chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired ACT-HIB dose was administered to a patient with no adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21-months-old and unknown gender patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2023, the patient received an unknown expired dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ792AA; expiry date: 06-Oct-2023) (Strength: standard; Frequency: Once) via unknown route in unknown administration site for Immunization with no adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  No additional information available at time of call; caller declined to respond to questions and has accepted follow-up.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
sore arm; chills; This is a spontaneous report from a contactable consumer from a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, chills on an unspecified date. Reported as, patient took steroids injection after the 1st dose. Patient had no side effects other than a sore arm and on the first shot had few chills on 2nd day. Outcome of all the events were unknown.  Follow-up needed. Information about batch/lot number has been requested.
Woke up with mild fever, chills, headache, weak, felt nauseous, where injection - redness, soreness, swelling, itching.
No visible symptom between vax administration at 4:15pm and bedtime at 8:00pm.  The next morning, patient had hives at vax site; he had itching and irritation that lasted 2 hours, then subsided on its own.
This spontaneous report as received from a pharmacist refers to a 53 year old female patient. The concurrent condition and medical history was not reported. On 19-MAR-2015, the patient was vaccinated with VAQTA lot # K002744, Expiry: 19-SEP-2015, dose 1. The concomitant medication was not reported. On 20-APR-2015, the patient was vaccinated with VAQTA dose 2 of the same lot (inappropriate schedule of vaccine administration). The patient has not experienced any adverse effect. No product quality issue was reported. Additional information has been requested.
swelling of the feet and legs/sewelling of my feet and leg; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the feet and legs/sewelling of my feet and leg) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling of the feet and legs/sewelling of my feet and leg). At the time of the report, PERIPHERAL SWELLING (swelling of the feet and legs/sewelling of my feet and leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pt recvd vax 930AM 11SEP92 & slept from 1130-430PM awakened t102.8 R, legs very sensitive-Tempra given slept until morning; 14SEP92 4PM noted rash;
This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A 69-year-old female patient of an unspecified ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date in Apr2012 single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced sweating profusely, trouble breathing, lungs were full, pneumococcal pneumonia and lower lung damage. The patient was hospitalized. The patient reported: "I was sweating profusely, trouble breathing. Was hospitalized with antibiotics being pumped into me, but nothing was helping, lungs were totally full as well as chest cavity. Had to have surgery and they opened up my back to dig the mucus out and did culture and knew it was pneumococcal pneumonia, so gave me another type of antibiotic to help me. Was hospitalized for 2 weeks and doctor said if I would have waited 2 more days, this would be a whole different story I am telling." She also has lower lung damage due to the illness and was told to be very careful if she gets a cough or gets sick. The clinical outcomes of the events were unknown. The patient received PREVNAR 13 after the events on 08Dec2015. No follow up attempts possible. No further information expected.
Myalgia, Arthralgia, fatigue, overall pain Narrative: Employee reports continuous symptoms of body aches, fatigue, and joint pain since receipt of vaccine ~6 weeks ago. Reports saw PCP and is pending an appointment with a rheumatologist. PCP prescribed meloxicam, and reports also using Tylenol arthritis (650mg). Reports increase in pain in left knee, left back, and right hand, which is interfering with range of motion and activities of daily living. Pain is ongoing, no resolution as of date of report.
Patient mentioned her husband received the same dose but only feel sore arms.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Patient mentioned her husband received the same dose but only feel sore arms.) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Walker user and Unable to walk.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient mentioned her husband received the same dose but only feel sore arms.). At the time of the report, PAIN IN EXTREMITY (Patient mentioned her husband received the same dose but only feel sore arms.) outcome was unknown.            Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741624 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741624:Wife case
Arm soreness; Itching injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Itching injection site) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Itching injection site). At the time of the report, PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Itching injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported. No concomitant medication reported.
received vaccine 7:30 am.   Began to have some discomfort in right hand and wrist around 4:00pm.  I have arthritis in that area as well as in the left  hand/wrist along with other joints.  I had knee replacement several years ago.   I also had some recent bursitis in the right elbow.   The injection was in the left arm.   By 8 or 9pm, my right hand and wrist were so painful, especially with any movement, I was almost screaming with pain.    I am not one to complain much, but this was terrible pain.   The pain was gone by 10 or 11 am this morning.
shingles; I developed sensitive skin; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Apr2021 at 13:00 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. Medical history included COVID-19 from 02Apr2021 to 12Apr2021 (had Covid starting 02Apr2021 - a light case lasting 10 days). The patient had no known allergies. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 06:00, 5 days after vaccination, the patient developed sensitive skin and muscle aches. 10 days after vaccine, the patient developed shingles. The patient's doctor told me to contact you. The patient still glad that got the vaccine. The patient had COVID starting 02Apr2021 - a light case lasting 10 days. The adverse events were resulted in doctor or other healthcare professional: office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 antibody test) was negative on 18Mar2021. Antiviral medication for shingles was received as treatment. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within an hour to two after my vaccine I felt extremely exhausted. The next day (Thursday), I couldn't read anything. For the whole weekend I could not read anything. Not blurry vision, just could not read. Also on Thursday, I started to not be able to concentrate. To this day I still have trouble concentrating. I also experience dizziness after my vaccine. For the next two weeks  I have had bad bout's of just feeling swimmy and weird. It has made me stay close to bed. I have been unable to do projects, I have had multiple migraines. For treatment, I have taken muscle relaxers and my migraine medicine as needed. I am going to see Dr. on 07/14/2021. I did see a doctor during a health fair on 07/09/2021 who recommended I see my doctor as soon as possible.
LUMP UNDER THE JAW; ITCHY; PAIN; SORE ARM; 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 and batch number: 180A9A0 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced lump under the jaw. On 11-APR-2021, the patient experienced itchy. On 11-APR-2021, the patient experienced pain. On 11-APR-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump under the jaw, sore arm, itchy, and pain. This report was non-serious.
Patient came in one week post vaccination stating that she had experienced severe arm pain at the injection site as well as severe itching from injection site radiating down to her bicep the day after vaccination. She explained she had headache, shivering, nausea, swelling at injection site, sweating, wheezing, coughing, and runny nose all lasting about one week post injection. Patient reported that she thought she was dying. But, one week post vaccine, she appeared to be doing better although she stated she was still having some mild soreness as well as itching from injection site down to bicep area. Will keep in touch with patient to follow symptom resolution.
Severe side effects / My whole body is paralyzed; Severe side effects / Numbness to his L arm. /  I can't feel my legs and my face; Severe side effects / Difficulty breathing and kept his mouth open; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 15-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3SM34, expiry date 4th December 2020) for prophylaxis.   In October 2019, the patient received Boostrix. On an unknown date, 10 min after receiving Boostrix, the patient experienced paralysis (serious criteria GSK medically significant), numbness and difficulty breathing. On an unknown date, the outcome of the paralysis, numbness and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the paralysis, numbness and difficulty breathing to be related to Boostrix.  Additional details were provided as follows: This case was reported by patient's mother. The age at vaccination was not reported. The patient received dose of boostrix and experienced whole body is paralyzed,numbness to his left arm, did not felt his legs, face and difficulty breathing. The reporter informed that paralysis lasted about 20 to 30 min and all this happened when she was was driving back home. The reporter stated that place where they went for the injection did not offered to monitor him for 15 min after the injection so called ambulance while driving as there was nothing near by. The reporter provided zip code. The reporter consented to follow up via email.
Tumor in muscle of uterus area; Lymph nodes swollen; Chest pressure; trouble breathing; Bloodwork is showing certain levels high; tired; forgetful; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration in arm left on 20Jan2021 at 14:00 (at the age of 50-year-old) as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in arm left on 20Jan2021 at 14:00 (at the age of 50-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history and concurrent conditions included herniated disks. The patient's concomitant medications received within 2 weeks of vaccination included gabapentin and oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]). It was reported that, the patient was not pregnant at time of vaccination. 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, has the patient been tested for COVID-19 was reported as no. On 01Feb2021 at 14:00, the patient experienced tumor in muscle of uterus area, lymph nodes swollen, chest pressure, trouble breathing, tired, forgetful. Bloodwork was showing certain levels high. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No prolonged hospitalization. Treatment received for the events was surgery. On 01Feb2021, the patient underwent lab tests and procedures which included bloodwork, resulted as high, certain levels high. The device date was on 11Jul2021. The outcome of the events was not recovered.
Induration circular area redness; Induration circular area redness; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]), KETOROLAC TROMETHAMINE (TORADOL), MORPHINE and IBUPROFEN for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness). On 01-Jan-2021, ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-024639 (Patient Link).
the evening of the second vaccine, patient had significant soreness and stiffness in her knee.  In addition she had an elevated temperature for 2 days with fatigue, malaise and body aches.  The knee issue progressed to require surgery for infection.  On 2/12 she woke up with  significant swell in in the area of the right temple and visual changes.  this is the area of her cranial plate from prior brain surgery.
No additional AE details; TE evaluation states vaccine had been administered; This spontaneous report was received from a medical assistant referring to an 11-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 3 hours and from -10 degrees Celsius to 8 degrees Celsius for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 25-APR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2205USA007821: US-009507513-2205USA007852:
The second evening after patient received the Varicella vaccine, my husband called me at work to tell me patient told him to look at his arm because it itched.  My husband, noticed a large, bright red, raised, bumpy, warm, irregular shaped reaction around the vaccination site.  This reaction sounded very similar to my daughters reaction just after she received her second varicella vaccination 2 days prior to my son receiving his, only my sons was larger--about 4 in X 3 in.  My husband treated it the same way we were told to treat my daughters reaction.  He mixed 1 quart of warm salt water with 2 Tbsp salt, soaked a washcloth in the solution and applied it for 15 minutes, then applied an antibiotic ointment.  When I got home that morning, my husband noted it did not look as red, but I could see it was raised, dark pink in the middle, white around the edges, bumpy towards the center and warm to the touch.  My son said it did not itch anymore or hurt. We continued to treat it with the solution and antibiotic ointment twice a day.  This evening it looks slightly less red and warm, but is still swollen, bumpy and looks as if there was a reation.  We contacted Dr. to alert her of patient's reaction since we had taked his sister in for the same reason, just the day before.  We will continue to monitor the site, treat as we stated earlier and pray for its total resolvement.
Extreme pain in both shoulders that has lasted for a week. I feel an intense sharp pain within my shoulder, not in the deltoid region. I can't physically move my shoulders from the sharp pain that I have. It feels like nerve pain within my shoulder, not the muscle. My primary care physician prescribed Methylprednisolone 4mg dospak 21S. The pain has started to subside some, but my full range of motion is not completely back.
Charlie horses in leg muscles , back muscles , abdominal muscles , arms hands, feet  and neck all at the same time !!! I have never experienced pain like that I was  paralyzed  in pain !
Swollen and painful lymph node in arm pit of arm that received vaccination.   Also got Flu vaccine at the same time in the same arm.  Lymph node about the size of a grape and painful on palpating and when moving arm.
Three days after the second dose of the vaccine I woke up and I could not see. My vision was blurry, and I was seeing double. It lasted for two days all day and than it went away. I went to the ER and I was Tachycardic. I went to the Ophthalmologist and there was no evidence of damage. Two weeks after the vaccine I had symptoms of a Stomach Virus with vomiting and diarrhea.
15 minutes after the vaccination, I developed a small red rash on the site. 2 days from the vaccination, the site is reddened, hard, and itchy
swollen arm--firm and hot beginning at the shot site--symptoms remained localized one day after receiving his shot.  progressed over the weekend to include: itching--there was some progression of itch distally--arm and proximally--into his neck on day 2 persistence of symptoms on day 3 and this morning (day 4) his shoulder was less swollen and the swelling was less tense -itching was mild and he experienced no sleeplessness,  -by day  pmhx: -asthma allergies, severe hayfever and they are considering getting him allergy tested and starting immunotherapy -he also is easily sunburned  -excessive swelling to mosquito bites -has never had a reaction to vaccines in the past swollen arm--firm and hot beginning at the shot site--symptoms remained localized one day after receiving his shot.  progressed over the weekend to include: itching--there was some progression of itch distally--arm and proximally--into his neck on day 2 persistence of symptoms on day 3 and this morning (day 4) his shoulder was less swollen and the swelling was less tense -itching was mild and he experienced no sleeplessness,  -by day
Vaccine on January 22. Rash close to injection site began on Friday, January 29. Area got larger on Saturday and Sunday January 30 and 31. I think it is called covid arm. Put Benadryl cream on it.