chrisvoncsefalvay/vaers-outcomes huggingface dataset:
His skin went grey for a time; Stayed in bed three days; Had to crawl because he could not stand up his feet; feet and ankles were burning; His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle; sore feet/ his feet started hurting; His feet started hurting and he could barely walk; Joint pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting), GAIT DISTURBANCE (His feet started hurting and he could barely walk), SKIN DISCOLOURATION (His skin went grey for a time) and MOBILITY DECREASED (Stayed in bed three days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced ARTHRALGIA (Joint pain) and FATIGUE (Tiredness). On 15-Jul-2021, the patient experienced JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting) and GAIT DISTURBANCE (His feet started hurting and he could barely walk). On an unknown date, the patient experienced SKIN DISCOLOURATION (His skin went grey for a time), MOBILITY DECREASED (Stayed in bed three days), DYSSTASIA (Had to crawl because he could not stand up his feet) and BURNING SENSATION (feet and ankles were burning). The patient was treated with NAPROXEN SODIUM (ALEVE) for Joint pain, Knee swelling and Sore feet, at a dose of 1 dosage form. On 14-Jul-2021, ARTHRALGIA (Joint pain) and FATIGUE (Tiredness) had resolved. At the time of the report, JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting), GAIT DISTURBANCE (His feet started hurting and he could barely walk), SKIN DISCOLOURATION (His skin went grey for a time), MOBILITY DECREASED (Stayed in bed three days), DYSSTASIA (Had to crawl because he could not stand up his feet) and BURNING SENSATION (feet and ankles were burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Today at 9:55am 15 minutes after COVID Pfizer vaccination in left arm patient complained of localized itching at the injection site. Patient denies rash, metallic taste in mouth,  hives, wheals,  swelling of lips, face, tongue, respiratory distress, shortness of breath, wheezing,bronchospasam, stridor, headache, dizziness, vomiting, nausea, abdominal pain, urinary incontinence, itching eyes or nose, sneezing, clear watery eye  discharge, nasal discharge. Provided Benadryl 12.5 mg PO X 1 dose. No cardiopulmonary or neurological distress noted. Monitored until 10:50 am. Provided juice and crackers. Itching resolved prior to leaving office. Left office in stable condition with mother.
Fever of 101.5, which persisted  for 3 days.  Headache for two days (04/09 PM thru 04/11) not elevated by 2X Tylenol dose. Pain and swelling at the vaccine sight. Left upper arm swelling and hot (102.4 with digital thermometer. Marked swelling in underarm (arm pit) grossly visible (photos taken) and arm it temp over 102 to 2 days and over 101 for 4 more days (total of 6 days) with notable swelling and elevated temperature in the area.  Appears normal at day 8 DPI.  This is the most adverse reaction I have ever had to any vaccine in my memory. As I have been working in Asia, I have had several vaccines in my life and in recent years. Never a reaction like this.
Redness, swelling, fever (localized & generalized redness w/induration approx 10cm in diameter;
Diarrhea and stomach pain started on day 5 after the shot.  Lasted for 5 days.  Dizziness and vertigo started in day 9 and is still persisting and getting worse through day 12. Had to call in sick from work; interfering with work in computer; walking, bending, turning head from side to side. The feeling is always near faint. Considering not to get second shot. The dizziness is just too severe.
staff member gave the liquid portion of PENTACEL to a 4 month old with no reported AE; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old patient of unknown gender to whom staff member gave the liquid portion of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine [Pentacle] portion and not HIB (PRP/T) Vaccine[ACT-HIB] portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the a staff member gave DTAP/IPV portion of the vaccine (lot - U7130AA) (strength, dose, route, formulation, expiry date not reported) via unknown route at  unknown administration site for Immunization and not the ACTHIB portion to a 4 month old with no reported adverse event (Product preparation error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
New redness and itching at injection site starting 1/23. Redness and itching continued spreading and increasing through majority of 1/24. Area increased to ~1.5-2in wide x ~4in long before beginning to subside quickly 1/24 night.  Oral Benadryl and topical hydrocortisone cream used PRN for itching/possible allergic reaction throughout course of event.
Slight pain at the injection site; Lowgrade headache; This is a spontaneous report from a contactable consumer (patient spouse) who reported for himself and his wife. This is the second report of the two reports reported by the consumer: the consumer wife.  A 69-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, first dose on 07Jan2021 (Lot Number: EJ1685) and second dose on 07Feb2021 (Lot Number: EN53182) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported that no real side effects were encountered except slight pain at the injection site and low-grade headache that resolved within 24 hours. The outcome of the events was resolved. ; Sender's Comments: Linked Report(s) :  same reporter/drug/AE, different patients
Lupus flare; Rash / Rash itches as it fades; Arthritis aches; Headaches; Interfered with my sleep; Skins continued to itch; This case was reported by a consumer via call center representative and described the occurrence of sle flare in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nonspecific reaction (received 1st dose on 28th August 2019). Concurrent medical conditions included systemic lupus erythematosus (from many years and had to be very patient to get back to normal).   On 30th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced sle flare (serious criteria GSK medically significant), itchy rash, pruritus, arthritis, headache and sleeplessness. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the sle flare, itchy rash, arthritis, headache and sleeplessness were recovering/resolving and the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the sle flare, itchy rash, pruritus, arthritis, headache and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient had 2nd injection and had severe reaction that caused Lupus flare rash, arthritis aches, headaches beginning the next day, the rah itched as it faded and the skin continued to itch for 4 o 5 weeks afterwards which interfered with sleep. The patient had already informed about the lupus but was told that it did not mattered, which was after the patient checked it out with the person who gave injection and told that there were no reported side effects from the injections. The patient used cortisone cream n on the reaction which caused her thrush. The patient received additional medicines for that it went on and on. The side effects were not completely resolved
Case number PHEH2014US013390 is an initial spontaneous report received from a healthcare professional (medical assistant) on 02 Jul 2014. This report refers to a 12 year old female patient. Her medical history and concomitant medication were not reported. She was inadvertently vaccinated with two doses of MENVEO both intramuscularly at a dose of 0.5 ml on 10 Jun 2014 (batch number: A12012) and on 01 Jul 2014 (batch number: A13065). No adverse event was reported following this administration error.
Received MMR. 14 days later developed pain, swelling and redness in right wrist.
DIALYSIS 2 DAYS AFTER COVID VACCINE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced dialysis 2 days after covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dialysis 2 days after covid vaccine was not reported. This report was non-serious.
Patient attended the COVID Vaccine clinic at School on 11/29/21 between the hours of 1530-1800.  When she approached our registration station to have her child vaccinated, she inquired about getting her booster dose.  The registrar did look up patient to confirm that she was eligible however, her last dose of Pfizer was administered on 06/16/2021 which would not render her eligible until 12/16/21.   Additionally, contrary to what patient was advised she did receive a vaccine and the date was missed by the vaccinator (RN) as well.  Unfortunately, the incident was not discovered until 11/30/21 (the next morning) post our vaccine clinic when our vaccine manager reconciled the paperwork to be entered into the Information System. Patient was phoned and advised of the medication administration error on 11/30/21 in 1830.  I explained that she was not eligible for another 2 + weeks and she did not seem concerned.  Patient went on to advise me that she has Asthma and that she had just recently gotten over pneumonia.  I did provide patient with my contact information if she had any questions, concerns, or if she experiences any adverse reactions soon to not hesitate to be seen by a medical provider and to advise me. Patient did advise me that she is doing well post vaccination and only has a sore/tender arm.
2hr p/vax pt became lethargic & slow to respond;pt recovered w/in 30min mom phoned provider;no office call or ER
Red, swollen, warm to touch and painful unable to bear weight on leg. (Right leg).
This spontaneous retrospective pregnancy report as received from a pharmacist refers to a 25 year old female patient. On 14-JUL1989 the patient was vaccinated with one dose of MMR II (lot # and dose not reported). On 10-APR-1990, the patient was vaccinated with one dose of RECOMBIVAX HB (lot # and dose not reported). The patient became pregnant. The LMP and EDD is not known. The patient delivered a infant. The pregnancy outcome was unknown. The pharmacist reported that the patient failed to seroconvert with one dose of each MMR II and RECOMBIVAX HB that she received a child on an unknown date (the LMP and EDD were not known). The pregnancy outcome was unknown. At the time of reporting, the patient was not a pregnant. It was reported that the patient had not recovered from these events. Additional information has been requested.
Chest pressure; Hives on both ears, both cheeks side of face, both legs, both arms; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest pressure) and URTICARIA (Hives on both ears, both cheeks side of face, both legs, both arms) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) and URTICARIA (Hives on both ears, both cheeks side of face, both legs, both arms). On 11-Jan-2021, CHEST DISCOMFORT (Chest pressure) and URTICARIA (Hives on both ears, both cheeks side of face, both legs, both arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment included lots of water.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Baby had a series of inconsolable screaming while crying that started after the injection was given. Two days after the injection, he was found with a pale grey complexion, unresponsive & not breathing. He was found quickly enough that we were able to bring him to and then brought him to the ER to be monitored. The more I research about vaccines, the more sickened I become by them. Giving a newborn any amount of formaldehyde, mercury, aluminum, and aborted fetus cells is both disturbing and unethical.
No additional symptoms reported; expired  "adult dose " of VAQTA was administered to an 15 year old patient; expired  "adult dose " of VAQTA was administered to an 15 year old patient; expired  "adult dose " of VAQTA was administered to an 15 year old patient; This spontaneous report was received from a medical assistant refers to a 15-year-old patient of unknown gender. The patient's pertinent medical history, concurrent condition, concomitant therapies and drug reactions/allergies were not reported. On 20-NOV-2019, the patient was vaccinated with an expired dose (also reported as " expired adult dose") of hepatitis a vaccine, inactivated (VAQTA) with lot # R025518 has been verified to be a valid lot number for (hepatitis a vaccine, inactivated), expiry date reported as 15-NOV-2019 (strength, dose and route were not reported) for prophylaxis (incorrect dose administered, product administered to patient of inappropriate age and expired product administered). No additional symptoms (adverse event) was reported. The reporter stated that the product was stored properly. No product quality complaint was reported. The outcome of incorrect dose administered, no adverse event, product administered to patient of inappropriate age and expired product administered was unknown.
temperature is 99.9 Fahrenheit  today; moderate left shoulder joint pain; has swelling; bump just a size of a quarter/bump has now grown to 3-4 inches in diameter; slight reddish round bump on the left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (bump just a size of a quarter/bump has now grown to 3-4 inches in diameter), PYREXIA (temperature is 99.9 Fahrenheit  today), VACCINATION SITE ERYTHEMA (slight reddish round bump on the left arm injection site), ARTHRALGIA (moderate left shoulder joint pain) and VACCINATION SITE SWELLING (has swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden mutation.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (slight reddish round bump on the left arm injection site). On 17-Aug-2021, the patient experienced SKIN MASS (bump just a size of a quarter/bump has now grown to 3-4 inches in diameter), ARTHRALGIA (moderate left shoulder joint pain) and VACCINATION SITE SWELLING (has swelling). On 19-Aug-2021, the patient experienced PYREXIA (temperature is 99.9 Fahrenheit  today). At the time of the report, SKIN MASS (bump just a size of a quarter/bump has now grown to 3-4 inches in diameter), PYREXIA (temperature is 99.9 Fahrenheit  today), VACCINATION SITE ERYTHEMA (slight reddish round bump on the left arm injection site), ARTHRALGIA (moderate left shoulder joint pain) and VACCINATION SITE SWELLING (has swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient taken her last dose of antibiotics for UTI on her vaccination day . Patient takes an anti-coagulant whenever she travels for she had a blood clot on her leg 3 years ago. No treatment details were provided by reporter.
PATIENT PRESENT AT INITIAL VACCINATION CLINIC 1/28/21--DOSE NOT DELIVERED PER PATIENT/VACCINE ADMINISTRATOR REPORT-PATIENT FOLLOWED UP WITH PCP FOR ANTIBODY LEVEL TO CONFIRM. PATIENT TO RECEIVE SECOND DOSE DURING RECOMMENDED INTERVAL OF 28-42 DAYS FROM INITIAL VACCINATION WITH MODERNA PRODUCT 3/5/21.
"normal sort of side effects"; Fatigue; Mild fever after those; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION ("normal sort of side effects"), FATIGUE (Fatigue), PYREXIA (Mild fever after those) and INJECTION SITE PAIN (Pain at the injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cold sores. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Cold sores, SERTRALINE HYDROCHLORIDE (SERTRALINE [SERTRALINE HYDROCHLORIDE]) and ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]) for an unknown indication.    On 22-Jan-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 VACCINATION COMPLICATION ("normal sort of side effects"), FATIGUE (Fatigue), PYREXIA (Mild fever after those) and INJECTION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION COMPLICATION ("normal sort of side effects"), FATIGUE (Fatigue) and PYREXIA (Mild fever after those) outcome was unknown and INJECTION SITE PAIN (Pain at the injection site) had resolved.        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.   The reporter was calling on behalf of the patient who after the first vaccine, had normal sort of side effects pain at the injection site, which was temporary and experienced fatigue, mild fever after those and did not have any cutaneous reactions to the dose.  No treatment information was provided.   This case was linked to MOD-2021-402965, MOD-2021-403274, MOD-2021-402691 (Patient Link).
dizziness, lightheaded, panic attack; seen & cleared by EMS. B/P-184/98, P-79; repeat B/P-165/94 and client took own anxiety medication, Klonopin as directed by EMS.
This spontaneous report as received from a nurse refers to a 13 years old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Itching; Rash in the area 2 x 4 in; Arm hurt a little bit for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt a little bit for a few days), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash in the area 2 x 4 in) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information reported .  Concomitant products included ANASTROZOLE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt a little bit for a few days). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash in the area 2 x 4 in). The patient was treated with PARACETAMOL (TYLENOL) from 12-Jan-2021 to 13-Jan-2021 at an unspecified dose and frequency. On 14-Jan-2021, PAIN IN EXTREMITY (Arm hurt a little bit for a few days) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching) had not resolved and VACCINATION SITE RASH (Rash in the area 2 x 4 in) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication included blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information received  contains non-significant information On 13-May-2021: Additional info added 2nd shot details.