chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4-5 days post-vaccination: Continued soreness at injection site, itchiness at injection site, and on day 5 a visible red patch on arm at injection site   (Reporting this on day 5 since most information indicates this is more common with Moderna than Pfizer and more common after dose 1 than dose 2.) (Earlier reaction had included 24 hours post-vaccination of chills, fever, fatigue lasting 8-10 hours)
Patient had severe arm pain, could hardley move arm.  Slightly better today, still difficult to move.  Pt went to MD, used Motrin and hot and cold packs for pain.
fever shot to 103; Vomiting; Headache; Body pain; Arm swoll to double its size from shoulder to elbow; Pain in my feet; Broke blood vessels in my upper body; Dry heaving.; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unknown route of administration on right arm the 20Mar2021 at 10:15 (age at vaccination 49-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took VIOXX, LEVEQUIN and DEMEROL; developed allergy for all the drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 10:30 (within 15 minutes), the patient experienced nausea, overwhelming headache, body pain, right arm was swollen to double its size from shoulder to elbow and the patient broke her blood vessels in upper body from dry heaving. At 11:00, nausea led to vomiting and the patient could not hold any liquids. At 12:30, the patient had fever 103 (units unspecified). The events of vomiting and nausea were debilitating for the next 24 hours and patient's overall body pain became unbearable. The major effects lasted more than 24 hours. On an unknown date in Mar2021 (72 hours after vaccination), the patient was still feeling nauseated, body pain was still off and on, and patient felt she was having flu at that point and stated first 24 hours was a nightmare. Therapeutic measures taken as results of events and included treatment with BENEDRYL or TYLENOL, but she couldn't hold down anything. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of events nausea, vomiting, headache, body pain, arm swollen, pain in feet, fever, Injury to blood vessel of head and neck and dry heaves were recovered with sequalae on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Slight trembling chills, worsening gradually to shaking chills throughout the next 20 hours.  No fever.  Weakness.
Information was received 02 May 2008 from a health care professional. A 4-year-old male patient had received an injection of IPOL, lot number A0298-2 (date, route and site of administration not provided) and on 24 March 2008, he subsequently developed a black dot at the injection site. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. This patient's case was one of four cases reported from the same satellite site. This report (2008-01427) and case numbers 2008-01338, 2008-01428 and 2008-01429 case from the same satellite location. All facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would provided as it is obtained. The reporter for this case is the same as for case numbers 2008-01333(IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338, 2008-01339 (Fluzone), 2008-01428 (IPOL), and 2008-01429 (IPOL).
Chills, Nausea, fatigue, vomiting, fever 101, headache, muscle pain, joint pain. Lasted for 12 hours. 3am-3pm.
No additional AE reported; a consumer received a dose of PNEUMOV AX 23 on June 24, 2019 and a second dose on September 21st, 2020; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-JUN-2019, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 21-SEP-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) (Inappropriate schedule of vaccine administered). No additional adverse event was reported.
Extreme joint pain, headache, not able to lift left arm starting app. 8 hours after injection.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Patient had localized raised red rash to right thigh where vaccines were given.  Per Father he noticed this reaction after he took the band aid off.
onset 1 hrs p/vax administration of high pitched screaming cry x 2 1/2 hrs;
Patient got PNEUMOVAX 23 shot 12/19/17 in the morning. By evening the arm was swollen, red and itchy from shoulder to elbow. It was uncomfortable to lift. Patient was advised to take Ibuprofen, BENADRYL and a cold compress.
Incredible soreness and difficulty moving that arm that has NEVER gone away. Ever since the second dose that arm is sore every single day in varying degrees. the spot itself is still tender to the touch. Occasionally that shoulder becomes inflamed and the muscle hard. On good days it is just a bit sore. On bad days I am barely able to move it. 8 months later. Very painful. I'm in pain ever since every single day and nobody really cares or responds or does anything except tell me to get another dose. I am terrified I will lose all mobility in that arm and become handicapped permanently if I do. There is no help for this. I felt forced to get it and still can't get a job.
sick in bed for 1-2 days; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 2nd dose of the Shingrix vaccine, he was sick in bed for 1 to 2 days.  The reporter did not consent to follow up
Patient experienced swelling of the face, eyes, and lips, and a burning sensation in her throat and chest.  We called 9-1-1 to check vitals and they recommended going to her doctor or the hospital in case of additional swelling.  We called the doctor and they told us to try Benadryl.  This worked a little bit, but she is still in a lot of discomfort today (Saturday after Thursday shot).
pt exp nausea about 1hr p/vax;@ 24hr nausea persisted associated w/vomiting but no fever;redness & small induration of 4cm @ inj site;
Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma. Concomitant products included CARBAMAZEPINE (TEGRETOL), ASCORBIC ACID (VITAMIIN C), TIMOLOL, BRIMONIDINE TARTRATE (ALPHAGAN), PILOCARPINE, ALBUTEROL SULFATE, AMLODIPINE and LISINOPRIL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was reported to have dizziness before first dose of vaccine after which it got worse.  Patient was advised to take meclizine by her HCP but she did not as she investigated it may worsen her glaucoma.
lt leg swelled twice the size of rt leg; had high fever; does not know how high because did not take temp; rash on lt leg; took pt to ER; seen by  MD; dx local react-OM;
Always confuse the PEDVAXHIB and DILUENT because their boxes look the same; Always confuse the PEDVAXHIB and DILUENT because their boxes look the same; No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient reported to confuse the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered as prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided); with the sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose, frequency, lot #, expiry date, route of administration, and indication were not provided) as their boxes looked the same (product packaging confusion).  The patient did not provide additional information to clarify if the confusion had ever led to a medical error (circumstance or information capable of leading to medication error).  No additional adverse events were reported (no adverse event).
Presented to Clinic on 8/4/06 with c/o HA, L arm swelling, body aches and lethargy. MD diagnosed as normal smallpox vaccine reaction, orders given to keep site covered, Motrin 400mg qid, and return to duty.
Received 1st Anthrax shot on 7 May 03. Noted gradual onset of pruritic, crusting facial rash over next several weeks. He received a second Anthrax shot on 21 May 03. Rash became more pruritic and 'burning' shortly thereafter but without increase in number or severity of lesions
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with VARIVAX (Merck) (lot, dose and route not reported), exposed to temperatures outside of the proper range. Concomitant medication was not reported. No adverse effect reported. This is one of two reports from the same source (1406USA005491). Additional information has been requested.
CVA recrudescence (no acute new stroke) and found to have myocarditis. Poor historian so did not endorse frank chest pain or dyspnea consistently.
Received Pfizer vaccines on 3/18/21, 4/8/21 Tested positive for COVID-19 (and Influenza A) by PCR on 4/11/22. Admitted to Hospital on 4/14/22 d/t acute hypoxemic respiratory failure, in ICU on BiPAP, diagnosed w/ pneumonia d/t COVID-19. Underlying Type 2 DM, CAD, asthma.
Worst shot ever. So much pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the Shingles vaccine and experienced so much pain and due to this the patient did not receive the 2nd dose.
I started having a cough and sinus problems about a week after the 1st shot.  It didn't get better or worse until I had my second shot. A week after the second shot I went to the Emergency room because my cough and sinuses were not getting better just worse. I was also having random heart palpitations and increased heart rate.  I am still having congestion and cough but it is starting to get better.
7 days after getting vaccine, I developed red itchy rash under injection site.  Arm soreness, which had resolved, returned.  Also, that same day I developed a non-itchy blotchy rash on my back, stomach & chest.  The arm rash has faded somewhat & itching stopped.  However the blotchy rash has remained
Patient had swelling, redness, and itching from the injection site all the way down to her elbow that had persisted for 4 days.  Patient visited medical doctor who did not prescribe medication but recommended she return to the pharmacy to show reaction.  At that time, she was told by RPh to take Benadryl as directed on package and watch site.  If no better within a couple of days or if worse or red streaks were noticed from site, then patient was told to seek medical treatment immediately. Pharmacy manager will contact patient within 2 days to check on progress. Patient did not report anaphylaxis at any time.
1. Nausea next morning - 2. Dizziness next morning and day 2 after shot - 3. Left arm stiffness unable to straighten. MSD-Merck 1190Y  Jan 22, 2011 exp date.
Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 14 years old male patient who received vaccine IPOL which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jul-2018, the patient received a dose of suspect IPV (VERO) (lot N1G411M, expiry date: 28-Jul-2019) in the left arm. It was a case of actual medication error due to incorrect product storage. The patient was administered with IPOL that was not valid due to temperature stability. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by sender: none.
Back pain; BULGING DISC IN NECK; COVID VACCINE ISSUE/SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC IN NECK) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid arthritis.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC IN NECK) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM). At the time of the report, BACK PAIN (Back pain) had not resolved and INTERVERTEBRAL DISC PROTRUSION (BULGING DISC IN NECK) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM) outcome was unknown.            Concomitant medications were not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient's back pain had worsened. Treatment information was not provided.
Missed miscarriage; appendicitis; colitis; unilateral lymphedema of entire left leg (unable to walk/pain); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Lot number: El3247) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Latex and rubber sensitivity" (unspecified if ongoing); "known allergies: nickel" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Date of last menstrual period: 12Dec2020. The patient was 6 weeks pregnant at the time of exposure to bnt162b2. The patient was 8 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 08Sep2021. The patient took concomitant medications (prenatal vitamins). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ej1685, Location of injection: Arm Left), administration date: 24Dec2020, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: ABORTION MISSED (hospitalization) with onset 10Feb2021 12:00, outcome "recovered" (2021), described as "Missed miscarriage"; APPENDICITIS (hospitalization) with onset 10Feb2021 12:00, outcome "recovered" (2021), described as "appendicitis"; COLITIS (hospitalization) with onset 10Feb2021 12:00, outcome "recovered" (2021), described as "colitis"; LYMPHOEDEMA (hospitalization) with onset 10Feb2021 12:00, outcome "recovered" (2021), described as "unilateral lymphedema of entire left leg (unable to walk/pain)". The patient was hospitalized for abortion missed, appendicitis, colitis, lymphoedema (hospitalization duration: 2 day(s)). The events "missed miscarriage", "appendicitis", "colitis" and "unilateral lymphedema of entire left leg (unable to walk/pain)" were evaluated at the physician office visit and emergency room visit. The patient reported missed miscarriage, which then led to colitis and appendicitis with need for appendix removal, then some type of unilateral lymphedema of entire left leg (unable to walk/pain) ruled out DVT/infection of leg, no fracture or break. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Feb2021) negative. Therapeutic measures were taken as a result of abortion missed, appendicitis, colitis, lymphoedema and included IV Antibiotics, IV fluids, appendectomy.
PREVNAR 13 ordered from pharmacy, PNEUMOVAX 23 received. Staff reviewed order and vial, PNEUMOVAX 23 returned to pharmacy. PREVNAR 13 then received and administered.
Approx. 10 minutes after receiving vaccine pt passed out and became unconscience for approx 1 minute.
Patient received the vaccine at 3:25pm. Patient then started feeling "off" and tongue started swelling and patient was having trouble talking. Patient then starting wheezing. Oxygen saturation was checked and was above 90%. Patient received epi at 3:35pm as patient's symptoms were worsening. The epi helped and patient returned to baseline. PCP was called and was present when epi was administered.
they got an allergy / a possible allergy to a patient getting  the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ALLERGY TO VACCINE (they got an allergy / a possible allergy to a patient getting  the Moderna vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (they got an allergy / a possible allergy to a patient getting  the Moderna vaccine). At the time of the report, ALLERGY TO VACCINE (they got an allergy / a possible allergy to a patient getting  the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.  The reporter asked whether the vaccine was made of any yeast or the whole product was made of yeast or not as the patient had an allergy to the vaccine.
headache; fever; tired; hot and cold; bone and joint ache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), PYREXIA (fever), FATIGUE (tired), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and PAIN (bone and joint ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache), PYREXIA (fever), FATIGUE (tired), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and PAIN (bone and joint ache).            Reporter did not allow further contact