chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Info has been received from an RN concerning a 7 year old white female with no allergies or medical history who on 4/6/99 at 10:40 AM was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live. Concomitant vaccinations given on the same day and time included: the 5th dose of Hib conj vaccine (Hib-Titer) (lot 402253A) given IM, in the right leg, the 4th dose of (Acel-Immune) ( lot 457792) given IM, in the left leg, the 1st dose of MMRII (lot 645399/0103N), given SC, in the right leg and the 4th dose of poliovirus vaccine live oral (Orimune) (lot 794L1) given PO. On 8/19/05, the pt experienced 5 lesions on the right shoulder and abdomen which was described as chickenpox characterized by a generalized red rash with slightly pruritic skin lesions. The pt also had 4 open sore areas on the antecubital area of the right arm which was described as impetigo. There was no fever. The pt was treated with Augmentin, 500mg/5ml, 2 tsp BID for 10 days; Tylenol and Benadryl or Claritin for itching. No diagnostic lab test were performed. At the time of the report, the pt's outcome was reported as unknown. No product quality complaint was involved. Follow-up info received from an RN on 9/26/05, indicated that there was no info on the recovery of the pt because the pt's parents had not called back. Additional info is not expected.
Initial misuse report received from a healthcare professional on 15 April 2013. ADACEL was administered to an infant (No more information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, injection site pain, chills, fatigue Narrative:  Employee reports symptoms of body aches, joint pain, chills, fever, vomiting, fatigue, and injection site pain/discomfort beginning a few hours after receiving vaccine. Reports took Tylenol (no dose/frequency provided).
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received HAVRIX 1440 adult. On 21st November 2014, the patient received HAVRIX 1440 adult 1 ml. On an unknown date, an unknown time after receiving HAVRIX 1440 adult, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and accidental overdose were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and accidental overdose to be related to HAVRIX 1440 adult. Additional information received: Adult dose of HAVRIX given to a 2 year old boy by mistake. No further details readily available.
Broke out in hives over entire face..also has fever but medicated with Tylenol.
Febrile sz 9 days after MMR, VARIVAX and hib.
Symptoms presented within 12 hours of injection.  Ezcema-like symptoms, including itching, redness, flaking and cracked skin, and warm sensation on hands (including wrists and knuckles). Anterior thighs also itching.
Joint stiffness in fingers in both hands, particularly in the morning. Periodically applying Voltaren, which helps alleviate stiffness during the day.
This spontaneous report as received from the mother of a 17 year old female patient. The mother stated the patient had no pertinent medical history. Concomitant medications included unspecified medications for acne and thyroid. On 28-NOV-2014 the patient was vaccinated with GARDASIL 1.5 ml  one time for prevention of human papillomavirus (HPV). The patient got her first menstrual cycle in August 2014. The next time she got her period (date not specified), she spotted for a day or two then stopped for a month or two and the next one was very little. After that, the patient stopped having menstrual cycles. In January 2017, the patient's doctor put her on unspecified birth control pills to bring back menstrual cycles. The intervention was successful but the mother took her daughter off the birth controls because she didn't want her to take them any longer. The patient's menstrual cycles stopped again after she stopped the birth control pills. The last time the patient had her period was in September 2017 "because she got blood work done". The mother stated "all counts came in fine". The mother also stated that her daughter developed acne, and was moody and aggravated (onset date not specified). The outcome of the events were unknown. The mother reported she was considering legal action. Additional information is not expected as there was no consent to contact the reporter's physician for follow-up.
First shot was fine. Second shot on the third day 3:30 a.m  woke up in a sweat and went to the restroom looked in the mirror and i notice I had a rash from head to toe. I called my Drs office and he told me to use benadryl tried it for four days  then i scheduled a dr. appointment and they gave me a shot then a z-pac 4-day-3day-2day -1day then it cleared up.
Pt received flu shot on 10/22/15 and then called pharmacy 10/23/15 approx. 12 PM and stated that he was achy, short of breath and fever. Recommended TYLENOL for fever and follow up w/ MD regarding breathing.
About 10 days after the vaccine there was itching at the vaccine site. 12 days later there was a rash approximately 4 inches in diameter. I am hoping it goes away on it's own.
I experienced severe joint pain and had trouble picking anything up and walking. I went to see my PCP and he performed some blood work. I was on Prednisone 10mg medication because he thinks that my Arthritis flared up along with a cough that I developed after the receiving the vaccine. Since I'm taking the medications, the symptoms are not as severe.
Hospitalized with severe flu vaccine reaction; This case was reported by a physician via call center representative and described the occurrence of hospitalization in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: Physician reported that the patient received unknown Flu vaccine and was hospitalized with severe Flu vaccine reaction. The patient had since been discharged home. No further details were available at time of call. The specialist attempted to obtain further patient details, but physician could not locate patient information while speaking with specialist.  The specialist attempted to clarify brand of vaccine, but physician noted it was not clear in documentation which Flu vaccine was given. The reporter consented to follow-up.
No additional AE reported; dose of PROQUAD [LOT/EXP unknown by reporter] was administered 37 year old postpartum female patient on 20OCT2022 instead of MMR II; This spontaneous report was received from a pharmacist and refers to a 37-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose reported as 1 (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis, instead of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (wrong vaccine administered. There was no additional adverse event reported.
Patient reports that she noticed hives starting in the evening of 1/28/22. She states that the hives were localized to her upper body only, mainly on her torso, back, and neck. She reports fatigue and general cold and flu like symptoms Friday and Saturday after vaccination. Patient took benadryl for rash, states that it began to fade on Sunday 1/30/22.
Dizziness; fever; pain at the injection site; This is a spontaneous report from a contactable physician. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via intramuscular route of administration in the left arm on 03May2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included Type 1 diabetes since the patient was 6 years old. The patient had no known allergies. Concomitant medications included insulin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an intramuscular route of administration in the left arm on 12Apr2021 at 09:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 12:30, the patient experienced dizziness, fever and pain at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of dizziness, fever and pain at the injection site and included treatment with ibuprofen. The clinical outcome of the events dizziness, fever and pain at the injection site were recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
An injection is given outside of the regulated time frame.  Vial received 08.12.2021 and injection given 08.27.2021.  Vial maintained in refrigerated condition since receiving.   Receiver reporting no adverse conditions associated with the injection.  The receiver was monitored for 15 minutes after injection for severe reactions with none noted.  Will continue to monitor for 72 hours for any reactions that may be delayed.
This is a spontaneous report from a contactable nurse. A female patient of unknown age, received a single dose of PREVNAR 13 (Lot H47688; Expiration date: May2015; NDC 0005197105) on 19Jun2014 and BENADRYL since unknown date, at an unknown dose and frequency. Relevant medical history and concomitant medications were unknown. On 19Jun2014, after vaccination and while being on diphenhydramine, the patient had allergic reaction, rash, fatigue, cough and baseball like red spot at site of injection. Relevant laboratory work was none. Last action taken with diphenhydramine was unknown. No therapeutic measures were taken in response to the events. Patient was still suffering from the reported events at the time of report. The nurse confirmed that allergic reaction was due to PREVNAR 13. Follow-up (20Aug2014): Follow-up attempts completed. No further information expected.
Hospitalization for COVID-19 symtpoms on dates 5/15/2022-5/20/2022. Treated with azithromycin IV, ceftriaxone IV, methylprednisolone, albuterol/ipratropium, Vitamin C 1000mg daily, Symbicort inhaler, Vitamin D3 25mcg daily, dexamethasone daily, zinc 50mg daily, remdesivir, and baricitinib.
ADULT OBSTRUCTIVE SLEEP APNEA, MILD PULMONARY EMBOLISM, UNSPECIFIED.
Intense shivering lasting about 3 minutes (7:00 pm the night of the injection), fatigue, muscle pain occurring the next day 910/17/2019), pain at injection site starting shortly after injection and continueing in to today (10/17/2019)
101.8 fever, chills, aches, confusion, body pain, headache, fatigue
Low-grade fever (slightly over 100), fatigue, headache starting day of injection, lasting 3 days with large swelling and pain starting second day and redness over most of upper arm for several days.
Chest pain; Difficulty breathing; Diarrhea; Headache; very tired and lost not knowing what to do; feeling very sick; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), ILLNESS (feeling very sick) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0409D8A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure abnormal.   On 03-Nov-2021 at 2:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (feeling very sick). 2021, the patient experienced FATIGUE (very tired and lost not knowing what to do). On 03-Nov-2021 at 7:00 AM, the patient experienced CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), ILLNESS (feeling very sick), HEADACHE (Headache) and FATIGUE (very tired and lost not knowing what to do) had not resolved.            No treatment medication has been provided.
About a minute after my shot I got a headache (which I assume is normal), but 5 minutes later my face felt warm and I looked into my car's vanity mirror and saw that it was flushed (my husband confirms this).  I would guess 10 minutes after the shot my lymph nodes on both sides under my jaw were swelling and my ears felt stuffed up, under pressure.  I tried swallowing and it felt a little harder than it should.  All of these symptoms cleared in four or five hours, except for the headache which had diminished by the end of the day.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No adverse events reported. No temperature excursion of the product was reported. Date place in refrigerator 18-Oct-202,  Treatment information was not provided.
Received PREVNAR 12/16/15. Returned to office 12/23/15 with c/o rash on left arm since shot received. Itchy red and swelling at injection site.
pt recvd vax & exp severe pain in both legs & paralysis; It was not known if the pt had recvd concomitant therapy; No further details were provided;
4/14/03: Pt has 2-3 inch circular area that is red/swollen and hot to touch and hard - had called on 4/12/03 and nurse told her to give ibuprofen - not helping. Augmentin 600/5  tsp twice daily.
Patient became dizzy.  Vital signs stable, given juice.  Patient was stable after 30 minutes.
Arm pain, nausea, severe headache, sleepiness, chills, tiredness
Over course of 90 minutes, pt. had 3 syncopal episodes and nausea. Unable to walk w/o having syncope. Very pale and tired.
MED ERROR RN gave 0.25 mL to the patient, and then gave another 0.25mL to equal the full .50mL dose. Patient waited 15 minutes for any adverse reaction. None was noted. The vaccination was the second in the patient's series.
Pfizer booster administered on 10/1/21 (9 mos post 2nd Pfizer vaccine) without issue. No adverse side effect from 1st or 2nd doses Pfizer. Felt significant body aches fatigue ~12 hours post booster into following day. Not a big concern though did not have this from either 1st, 2nd dose.  2 days post booster broke out with significant urticarial rash posterior L leg, few hives on R leg and torso. Extreme pruritus area of urticaria.  Some extension of rash area over next couple days. Rash has not resolved, but is stable 10 days post booster. Few scattered, isolated hives have appeared on legs over the week since initial rash outbreak. Flare ups typical of histamine response when hot, or any increased blood flow to area.  OTC Zyrtec 10 mg PO taken most days since outbreak helpful for itching, discomfort.  Triamcinolone cream applied topically to rash somewhat helpful too.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Patient have not been infected with COVID 19, which patient monitored with a blood test for Blood immunoglobulin G (IGG) and Blood immunoglobulin M (IGM). In APR-2021, laboratory data included: Blood test (NR: not provided) Blood immunoglobulin G: negative. Blood immunoglobulin M: negative and immunoglobulin Total: 0.0. The patient confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422640-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Pt recvd 3 doses of Engerix-B on 18OCT90, 19NOV90, 25APR91 & did not respond; no tx given; reporter indicated that outcome was pending;
reported that a patient received 2 doses of MENACTRA at 4 weeks apart, instead of the recommended 8 weeks apart with no reported adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 70 years old female patient who experienced reported that a patient received 2 doses of menactra at 4 weeks apart, instead of the recommended 8 weeks apart with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Eculizumab (Soliris).  On 18-Jan-2022, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U6952AA Expiration date: 09-Jun-2022, frequency: once, unknown strength and formulation via intramuscular route in the left deltoid as immunization and received same vaccine at the interval of 4 weeks with unknown batch lot, route, administration site, frequency, formulation and expiry date.  On 18-JAN-2022 the patient developed a non-serious event reported that a patient received 2 doses of menactra at 4 weeks apart, instead of the recommended 8 weeks apart with no reported adverse event (inappropriate schedule of product administration) latency: unknown following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Body aches, fatigue, headaches and low grade temperature starting about 8 hours after shot and lasting 36 hours. On day 2, I developed an itchy red large rash at the injection site that lasted 5-6 days then resolved
Nausea, started 1/4/2023 6 pm, states had vomiting and severe headache starting 1/5/2023. Headache lasted 24 hours. Vomiting lasted x approx. 8 hours. Had one episode of "sweats" on 1/6/2023 in evening. Weak but recovered by 1/7/2023.
16 hour post vax noted 7-8 cm circular area with erythema, swelling, tenderness @ site where varicella administered. No other S/S. Advised re: seeking medical care if symptoms worse involvement of Lymph or generalized upper extremity, fever.
I experienced with my second dose, chills, body aches, mild fever, fatigue. I had a huge sciatic nerve flare up. I could not stand up. I still continue experiencing my sciatic pain. My A1C had been elevated and in March had gone up a whole point, my doctor thinks that with all the inflammation, triggered my A1C to go up.  My doctor also started me on insulin to try to get my A1C down.  I am pretty sure I had Covid late December 2019 into January 2020 and was sick for 6 weeks.  I had a patient that came back from oversees and I did a swab on her and got sick after that.   I am still experiencing the sciatic pain and I am now getting acupuncture.   I experienced with my first dose, chills, body, aches, fatigue.  I also had sciatic pain but had it under control and took OTC Motrin which helped.
Head hurts to touch getting itchy on arms legs and Buttocks  also arems sweeling
pt c/o slight chest pain with breathing/laughing and lower back pain the evening after receiving the covid bivalent booser.  pt still has those symptoms present today as of 1/31//23.
She took Benadryl due to previous reaction, got the vaccine, it felt fine when she did it, and then about 6:00 PM it was a little sore.  Then around 8:00 PM felt a knot that was underneath the skin that was painful to touch.  She woke up all night long as if she touched the knot or bumped it or tried to lie on it it was extremely painful.  This morning it is red, hot, and larger than it was.  Last night she did take Motrin before going to bed, but did not help.  She has not taken anything today.  Her temp is 96.7.  She is starting to have the same reaction that she had with the first vaccine but at a much faster rate.   She is going to call her doctor today.