chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 doses of Havrix and one of Non-GSK HepA Vx; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received HAV (Havrix pediatric) (batch number X34HF, expiry date 10th December 2020) for prophylaxis.   Previously administered products included Havrix pediatric (received 1st dose on an unknown date, batch number ZK374, expiry date 19th March 2020) and Havrix pediatric (received booster dose on an unknown date, batch number 3KT7B, expiry date 10th December 2020).   On an unknown date, the patient received Havrix pediatric. On an unknown date, unknown after receiving Havrix pediatric, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3 doses of Havrix which led to extra dose administered. The patient also received one dose of another manufacturer's Hepatitis A vaccine, which led to extra dose administered.   The reporter stated 4 vaccines were given over 4-years period. The reporter requested to speak to Medical Information for advice.   The reporter consented to follow up. Note- As it was unknown which dose was received in 2018, hence not captured for any dose.
A non-serious report of "we gave a partial (1/2) of H1N1 Vaccine to 5" was received from a physician concerning a 32-year-old female. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
patient received first dose on 1/5 L side.  Wed 1/6: Unable to lift arm, 8/10 pain in whole upper arm and 1/3 forearm, and very drowsy/ "out of it"  Thu 1/7: Mobility returned, injection site and upper arm still v sore (7/10 pain), 1 supraclavicular LN swollen to size of marble on L side. Fri 1/8: Injecting site still v sore (7/10 pain), supraclavicular LN swelling increased to size of gumball, more 3-4 supraclavicular LNs   posterior cervical LNs swollen. Late Friday night noticed mild pain in armpit.  Sat 1/9: still very swollen firm mobile and slightly larger, armpit pain now sharp 7/10 pain (felt like someone was stabbing me if moved too suddenly)- unable to palpate/ find a mass, injection site still sore (6/10 pain) now raised red rash (non-itchy) 4cm x 2cm, Sun 1/10: same as 1/9, armpit pain lessened (5/10), injection site less sore than 1/9 (5/10 pain), increasingly itchy as day progressed and very warm, rash borders raised 10cm x 7cm -measured at 12:00am (mon 1/11)  Mon 1/11: same as 1/9, armpit pain lessened (4/10), injection site less sore than 1/10 (4/10 pain), significantly itchy and very warm, less red, rash border raised 12cm x 9cm -measured at 8:00am
Received third dose without being immunocompromised; 0.5 ml administered as Moderna booster vaccine; Flu-like symptoms; Large tender area belowinjection site on arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE PAIN (Large tender area belowinjection site on arm), OFF LABEL USE (Received third dose without being immunocompromised) and ACCIDENTAL OVERDOSE (0.5 ml administered as Moderna booster vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. In October 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and VACCINATION SITE PAIN (Large tender area belowinjection site on arm). On 17-Oct-2021, the patient experienced OFF LABEL USE (Received third dose without being immunocompromised). 17-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (0.5 ml administered as Moderna booster vaccine). On 17-Oct-2021, OFF LABEL USE (Received third dose without being immunocompromised) and ACCIDENTAL OVERDOSE (0.5 ml administered as Moderna booster vaccine) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and VACCINATION SITE PAIN (Large tender area belowinjection site on arm) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-360778 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Added booster dose details. On 27-Oct-2021: Patient demographics and events were updated
930am on 10/9 fever began. Spent all day with fever, no appetite, joint pain. Fever varied from 100.9 - 102.6 1130pm on 10/9: got into bed. Temp 99.1,   All following events occurred on 10/10  2:45am: woken with severe abdominal cramping, flushing of skin, diarrhea. While in the bathroom dealing with diarrhea my eyelid began to swell and breathing turned wheezing. Took a tablet of benadryl and decided to monitor to see if it would progress or if I needed to administer epipen/inhaler and go to ER.  4:00am: I noticed breathing had improved, no longer wheezing, eyelid wasn't swelling further. 4:30am: uncontrollable shaking/chills (temp 98.4) No amount of clothing or blankets helped but a hot bath for 30 min helped.  515am: no longer shaking, and comfortable enough to sleep. 830am: woke up for the day. Eyelid still swollen, still having diarrhea but infrequently need to run to toilet. Normal temp. Normal breathing. Okay as of now. We will see if anything happens today but suspect it wont.  This is typically how allergic reactions start with me. Always early morning, diarrhea, one eyelid will swell. This is #3 in my life. The prior 2 resulted in ER visit.
PT WAS SEEN IN ER ON 1/6/2022 FOR RIGHT SIDED FACIAL DROOP AND WEAKNESS. WAS GIVEN DOSE OF STEROIDS AND VALACYCLOVIR WHILE IN ER AND WAS SENT HOME OF THEM AS WELL. LYME TITER AND EBV TITERS DRAWN WHILE IN ER AS WELL, SENT OUT TO LAB.  PT WAS SEEN I OUR OFFICE ON 1/11/22 AND WAS STILL SYMPTOMATIC.  PT WAS AGAIN SEEN ON 1/18/2022, AND WAS 75% BETTER.
NOT FEELING GOOD; BACK HURTS; JOINT ACHES/SHOULDER PAIN; MUSCLE PAIN; HEADACHE; ALL OVER BODY ACHES; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced all over body aches. On 07-MAR-2021, the subject experienced back hurts. On 07-MAR-2021, the subject experienced joint aches/shoulder pain. On 07-MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021 09:00, the subject experienced not feeling good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from all over body aches, muscle pain, joint aches/shoulder pain, headache, not feeling good, and back hurts. This report was non-serious.
9/18/23-9/20/23 Sore/painful right arm to touch and use arm Rapid pulse/HR to 120 Headache Temp 99+ Fatigue
pt recv vax 6NOV98 & had onset of fever that evening lasting for next 2wk;then c/o back pain, began walking bent over;22NOV refused to walk & unable to urinate;MRI revealed demyelinating disease from T2-3;tx w/high dose steroids;
This spontaneous report as received from a nurse refers to a 1 year and 1 day (12 months and 1 day old) male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
2 days post vax, pt reports urticaria at inject site, slight redness 3 inches in diameter at inj site.Urticaria at other areas on body and move around.  Pt will continue to take claritin as dircted by MD and will phone if sx's worsen.
Moderna 1/7/21 and 2/4/21. Positive on 1/5/22
After receiving shorts below, became pale, diaphoretic, dizzy; required H2O. To exam table, Trendelenberg BP 102/70, P 56 at 3:55PM. 4:05 BP 110/72, P 56, BP 108/78, P60. 4:10 color pink, skin warm and dry. States fine. Discharged home with parent and return PRC/to ED if further.
2nd shot and booster I had swelling of lymph nodes size of a lemon very sore. Swelling lasted about seven days.; 2nd shot and booster I had swelling of lymph nodes size of a lemon very sore. Swelling lasted about seven days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 12:00 (Lot number: En6199) as dose 2, single and administered in arm left, administration date 20Oct2021 13:00 (Lot number: Ff8839) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Have an ileostomy" (unspecified if ongoing), notes: Have an ileostomy; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies :eggs" (unspecified if ongoing), notes: Known allergies: eggs. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine; Sulphuric, reaction(s): "Known allergies: Sulphuric", notes: Known allergies: Sulphuric. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6200, Location of injection: Arm Right, No event reported), administration date: 03Mar2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "2nd shot and booster I had swelling of lymph nodes size of a lemon very sore. Swelling lasted about seven days.". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  2nd shot and booster I had swelling of lymph nodes size of a lemon very sore. Swelling lasted about seven days. Date of start of reaction/event: 21Oct2021. Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. Outcome of reaction/event at the time of last observation: Recovering/Resolving as reported. Hospitalization Prolonged: No  No follow-up attempts are possible. No further information is expected.
Somatic reaction; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced influenza-like symptoms with Shingrix. No further details were provided. The reporter consented to follow up. This case has been linked with case US2019199353, reported by the same reporter.
I had a sinus infection that resulted in upper respiratory stuff or a good ole fashioned sinus infection, I tested four times for COVID-19 all results being negative.
I reacted to the first vaccine, the health department took me to the hospital. I was monitored immediately having trouble breathing, took Benadryl, used my inhaler but then after that I started having problems to allergens that were not a problem before. I ended up needing an epi pen, I started to have trigeminal episode where it started to have them everyday. I also had fibromyalgia every day, pain scale 7 out of 10 on VAS scale. I ended up going to the doctors where they tried different medications. I started getting heavy periods and my birth control medication I had been out for 7 years, stopped working. I have lost a lot of weight, about 40 pounds. I was having migraines pretty much every day. I also started to get on one side of my face, left side. Then the same started happening to my right leg. I started to have vision problems, where me the sides of my eyes would go black and cracks in my vision. I went to the neurologist, ophthalmologist and no one had been able to figure out what is wrong with me. I have not been able to work for months. I was pretty active before the vaccine, I worked with a cancer institute for kids, but now I could not perform my daily activities, got so sick all the time. I had to move back with my parents. I still have pain a lot of the time, I do not have Covid and my symptoms have been pretty horrible since receiving the vaccine. I've had blood panels done, eye exams, MRI of the brain and pap smears but the exams are all negative and can not find the reason to my symptoms.  No spinal tap yet done.  Also my asthma is not under control and I get winded when going up a flight of stairs.  I do not have the lot# to provide today.
Info regarding Prevnar was received from a public health nurse regarding a female pt who, on 1/12/04, at 17 months of age, received a fourth dose of Prevnar, along with a dose of hepatitis B vaccine and a dose of varicella virus vaccine, live. On 5/28/05, at 33 months of age, the pt developed pneumococcal bacteremia. Indication for Prevnar was immunization. Product was administered on 1/12/04. Dose regimen was 1 dose 1 time per day. Concomitant therapy included hepatitis B, varicella live, Hib-Titer, DTAP and Polio. Event details: On 1/12/04, at 17 months of age, the pt received a fourth dose of Prevnar. On 5/28/05, at 33 months of age, the pt developed pneumococcal bacteremia, requiring hospitalization., after a blood culture performed on an unspecified date was positive for Streptococcus pneumoniae (drug ineffective). The reporter indicated the pt recovered. No additional info was available at the time of this report.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 30-MAY-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX injection, (lot # M025864, expiry date: 24-MAY-2018), subcutaneously for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided). It was reported that Merck sterile diluent used for reconstitution was properly stored. No adverse effect reported.
wife received first dosage of moderna vaccine after getting his 2 doses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXTRA DOSE ADMINISTERED (wife received first dosage of moderna vaccine after getting his 2 doses) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (wife received first dosage of moderna vaccine after getting his 2 doses). At the time of the report, EXTRA DOSE ADMINISTERED (wife received first dosage of moderna vaccine after getting his 2 doses) had resolved.            No concomitant medication information provided.  It was reported the reporter's wife got the shot again after her 2 doses thinking it was a booster shot.     Reporter did not allow further contact
PATIENT WAS SWEATING, DIFFICULTY SWALLOWING AND INTENSE HEART POUNDING AFTER 5 TO 10 MINS OF ADMIN.  RPH GAVE EPIPEN JR SHOT ON RIGHT THIGH.  CALL 911 AFTER EPIPEN SHOT.  PARAMEDICS ARRIVED AND TOOK VITALS.  BREATHING, PULSE, BLOOD PRESSURE AND HEART RATE WERE STABLE.  PATIENT DID NOT NEED TO GO TO ER.  PATIENT WALKED AWAY WITH NO ISSUE.
Leg muscle pain in quadriceps in both legs, headache, nausea, one instance of vomiting
Overall body pain, extreme weakness, extremely lethargic, excessive sleeping, nausea,  vomiting, fever, eye socket pain,
Patient had a very high fever of 105 degree F 2 days after the vaccination and went to ER. The next day 3/4th of his rt arm (Pneumovax Vaccine arm)was red swollen and slightly painfull from just below the injection site
nausea; This is a spontaneous report from a contactable consumer reporting for self. This 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at 07:30 AM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included neuropathy, IBS (irritable bowel syndrome). No known allergies. Concomitant medications in two weeks included: duloxetine hydrochloride (CYMBALTA), venlafaxine hydrochloride (EFFEXOR) and birth control. Patient was not pregnant, and did not receive other vaccine in four weeks. The patient experienced extreme nausea on 24Jan2021 at 10:00 PM and got fine until about 14 hours after receiving shot (as reported). No treatment received. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of event was recovered in Jan2021.  Information on the lot/ batch number has been requested.
Syncope after urinating in the morning on day after vaccination.  Never had syncope before.  LOC lasted about one minute and was followed by dry heaves and diaphoresis.  +Headache.   Symptoms (except for persistent headache) resolved after 20 minutes.
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccinated 7am 1/5/21. Low fever of 99, chills, malaise, and body aches started 8pm 1/5/21. Headache around 12am 1/6/21. The date and time currently is 3pm 1/7/21 and symptoms are persisting but more mild.
patient receiving age appropriate shots. TdaP and Menveo given then Gardasil. Within 1 minute of last injection, she began to feel faint and fell forward and was caught by the M A but hit her head on the tile. She then began to seize with arms jerking for a few seconds (less than 20) she was placed on the ground and on her side. She then came to and started to cry and answered questions appropriately. Her pulse was 86. Her pulse ox was 100 percent. Her BP was 100/65. EMS was called. She was taken to ED for further evaluation.
Initial report received from an investigator on 08 march 2010 under the reference number FUF14. A 64 year-old female subject with a history of occasional heart palpitations, hyperlipidemia, urinary incontinence, sciatica, back pain, dry skin, depression, seasonal allergy to penicillin, spinal stenosis, dysthymia, skin tag, sleep apnea, osteopenia, and hypertension developed cellulitis of the left ankle secondary to a cat bite 36 days after receiving a second injection of H1N1 (7.5 ug HA, lot number UD12414) on 28 August 2009. The first dose was administered on 06 August 2009. On 29 September 2009 the subject was bitten by her cat on her left ankle. As a result, the subject developed swelling, redness, and pain. She went to an urgent care center on 02 October 2009 and was given tetracycline and keflex without improvement. On 03 October 2009 she was admitted to the hospital. An incision and drainage were performed. She was given fentanyl during the procedure and CIPRO and clindamycin at a later time. She was discharged on 04 October 2009. The subject continued participation in the study and recovered from the event. According to the investigator, the event of cellulitis was not related to the study product. Follow-up information was received from the investigator on 23 March2010. The event began on 29 September 2009 was considered to be fully recovered on 04 October 2009. The subject was taking CELEXA 20 mg per os since 2006. No additional information was reported. Follow-up information was received from the investigator on 26 March 2010. The event was updated to "Cellulitis left lower extremity secondary to a cat bite"; redness, swelling, and pain were added as symptoms, beginning 29 September 2009 and resolving 04 October 2009. Study vaccine was administered intramuscularly in the right deltoid. Treatment medications tetracycline and keflex were started on an unknown date. Fentanyl 500mcg was taken x1 on 03 October 2009; ciprofloxacin 500mg was taken 03 October 2009 - 12 October 2009; clindamycin 300mg was taken 03 October 2009 through 12 October 2009.In addition, the patient also received ZOFRAN 4mg x1 on 03 October 2009 and PERCOCET 1 tab on 03 October 2009. The outcome was updated from "recovered; to "recovered with sequelae". Follow-up information received from the investigator on 31 March 2010. The subject had received additional treatment for the serious adverse event of bacitracin topical (Start date 03 October 2009, stop date unknown). The dose for fentanyl treatment was 50mcg times one dose (not 500mcg as previously reported). The stop date of 04 October 2009 was removed by the investigator from the symptoms of redness and swelling as the subject was evaluated by her primary care physician on 07 October 2009 for follow-up and the wound was healing, but was still swollen and red. At that time, the subject was still taking antibiotics. Per investigator, the subject has not followed-up with them since that time. Recovery status remains "recovered with sequelae." This study was unblinded on 25 October 2009. Documents held by sender: None
diffuse over lying erythema & Pecan size (2-3cm) reactive lymphadenitis in lt inguinal area above inj site on lt thigh;no inj site inflammation nor abscess
Information was received from a licensed practical nurse referring to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On multiple unspecified dates, the patients were administered 0.65 ml of improperly stored ZOSTAVAX (lot#L046899, expired on 23-FEB-2017, lot#L039096, expired on 01-JAN-2017, lot# reported as M00055, expired on 27-MAR-2017) (route unknown). The vaccines were exposed to 3 separate excursions as followed: 32 Fahrenheit degree (F) for 24 hours, 46 Fahrenheit degree (F) for 73 hours and currently 38 Fahrenheit degree (F) for 24 hours. Data logger was involved. No adverse event was reported. Additional information has been requested.
Patient given Moderna COVID vaccine which is only indicated for 18 years of age and older. No symptoms reported.