chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant referring to a female patient of unreported age. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 30-SEP-2021, the underwent vaccination with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1707496 has been verified to be a valid lot number, the expiration date was reported and established as 29-MAR-2022; dose and vaccination scheme were not reported). On 01-DEC-2021 (reported as "today"; inconsistent information, also reported as "01-NOV-2021"), the patient was sick. The medical assistant further described that the patient was experiencing cold symptoms (nasopharyngitis) (not resolved). Therefore, the patient did not receive the subsequent dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on that day (withdrawn). The medical assistant did not provide a causality assessment between nasopharyngitis and the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
pt recv vax & devel an inj site rxn characterized by warmth, redness & a nodule;tx w/ATB;
slightly raised itchy  bright pink rash starting on chest spreading to L side of neck.; slightly raised itchy  bright pink rash starting on chest spreading to L side of neck.; slightly raised itchy  bright pink rash starting on chest spreading to L side of neck.; itch scalp and arms; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 53-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ew0176, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Jun2021 at 19:30 pm (age at vaccination was 53 years) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any known allergies. Concomitant medication the patient received in two weeks included multi vitamin. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test which included COVID test (rapid, nasal swab): negative on 04Jun2021. On 06Jun2021 at 21:00 pm, the patient experienced slightly raised itchy bright pink rash, starting on chest spreading to L side of neck also noted on fingers and lower extremities, itch scalp and arms. No treatment was received for the adverse events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
pt vaccinated w/1st dose w/o adverse effect; Following 2nd dose experienced serum sickness w/fatigue, low grade fever, stiff neck, malaise, generalized weakness, h/a, rash, joint swelling & tenderness;
Patient had a rash on arm, that was red and warm to the touch. Patient also stated it was very sensitive and hurt. She went to urgent care thinking it was Cellulitus based on symptoms, Doctor stated it may be a reaction to vaccine but may treat her anyways.
Right upper arm erythema and induration with extension to the axilla, associated with axillary adenopathy. Fevers and chills noted at onset of symptoms. PCP prescribed Keflex.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, flushing, tired, fever Narrative:
white blood cells have been very low; lose weight; pain on the left wrist side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "deaf" (unspecified if ongoing), notes: Caller is deaf/hard of hearing; "hard of hearing" (unspecified if ongoing), notes: Caller is deaf/hard of hearing. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "white blood cells have been very low"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lose weight"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain on the left wrist side". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller is deaf/hard of hearing, calling using relay application, operator #(number withheld), #(number withheld), #(number withheld). "I wonder if it can cause to have white blood cells to go down because my white blood cells have been very low." "I wonder if my Pfizer shot vaccine caused my white blood cells to go down." Caller is not sure if Pfizer vaccine shot had caused her to lose weight, pain on the left wrist side, low white blood cells etc. Caller's doctor is helping her to find out what may have caused these side effects. "I'm calling because I am not sure if it is true that Pfizer has been recalled?" Caller had Pfizer shot in Jul and Aug2021. Should she be worried? Caller saw about recall for Pfizer. Caller is not sure which Pfizer product has been recalled, if it is the tablet or shot that has been recalled. Caller confirmed she is calling for the Pfizer Covid-19 vaccine but unable verify which presentation. Caller provided lot number EWOR N0107 from her vaccination card with the following dates. 03Aug2021, 24Aug2021. Caller stated that she doesn't understand how the vaccine works in the body.  Caller hoped it would not harm the white blood cells.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional and described the occurrence of injection site warmth in a subject of unspecified age and gender who was vaccinated with Boostrix (GlaxoSmithKline). On an  unspecified date the subject received 1st dose of Boostrix (unknown, right arm). At an unspecified time after vaccination with Boostrix, the subject experienced injection site warmth, injection site redness and injection site reaction. At the time of reporting the injection site warmth, injection site redness and injection site reaction were resolved. The healthcare professional considered the events were probably related to vaccination with Boostrix. A total of four subjects were report to have had an injection site reaction for the other three cases see A0911325A, A0911826A and A0911828A.
Severe burning stinging in muscles in back.  Weakness in left arm.  Painful tingling pin pricks in feet, moving to include hands and now systemic.  Nauseous. Balance is off.  Doing some detox with my Naturopath doctor.
A non-serious spontaneous report of a patient less than 2 years of age received FLUMIST was received from a health professional concerning a 23-month-old male. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 21-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. 08-Mar-2011: Follow up call was conducted on 08-Mar-2011, no adverse events were reported following administration of the FLUMIST.
This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 13-NOV-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 14 of several reports from same reporter. Additional information has been requested.
PT CAME TO PHARMACY TODAY (3/9/21) STATING THAT HER ARM WAS RED AND HOT AND THE HEAT WAS SPREADING DOWN HER ARM AND THE PAIN AND HEAT IS GETTING WORSE OVER TIME. SHE SAID THAT IT STARTED ABOUT A WEEK AFTER SHE RECEIVED THE SHOT (2/24/21) BUT THAT SHE ONLY CAME BY TODAY BC HER PCP IS OUT OF TOWN AND HER SON, WHO IS A DOCTOR, TOLD HER TO COME BY AND LET US KNOW. HE ALSO TOLD HER TO GET FEXOFENADINE TO TAKE DURING THE DAY AND DIPHENHYDRAMINE AT NIGHT. SHE WAS ALSO ADVISED TO TAKE IBUPROFEN TO DECREASE THE PAIN AND SWELLING AND APPLY HYDROCORTISONE CREAM TO THE SITE. SHE SAID SHE WILL GET A STEROID SHOT FROM HER SON AS HE SUGGESTED IN CASE IT GOT WORSE.
I was given the  COVID-19 vaccine EUA on 1/15/2021. Other than mild injection site soreness the following day, I had no adverse events until approximately 5:00 am on 1/23/2021, when I awoke with my injection site itching, somewhat painful, red (approximately 4" X 4" in size), swollen, and hot. It continues to be swollen, hot, red and itchy at this time (1/24/2021). I do not have a fever and otherwise feel fine. It's just strange to me that such a delayed reaction occurred so I decided to report it. If it becomes worse or if I develop a fever, I will seek medical attention. I have a Doctorate in Public Health degree and understand mRNA vaccines.
On the Saturday after receiving my 1st dose, I felt chest pain, right arm and right side of face numbness.  I was taken to ER.
had fever, nervousness, some hematuria, inc in lt testicular size, pulse 110, BP 190/96; pt admitted to observe; inc suptrapubic;
Pt developed migraine like symptoms and went to ER on 6/13, had normal CT of head, had ER f/u in clinic on 6/14, second ER visit with admission on 6/16 for Right vertebral artery occlusion with left sided stroke symptoms. She was given t-PA and started on aspirin and plavix 24 hours later; discharged with referrals to cardiology, neurology and PT
No additional AE; expired dose of M-M-R II was administered to patient; This spontaneous report was received from registered nurse referring to a patient of unreported age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 31-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II)  (expired product administered) 0.5 ml (lot number T001214, expiry date 12-JAN-2022 ; vaccination scheme, route of administration, and anatomical location of vaccination were not provided) for prophylaxis. Nurse confirmed that expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) did not experience a temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
fever of >105 5 dasy p/immun; fever off & on for 1 mo; crying inconsolably @ noc; wouldn't sleep for 1 mo p/immun;  MD 4MAR94 mom to MD didn't connect react to immun;
CVA (cerebral vascular accident). ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Red circle, swelling, hot to touch. Spread to 2" x 4" by 1/3/2017 resulting in cellulitis.
10/16/2008 3 PM R eye feeling "puffy".  Discomfort in eyes with redness and swellling of upper lids.  Took OTC allergy med ? claritin.  Hydrocortisone cream on both lids.  Swelling has decreased this am 10/17.  Cont. with OTC allergy med and CVS medication for "chest congestion"  Zythromycin for 5 days
Face Flush, Swelling, - Prescribed- Zyrtec- Within 24x  sysmptoms cleared up.
Took shot at 5pm, had Sore arm & diarrhea, by 1130pm
Information has been received from a physician concerning a 4 month old female with no medical history and no allergies, who on 09-SEP-2006 was vaccinated with a second oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Three days after on 12-SEP-2006, the patient developed an ear infection. The patient was given antibiotics and the ear infection resolved. There were no laboratory or diagnostic tests performed. No additional information was provided. Additional information has been requested.
Approximately 2.5-3 hours after receiving the vaccine shot, it became more and more difficult to breath. Breathing became very labored and almost felt like  an asthma attack-hard to catch my breath, not able to take a deep breath and wheezing.  My temperature was 101.5 and my breathing was quite labored for the next 6+ hours. Since then I have a cough (with discomfort just below the trachea) that continues. Additionally, I had and still  have muscle ache and fatigue
This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a adult female patient who received FLUARIX. Co-suspect products included Amoxicillin unknown for an unknown indication and lisinopril for an unknown indication. Concurrent medical conditions included egg allergy. Concomitant products included LYRICA, PROTONIX and NITROSTAT. On an unknown date, the patient received FLUARIX at an unknown dose, Amoxicillin at an unknown dose and frequency and lisinopril at an unknown dose and frequency. On an unknown date, an unknown time after receiving FLUARIX and Amoxicillin, the patient experienced allergic reaction. The action taken with Amoxicillin was unknown. The action taken with lisinopril was unknown. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLUARIX and Amoxicillin. Additional details provided were as follows: The concomitant medicinal products included Aspirin (81 mg OD), Vitamin E (100 unit OD), Multivitamin (OD), Doxepin HCl (100 mg OD at bedtime). PAXIL (for depression, 30 mg OD), Hydrochlorothiazide (for blood pressure, 25 mg OD), Fenofibrate (for cholesterol, 160 mg OD). Levothyroxine (for thyroid, 125 mcg OD), Clonidine HCl (for blood pressure, 0.1 mg), Metformin (for diabetes, 1000 mg BD), PLAVIX (as blood thinner, 75 mg every other day), Promethazine HCl (for nausea, 25 mg PRN), SOMA (pain, 350 mg PRN), Garcina Camboia (for weight, 60 percent HCA BD), Fiber supplement (for IBS, BD), Probiotics (IBS OD) and Dicyclomine (for IBS, 20 mg PRN). The patient experienced an allergic reaction after reaction after receiving FLUARIX vaccine (unspecified season). Amoxicillin and Lisinopril. The age at vaccination was not provided.
24 hours after the 2nd shot I got tired, dull headache, low grade fever, and neck & shoulders were achy.  Eyes felt like I was sick.  I rested all  afternoon and evening and was fine the next morning.  None of the reaction was severe just uncomfortable.  It was worth it if the shot works.
10:55 AM- Increased heart rate, sweaty, dizzy, fatigue Vitals: 160 Pulse, 130/80 11:12 AM: Shaky, fatigue 11:15 AM- EMS arrives, Vitals- 130/77, 86 Pulse
Weakness and throwing up. Fever of 102.5 and blood pressure of 173/115.
August 3rd 2021, 6 weeks after the COVID-19 vaccination administration, the patient (myself) started to experience symptoms of a blocked tear duct that evolved into dacryocystitis, which was resistant to PO and IV antibiotics and continued to worsen despite an I & D. At which time, September 11th 2021, an MRI was done which showed a mass near the lacrimal sac. Biopsy results showed necrotic Granulomas with numerous acid fast bacilli consistent with a mycobacterial infection. Currently speciation and sensitivities are unknown. Modified RIPE therapy had been implemented with the concern that IV antibiotics may also need to be used depending on PCR and culture results.  I have yet to recover from this infection and have been out of work since 8/13. I have lost weight, suffer from right sided headaches, right eye pain, slightly blurred vision on the right side, and will have a facial deformity due to the I&D and surgery. I also suffer from fatigue and general malaise.  I will still require at least one more surgery to reconstruct the lacrimal duct system.  While I understand that one could argue that I am immunocompromised due to the medications I?m on for Crohn?s disease, I would argue that I do not have a history of infections, risky personal habits or travel. I am vegan, plant based and work out daily. With mycobacterial infections commonly known as opportunistic, I have to wonder if the vaccine altered my immune response, allowing for the mycobacterium to proliferate and cause a serious infection.
This was a medication error.  Patient requested Novavax as a booster dose, and one of our nurses administered the dose.  The patient's vaccine history was Dose 1 (Primary series):  Janssen COVID-19 vaccine 6/10/2021; Dose 2 (Booster dose): Janssen COVID-19 vaccine 12/15/2021.  Novavax is only approved for use as a booster for individuals who have completed a COVID-19 primary series and have not received any previous booster dose.  There was no adverse event at the time of vaccination.
This initial spontaneous case initially received on 02-Nov-2017, was reported by other non-health professional, concerns a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, expiry date: not reported). On unspecified date, after administration flu vaccine, the patient had allergy because of preservative in it. The outcome of the event was not reported. The reporter assessed the case as non-serious.
Fever developed the day after the vaccine and has lasted for 5 days. ( ongoing fever currently )Temp ranging between 101-102.7. Chills and body sweats. No other symptoms.
Fatigued, swellling and soreness in armpits for over a week, headache for two days, depression and moodiness, lack of appetite for several days after the shot
mom states immediately p/receiving MMR area became painful w/edema; erythematous patchy area @ site of inject; approx 2" in diameter; no fever, numbness tingling;
Received vaccine on 06/12/2018 and symptoms developed 06/16/2018: pustules (pencil-eraser-tip size), green, 6 inside mouth, and 1 outside mouth (larger on the outside of lip). 4-5 days they persisted, and then gone. Did not come back after.
Information has been received from a nurse referring to a 12 years old patient of unknown gender. On 25-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot number/exp date, dose were unspecified). On 10-FEB-2016, the second dose of GARDASIL 9 (lot number/exp date, dose were unspecified) was administered. On 22-APR-2016 the patient was vaccinated with the third dose of GARDASIL 9 (lot # L045711, expiration 08-MAY-2017, dose was not reported), with the third dose being administered sooner than the recommended dosing schedule (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
The patient consented to receive the vaccine at the facility on 1/31/21.  She admitted to the facility on 1/29/21.  She failed to inform us that she had already received her first vaccine at her rest home on 1/28/21.  Consequently she received 2 doses of the Pfizer Covid-19 vaccine within 4 days.  She had no adverse effects from either vaccine.
Patient was given an expired menveo vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19th April 2021, the patient received Menveo. On 19th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details was reported as follows: The patient received Menveo vaccine which was expired 19 days before administration, which led to expired vaccine used. The reporter did not consented to follow up.
Head, Myalgia, Fever, Rash,  CHILLS, SWOLLEN ARM Narrative:
Red rash itchy with around 8 bumps; Red rash itchy with around 8 bumps; Red rash itchy with around 8 bumps; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included CARVEDILOL, ATORVASTATIN, HYDROCHLOROTHIAZIDE and RIVAROXABAN (XARELTO) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy). The patient was treated with ACRIVASTINE (BENADRYL [ACRIVASTINE]) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 1 dosage form and TRIAMCINOLONE at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-229894 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant follow up updated on 21-Jun-2021
Information has bee received from a medical assistant (MA) concerning a 2-month-old male who on 29-JUN-2007 was vaccinated PO with a dose of Rotateq. The MA reported that on 29-JUN-2007, the patient spit up the dose after being vaccinated. Unspecified medical attention was sought. No other side effects were noted. At the time of this report, the outcome was unknown. Additional information has been requested.