chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some swelling and redness below the injection site.; Some swelling and redness below the injection site.; The patient received the third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 30Sep2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to pecans and cashews. 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 vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 65-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the right arm on 16Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021, the patient experienced some swelling and redness below the injection site for about 5 to 7 days but there was no pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events some swelling and redness below the injection site were resolved on an unknown date in Oct2021.
Fever, myalgias, diarrhea, nausea, orthostatic hypotension, dyspnea, anorexia, HA, cough
Hair loss/hair started falling out; Left arm achy; body aches; alopecia areata diagnosed after the vaccine.; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss/hair started falling out), ALOPECIA AREATA (alopecia areata diagnosed after the vaccine.), PAIN IN EXTREMITY (Left arm achy) and MYALGIA (body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A2119 and 030B2117) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in January 2021. Concurrent medical conditions included Blood pressure high since 2018. Concomitant products included LISINOPRIL for Blood pressure high, DOXYCYCLINE for Rosacea, FLUOXETINE and CLONAZEPAM for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Mar-2021, the patient experienced ALOPECIA AREATA (alopecia areata diagnosed after the vaccine.). On an unknown date, the patient experienced ALOPECIA (Hair loss/hair started falling out), PAIN IN EXTREMITY (Left arm achy) and MYALGIA (body aches). At the time of the report, ALOPECIA (Hair loss/hair started falling out) had not resolved, ALOPECIA AREATA (alopecia areata diagnosed after the vaccine.) outcome was unknown and PAIN IN EXTREMITY (Left arm achy) and MYALGIA (body aches) had resolved.            It was reported that patient had thyroid test normal. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-June-2021which contains added events: Body ache, Left arm achy and alopecia areata. Added event outcome: unknown to recovered. Added medical history: Shingles vaccine. Added concomitant medications :   Lisinopril, Fluoxetine, Doxycycline and Clonazepam.Added product details : Dose number, drug start ate and Batch number.Added patient demographics : age On 08-Jul-2021: Follow up received on 08-June-2021which contains . Added concomitant medications dose details.Added patient demographics : Hight weight and pregnancy informationAdded medical history: High blood pressureAdded Vaccine facility information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pt had this age appropriate Covid vaccine in the Health clinic at 1633.  Pt then later that evening had a seizure and went to ER.  In the ER patient tested + for Covid.  I do not have access to the ER record.  In the Health clinic prior to vaccine administration pt had no symptoms of being ill.  Mother of child is now vaccine hesitant.
Patient had syncopal episode at home on 3/12/21, same day as second dose of vaccine, and fell. Was on floor for 8 days until admitted to hospital upon being found by family. Admitted with altered mental status and AKI.
within an hour of receiving  the moderna covid shot started to have blurry vision, strobe light effect vision. puked the next day  rushed to the emergency room on apr 9
Patient immediately developed rash around her eyes and on her forehead. 2 mls of BENADRYL.
After an hour and a half to two hours after injection, I began to have an allergic reaction but it was slight. Cheeks turned red and under right eye was slightly swollen and slightly itchy  it continued for about 45 min and then my feet and lower legs began to feel the same. The tops of my feet were red for approximately 10 min and then all symptoms subsided. No other problems afterwards
Information has been received from a registered nurse who heard from a colleague that a child was vaccinated with measles virus vaccine, mumps virus vaccine live, rubella virus vaccine live and developed autism. Upon internal review, autism was considered an other medical event. Addtional information has been requested.
The pain started in the left shoulder and migrated to my back and left forearm.  Progressive weakness in my arm and left hand that has increased to the point that I can no longer pick up small objects.  I have lost all fine motor control in my left hand.  This pain and weakness increased markedly after I received my booster of Pfizer Covid vaccine on December 1, 2021.  The pain and weakness persist to this day.
swelling in his left shoulder, hand, wrist, and arm; pain arm/pain in arm; pain in shoulder; pain in wrist; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm, shoulder pain and wrist pain. The patient was treated with analgesic, nos (Pain Pills (Nos)) and paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, shoulder pain and wrist pain were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm, shoulder pain and wrist pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed severe pain and swelling in his left shoulder, hand, wrist, and arm. He states it was so severe he went to the emergency room, and called his MD. He states he took two pain pills and tylenol. He states the swelling was decreasing, but the pain and swelling are still there at this time. The reporter consented to follow up. The emergency room visit was required. The reporter did not have vaccine adverse event information for this case.
I had a flu shot. That night I was super, super, super dizzy. Couldn't lift up head or stand up without vomiting. I was helped by a friend to bathroom for 3 days otherwise vomit, poop, urine would all be in bed a week later I started getting better. I think I was given a manly man dose
Patient was given her MMRV immunization at 4 months.  It was not discovered until her 12 month exam by a different clinic.  Her MMR vaccination was given again at 15 months.  She ran a fever off and on of 104 for 4 days.
Patient fainted in observation area after receiving shot after about 5 minutes, called 911, she woke up on her own, paramedics checked her out, she was fine and left with her parents.  Family speaks another language.
death; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cirrhosis of liver.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 17-Apr-2021 The patient died on 17-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded.  It is not clear if the patient was hospitalized at the time of their death, only that they died in hospital; Sender's Comments: Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded.  It is not clear if the patient was hospitalized at the time of their death, only that they died in hospital; Reported Cause(s) of Death: Unknown cause of death
Fever, general feeling of like she is sick, muscle soreness, and feeling sweaty upon doing small task like walking.
N17.9 - AKI (acute kidney injury) (CMS/HCC) E87.1 - Hypo-osmolality and hyponatremia
Received shot 10-3-09 (Sat. afternoon). Had some itching and redness Sun.10/4/09. Came into store Mon. 10/5/09; upper arm (R) swelling and redness 3-4 inches in shot area from PNEUMOVAX. FLUVIRIN in other arm. Given ADVIL.
Ear ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR PAIN (Ear ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.     On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced EAR PAIN (Ear ache). The patient was treated with IBUPROFEN for Ear ache, at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt came to ER c/o difficulty breathing and cough, onset just prior to arrival.
Nausea, chills/low temp (95.5) for several hours, tiredness
Right arm red, painful, swollen, rash around injection site. Advised-hydrocortisone cream, apply ice.
Information has been received via medical records concerning a 9 week old female with gastroesophageal reflux disease, no known allergies and a history of jaundice neonatal, group B streptococcus (GBS) positive and oral thrush who on 10-JUN-2010 was vaccinated orally with the first dose of ROTATEQ (lot # 664945/0147Z). Suspect therapy given on the same day included the first dose of PENTACEL (lot # C3591AA) given IM in the right thigh, the second dose of hepatitis B (unspecified) (lot # AHBUB6KAA) given IM in the left upper thigh and PREVNAR (lot # E44433) given IM in the left lower thigh. On 11-JUN-2010 the patient was seen in the office presenting with fussy, pulling at ear. It was reported that mom found two tiny spots of pink blood in the front of her diaper in the morning around 11:00. The location was right ear. The onset was sudden, 1 day ago (on 10-JUN-2010). There were relieving factors including TYLENOL. Associated symptoms included fussy and no other symptoms. The patient got 2 month immunizations "yesterday". The patient continued to take PO well. Mom had not noted any blood in the diaper before or since the one incident. All the review of systems was negative. No findings were noticed in the physical examination. The patient was diagnosed as fussy infant, which was "likely secondary to receiving immunizations yesterday". The patient was instructed to follow up and return to the office (RTO) if any acute changes, or no improvement by "Monday" (14-JUN-2010), monitor closely for any further signs of blood in the diaper and call or RTO if positive. This is one of several reports received from the same source. Additional information is not expected.
Next morning just felt like i was getting a cold.  Fever started about 9am and I went to bed at 11pm with fever, 101.5. Woke up next morning feeling fine.
red swollen bump at injection site. slight itching leading up to stinging pain and a "fever" at the site
Info has been received from a consumer concerning her 5 year old daughter with an insect bite allergy and no other medical history who on 3/29/05 was inadvertently vaccinated, SC with a 0.5 ml 2nd dose of varicella virus vaccine live. Concomitant vaccination at the same injection site included a dose of DTP. Other concomitant vaccination in different injection sites included a dose of MMRII and a dose of Hep-A vaccine (inactive). The pt had received a 1st dose of varicella virus vaccine live at 12 months of age. On 3/30/05, the pt experienced an injection site reaction. No medical attention was sought and no diagnostic laboratory tests were performed. At the time of the report, the pt's injection site reaction persisted. A product quality complaint was not involved. No further info was available.
Dizziness; sweat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HYPERHIDROSIS (sweat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (Dizziness) and HYPERHIDROSIS (sweat). At the time of the report, DIZZINESS (Dizziness) and HYPERHIDROSIS (sweat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine used) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047C21A) for COVID-19  immunization. No medical history reported. On Dec 2, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 2, 2021, patient administered expired product (expired vaccine used). On Dec 2, 2021, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vaccine remained in the freezer at -24 degrees F up until the day of the administration.
Information has been received from a nurse concerning a 19 year old female with no drug reactions/allergies and no reported medical history who on 08-MAY-2007 was vaccinated IM with the first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On th evening of 08-MAY-2007 the patient experienced headache, sore throat, swollen glands and felt lethargic.  She had no fever.  The events persisted as of 10-MAY-2007.  Additional information has been requested.
Severe dizziness; Felt tired; off kilter; nausea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 28Jan2021 15:00 at a single dose for covid-19 immunization at a Administration facility. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe dizziness upon awaking the following day (29Jan2021), which lessened as the day wore on. The patient also felt tired and off kilter all day with nausea from midday to night. The patient has not been tested for COVID-19 since the vaccination. The events were not treated. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
High fever, vomit, body and headaches, flulike suymtoms. Lasted three days.
Information was received from a pharmacist concerning a patient of unknown age and gender. In approximately 2015 (reported as "2 years ago"), the patient began the HPV series with dose one of GARDASIL (lot number, expiration date, dosage and route of administration not provided). On 27-MAR-2017, the patient presented for vaccination with GARDASIL 9 (lot number M041213, expiration date 22-JUN-2019) as the second dose in the HPV series. At the time of the call, the patient had not yet received the second dose of GARDASIL 9. No adverse effects reported. No additional information was provided. Additional information has been requested.
Severe headache, nausea, vomiting, body aches and pain, neck and shoulder pain, fever, general malaise
Right shoulder pain x3 weeks, do not have full range of motion. Pain when lifting my arm. Slight weakness in that arm now.
This spontaneous report was received from a healthcare worker concerning multiple unspecified patients (demographics unknown). On unspecified dates, the patients were administered with doses of improperly stored PROQUAD (Merck) (Lot# reported as K010212; expiration date: 17-JAN-2016) (dose and route not provided). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
After 5 hours, severe pain at injection site. Continued all night so I didn't sleep at all. Felt nauseated and faint. Sick the entire day after with arm pain, nausea, dizziness and headache. Arm pain lasted a couple more days but all other symptoms were gone.
One week after injection, localized itching and redness occurred. Marked at roughly 2cm in diameter on left deltoid. Over 72 hours, site was sore, redness increased in size to roughly 5cm in diameter, itching, indurated and warm to touch. Regimen of ice, Motrin, Benadryl, hydrocortisone cream has not helped.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, (lot # K010522, expiry date 25-FEB-2016) (dosing regimen, route and frequency unknown) that had been exposed to temperatures above 46 degrees Fahrenheit for an unspecified amount of time. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. There was no product quality issue reported. This case is linked to case 1410USA016261 via same reporter link. Additional information has been requested.
severe fatigue and pain all over my body.  extreme discomfort.  (I've been told by a neurologist that I have a dangerously high tolerance for pain so this is what concerned me.   I noticed yesterday (3 days after receiving vaccine) that on my upper arm, about 2" below needle insertion site,  there is an oval shaped, raised bump 2" x 4" that is pink and warm to the touch.  My arm (actually both arms) feels heavy but does move easily without pain now.
Moderna COVID-19 vaccine EUA Headache - 18 hours after Fever - 100.5 (26 hours after) Arm soreness
COVID19 vaccine #1 given 1/13/21 on 1/15/21 woke with c/o significant nausea, dizziness and nystagmus. Tele appointment with healthcare provider. Symptoms began to resolve a few hours later (10:00am).
headache, productive cough, nonproductive cough, fever, chills, ear pain, sinus congestion, nasal congestion watery eyes.
Patient was accidentally vaccinated too soon for her 2nd dose of Pfizer. As per our record, patient received her 1st dose on 4/6/2021, Pfizer, Lot# EW0150  2nd dose was given on 4/14/2021, Pfizer, Lot# EW0158
Initial misuse report received from a healthcare professional on 02 August 2013. It was reported that DAPTACEL was administered to an 11 year old patient. No adverse event was reported. List of documents held by sender: none.
diarrhea for days -10 days   lost 20 lbs. , upset stomach for 18 months
severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
Presented with weakness x 2-3 days; hypotension; + Covid in ED; admitted with Covid PNA, sepsis; tx with maxipime, Vit C, steroid, zinc, minimal O2 supplementation.
Pt vaccinated with Influenza developed adult respiratory distress synd following administration of Influenza Virus Vaccine. Considered to be life threatening.
Nausea, aches all over, chills, headache, excessive sweating - starting about 7 hours after vaccination and getting worse throughout the night.  Persisted another day and night. Lessened with Tylenol and ibuprofen. Symptoms lasted about 36 hours total.
Patient development rapidly declined after every vaccine. Her weight and head circumference moved below the charts, she stopped thriving, becamse severely hypotonic and showed significant brain damage.
Information has been received from a physician concerning an approximately 14-week-old male patient who was vaccinated with the first dose of ROTATEQ about 2 months ago (in approximately April 2009).  Two weeks after vaccination the patient was admitted to hospital for pneumonia and respiratory distress.  He was in the ICU and on a breathing machine and getting sicker.  He also had diarrhea and was positive for rotavirus.  The patient was not recovered at the time of report.  The reporting physician felt that the respiratory distress, pneumonia and diarrhea/positive for rotavirus were other important medical events.  Additional information has been requested.  8/21/09 Hospital records including extensive lab testing received DOS 6/8/09 to 6/23/09. Assessment: Respiratory failure, Adult respiratory distress syndrome, anemia, coagulopathy. Immune deficiency, most likely common variable immune deficiency. presents with tacky mucous membranes, anterior fontanelle slightly sunken, crackles in bilateral lung fields. Tachypneic, grunting.  Patient was sick and having episodes of spitting up. Developed fever, short shallow breaths. Decreased oral intake and decreased urine output. More fussy. Liver edge palpable 2-3 cm below right costal margin. PICU. 11/16/09:  ICD 9 Codes received:  799.02, 518.81, 584.9, 482.89, 276.2, 518.0, 279.00, 780.61, 285.9, 780.91, 782.7, 276.8, 079.3, 079.89.