chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration on 17Mar2021, at 12:30 on left hand, as a single dose (at the age of 55 years) for COVID-19 immunisation. The patient medical history included asthma, hypertension, and high cholesterol. The patient was not allergic to medications, food, or other products. Concomitant medication included Irbersartan/ HCTZ (MANUFACTURER UNKNOWN) 150-12.5 mg and atorvastatin (MANUFACTURER UNKNOWN) strength 200 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced very sore arm the night of the injection and on 18Mar2021, the patient experienced headache, severe body ache and swollen lymph nodes which caused a lot of pain in my armpit until three days after injection. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of painful arm, headache, general body pains and swelling of lymph nodes was recovered. No follow-up attempts are possible. No further information is expected.
Raised red, warm to the touch area surrounding injection; NP would like pt to F/U in 2 days or sooner if symptoms worsen.
Information has been received from a nurse practitioner concerning a 31 year old female with no allergies who on 13-JUN-2007 was vaccinated SC with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 23-JUN-2007, 10 days after vaccination the patient experienced joint pain and swollen ankles. It was reported that patient also experienced tingling and numbness in her hands. At the time of report the patient had not recovered. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
half hour - itchy mouth, dizzy, lightheaded, headache  (30 mins) - BP surge 151/104 (2 hours after),  chest tightness,   heart racing (3 hours after)  - some of this went away after a while - mostly subsided (still having some chest pains and racing heart off and on) - red blotchy face,  hands, bit of nausea -  1 day following
12x6.25 red area, warm to touch, also tender x 1 day. Advised Tylenol and cool compress.
Over a 3 month period (10/13/22 until 1/30/33, patient experienced mood disturbances, loss of social/safety judgement ability, a sudden and significant increase in memory loss, slurred speech and difficulty swallowing, CVA-type " word loss",  complete loss of reading and writing ability, disorientation and confusion, hallucinations, balance & gait disturbance which caused severe increase in unsteadiness and falls,  myoclonus, and debilitating tremors.  On 1/17/22, he fell and was admitted to hospital with no injuries from fall, but developed aspiration pneumonia related to inability to swallow.  He died on 1/30/22.
p/vax pt devel bad case of chickenpox;more than 10 lesions in head alone;
Headache / migraine; This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Bexsero and Menveo. On an unknown date, less than a month after receiving Bexsero and Menveo, the patient experienced migraine headache. On an unknown date, the outcome of the migraine headache was not recovered/not resolved.   It was unknown if the reporter considered the migraine headache to be related to Bexsero and Menveo.  Additional details were provided as follows: The patient meningitis vaccine a month ago and was not sure if the vaccine was Bexsero or Menveo, believes was Bexsero since the patient started college and had headache migraine since then.  The reporter was not sure about the onset date and mentioned did not know if it was or not related to the vaccine.  The reporter mentioned the patient was still had headache.  No other information was provided. Th reporter did not consent to follow up.
A lady died after getting their second Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (A lady died after getting their second Moderna shot) in a 6-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  No treatment details were provided.  Company Comment - Very limited information regarding this event has been provided at this time.  Further information is not expected as no consent for follow up was obtained.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information is not expected as no consent for follow up was obtained.; Reported Cause(s) of Death: Unknown cause of death
2 hrs p/vax pt devel fever (101-102), irritability, generalized achiness & swelling @ inject site;
I have a fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (I have a fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PYREXIA (I have a fever). At the time of the report, PYREXIA (I have a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information were not provided.   Reporter did not allow further contact
Sweating; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), CHILLS (Chills) and HEADACHE (Headache) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (Sweating), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not provided.  Treatment information was not provided by reporter.
Information has been received from a nurse concerning a 17-year-old female with no known relevant medical history nor drug allergy, who on 10-FEB-2009 was vaccinated IM with the first dose of 0.5 ml GARDASIL (lot # 661952/1129X) in her deltoid. There was no concomitant therapy. On 12-FEB-2009 the patient's mom called to office to seek medical attention concerning the patient's reaction that took place on 11-FEB-2009. The patient's face was described as "puffy from the neck up to her cheeks". The patient felt it was a little difficult to breathe and her throat "felt funny". She took BENADRYL 2 doses on 11-FEB-2009 and on 12-FEB-2009 she took CLARITIN. No laboratory test was performed. On an unspecified date, the patient recovered from the event. Her primary physician and school nurse felt the reaction was due to GARDASIL and recommended discontinuing the series. Additional information has been requested.
Fever, chills, dizziness, weakness, pain at injection site; Tylenol provides relief.
1 minute after vaccine administration,  patient acutely experienced dizziness and vocalized light headedness resulting in syncope. Syncope witnessed by staff lasting 15-20 seconds. Patient was provided with water and gatorade and no additional issues noted.  VITALS: T 97, HR 80, BP 122./84 Lungs CTAB
Information has been received from a registered pharmacist concerning a 53 year old male patinet who was vaccianted IM in the left upper arm with MMR (second generation) on 7/25/02 (lot # 639374/0180M, expiration date 1/8/04). On 7/12/02 the patient experienced joint pain and stiffness in his right knee and it progressed to his wrists, elbow and figners. The patient was seen by a registered nurse on 7/16/02. The pharmacist stated that the patient had reaction to injection and was hospitalized. The patient is a hospital employee and was hospitalized on approximately 7/21/02 for thrombocytopenia (platelet count was 9.7). The reporter also discussed the events of a patient who was vaccinated with MMR (second generation). Additional information has been requested.
pregnant patient receive the vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 31-Aug-2021 from a Physician via Medical Information (Reference number- 00748401) and transmitted to Sanofi on 31-Aug-2021.  This case involves a 35-year-old female patient who had taken INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant (Maternal exposure during pregnancy) with no adverse event.  Gestation period at onset was not reported.  Data regarding this pregnancy were received prospectively for example before pregnancy outcome was unknown.   The date of last menstrual period was not reported.  The estimated due date is 29-Aug-2021.  The medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On 31-Aug-2021, the patient received a 0.5 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ686AA, expiry date 30-Jun-2022] via intramuscular route in the left arm for prophylactic vaccination.  It was a case of Maternal exposure during pregnancy as patient was pregnant when she received vaccine (latency on the same day).  It is unknown if the patient experienced any additional symptoms/events.  Relevant prenatal testing after exposure was not reported.  It was not reported if the patient received any corrective treatment. . At the time of report, the outcome of event was unknown.
12/19/2021 Patient age 14 received a booster dose of Pfizer. The patient received his first Pfizer vaccine on 05-20-2021 and completed the series on 06-10-2021. The client received a booster dose of Pfizer administered at approximately 12:59 p.m. The patient was not scheduled to receive the booster dose as the age for boosters starts at 16. The parents were notified twice and a voicemail was left. There was no response back from the parents. The nurse who administered the vaccine was made aware and educated on the 5 rights of medication administration and received extensive training on who can get what vaccine. Will follow-up with parents to educate them on this matter.
h/a, muscle aches, weakness & dizziness w/in a few days of flu & pneumococcal vax;
After first shot (Tuesday, 2/2/2021), there was only arm pain, mild on the day of the dose and acutely painful for the following two days before being completely gone. After second shot (Tuesday, 3/2/2021), arm pain was consistent with first shot timeline but by Wednesday 3/3/2021, there was also a severe headache that formed that felt like my brain was too big for my skull and was pushing painfully out. The pain was dulled slightly but not negated with both Tylenol and Ibprofen (taken separately, 12 hours apart) and lasted until Sunday 3/7/2021. Both shots taken 2 days before menses; neither AER (arm pain/headache) was consistent with normal/expected menses side effects.
Parent called stated child was fine until 6/11/06. Noted red streaks and swollen red. After questioning parent, stated patient did scratch at arm, left deltoid. Parent took to ER. Stated cellulitis; put on antibiotic.
SEVERE fatigue, muscle pain, chills, temors, headache, constipation, naseau, flare up of Multiple Sclerosis symptoms, inability to walk unassisted, loss of appetite, change in taste of food, no interest in liquids (water), lasted 48 hours
I have been experiencing ringing in my left ear. I didn?t think anything of it at first, so I haven?t been reporting it in my daily V-Safe check-ins. However, it?s now been 4 days with persistent ringing, so I figured it would be a good idea to report it. My 61-year-old father has suffered from severe tinnitus in both ears since his first vaccine (though, he received Pfizer and I received Moderna). That?s how I connected the dots between my vaccine and the ringing in my ear.
I had an iritis flare up that started on 02/05/2022. On 02/07/2022 I went to the doctor and they just looked in my eye and diagnosed it. They gave me Prednisolone Acetate eye drops. It is still ongoing and it is going to take a couple of weeks to go away.
Swollen glands in neck (predominately on right side...same side as injection) - started around 7:30AM on 9/6/12 and lasted ~24hrs. Tiredness - started around 7:30AM on 9/6/12 and continues after ~48hrs. Body aches/chills - started about 4:00PM on 9/6/12 and continues after 20hrs - taking Ibuprofen.
Initial report was received from the scientific literature on 30 January 2014. The following is verbatim from the abstract: Background. Each year, the Influenza Vaccine Effectiveness Network examines the effectiveness of influenza vaccines in preventing medically attended acute respiratory illnesses cause by influenza. Methods. Patients with acute respiratory illnesses of 7 days duration were enrolled at ambulatory care facilities in 5 communities. Specimens were collected and tested for influenza by real-time reverse-transcriptase polymerase chain reaction. Receipt of influenza vaccine was defined based on documented evidence of vaccination in medical records or immunization registries. Vaccine effectiveness was estimated in adjusted logistic regression models by comparing the vaccination coverage in those who tested positive for influenza with those who tested negative. Results. The 2011-2012 season was mild and peaked late, with circulation of both type A viruses and both lineages of type B. Overall adjusted vaccine effectiveness was 47% (95% confidence interval [CI], 36-56) in preventing medically attended influenza; vaccine effectiveness was 65% (95% CI, 44-79) against type A (H1N1) pdm09 but only 39% (95% CI, 23-52) against type A (H3N2). Estimates of vaccine effectiveness against both type B lineages were similar (overall, 58%; 95% CI, 35-73). An apparent negative effect of prior year vaccination on current year effectiveness estimates was noted, particularly for A (H3N2) outcomes. Conclusions. Vaccine effectiveness in the 2011-2012 season was modest overall, with lower effectiveness against the predominant A (H3N2) virus. This may be related to antigenic drift, but past history of vaccination might also play a role. The following is verbatim from the full article: A cluster of 213 patient of all ages (initials, gender and date of birth was not reported) had received a dose of Influenza vaccine (manufacturer unknown, batch number, dose in series, route and site of administration was not reported) on an unspecified date. The patients had medically attended acute respiratory illnesses that were confirmed by RTPCR as influenza; Total 681 influenza positive cases was identified out of this total 213 patients were vaccinated with influenza vaccine. 178 patients were Influenza A positive (155 Influenza A H3N1 and 23 patient influenza A H1N1) and 35 patients with Influenza B positive. The event was lack of efficacy. The RT-PCR (Reverse transcription polymerase chain reaction) was done. Documents held by sender: None.
they got the virus; is still weak; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information Team. This consumer reported similar events for two patients. This is the first of two reports.  An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included leukaemia. The patient's concomitant medications were not reported. The reporter reported that her parents received the first dose of bnt162b2 vaccine. Then, after a week, they got the virus on an unspecified date. The reporter said that they got it from the doctor's office. The reporter also mentioned that her parents are still recovering and are still on quarantine. The reporter also mentioned that her father who has leukemia, was still weak and was under hospice care on an unspecified date. The reporter wanted to know if they should still receive the 2nd dose of the vaccine. The reporter was also concerned because they were scheduled to receive the 2nd dose 3 days earlier than the recommended 3-week-interval, and wanted to know if that was acceptable. The patient was recovering from all the events.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170461 same reporter/drug, similar event, different patient
headaches/i was waking up in the middle of the night with my head throbbing; uncomfortable feeling; I can't remember much; memory/brain fog; within an hour she started experiencing the allergic reaction; compared it to looking at a blue screen; my eyes were inflamed; eyes were tearing; face blowing up/swollen on one side of cheek; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (within an hour she started experiencing the allergic reaction), EYE DISORDER (compared it to looking at a blue screen), EYE SWELLING (my eyes were inflamed), LACRIMATION INCREASED (eyes were tearing) and SWELLING FACE (face blowing up/swollen on one side of cheek) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced HYPERSENSITIVITY (within an hour she started experiencing the allergic reaction), EYE DISORDER (compared it to looking at a blue screen), EYE SWELLING (my eyes were inflamed), LACRIMATION INCREASED (eyes were tearing) and SWELLING FACE (face blowing up/swollen on one side of cheek). On 18-Apr-2021, the patient experienced AMNESIA (I can't remember much) and FEELING ABNORMAL (memory/brain fog). On an unknown date, the patient experienced HEADACHE (headaches/i was waking up in the middle of the night with my head throbbing) and FEELING ABNORMAL (uncomfortable feeling). On 18-Apr-2021, HYPERSENSITIVITY (within an hour she started experiencing the allergic reaction), EYE DISORDER (compared it to looking at a blue screen), EYE SWELLING (my eyes were inflamed), LACRIMATION INCREASED (eyes were tearing) and SWELLING FACE (face blowing up/swollen on one side of cheek) had resolved. At the time of the report, HEADACHE (headaches/i was waking up in the middle of the night with my head throbbing), AMNESIA (I can't remember much), FEELING ABNORMAL (memory/brain fog) and FEELING ABNORMAL (uncomfortable feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She took Ibuprofen every night. Patient almost went to the emergency room, but stated it went away about 5 minutes later. Patient stated her PCP prescribed her an unspecified steroid pill to take for her memory loss. Her PCP and cardiologist were aware, and recommended she report it to the CDC, which the patient stated she did report it, and was told she would get a call back, and never did. Patient stated her PCP recommended she did not get the second dose of the Moderna Vaccine.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of ZOSTAVAX and (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the ZOSTAVAX and (Merck) VARIVAX were stored in the freezer. There were 9 patients who received ZOSTAVAX. On 25-JAN-2013, one of the them was vaccinated with a dose of ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported). No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Breakthrough Covid-19 hospitalization  Chief Complaint: Visit CC: FEVER, sore throat, hypoxic.     Informant:Self   Mode of Arrival:POV     Emergency care given to patient prior to arrival:   Ibuprofen @2100    Nursing notes:   HX of DM, hasn't been taking meds. Hypoxic on triage,   admits to  having to    use O2 as a child, recent Dr visit, was informed   lungs have scars.   Impression:  Covid-19 pneumonia Hypoxic respiratory  Disposition: Admission Condition: Stable Date and Time of Arrival: 29-Nov-2021 14:45   Diagnosis:  COVID-19   Mode of Arrival: Wheelchair   Admitted From: ER
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. Information regarding concurrent condition, medical history and concomitant therapy was not reported. On an unknown date, the patient was vaccinated with a dose of PNEUOMOVAX 23 (dose and route was not reported). On an unspecified date, the patient experienced swelling at the injection site after receiving the vaccine. The outcome of event was unknown. The relationship between event and vaccine was not reported. Additional information has been requested.
Sore arm then fever, chills and total body aches. Unable to sleep due to pain. It happened on the second vaccine also. Lasted for 36 hours and slept for a day after.
pt recvd vax 27SEP94 in the AM & 28SEP94 PM had 4 1/2" area erythema lt arm, indurated area size of silver dollar; temp not taken, but states skin felt warm; per mom as above-erythema lasted 4 days;
Fever, body aches, back aches, severe headaches, uncontrollable urinations, took Tylenol.