chin, and can't smile 100%. Hear heartbeat in the left ear. All those happened on 8/3/2021. I went to the urgent care and they advise to go to the emergency. I went to the emergency and they said they are not 100% sure what this is but I might got bell's palsy. No treatment were given and doctor advised to watch symptoms. On 8/7/2021 I had bad headache on the right side and a strong pain under the right side of the ear.
Chills; Aches; Sweating; Dyspnea; Wheezing; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 21Dec2020, the patient experienced chills, aches, sweating, dyspnea, wheezing, and fatigue. The events are considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date.
REDNESS AT SITE OF INJECTION. FOLLOWED BY BUMPS AT SITE OF INJECTION. FOLLOWED BY BUMPS ON TORSO AND LEGS.