chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; eye dryness; having trouble with my eyes; soreness; This is a spontaneous report from a contactable consumer (patient) via Medical information Team. A female patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/lot number: Not Provided, NDC number of Pfizer COVID 19 vaccine: Not Provided, Reason for no lot number: of Pfizer COVID 19 vaccine: Caller unwilling to complete the report, Expiry Date of Pfizer COVID 19 vaccine: Not Provided) as 1st Dose, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced headache (non-serious) on an unspecified date, eye dryness (non-serious) on an unspecified date, having trouble with my eyes (non-serious) on an unspecified date, soreness (non-serious) on an unspecified date. Consumer was calling reporting AE after receiving her first dose of Pfizer-Biontech Covid19 vaccine.  She stated that she got the headache and the soreness but those "didn't bother her" she was worried about "having trouble with my eyes" specifically eye dryness, was this normal.  She was due for the second shot on 09Feb2021, should she still get it. Patient stated that HA soreness but that didn't bother me- " i've been having trouble with my eyes" due for 2nd shot 09Feb2021. Trouble with her eyes being dry- SE. Should I go ahead and get the second one. Headache lasting 2-3 days. Additional Context: Received call from consumer regrading the Pfizer Covid 19 vaccine which she received a few days ago. She had a slight headache for 2-3 days, which she thought was normal. She was also having trouble with her eyes being dry and she would like to know if that is normal. She did not wish to provide an address or email. She did not wish to complete report and requested to be transferred to have her question answered. No further details provided. For events, headache, outcome was recovered on an unspecified date, eye dryness, outcome was unknown, having trouble with my eyes, outcome was unknown, soreness, outcome was unknown.    Information on lot and Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Dose given at 1649hrs. At 2030hrs, complaints of headache and diarrhea. At 0100hrs on 03/21, family noticed patient unresponsive and not breathing. Fire rescue called out and pronounced her at 0210hrs.
extremely sore arm; headache; fever of 100.2; body aches; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and pre-diabetes. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administration in the right arm on 25Mar2021 as a single dose for COVID-19 immunisation. 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 16Apr2021 at 06:00, the patient experienced extremely sore arm, headache, fever of 100.2 (unspecified unit) and body aches. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 16Apr2021, The patient underwent body temperature test and the result was 100.2 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely sore arm, headache, fever of 100.2 (unspecified unit) and body aches was resolved on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
symptoms occurred about 1.5 week after vaccination from the flu shot. - sensitivity to touch on lower front thigh, wasn't able to wear  clothes on the left leg - muscle pain in hip both pains still exist, and slowly fading. the vaccine given was: vaccin antigrippal VAXIGRIP (DIN 02223929) INFLUVAC (DIN 02269562) not sure which one was given since it was not checked off last year, the same happened, but no muscle pain, only sensitive to touch.  2 years ago, I had the same problem but extrememly worse. sensitivity to touch was unbearable on both legs, muscle pain was excruciating, behind the calves and complete lower waist, these symptoms lasted 1.5 months.
Initial report received from a consumer on 13 Jul 2010: A patient received a 0.5 ml, intramuscular dose of liquid conjugate of MENVEO (batch number not reported) without being reconstituted with MenA conjugate component on 12 Jul 2010. No adverse events were noted following this administration.
pt underwent 1 of the two Shingerix vaccines, roughly 48-72 hrs later developed painful herpteic rash along T1 dermatomal distribution.
A patient of 5 years old and 2 months received the vaccine VAXELIS; This non-serious spontaneous safety report, with reference number 2022SA404522, was received by the partner on 29-SEP-2022 and forwarded on 30-SEP-2022, from a physician.   Due to the nature of the event the causal relationship between Vaxelis and the event "A patient of 5 years old and 2 months received the vaccine VAXELIS" was not applicable.    Further information is expected.  Non-significant follow-up information was received on 14-OCT-2022 from health care professional.  Due to the nature of the event the causal relationship between Vaxelis and the event "A patient of 5 years old and 2 months received the vaccine VAXELIS" was not applicable.   No further information is expected.
Sore arm, extreme fatigue, sore muscles throughout upper body, intermittent shooting pains
shingles; my eye sight is affected; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported) via an unspecified route of administration on 29Mar2021 as the first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. The patient's eye sight was also affected just when she was finishing up with her shingles on an unspecified date (it was reported that the patient needs to see her doctor because of this event). The outcome of shingles was recovering; and the outcome of the event eye sight was also affected was unknown. It was reported that the  patient have a second dose appointment (reported to be on Monday) and was inquiring how long does she have to postpone to get the second.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is needed.
Bump/lump; Itchy; Swollen; Little burning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little burning), VACCINATION SITE MASS (Bump/lump), PRURITUS (Itchy) and VACCINATION SITE SWELLING (Swollen) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little burning). On 11-Feb-2021, the patient experienced VACCINATION SITE MASS (Bump/lump), PRURITUS (Itchy) and VACCINATION SITE SWELLING (Swollen). On 05-Feb-2021, VACCINATION SITE PAIN (Little burning) had resolved. At the time of the report, VACCINATION SITE MASS (Bump/lump), PRURITUS (Itchy) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Unknown.
Patient received improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse concerning a 9 month old female patient. In 2018, the patient was vaccinated with 2 unspecified vaccines and had seizures for which, she was hospitalized on 11-MAY-2019 and discharged on the same date (# 1905USA010626). The patient's concurrent conditions was unknown and the patient had no concomitant medications.  On 11-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and frequency were unknown) (lot # R017926, expiration date 30-APR-2020) orally for prophylaxis. The reporter stated that the vaccine had a temperature excursion of a highest temperature of above 47F/9C (56F) for 43 minutes and it was detected by a data logger. The vaccine had no previous temperature excursions.  This is one of two reports for the same patient.; Sender's Comments:  US-009507513-1905USA010626:
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 17-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 1008 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 26FEB97 & w/in an hr of 1st dose pt was ill-h/a, weak, neck pain, chills, fever & slept for 2 days;p/2nd dose had same rxn although delayed for 12hr;T104,  weak, sleeping;MD felt coincidental virus both times;
Patient presented to the ER after developing pain and itching at injection site after COVID-19 vaccine.  Pain was worsening and redness was expanding.  Patient was diagnosed with early mild cellulitis and treated with Keflex 500mg QID for 10 days.
Initial solicited report and follow up information received on 05 October 2016 from an investigator participating in a study. This is a prospective pregnancy registry case. This case involves a 40-year-old female subject who had vaccine exposure during pregnancy. The date of LMP was not reported. The estimated date of delivery was reported 13 January 2017. The mother's health status reported healthy. The father's healthy status was not reported. The father's age was not reported at the time of report. The current pregnancy history reported subject had no health issue and the subject had allergy to cephalexin. The subject previous pregnancy was not reported. The subject's maternal drug exposure was not reported. The subject received a first intradermal dose of Fluzone ID on the left arm on 03 October 2016 (batch number not reported). The subject's pregnancy complication was not reported. The subject's treatment for infertility was not reported. The subject's family history of congenital abnormality was not reported. The subject notice non serious adverse event of a 3 inch red, warm, indurated area at the injection site on 04 October 2016 i.e. one day after vaccination the subject received Fluzone ID in back part of upper left arm. The non-serious adverse event of a 3 inch red, warm, indurated ares at the injection site were ongoing at the time of report. Prenatal testing were not performed. The pregnancy was ongoing at the time of report. List of documents held by sender: none. Sender's Comments: A 40-year-old female subject received a dose of study vaccine at 25 weeks of pregnancy (calculated from the expected date of delivery). The subject had non-serious adverse events of 3 inch red, warm and indurated areas at the vaccination site, the day after vaccination.
I had a dull headache for a week ,  arm pain at the injection site and some fatigue/muscle aches
Customer reported soreness in arm, nausea, light headness, fever 99 degrees. Claimed he wasn't counseled about the possibility of these side effects (he was)
The patient received the Covid-!9 Vaccine on 03/30/21.  The patient started experiencing blurry vision that evening.  The blurry vision was the worst on Day 3 but cleared up after 4 days.  The patient is completely fine now and vision is back to normal.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 01/28/2021, 03/08/2021, and 12/21/2021. Lot numbers, route, and injection site were not entered into the immunization system. The individual presented to emergency department on 02/19/2022 and tested positive twice, once in emergency department and once upon hospital admission. Primary complaints were dyspnea, diaphoresis, and altered mental status. They were admitted to hospital 02/19/2022. They were found to be having multiple medical conditions and complications including: acute respiratory failure due to COVID-19, acute encephalopathy, septic shock due to Klebsiella pneumonia infection and cirrosis, Strep pneumoniae infection (urine was antigen positive), anion gap metabolic acidosis, lactic acidosis, bilateral pleural effusions, and decompensated hepatic cirrhosis, and dissemited intravascular coagulation. They also suffered a cardiopulmonary arrest due to the septic shock. The individual was transitioned to comfort cares after condition did not improve, and they remained hospitalized until their death on 02/22/2022.
Parents reported at today's MD appointment that patient had 1 episode of blood in stool on day 3 after receiving Rotavirus vaccine.
Knee pain; Back pain; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), HEADACHE (Headaches) and ARTHRALGIA (Knee pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced BACK PAIN (Back pain) and HEADACHE (Headaches). On 24-Jan-2021, the patient experienced ARTHRALGIA (Knee pain). At the time of the report, BACK PAIN (Back pain), HEADACHE (Headaches) and ARTHRALGIA (Knee pain) 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.   Treatment medication included Tylenol. N o concomitant medications were provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
extremely allergic to your drugs; Brain Fog; I have swollen lymph nodes still after 10 days; extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "extremely allergic to your drugs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain Fog"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "I have swollen lymph nodes still after 10 days"; FATIGUE (non-serious), outcome "unknown", described as "extreme exhaustion".  Additional information: The patient stated that received booster shot and had swollen lymph nodes still after 10 days, brain Fog, extreme exhaustion. My doctor informed me I am extremely allergic to your drugs which literally poisoned me. So No More shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Client received immunization in the morning and states he started feeling systemic symptoms by the next day. He mentioned symptoms included headaches, muscle aches, malaise, loss of appetite, nausea. States he felt a sore arm the evening after immunizations were administered but that systemic symptoms "hit all at once." Symptoms continued for 2 days and today states he feels better. States symptoms were not those that he usually has felt after vaccinations in the past, but were intense systemic symptoms. Describes as feeling "significantly sick." Client used anti-inflammatory medications for symptoms. Did not visit a provider.
Pain at injection site worsening over time and involving the right shoulder.  Patient without redness or swelling. Physical exam c/w pain with active and passive ROM and +impingment testing.  Pain over subacromial bursa. No swelling warmth redness. Pain at site of injection.
March 26th, 2021 I received the Moderna vaccine. After the Moderna vaccine, my arm felt very sore.  I was dizzy and tired.   On March 29,2021 I got a heavy menstrual cycle. It was the heaviest on March 31-April 2.  (March 14th, 2021 I put in a new nuva ring, I should not have gotten my period)  On March 29th, 20201 I went to the chiropractor. My lower back was hurting and I felt awful.    On April 8th I woke up to bloody blisters in my mouth. The right side kept bleeding and wouldn?t clot.  On April 9th,  I developed inflamed blood vessels all throughout my body from my head to my feet called purpura and petechiae. I called doctor immediately because bruises and red dots were spreading quickly. He sent to me immediately to get labs drawn at the hospital.  My platelets were critically low and I was told to head to the ER. From there I was admitted.  On April 9th, 2021, my blood platelets were 2,000. They are supposed to be 150,000-450,000  Prior to the vaccine,  a full  physical with labs were done by physician on March 22.  My platelets were 210,000. Everything in my labs were perfect.   Currently I am battling kidney stones. I had surgery on May 10th. I?ve never had a kidney stone in my life.
died; sick; Initial information was received on 18-Nov-2020 regarding an unsolicited valid serious case from social media via a consumer or non-health care professional (patient's husband).   This case involves a female patient (age unspecified) who was sick (Illness) and died (Death), after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date in 2016, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2016, the patient was sick (Illness), 20 minutes following the administration of INFLUENZA VACCINE. On an unknown date in 2016, the patient died (death) 02 days following the administration of INFLUENZA VACCINE. This event was assessed as serious and medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment before death.  At the time of reporting outcome for illness was unknown.  It is unknown if an autopsy was done. Cause of death was not clearly specified.  Information on the batch number was requested.; Sender's Comments: This social media case received involves a female patient (age unspecified) who had illness (latency: 20 minutes) and died (death) 02 days after vaccination with INFLUENZA VACCINE. The time to onset is compatible with role of vaccine. This was poorly document case in which cause of death was not clearly specified. However, information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations, autopsy result and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: died
Post-Herpetic Neuralgia; Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65-year-old female patient (pt). The pt's concurrent conditions, medical history and concomitant medications were not reported.  On or about 11-AUG-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) by a pharmacist in a pharmacy for the long-term prevention of shingles and zoster-related conditions. The pt was treated by the physician for herpes zoster and post-herpetic neuralgia from an unknown date, which resulted from pt's zoster vaccine live (ZOSTAVAX) use.   The outcome of herpes zoster and post-herpetic neuralgia was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
The first health event, I've been diagnosed with essential tremors (diagnosis was in January 2022). I believe that as an inherited condition. My lay person opinion is that getting vaccinated didn't trigger that. I'm probably not the one to decide that so it may be worthwhile to report that. In November of 2021, I visited my regular family doctor and told her about hand tremors that I was having along with tremors in my voice. She did a physical exam and asked questions and referred me to a specialist. A neurologist. She wanted to rule out Parkinson's primarily. On 01/12/2022, I saw the Neurologist and he did a neurological exam on an outpatient visit in his office. He diagnosed essential tremor. He also detected an irregular heartbeat which was never detected before and referred me. So after January 12th's visit, the same day I had an EKG. On January 26th, I saw my family doctor as follow up to the neurology appointment. She detected heart beats that were concerning to her. As part of the EKG and listening to my heart, what she detected was irregular heartbeat as well so she had me on a Holter monitor for 48 hours. After that, on January 29, 2022, I started the medication Primidone 25mg and I'm titrating to, every 2 weeks I go up 25 mg. I'm currently on 50mg. Follow up appointments in the future for cardiology. Cardiology appointment in April 2022.
Headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The reporter heard that the second Covid shot really hurts and that someone (patient) she knew got a headache after the Covid vaccine, but the reporter knew that everyone was different. The outcome of the event was unknown.  Information about lot/batch number has been requested.