chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator on 22 February 2012 with additional information received on 28 February 2012. A 19-year-old male subject had received the following vaccinations: On 21 June 2011, an injection of ACAM2000 (lot number not reported), an injection of ANTHRAX (manufacturer and lot number not reported) and injection of HEPATITIS A-HEPATITIS B (manufacturer and lot number not reported). On 02 July 2011, the subject had an abnormal troponin I of 00.15. On 19 July 2011, the subject had a normal echocardiogram. The subject's ECG results were not available. The subject was diagnosed with painful respirations on 02 July 2011. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
In February 2022, he started writing down suicidal thoughts. We took him off CONCERTA and put him on fluoxetine. He had to go to the emergency room so that he could be evaluated, and they didn't hospitalize him but put him on the maximum dose of fluoxetine. He is stable now and going through therapy.
Information has been received from a registered nurse who was vaccinated with a three dose series of RECOMBIVAX HB (manufacturer unknown) years ago. When she did not have an adequate titer after the series, she required to get a booster dose. After the booster dose, the patient developed flu like symptoms and was "quite sick". It was unknown if the patient sought medical attention. On an unknown date, the patient recovered. Follow-up information has been received from the nurse with allergies to iodine, cashews and soy and no illness at the time of vaccination who in 1994 (approximately at the age of 53 year old) received a three dose series of RECOMBIVAX HB (manufacturer unknown) in upper deltoid but was non-immune. After receiving a fourth booster dose in 1994, the patient became very ill with flu like symptoms including fever, muscle pains, headache and extremely stiff neck for 3 days. The flu like symptoms rapidly resolved after emesis on the third afternoon. The patient didn't seek medical attention. It was reported that "no residual symptoms but unable to done to blood now, due to antibodies to hepatitis B virus in blood". Additional information is not expected.
Caller states they only caught light Covid because they have the Pfizer's, his mom has 4 and he has 3.; Caller states they only caught light Covid because they have the Pfizer's, his mom has 4 and he has 3.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086).  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia" (ongoing), notes: Mother has pneumonia and had pneumonia in the past. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Mar2023, outcome "recovering" and all described as "Caller states they only caught light Covid because they have the Pfizer's, his mom has 4 and he has 3.". The events "caller states they only caught light covid because they have the pfizer's, his mom has 4 and he has 3." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included the patient went to urgent care last Friday and tested positive. Reporter stated 3 hours into getting Paxlovid, the symptoms stopped, patient was feeling better and started to recover.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
nausea; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and PYREXIA (high temperature) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and PYREXIA (high temperature). At the time of the report, NAUSEA (nausea) and PYREXIA (high temperature) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Rcv'd PREVNAR vaccine on Friday, Jan 23rd, 2015 AM. Sunday, Jan 25, 15: Red spot, quarter size at site of injection. Wed, Jan 28, 15: Bruising further down the arm. Arm feels warm to touch. No loss of feeling, no other symptoms.
Initial information was received on 18 February 2010 from a health care professional. A female patient (age not provided) developed injection site pain on the day of vaccination after receiving ADACEL (lot unknown) in the left arm and MMR vaccine (manufacturer unknown) in the right arm on 08 February 2010. On 10 February 2010 the patient developed jaw pain on both sides of her jaw. The patient required a doctor's visit; date not provided. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Information has been received from a medical assistant concerning a 57 year old female patient with hypertension, chronic obstructive pulmonary disease, hypercholesterolaemia, ampicillin allergy and allergic reaction to AUGMENTIN, who on 01-JUN-2009 was vaccinated with 0.5 ml of PNEUMOVAX 23 (Lot: 662661/0978X) intramuscularly in the left upper arm. Concomitant therapy included lisinopril, CYMBALTA, ADVAIR, BENADRYL, KADIAN, COREG, SPIRIVA and LIPITOR. The patient developed redness, swelling, warmth, and pain at the injection site of the left upper arm 3 hours after receiving PNEUMOVAX 23 on 06/01/2009. The patient was examined in the office on 06/02/2009 and a diagnosis of cellulitis was made. The patient was treated with KEFLEX and ibuprofen. The patient was seen in the office on 06/04/2009 and was recovering. This is one of two reports from the same source. Follow up information was received from a physician regarding the 57 year old female with chronic pain and a smoker. On 01-JUN-2009, the patient was vaccinated intramuscularly into the left deltoid with first dose of PNEUMOVAX 23 (lot number 662661/0978). It was noted the patient had no known illness at the time of vaccination. It was reported that on the same day, at 10:00 p.m. the patient experienced left arm cellulitis. The patient recovered from this event on 11-JUN-2009. An ultrasound was performed on 12-JUN-2009 within normal limits. The physician considered left arm cellulitis to be an other important medical event. No further information is available.
You killed my mom, after she got the vaccine. I can't prove it, but you did; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "You killed my mom, after she got the vaccine. I can't prove it, but you did". The patient date of death was unknown. The reported cause of death was "You killed my mom, after she got the vaccine. I can't prove it, but you did". It was not reported if an autopsy was performed.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: You killed my mom, after she got the vaccine. I can't prove it, but you did
Given MENACTRA 11/12/08 Left upper arm swelling redness itchy and painful 11/13/08 worsening. Took BENADRYL and MOTRIN, induration 12 x 11 cm. 11/14/08 return with induration 22 x 20 cm.
Patient received the varicella vaccine on 4-17-07 and began feeling stiffness in a joint on his left hand and, by 4-20-07, he was feeling this stiffness in bith upper extemities and his neck with some joint grip weakness in his hands.Today, he also noticed and fine, non-itchy erythemic rash all over his body.
This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 38, via an unspecified route of administration, left arm on Apr 4, 2021, at 14:15, single dose, for COVID-19 immunisation. Medical history included blood donation on Mar 31, 2021. The patient has no allergies to medications, food or other products. Concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 6, 2021, at 14:15, after 2 days, patient experienced a runny/congested nose. At 16:00, patient experienced arm pain, sore throat and weak body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The arm pain resolved after 48 hours on Apr 8, 2021. Runny/congested nose, sore throat and weak body: not resolved. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Abdominal pain; This is a spontaneous report from a non-contactable consumer, the patient.  A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 20Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021, the patient experienced abdominal pain. On the same day, the patient underwent Computed Tomography (CT) scan and colonoscopy and the result was clean for both the tests. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the event abdominal pain was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A pharmacist reported that a pt received Pnu-Imune 23 on 10/28/99 or 10/29/99 and subsequently developed an injection site reaction. The pt was treated with antihistamines and applications of ice. The pt recovered. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23, lot 463747.
Friends got the flu weeks after they had the flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer/Non-HCP via media on 14-Dec-2020.  This case involves a patients of unknown demographic who got flu (Influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that she had one INFLUENZA VACCINE, and had flu (Influenza).  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to received PREVNAR13, via an unspecified route of administration in 2014 at a single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On unknown date in 2014, the patient experienced at the injection site started itching and she scratched it with outcome of unknown. It swelled up a little bit and its red on 2014 with outcome of unknown. The action taken in response to the events for PREVNAR13 was not applicable. Follow-up (31DEC2014): Follow-up attempts completed. No further information expected.
Caller stated that she has seen death as being an adverse event of the Pfizer Covid-19 vaccine (did not specify how many patients or demographic information).; This is a spontaneous report from a contactable consumer. The consumer reported that unknown number of patient (unknown age and gender) received BNT162b2 (COMIRNATY,COVID 19 Vaccine, mRNA), on an unspecified date, via an unspecified route of administration as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The reporter mentioned that she has seen death as being an adverse event of the Pfizer Covid-19 vaccine (did not specify how many patients or demographic information). Reporter asking if there was any information about seizures being a side effect of the Pfizer Covid-19 vaccine and what are the side effects for the orange cap Pfizer Covid-19 vaccine. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number not available. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101557104 Same reporter/ drug, different patients/ events.; Reported Cause(s) of Death: Caller stated that she has seen death as being an adverse event of the Pfizer Covid-19 vaccine (did not specify how many patients or demographic information).
Blood sugar levels were doubling in count; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar levels were doubling in count) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 125K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar levels were doubling in count). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar levels were doubling in count) outcome was unknown.        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.   Patient reported that on 28DEC2020 he received the vaccine in his right arm and on 04JAN2021 he noticed that his blood sugar levels were doubling in count. His average blood sugar is 120-135 on average and since taking the vaccine his blood sugar has been reading 280-300. Patient stated that he does not feel bad.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
CDC report: 5 mo infant developed fever to 100.2, local rxn, rash & screaming episode following DTP/OPV immunization, duration of illness 5 days. Dx by PMD as rxn to DTP.
Patient had her Janssen vaccine on 04/10/2021. She is currently c/o blurred vision, headaches with left eye pain, and thoracic back pain since she received her vaccine. She reports the headaches and back pain as a 10/10 on the numeric pain scale despite taking OTC medications. She says she attempted to come in as a same-day walk-in last week but the wait was too long and she left home. She denies any nausea or vomiting but says that these are the worst headaches of her life and that she never had these headaches prior to the vaccine. She is also c/o extreme fatigue. She denies any fevers, CP, or SOB
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, local Health dept. took the following steps: ? Contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  ? Contacted a local medical director and based on this information from Moderna, no re-vaccination is needed.
Patient states feeling shaking, headache,  aching  and chills about 8 hours or so after receiving her 2nd dose of Shingrix. The patient also reports arm soreness and redness around the injection site. The patient had her vaccine administered at 1/30/21. She called us at 1/31/21 because Pharmacy is closed on Sundays. The patient reports taking her temperature, but the  reading was within normal range. She took Tylenol PM to help her with symptoms about every 8 hours. We recommended that the patient use a cold compress around the injection site if she continues to feel redness around the injection site and continue acetaminophen as needed. We inquired about the use of NSAIDs to help her with chills and aching, but the patient reports an allergy to NSAIDs. The patient has not sought out any additional medical attention at this time.
Patient fainted and fell to floor hitting head on exam stool. LOC was approximatedly 10 seconds, BP 90/60, P 56, arms jerking, laceration on left side of forehead, c/o blurry vision and abd pain. EMS called and was transported to hospital via ambulance.
Noticed a mark at injection site; It was warm and blotchy; Rash clear down her arm 6 inches long but is not bothersome; A spontaneous report was received from a consumer concerning a 90-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 043L20A)  in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome.Consent to contact given.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome were  unknown.
Migraine; Muscle aches; fatigue; fever; A spontaneous report was received from a female patient, nurse, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced migraine, muscle aches, fatigue and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, at 2pm, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection . On 30 Dec 2020, at 4am, the patient experienced migraine, muscle aches, fatigue, and fever. She measured for fever that evening at 102.7 Fahrenheit. Her symptoms lasted for 48 hours before resolving.  The patient mentioned that she took naproxen as treatment, without improvement.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, migraine, muscle aches, fatigue, and fever, were considered resolved on 01 Jan 2021.; Reporter'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. Further information has been requested.
An area above injection site broke out in a red splotch and was having some pain at that location. Patient also said she was having some nerve tingling in an area where she had previously broken out with shingles.
the pediatric pfizer vaccine was mixed with 1.8ml NS and 0.3ml dose was given to an adult. no adverse reactions in the 15 min following the administration. It was not found out until 1.5 hours later that the wrong vaccine was given. Pt was called and was unable to be contacted. It is currently unknown if there were any additional adverse reactions later.
Patient reports having a 1 cm x 1.5 cm " blister- like " lesion at his injection site since 01/03/2021 at 7:00 pm.
Information has been received from a registered nurse concerning a 12 year old male with no medical history or allergies who on 03-OCT-1995 was vaccinated with a first dose in the right arm of Varivax (lot # 608655/0417B). Concomitant therapy vaccination that day included a first dose in the left arm of MMR II (lot # 615839/0885B). There was no illness at the time of vaccination. On 27-NOV-2006 the patient developed a fever of 104 and lesions on face, trunk, and buttocks with a total of 75. Medical attention was sought. No laboratory diagnostic tests were performed. Treatment was symptomatic. Subsequently, the patient recovered. The patient did not experience any adverse events following prior vaccination. There was no product quality complaint involved. Additional information is not expected.
On 9/17/21: Body aches, fever of 100.2, fatigue and waves of nausea, dizziness. Fatigue, waves of nausea/dizziness continued until 9/26/21. Continues to complain of pain between shoulder blades.
tested positive for covid a week after she got her 1st dose of vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive for COVID a week after first dose of vaccine. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sudden & Nov 6 normal hearing - woke up Nov 7 4am left ear hearing weak. Dr PCP seen - prednisone 60 mg x 10 days tapered - 90% left ear; MRI contrast and non-contrast head.
A few days after being vaccinated with Moderna, I started developing migraines with aura (visual disturbances in which I will see tiny blind spot and some streaks of light appearing on the bottom left corner of both eyes). I always had migraine before but never had it with Aura. Within the 1st 3 weeks of receiving the 1st dose of Moderna. I had migraines with aura about 6-7 times. I had it in May and by September, the aura occurrence has lessened.   However, in August, about 3 months after receiving the 1st Moderna shot, I started have constant tinnitus in both ears. Not sure if it's related to the vaccine.