chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner referring to unknown number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date, the patients were vaccinated with improperly stored PROQUAD (lot # M003436, therapy type: RHA, expiration date: 19-JUL-2017; lot# M015698, therapy type: RHA, expiration date: ,26-SEP-2017; lot# M017334, therapy type: RHA, expiration date: 05-OCT-2017; lot# M023932, therapy type: RHA, expiration date: 09-NOV-2017; lot# M035689, therapy type: RHA, expiration date: 06-FEB-2018; lot# M037651, therapy type: RHA, expiration date: 28-FEB-2018; lot# M038227, therapy type: RHA, expiration date: 06-MAR-2018; lot# M039448, therapy type: RHA, expiration date: 20-MAR-2018; lot# M041082, therapy type: rha, expiration date: 04-APR-2018; lot# M042499, therapy type: RHA, expiration date: 17-APR-2018; lot# M018635, therapy type: RHA, expiration date: 11-OCT-2017; lot# M029598, therapy type: RHA, expiration date: 10-DEC-2017; lot# L034930, therapy type: RHA, expiration date: 03-MAR-2017; lot# L039269, therapy type: RHA, expiration date: 05-APR-2017; lot# L041626, therapy type: RHA, expiration date: 20-APR-2017; lot# L042817, therapy type: RHA, expiration date: 26-APR-2017; lot# L046510, therapy type: RHA, expiration date: 19-MAY-2017; lot# reported as "L047375", expiration date: 23-MAY-2017; lot# L050907, therapy type: RHA, expiration date: 14-JUN-2017; lot# L051101, therapy type: RHA, expiration date: 17-JUN-2017; lot# reported as " K012930", expiration date: 27-JUN-2017; lot# M001152, therapy type: RHA, expiration date: 05-JUL-2017; lot# M004892, therapy type: RHA, expiration date: 25-JUL-2017; lot# M010475, therapy type: HSA, expiration date: 01-SEP-2017; lot# M010478, therapy type: HSA, expiration date: 01-SEP-2017; lot# M011663, therapy type: RHA, expiration date: 08-SEP-2017; lot# M012987, therapy type: HSA, expiration date: 12-SEP-2017; lot# M015699, therapy type: RHA,  expiration date: 26-SEP-2017; lot# M017337, therapy type: RHA, expiration date: 05-OCT-2017; dose and route unknown) for prophylaxis. The PROQUAD was stored at 10 Fahrenheit for 3024 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same source. Lot number L047375 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. Lot number K012930 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA002612:
Soreness in left arm, knot in left arm, chills, achy, headache, fever over 104.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at the injection site) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain at the injection site). At the time of the report, INJECTION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-071407 (E2B Linked Report); Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071407:
Patient received SHINGRIX 2nd dose on 11/11/2018 and on 11/15/18 started having severe itchy sensation on right side of back. When she went home and looked at her back, she noticed there were small red dots/bumps. She said that the itchiness and red bumps have steadily gone down since 11/15/18.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical event.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 20-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
pt recv vax 13JUN97 & 21JUN97 pt exp a febrile sz in which stiffened up & eyes rolled back;pt mom thought that had stopped breathing for approx 30 sec to 1min p/limp, minimally responsive;fever;CXR revealed pneumonia dx feb sz & pneumonia;
severe pain in her back, hip, and legs that began 3.5 to 4 hours after her 2nd Moderna vaccine. She says she was so uncomfortable she had great difficulty getting to and from the bathroom for 2 days. She denied having weakness to legs.
About eight hours later, extreme fatigue, fever, chills, shivering, headache, body aches, red watery eyes
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route of administration and indication were not reported). No adverse effects were reported. Additional information has been requested.
Pt had high fever & prolonged crying p/3rd DTP on 14JAN91, & then ceased to devel normally; pt is now considered to have quadripalegic cerebral palsy;
pt recvd DTP/OPV/HIB 29APR92 930AM;w/no problems; no fever; no fussy; very active & playful afternoon of 1MAY92; fed 6PM 1MAY92 was OK in crib 15 min later 635PM found pulseless & not breathing; intubated & given meds; ?SIDS, lung congest
On 7/19/02 day after vaccine pt. broke out into a rash that looked like chicken pox. At age 8 pt. was diagnosed with shingles. Was also diagnosed at age 6 with abrasive deficit disorder.
On Saturday, 04/10/2021 patient reported that she had a swollen leg  that first appear with 24 hours  of the vaccination which later disappear but reappear again on that day.  The ankle area was a little swollen and red, Patient applied benadryl and took tylenol over the weekend, on seeing the patient on Monday 04/12/2021, the swelling and the redness has gone.  We told patient to inform us and also refer patient to Doctor if the swelling come back again.
Describes tightness in throat.  Denies SOB  Vital signs 118/82, HR 58  Pulse OX 99%.  Resolving quickly with time.  Observed for an extra 10 minutes with increses in symptoms.  Symptoms described as subsiding.  States she had similar symptoms withher first dose but symptoms subsided.  Monitored and given water.  Advised to seek medical advice if symptoms worsen after she leaves.
Patient was given HEP & DTAP vaccine in the (L) arm on 4/28/09, 1 day later was noted to have swelling, redness itching on the (L) deltoid area, lesion became bigger then parents sought consultation. Lesion was 8x9 induration w/redness on (L) deltoid area.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On 23-JUL-2013, the pt was vaccinated by a pharmacist with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, anatomical location, lot number and expiration date were not provided).  On an unknown date, the pt experienced herpes zoster and due to this event was treated by a healthcare provider. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to zoster vaccine live(ZOSTAVAX).
patient receive the first dose of the vaccine and has now tested positive for Covid; patient receive the first dose of the vaccine and has now tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program.  A contactable pharmacist reported a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that they had a patient receive the first dose of the vaccine and has now tested positive for Covid. He stated the patient is a week out from receiving the second dose and asks what information Pfizer can provide on receiving the second dose for someone with Covid infection. Outcome of the event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Moderna Vaccine; 7 days after vaccination my arm became itchy, red, and swollen. It is round and redness is around the size of a softball. Also developed rash/like hives on upper legs.
Pt recv vax on 10/21/98; on same day pt exp hives, swelling & red vax site x 24 hr; tx=Benadryl
11pm pain at injection site through arm and shoulder, also joint pain in knees.  By next morning, flu type symptoms including aching muscles, headache, nausea.
Flu like symptoms; All over body aches; bruising like pain on the arm of the injection; bruising like pain on the arm of the injection; Fever that lasted approximately 10 hours; soreness around lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 18:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8723) via an unspecified route of administration in the left arm on 24Mar2021 at 18:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 16:00, the patient experienced flu like symptoms about 22 hours after vaccination, all over body aches and bruising like pain on the arm of the injection, fever that lasted approximately 10 hours and soreness around lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events flu like symptoms about 22 hours after vaccination, all over body aches and bruising like pain on the arm of the injection, and soreness around lymph nodes was recovered on an unknown date in Apr2021 while the event fever that lasted approximately 10 hours was recovered on 16Apr2021 at 02:00.  No follow-up attempts are needed. No further information is expected.
Shot was administered abnormally high on left arm.  Severe pain and weakness in left arm that lasted 3-4 days, followed by reoccurrence of severe pain on day 7-8 post vaccination.  Numbness in left arm, elbow, hand & fingers.
Severe shoulder and arm pain; Severe shoulder and arm pain; Chest pain; Feeling of extreme fatigue; Heart racing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 at 15:30 as dose 1, single (Lot number: FK9893) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden" (unspecified if ongoing); "Thyroiditis" (unspecified if ongoing); "PCOS" (unspecified if ongoing), notes: PCOS; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 29Apr2022 at 08:00, outcome "not recovered"; FATIGUE (non-serious) with onset 29Apr2022 at 08:00, outcome "not recovered", described as "Feeling of extreme fatigue"; PALPITATIONS (non-serious) with onset 29Apr2022 at 08:00, outcome "not recovered", described as "Heart racing"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 29Apr2022 at 08:00, outcome "not recovered" and all described as "Severe shoulder and arm pain". Therapeutic measures were taken as a result of pain in extremity, arthralgia, chest pain, fatigue, palpitations.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and not tested for COVID-19, since the vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
She got her vaccine, she had fever for about 3 days, aches and pains.  This was the booster. In December she started with shoulder pain but did not pay it any attention.  In the beginning of January is when she thought she hurt her rotator cuff, the pain was worse and was going to call her PT as she had partial knee replacement.  She thought it would go away and then the pain got worse.  It got so bad that she was not able to lift her right arm, and is right handed.  She started to have aches and pains all over.  In February she called her endocrinologist who did blood work and that her C-reactive protein which is supposed to be 1 was 50.2 which was extremely high, and the Westergren Sed rate was 45, which was very high and it should be under 30 and was told to see a rheumatologist.  She had seen Dr. in the past, and saw him on 3/17/22 in a video conference and had had a battery of blood work done.  This confirmed that the blood work was completely high and he believed that she had polymyalgia rheumatica.   He put her on Prednisone to reduce the inflammation in her body and she has been having blood work every week and the inflammation has gone way down.  He recommended that she see a 2nd doctor at Hospital for Special Surgery, and her name is Dr.  She saw her last week and was examined and she did blood work also, and she determined that she did have the  polymyalgia rheumatica and the prednisone was working and that she felt that she had giant cell arteritis.  She felt that the prednisone was appropriate, taking 13 mg a day, and that her inflammation was coming down and she was studying the correlation from the vaccine to the arteritis and there was a link and it is under investigation.  She suggested that she might change to methylprednisolone and has a FU video appointment next week to see if she should change from prednisone to that.  She felt that she may also be tapered off the Prednisone as her levels are better.   She may do an antigen test to see if she should get the 4th vaccine.  She called her yesterday on 4/18/22, and her antigen levels were extremely high over 150 and this is 6 months after the booster.  She recommended that she not get the 4th COVID booster as her levels were so high.    Dr. told her that hopefully the vaccine affects will wane and it takes about 2 years to get the inflammation to go down if you have polymyalgia rheumatica.
SIGNIFICANT JOINT PAIN, HIGH FEVERS X 4 DAYS (BETWEEN 101-103F), SEVERE HEADACHE, LEFT ARM PAIN
Prolong pain (slight) at injection site. Muscle soreness from injection site to above elbow. Worse when I awake, gets better as the day goes on.
10 Minutes after receiving  vaccine had dizziness, headache, nausea and not feeling well.  Several hours later had  w/ fever of 103 and redness/ swelling of vaccine site. Next day ( 6/18/2022) continued w/ headaches, dizziness, fever, nausea, and vomiting x 5 times. Next  day (06/19/2022) still w/ same symptoms and vomited another ~5 times, fever persisted w/ last fever low grade to 100.4 on early 06/20/2022. Slowly other symptoms resolved with little nausea, dizziness and abdominal pain still present on 06/29/2022   Seen 07/01/2022 w/ cervical adenopathy  Seen 07/05/2022  adenopathy improved with no other symptoms at all
Continues to have pain L deltoid after flu shot on 10/4/02 at 1600. On scale 1-10, rates pain as "4" today 10/11/02.
Initial report received from a nurse on 04 November 2010. A healthy pregnant female patient, who, per the patient, was approximately 5 weeks gestation had received an intramuscular left deltoid injection of FLUZONE (lot number U3726AA) on 25 October 2010. The date of the patient's last menstrual period and estimated date of delivery were unknown. The patient had not been evaluated by her OB/GYN at the time of this report. The patient had not experienced any adverse events. Follow-up information was received 13 December 2010 from a health care professional. The patient also received an intramuscular injection of ADACEL, lot number C3519AA on 25 October 2010, the same day she had received FLUZONE. Past obstetric history included two previous pregnancies; one which resulted in a full-term live birth with no congenital anomalies and one which resulted in a spontaneous abortion prior to 20 weeks gestation. The patient had no illness at the time of vaccination. According to the reporter, the patient experienced an adverse event; however, no additional information was provided pertaining to the event. Documents held by sender: None.
Approx. 5 months after my 2nd Pfizer Covid-19 vaccination, I started losing my hair; After 1 month after the 2nd dose, my blood glucose & thyroid levels rose; After 1 month after the 2nd dose, my blood glucose & thyroid levels rose; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 30Jan2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included multivitamins, colecalciferol (VITAMIN D3), zinc (MANUFACTURER UNKNOWN), imipramine (MANUFACTURER UNKNOWN) and probiotics nos (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously took chlorhexidine gluconate (SURGILUBE) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, after one month after the second dose, the patients blood glucose and thyroid levels rose. On 01Jul2021 at 08:00, approximately five months after second Pfizer COVID-19 vaccination, she started losing her hair. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events after one month after the second dose, blood glucose and thyroid levels rose and approximately five months after her second Pfizer COVID-19 vaccination, she started losing her hair was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker refers to unknown number of patients with unknown demography. On an unknown date, the unknown number of patients was vaccinated with improperly stored PNEUMOVAX 23 (dose, route and frequency were not reported). No adverse effect reported. No further information was provided. The case is linked to the case 1404USA0102442 and 1404USA010658 (same reporter link). Additional information has been requested.
Approx 10 min p/shot recvd, mom returned w/pt, red, asymmetrical blotches pre-auricular & cheeks; One single blotch on chest; Ears red, no wheezing; HR reg 132, consulted w/NP, given DPH & observed; pt fully recovered;
Pt received 1st dose of covid-19 vaccine 89 days after receiving monoclonal antibody treatment. One day early from CDC recommendations.  No adverse reactions.
Pain feeling: feels like a deep bruise (no bruise on skin); when in neutral position it's fine, when flex bicep is feeling okay. When raising the arm fully up feels like somebody did a big punch into the arm.
Fever, diarrhea, shortness of breath, weak. Went to hospital, tested positive for Covid-19 and died.
Pt received Flu vaccine on 10-20-15 - within 1 1/2 hrs arm pain - 7 1/2 hrs later fever, chills, nausea - fever, headache, rash next couple days temp 104.2.
After getting flu vaccine, patient developed progressive weakness of his arms and legs and was diagnosed with Guillain Barre syndrome. He received plasma exchange x5 treatments.
Information provided by patient below.  I received the 2nd COVID vaccine on 2/11/21. A week later in the afternoon of 18th, i began to have episodes of high heart rate and heart palpitations that would occur randomly without relation to movement. This happened for 24 hours and then disappeared the night of the 19th. I did have to take off work on the 19th because of it. I checked in with my OB ( I am 29 weeks pregnant) and they were not able to think of anything that would be causing the random periods of high heart rate that only lasted 24 hours as I had not been experiencing this previously.