chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 28-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Patient experienced severe dizziness when she woke up on 2/24/2021.  The dizziness had lessened some when she called the pharmacy at around 9:20am.  Recommended patient to call PCP to see if they wanted her to come in.
Pt recvd 3rd dose of Hep B vax & devel optic neuritis.
MyChart message sent from parent: "At about 1:45pm I put her down for a nap. She cried her normal cry until about 2:05 I decided it had been 20 mins & it didn?t sound like she was going to nap. When I entered the room she clapped & was happy like she has in the past & she knew I was taking her out. I sat her down to play with this baby shark walker. I was pressing all of the buttons to make it go on. I heard something weird & I looked over she was completely blue. She looked like someone who overdosed on drugs like on tv. She was pale & everything was blue & purple & she was unresponsive. I started shaking her & I got up & was trying to dial 911. After 30 seconds she became conscious again & was looking at me drowsy. She was awake for about 15-20 seconds & then she rolled her eyes back & was completely limp. She didn?t respond at all. So I completed the call to 911. While I was trying to tell the operator my address I sat her upright from a laying position & was shaking her & she woke up. Her skin went back to normal completely & she just looked tired. Her cheeks were clammy & her forehead seemed normal. By the time the ambulance showed up which was 22 mins after I called 911. All her vitals were fine & at the hospital were fine."  MD Note 02/18/2021: Mom said vaccines and blood work were done on day of her 1yo physical. And she went to the park and played. After getting home, mom tried to put her down for a nap and after 20minutes she didn't seem like she was going to fall asleep. Mom said she was happy when entered the room and mom said she went to pick her up and she flailed back but didn't make a noise. Mom tried to make her smile and noticed she wasn't making noise. She was pale and lips were blue and that lasted about 30 seconds. Mom said she was not responsive mom said she was able to arouse her and then her eyes rolled back again and she was limp for about 30-60 seconds. She then sat her up and she was back to normal. Paramedics came about 20 minutes later and took to ER. Vitals were all normal. First MD was a pediatric ER MD and then brought attending who thought it was a breath holding spell.  Chest Xray and Chest CT were normal. EKG was not done. Mom said this morning the owlet alerted that her heart rate was above 220 but was very brief.  Alarm went off and by the time mom got there her HR was 117. Mom said she has had temper tantrums before and turned red but not blue. Since then has been acting like her normal self.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP
painful, swollen lymph node in left clavicle with tenderness/pain in left axilla
Ran a fever of 102.1.   Very weak. Dry heaves. I took Tylenol for the fever. The fever broke about 4:00 am.
Patient stated that she developed lightheadedness and dizziness along with feeling like she was going to pass out after getting the vaccine. She also experienced pain that radiated from the injection sites to her jaw.
Patient think a nerve was probably hit when the vaccine was given; Patient right arm where it got injected was half asleep and sparkle like tingles; Patient was light headed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NERVE DAMAGE (Patient think a nerve was probably hit when the vaccine was given), PARAESTHESIA (Patient right arm where it got injected was half asleep and sparkle like tingles) and DIZZINESS (Patient was light headed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NERVE DAMAGE (Patient think a nerve was probably hit when the vaccine was given), PARAESTHESIA (Patient right arm where it got injected was half asleep and sparkle like tingles) and DIZZINESS (Patient was light headed). At the time of the report, VACCINATION SITE NERVE DAMAGE (Patient think a nerve was probably hit when the vaccine was given) and DIZZINESS (Patient was light headed) outcome was unknown and PARAESTHESIA (Patient right arm where it got injected was half asleep and sparkle like tingles) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     Reporter did not allow further contact
Pt got fever of 102 and felt like she had covid so she went to urgent care. They gave her medication and steroid. She is feeling better now, but she has a rash at the site of injection
PATIENT WAS BREATHING FAST BEFORE GIVING THE VACCINES BECAUSE SHE WAS NERVOUS.  WE HAD HER SIT FOR 20 MINUTES AFTER GIVING THE VACCINES AND WHEN SHE STOOD UP TO LEAVE, SHE PASSED OUT AND RECEIVED A SIGNIFICANT LACERATION TO HER FOREHEAD. SHE WAS ONLY OUT FOR A FEW SECONDS BUT DOESN'T REMEMBER FALLING. AFTER STOPPING THE BLEADING AND CHECKING HER VITALS, SHE SAT IN OUR OFFICE FOR ANOTHER 20 MINUTES WAITING FOR HER OTHER PARENT TO ARRIVE AND THEY ESCORTED HER TO THE ER TO HAVE STITCHES OR STAPLES PLACED.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 04-APR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA0082972, 1405USA008203, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Involuntary movements of his arms and legs.  Eyes roll behind his head and these episodes last for 5-10 seconds.  Started with just a few episodes a day and then jumped up to 35 episodes a day. Pt says he noticed this started in April- but they were subtle movements and only a few a day.  On June 27th, 2021, when I noticed it, it appeared he was having a seizure and was much more intense than he had ever experienced up until this point.   MRI done -at Hospital clear (6/27/2021) EEG's done at Hospital clear (July 2nd. 2021) Prescribed Trileptal anti-seizure medication BUT we did start it yet.  We have been treating with supplements and chiropractic care. Changed his diet to eliminate sugars and clean up his digestive tract.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Coroners Office contacted Pharmacy on 3/21/21 to report a patient who had recieved a dose of the covid vaccine on 3/18/21 and was founded deceased on 3/20/2021
Headache, Myalgia, Fever, NauseaVomiting, employee has other symptoms like pain on both eyes, inmalance, and neck pain,
Neuropathy-hand and foot pain, numbness, pins and needles, numbness.  Hands hurt and trim red when lowered and turn pale when held up.
Feet flushed, itchy chest, shaky, hives. Was treated with Solumedrol 125 mg IM, Benadryl 50mg IM. Discharged at 6:30pm feeling "much better." She was seen and found to be having  an allergic reaction (hives, redness itching on anterior chest).
This case was reported by a consumer and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 11 September 2009, the subject received a dose of FLUARIX (unknown).  At an unspecified time after vaccination with FLUARIX, the subject experienced injection site redness, swelling injection site, injection site pain, headache, pain and leg calf muscle cramp.  The consumer reported she received FLUARIX vaccination on 11 September 2009.  "Aside from the expected redness, swelling and injection site pain, I've also experienced a sever headache and a terribly painful muscle cramp in my left lower calf muscle.  The calf cramp was so intense that I could actually feel the muscle tighten up and release.  It happened several times, one after the other, lasting a total of approximately 15 minutes.  On a scale of 1-10, with 10 being the most pain, I would rate it a 10."  At the time of reporting the outcome of the events were unspecified.
This spontaneous report as received from nurse refers to unspecified number of patients of unknown age and gender. In 2012, patients were vaccinated with a dose of GARDASIL (dose, route and lot number not reported) that was improperly stored. Nurse reported that GARDASIL was exposed to temperature as low as -1 C for several occasions from January of 2012 to July of 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, patient's outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.
pt recv vax & devel chickenpox;the reporter noted that it looked like mosquito bites all over body;
Swollen lips, tightness, numbness (Left side face and Left side of body) tocal seizure.
discomfort in the right ear; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (discomfort in the right ear) and TINNITUS (tinnitus) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EAR DISCOMFORT (discomfort in the right ear) and TINNITUS (tinnitus). At the time of the report, EAR DISCOMFORT (discomfort in the right ear) and TINNITUS (tinnitus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Patient stated that on 25-Mar-2021 in the middle of the night, he got up in the middle of the night to go to the bathroom and noticed that the right ear was acting strange, like it had to pop. On 26-Mar-2021, he felt discomfort in the right ear which continued along with tinnitus. If it was block in the left ear, then the hearing was muffled in the right ear. He stated he has no health problems and is physically active. On 29-Mar-2021, there is no improvement at all.  Concomitant medication not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-Jun-2021, outcome updated to recovered or resolved
Information has been received from a consumer concerning her daughter (a 21 year old female) with no medical history who on 14-JUL-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. It was reported that the patient fainted and hit her head immediately after receiving the vaccine on 14-JUL-2009. The patient sought medical attention by visiting the physician's office. A CT scan of the head was scheduled for 14-JUL-2009. The patient recovered after observation and monitoring. No further information is available.
3/25/09 received vaccination. 3/30/09 developed rash along jaw bone on face worse on L then on R - rash at base of throat down midline shape triangle. 4/1/09 contacted pharmacy told rash not due vaccine. Used OTC allergist cream - area on face resolved but not on upper chest flat blotchy rash with pin point flat areas covers area 3 1/2" triangle area allergist made it worse. Causing severe itching.
Information has been received from a physician concerning a 35-year-old male with no pertinent medical history and no drug reactions/allergies who on 11-SEP-2006 was vaccinated SC with a dose of Varivax (Lot # 653308/0440F). Concomitant therapy that day included a dose of tetanus toxoid and a dose of Recombivax HB. On 16-SEP-2006 the patient developed a fever which was followed by a rash on his trunk, extremities, and face. The outcome was not recovered. There were no lab diagnostic studies performed. There was no product quality complaint. The events were considered to be disabling by the reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 07-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
After third vaccine (HPV) administered client got cool, clammy and pale. Client fainted for approx. 20-30 seconds. Oxygen was administered - BP was 100/60. Client was alert and oriented to person, place and time. Blood pressure rechecked 15 min later 110/60. Client stayed at office for an hour and felt fine.
Second dose was invalid; There were storage issues; Second dose was invalid; There were storage issues; Headache; Nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for her boyfriend (Patient) that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW0161) as SINGLE DOSE for covid-19 immunisation. Patient received the first dose on 19Mar2021. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received a notification stating that the second dose was invalid and told that it was a storage issue, that is basically the concern that the second dose was invalid. Also, patient did have side effects from the invalid dose just like kind of typical side effects like headache, nausea and so, I was just wondering if there is a risk of getting like a third dose or if there was some sort of efficacy in the invalid dose. Outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411228 same reporter, different patient and event
My wife fainted the day after having both the first and second shingles vaccine. The first time was blamed on low blood pressure from being overheated, but the second time was unrelated to heat. She does have chronically low blood pressure. First event in April resulted in visit to emergency room, x-rays for spinal injury from fall. No fracture, but recovery from muscle sprain still on-going after 10 weeks. Did not go to emergency room after second event.
Mom stated that patient went home, ate, and napped. Pt woke up from nap and mom noted a rash to his face. Mom returned to the clinic to have child evaluated. Petechial rash noted around eyes, to cheeks, and a small area of the chin. Rash not noted anywhere else on the patient's body. Physician did assess patient. No signs/symptoms of distress noted.
Information has been received from Physician assistant concerning a 31 year old patient of unknown gender. On 20-SEP-2012 the patient was intended to receive a dose of VARIVAX and was inadvertently vaccinated with a dose of ZOSTAVAX single dose, subcutaneously (dose not reported). Additional information has been requested.
Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contactable physician, the patient.  A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 immunization.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On an unknown date, the patient experienced arm pain at injection site, runny nose, and lightheaded. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of arm pain at injection site, runny nose, and lightheaded were unknown.    No follow-up attempts are possible; information about lot number cannot be obtained.
Three day post shot (8/13/21) had sever pain/spasms in left side of neck and left shoulder.  Pain resolved in about 5-8 minutes. On 8/20/21 I was admitted via ambulance for acute left-sided neck spasms/pain and left shoulder pain accompanied with stroke-like symptoms (numbness of tongue, left arm, lower jaw, impaired speech) and for an AFIB ECG read by paramedics on scene.  Transported to local ER. Remained in AFIB FOR SEVERAL HRS.  Acute Neck pain/spasms have reoccured several times since ER discharge
Broke out with varicella rash 4/1/03; mild case. No treatment.
99.9 fever taken at 2am 4/21/21, noted again above 99 evening of 4/21/21.   Chills, aches, fatigue, headache, lower back pain,  pain at site of injection / left arm, increase in sensitivity to light and sound  observed until 9am Friday 4/24/21.
Tremor on left foot; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Jul2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, in Jul2021, the patient experienced tremor on left foot. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Jul2021, patient underwent lab test and procedure which included Nasal swab COVID-19 test and the result was unknown. The clinical outcome of the event tremor on left foot was unknown at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two weeks after the flu shot given to my son's right arm he told me that he felt his arm sleepy and he couldn't life his arm on it's own.  I thought is was a muscle tension so tried heating pad and massage the area. When I didn't see any improvement in 2 days I made an appointment  with a hand and upper extremity specialist and also neurologustbecause the area affected was his brachial plexus of his C5 and C6 with the supraspinatus and infradpinstus muscles where affected. Currently on occupational therapist and had a EMG done to check his nerve signals.
VACCINE ADMINISTRATION ERROR: Nurse administered 0.25mL of the Moderna Red vial cap with blue bordered label or in summary the equivalent of the adult Moderna booster dose.  There were no adverse events, symptoms, signs or concerns reported by the parent as a result of the error.
Headache, NauseaVomiting, Tachycardia,  chills
Severe Headache. Started late morning the day after vaccine. Took 1500mg Acetaminophen which gave relief after 1 hour. Headache returned in less than 6 hours. Took another 1500mg doses every 12 hours for the past 5 days. Severe headaches continue and have been constant. Note: today's headache is beginning to return only 3½ hours after 1500mg dose of acetaminophen. Location of headache starts in the eye area, specifically at the brow bone and spread up to the top of the skull. Sensitivity to light and sound accompanying headache.
I had my first Moderna shot on my left upper arm on April 25, 2021. On May 2, 7 days later, I noticed red itchy rashes (fairly large) around the area where I received the vaccine shot. I took 2 Benadryl tablets each night for 3 consecutive nights (May 5-7). The rashes went away on May 9, 7 days after my first notice of the rashes.
Pt was to get rabies series of 3. 1st vaccine given, 2nd vaccine given 7 days later, 3rd vaccine given 14 days after 1st dose. Should have been 21 days. Give 4th dose at 28 days, no adverse reaction.
Vaccine received 03/01/19. 3/7/2019 rash appears. On 3/8/19 went to dermatologist with full blown case of shingles. Took antiviral valacyclovir.
MD has noticed inc incidence of hematomas @ the inject site following immun w/Tetramune; 1 of 5 pts (out of 10 pts immunized) who exp hematomas, approx 1 inch in diameter; treated w/massage;