chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started having a fever.; headache; chest discomfort; nasal congestion; coughing; nausea; sore arm; fatigue; sick the whole day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick the whole day), CHEST DISCOMFORT (chest discomfort), NASAL CONGESTION (nasal congestion), COUGH (coughing) and NAUSEA (nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (sick the whole day), NAUSEA (nausea), LIMB DISCOMFORT (sore arm) and FATIGUE (fatigue). On 12-Jul-2021, the patient experienced CHEST DISCOMFORT (chest discomfort), NASAL CONGESTION (nasal congestion), COUGH (coughing) and HEADACHE (headache). On an unknown date, the patient experienced PYREXIA (started having a fever.). On 24-Mar-2021, ILLNESS (sick the whole day), LIMB DISCOMFORT (sore arm) and FATIGUE (fatigue) had resolved, NAUSEA (nausea) outcome was unknown. At the time of the report, CHEST DISCOMFORT (chest discomfort), NASAL CONGESTION (nasal congestion), COUGH (coughing), HEADACHE (headache) and PYREXIA (started having a fever.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, SARS-CoV-2 test: positive positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include over the counter allergy medications, not otherwise specified. No treatment medication details was reported.   This case was linked to MOD-2021-259111 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up appended to AER
I began experiencing extreme depression and anxiety followed by unexplained crying and suicidal thoughts that have continued currently. Unable to complete daily tasks due to severe depression. Very close to commiting suicide.
This individual was given the Covid-19 vaccine at on offsite clinic at the age of 15 when the vaccine is only approved for 16 and older. No adverse reaction reported.
Pt experienced syncope about 10 minutes after the dose.   He became very light headed and began to sweat.  He fell to the ground and remained there for about 5 minutes until he "came to" fully.  He was able to stand on his own and get into a chair.  He refused medical treatment stating that he was fine.
One day, post vax, pt had 13-15 cm of erythema, induration and warmth. Pt experienced significant discomfort and disability of the left arm which required 2 days out of work for resolution of symptoms.
Pt vaccinated with Engerix-B developed depression, aggressive reaction for 1 wk, agitated, moody.
admitted 8/28, Went to urgent care and dx with COVID 3 days ago. Was prescribed Medrol by urgent care. Had low grade fever previously but today went up to 102. +cough. +SOB.
This reaction happened after my second COVID vaccination from PZIFER--not almost immediately the same evening post vaccination I had a mild rash on my neck which resolved immediately and I had some flu like symptoms. But that isn't the reaction. About 9 days after the inoculation, My arm was developing a raised oozing rash which burned--this progressively became worse over the course of several days,, at which point my arm looked like I had a crusted fungal infection (very painful) or necrotizing bacteria--I did see an MD and a dermatologist looked at my arm via pictures--(still have them) It was deemed a vaccine reaction and I was prescribed "Fluocinide" ointment. Eventually my arm healed but it took a couple more weeks,. It was painful and extremely unattractive at the time of reaction.
Pain from the injection site down to her pointer and thumbs, pain as a tingling of pins and needles that will stay then go away; Pain in her arm which comes and goes; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm which comes and goes ), PARAESTHESIA (Pain from the injection site down to her pointer and thumbs, pain as a tingling of pins and needles that will stay then go away) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031M12A) for COVID-19 vaccination.     The patient's past medical history included Frozen shoulder (At first it was the patient's her left arm, however during the physical therapy the frozen shoulder then moved to her right arm. The patient iis alright now and recovered.) in 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALENDRONATE SODIUM (ALENDRONATE), CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm which comes and goes ). On 29-Mar-2021, the patient experienced PARAESTHESIA (Pain from the injection site down to her pointer and thumbs, pain as a tingling of pins and needles that will stay then go away). At the time of the report, PAIN IN EXTREMITY (Pain in her arm which comes and goes ), PARAESTHESIA (Pain from the injection site down to her pointer and thumbs, pain as a tingling of pins and needles that will stay then go away) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. The patient states that if she is moving then she does not feel the tingling of pins and needles like pain, however if she is at rest the pins and needles come back. Sometimes the pain doesn't go directly down to the two fingers, it just goes down to the arm.   This case was linked to MOD-2021-037251 (Patient Link).
Tested PCR positive for COVID 8/11/21 after being fully vaccinated. Symptom onset 8/7/21.
Received several vaccines to include smallpox 9 APR 08. Presented with 1 day old overall rash, mild malaise, Temp 100.4. Rash mildly pruritic. Had Clindamycin 1 week for nasal fracture. No Hx of allergy to Clindamycin.
This spontaneous report was received from a physician via field representative refers to a 12 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 25-MAY-2016, the patient was vaccinated with first vaccine GARDASIL 9, one shot intramuscularly. On the same day, the patient had syncope. The physician's staff took the patient back to the exam room for observation and after drinking some water and rest she had recovered. None treatment was given for adverse events. Patient had a bump on her head and a headache but the symptoms had subsided. None lab diagnostics studies performed. The outcome of the events was recovered. The reporter did not provide any causality assessment between events and GARDASIL 9. Additional information has been requested.
PAIN IN THE BONES, JOINTS, SLEEP, FEVER, RASH ON THE SKIN (LIKE MEASLES), ITCHING ALL OVER BODY. DAY 3 AND 4 WAS STRONGER. AFTER TAKING BENADRYL IN PILL AND CALADRYL ON MY BODY, ITCHING WAS REDUCED. EVEN SOMETIMES I HAVE IT, BUT LESS INTENSE.
No adverse effects; the patient inadvertently received proquad due to medication error; This spontaneous report as received from a nurse refers to a 27-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 20-JUN-2019, the patient was inadvertently vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot number, expiration date and route of administration were not reported) dose of 0.5 ml, diluted in sterile diluent. The patient received the vaccine due to medication error. It was unknown if the intended vaccine was measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) or varicella virus vaccine live (Oka/Merck) (VARIVAX). Confirmed that was not product confusion. No adverse effects were reported.
waited in clinic for 15min post vax was fine;while driving home felt swelling back of tongue, light diff swollen, SOB, h/a, felt weird;episode lasted about 20min;
fever,chills,fatigue,body aches,nausea, and headache, lingering for 2 days
Headache, Myalgia, Fever, cold, chills, super tired, right arm sore Narrative:
Pt recvd vax 16JUN93 & exp neck pain; a few hrs later exp shoulder pain, pain generalized to include whole rt side; pain was in joints & deep pain @ the inject site; dx carpal tunnel synd; poss transient polyarthritis, fatigue, depression;
Had small red area that started on 04/24/21 but then on 04/27/21 area became inflamed like a welt and doubled in size. By end of day on 04/27/21 area was even more inflamed and itchy. By morning of 04/28/21 area has tripled in size though not itching as of now. Area is also warm to touch and is somewhat painful if pressed on.  Area is also no completely circular as it is spreading to about the size in uneven circumference the size of a baseball. I am on daily antihistamines once daily but on 04/27/21 took it a second time. This did take away the itching but has not reduced the size of the rash/redness/swelling.
- NOTE : Date given in step 4 are those of the 2nd dose. First dose was given at 03/19/2021 at 03:00 PM - ADVERSE EVENT:       - Sudden Hearing Loss in the Right Ear       - Loss of Balance       - MRI shows what is currently believed to be inflammation in the IAC.          - MRI shows no MS related lesions          - MRI shows no masses or tumors
congestion; elevated blood pressure; nausea; fever; head ache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION, HYPERTENSION, NAUSEA, PYREXIA, and HEADACHE in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION, HYPERTENSION, NAUSEA, PYREXIA, and HEADACHE. At the time of the report, NASAL CONGESTION, HYPERTENSION, NAUSEA, PYREXIA, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medication. Treatment details included paracetamol and did nothing.
Chest and Back pain started in the evening of 4/4/18. I assumed it was heartburn, I felt unwell but could not put a finger on it. I took ZYRTEC 150 for reflux before going to bed. During the night I started feeling itchy but did not get up. At 6:00am on 4/5/18 I woke up and my face was swollen under my right eye extending to my lips. I had a large hive on the back of my left shoulder and hives on my hips. I took 50mg of BENADRYL with all my other daily medications.
I noticed a lump on the side of my body and went to the doctor. She identified the lump as a lipoma and advised there was nothing that could be done about it.
Stinging in arm, followed by dizziness, then light convulsions.  Still on table so laid her down.  She came mumbled 'cant do this' 20-30 times and then came to saying she didn't remember anything after the shot.  Stayed in office 20 minutes but then she still felt dizzy afterwards.
Began having pain in L sacral area and L hip which radiated to foot.  Pain spread to R sacral area and radiated down to right foot.  Had spasms, severe muscle pain in both legs.  Pain not relieved by Tylenol, Motrin, heating pad or rest.  Was unable to walk without holding onto wall. Lasted for 5-6 days.
the one vial presentation of Menveo in a 2 month old patient; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 2R7L7, expiry date 31-DEC-2024) for prophylaxis.   On 09-NOV-2023, the patient received the 1st dose of Menveo. On 09-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: the one vial presentation of Menveo in a 2 month old patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 09-NOV-2023 A nurse reported to inquiring about Menveo and what information was available about the information available for the use of the one vial presentation of Menveo in a 2-month-old patient.  HCP reported that the wrong formulation of Menveo vaccine was administered to a 2 months old male infant.  Menveo comes in two formulations, the single vial pre-mixed formulation was approved for ages 10 through age 55. The two-vial formulation (requiring reconstitution) was approved for ages 2 months through 55 years of age.  Since this patient was an infant this patient should had received the two-vial formulation but instead received the single vial pre-mixed formulation.  The reporter stated that the child was under observation and no adverse reactions were observed. The one vial presentation of Menveo received a 2 month old patient which led to inappropriate age at vaccine administration.  The reporter consented to follow up.
I had a high fever peaking at 101, chills, and fatigue. This lasted about 2 and a half days. The symptoms just vanished suddenly and returned to normal. Tele-visit with doctor who advised to take TYLENOL.
12MAR97 330PM mom reported inconsolable crying for about 2-3hr (pt now crying ow) also soreness @ inj site;fever of 100 ax;mom gave APAP x 1 since vax given;13MAR97 pt still fussy w/low grade fever 100-101;
shooting (Left) eye pain/more into the corner of her eye, whole head hurting; Could not even focus out of her left eye; irritating; shooting (Left) eye pain/more into the corner of her eye, whole head hurting; This is a spontaneous report from a contactable consumer via Pfizer. (Patient, reported for self).  A 64-years-old female patient received first dose of BNT162B2 (Pfizer-BioNTech mRNA Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0175, Expiration date: 31Aug2021), via an unspecified route of administration on 06May2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications includes: clopidogrel bisulfate (PLAVIX) taken at 75 mg, 1x/day (one time a day by mouth) and  acetylsalicylic acid (ASPIRIN (E.C.) taken at 81 mg, 1x/day (one time a day by mouth) both from unspecified dates for indication: Stents and ongoing. It was reported that after receiving the first dose of Covid vaccine the patient's eye has had shooting pain every now and then since the vaccine, her whole head was hurting, has been to multiple healthcare providers, wants to report and wants to know if other people have experienced this as well, also wants to know whether to take second dose or not as well. It was reported that the patient has seen her primary for this event, two ER (Emergency Room), two urgent care doctors and an eye doctor and no one knows what was going on. The patient stated that the extreme eye pain started between the 13th and the 19Jun2021, exact date unknown, clarifies the pain was in the left eye, felt like someone was just stabbing her in the eye, it would come when it wanted, the pain would shoot into her eye. Her doctor numbed her eye and pain kept shooting through her eye, it is unbearable. Could not even focus out of her left eye, noticed the pain is a little better but keeps getting the shooting pains into the eye, more into the corner of her eye, it is so irritating. Patient clarified that she received the vaccine on 06May2021 and has not received second dose yet. No investigation Assessment was reported. Patient enquired how long symptoms should last after the vaccine, has anyone else reported this symptom, should she get the second dose. The clinical outcome of the events shooting (Left) eye pain/more into the corner of her eye, whole head hurting had not recovered, and the outcome of other events were unknown.
5FEB97 inc temp, c/o SOB, BP 190/100 adm to hosp;07FEB97 +influenza upon cult as reported by hosp;dx influenza A & pneumonia;
Fever of 104 degree F. after last set of vaccinations.  Mother called physician to see what to do about fever and he said continue to medicate with Tylenol and give cool bath.  No office visit or hospitalization required.
This case was reported by a healthcare professional and described the occurrence of inappropriate dose of drug administered in a 20-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hepatitis B vaccine. Previous vaccinations included completion of a three dose series of hepatitis B vaccine (unknown manufacturer) with the 1st dose given in infancy. Dates were not specified. It was also reported that the subject received a PPD skin test. On 19 January 2010, at 11:00, the subject received 1st dose of ENGERIX B at 10 mcg in the left arm. This was an inappropriate dose of drug administered. The subject should have received an adult dose of ENGERIX B. No adverse events were reported. Lab work performed on an unspecified date prior to receiving ENGERIX B indicated that the subject's hepatitis B titer was not detectable. She had not responded to therapy. Note: Two separate reports for this same event reported the lot number for ENGERIX B to be AHB284DA or AHAVB284DA. Linked case number A0840589A was made void as two reports for this same subject were received in GlaxoSmithKline safety and a second case was created in error. Any future correspondence will be added to case number A0840586A. Follow-up information received on 24 February 2010 indicated that the lot number of ENGERIX B administered was AHBV706AA with an expiration date of 25 June 2011. The PPD skin test was intradermal at 0.1 ml on 19 January 2010. The subject was inadvertently administered a 10 mcg intramuscular dose of ENGERIX B rather than the appropriate adult dose of 20 mcg. No adverse events were reported. The subject was advised to wait one month and then restart the hepatitis B series. It was again noted that the subject had 3 prior doses of hepatitis B vaccine given by another provider and testing reported non-detectable antibodies.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-APR-2012, the patient was administered with a dose of VARIVAX (Lot # 1218AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Information has been received from a Registered Nurse (R.N) concerning a 4 month old female patient who on 25-NOV-2008 was vaccinated with a dose of PNEUMOVAX (Lot # 662661/0978X). It was reported that the patient received PNEUMOVAX instead of PREVNAR due to human error. It was reported that the patient had received her first dose of PREVNAR on 26-SEP-2008 and a second dose on 29-JAN-2009. No adverse reaction reported. Additional information has been requested.
01/2022 I started having problems with my left leg. I noticed it was swelling, it was uncomfortable and would hurt when I slept at night. Also, it felt like thickening above the back of my knee. I went to the doctor. He felt like I would be fine. It progressively got worse, and I started having trouble breathing. They had put me on Lasix and HCTZ thinking it was water retention. It did not get better. I went back to the doctor. A doppler ultrasound was performed on my left leg at the hospital. I had DPV, 2 blood clots in my left leg. Because I was still having issues breathing, he sent me back to the hospital the next day. They did a CT scan with dye to check my lungs and found multiple blood clots in my lungs (not sure if both). I was hospitalized for 4 days on a Heparin IV. I was discharged with Xarelto. I will be on this for at least 6 months for the clots to dissolve. I have had no further tests, but am still having swelling in my leg. I am to continue to monitor.
Fever began night of vaccine with irritation at site seen by redness, warmth, and 2.6cm area of swelling.
patient developed soreness at the injection site; Information has been received from a physician referring to a 5 years old female patient. The patient had no medical history, no concurrent condition, no drug allergies or concomitant medications.  On 16-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, lot#, expiration date were unknown) and sterile diluent(STERILE DILUENT) (dose, strength, lot#, expiration date were unknown) subcutaneously into her inner upper thigh for prevention of measles, mumps, rubella and chicken pox.  On the same date, the patient experienced soreness at the injection site. On 17-OCT-2019, the patient came to physician's office and the patient recovered from the event. No treatment was given for the event. No lab diagnostics/studies were performed. The causality was unknown by reporter.
This case involves an unknown age and gender patient who experienced sick this month, while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination. On an unknown date, the patient developed a non-serious event " sick this month" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported"Got one last month and sick this month." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (sick this month). At time of reporting, the outcome was Unknown for the event sick this month.
Pfizer's vaccine caused several friends of mine suicidal thoughts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUICIDAL IDEATION (medically significant), outcome "unknown", described as "Pfizer's vaccine caused several friends of mine suicidal thoughts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer vaccine was administered outside of location - reported by patient  I21.9 ACUTE MI 2/15/2022 FAILURE TO THRIVE SYNDROME, ADULT