chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Dose 2 on 14Apr2021; Left sore arm especially when lying on it; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (Received Dose 2 on 14Apr2021) and MYALGIA (Left sore arm especially when lying on it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 015M20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included AMLODIPINE, ATENOLOL, METFORMIN, VITAMIN D [VITAMIN D NOS], ROSUVASTATIN, MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) and VITAMINS NOS 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 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (Received Dose 2 on 14Apr2021) and MYALGIA (Left sore arm especially when lying on it). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (Received Dose 2 on 14Apr2021) had resolved and MYALGIA (Left sore arm especially when lying on it) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-076941 (Patient Link).
Reported generalized itchy hives that lasted for 6 days. Resolved with benadryl. Saw PCP Doctor already.
Fever up to 101.4 degrees F- fever persistent for >48 hours Muscle aches Left axillary lymphadenopathy/pain Headache Neck pain Nausea Chills/Sweats Injection site pain
Two adverse events: (1) Persistent cough. Would cough at random times uncontrollably  for many minutes unable to stop. Began subsiding around June 18 and was gone by June 25. (2) On April 25 started to feel sharp pain inside right thumb. Pain increased steadily until extremely painful. On May 5 the top right of the thumb began getting very red. By May 16 pain was unbearable. on May 20 notice it was clearing, but by May 23 it was worse. Went to Urgent care: Diagnosed as PARONYCHIA. Lanced and drained infection. Note that this infection started deep inside the thumb and moved out. No skin wounds. Urgent care ordered chest Xray for the cough but it was negative. Never a fever during any of this. Nail 1/3 dead now.
Information has been received from a registered nurse concerning a 6 year old female with no pertinent medical history and no known allergies who on 24-AUG-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#658419/1027U). There was no concomitant medication. On 24-AUG-2007, the nurse was uncertain of the route in which the vaccine was given, she was not sure if she aspirated prior to administration. After administering the dose she noticed that there was blood in the syringe. The patient developed some bruising at the injection site. Unspecified medical attention was sought. The patient was instructed to place ice on the site. No lab studies were performed. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Initial unsolicited report received from a consumer on 05-Jan-2016. This case involves a 46-year-old female patient who was vaccinated with a 0.5 ml intramuscular dose of ADACEL (batch number was not reported) in left arm on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, next day after the vaccination (day two as reported) the patient experienced pain as expected, swelling around site, hard like an egg, itchy, hot and patient was tired. It was reported that swelling was 2" wide and 1" high. Lab tests were not reported. Patient had treated herself. Patient was recovered from the event. It was reported that all the symptoms were subsided 48 hours after the shot except but the knot which lasted for a month. Documents held by sender: none.
6 weeks post-vaccination experienced consistent tingling in feet.  8 weeks post vaccination, pins and needles and tingling in both arms from hands to elbows and in both legs from feet to knees.  Tinnitus that I have had for years also became louder.  Muscle tightness in calves and backs of arms and lower back muscles on either side of spine very tight at all times.  These symptoms are still present today.  Was diagnosed with a variant of Guillain Barre or Transverse Myelitis.  Neurologist would not confirm that this is due to COVID shot - he stated, "we just don't know."
Swelling in his feet; This is a spontaneous report received from contactable reporter (consumer) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 27Jul2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 69 years for COVID-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: He has little things he is allergic to but nothing major.; "Diabetic" (unspecified if ongoing), notes: He also has diabetic strips that he uses for his meter.; "Amyloidosis in the heart" (unspecified if ongoing). Concomitant medications included: VYNDAMAX oral taken for cardiac amyloidosis, start date: Jul2022; HYDROCODONE; GABAPENTIN; LEVOTHYROXINE; AMLODIPINE; METOPROLOL SUCCINATE; IBUPROFEN; PANTOPRAZOLE; METFORMIN; ASPIRIN [ACETYLSALICYLIC ACID] oral; ATORVASTATIN; ALLOPURINOL oral; FOLIC ACID; THIAMINE; VITAMIN B12 [VITAMIN B12 NOS]; MULTIVITAMINS. Vaccination history included: BNT162b2 (lot number: EL9266, as dose 1, single), administration date: 24Feb2021, when the patient was 67-year-old, for COVID-19 immunisation; BNT162b2 (lot number: FN6199, as dose 2, single), administration date: 17Mar2021, when the patient was 67-year-old, for COVID-19 immunisation; BNT162b2 (lot number: FD0809, as dose 3 (booster), single), administration date: 02Dec2021, when the patient was 68-year-old, for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "not recovered", described as "Swelling in his feet". Additional information: The patient experienced swelling in his feet. He received the second booster of the COVID-19 vaccine on 27Jul2022 and noticed that the swelling started after he received the shot. He wanted to know if swollen feet are a reported side effect after receiving the COVID-19 vaccine. Overnight, the swelling goes away, but then during the day, it seems to come back. It started either the end of Jul2022 or beginning of Aug2022. The swelling was in both feet, and it's about the same as when it first started. There was no redness or warm temperature with the swelling. At the time of reporting, his feet were starting to swell, but it was good this morning.
Reaction to MCV4. 2 red swollen areas (R) upper arm 6.7 cm slightly erythematous-splotchy region (R) upper arm.
PATIENT CALLED AND REPORTED SWELLING, REDNESS, WARMTH, AND DIFFICULTY MOVING ARM
Pediatric Monovalent (6 months to 5 years) was incorrectly administered for patient anticipating adult Bivalent dose
Immediately after receiving the vaccine I felt fine. Around 7 pm that night I began having body aches that continually worsened throughout the night. At 2 am on Saturday I took my temperature and it was 101.6 F, at 3 am it was 102 F. The body aches, joint pain, fever, and headache continued through the next day until about 6 pm on Saturday. Also on Saturday around 12 pm I began experiencing severe nausea, abdominal pain, and dizziness. At one point it felt as if I was going to pass out. All the major symptoms finally subsided Saturday night around 6 pm. Saturday till Sunday I have felt fatigued and sore but otherwise fine.
Itching at the vaccination site; I notice it was red; Swollen, Bump under the skin; Patchy red, Rash type thing; Arm was pretty sore,Hurt to raise my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was pretty sore,Hurt to raise my arm), VACCINATION SITE PRURITUS (Itching at the vaccination site), VACCINATION SITE ERYTHEMA (I notice it was red), VACCINATION SITE SWELLING (Swollen, Bump under the skin) and RASH (Patchy red, Rash type thing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder and Plasma cell disorder NOS (abnormal plasma cells so they don't produce antibodies or strong antibodies.).    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was pretty sore,Hurt to raise my arm). On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the vaccination site), VACCINATION SITE ERYTHEMA (I notice it was red), VACCINATION SITE SWELLING (Swollen, Bump under the skin) and RASH (Patchy red, Rash type thing). At the time of the report, PAIN IN EXTREMITY (Arm was pretty sore,Hurt to raise my arm), VACCINATION SITE PRURITUS (Itching at the vaccination site), VACCINATION SITE ERYTHEMA (I notice it was red), VACCINATION SITE SWELLING (Swollen, Bump under the skin) and RASH (Patchy red, Rash type thing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
18 year old male with no known history of allergies presented to covid-19 vaccine pod for first dose of Pfizer. After vaccine administration  patient sat during holding area and started to have dizziness, vision changes, tingles in left arm and hot flash. Patient appeared pale with no diaphoresis noted no change mental status. Alert and oriented x 3. Vitals BP 88/53 HR 88 Respirations 17 Pulse Ox 98% Patient admitted to eating only one bowl of cereal and one glass of water for the entire day. Patient denied any SOB, chest pain, swelling or tingling sensation around mouth or tongue however report heart racing. Patient observed for 15 minutes and given water and snack which patient noted to have improvement. Color returned to face. Vitals BP 110/67, HR 89, R 18, Pulse OX 98%. Notified family present of symptoms and at home education. Patient then started to feel cold, noted tremors of upper extremities and patient lips blue tinged. EMS called and spoke to mother on phone regarding patients status. EMS arrived on scene no visible improvements. Patient left via EMS to ED
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects ) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects ). At the time of the report, VACCINATION COMPLICATION (Side effects ) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
This reporter received paperwork for report of Pt. experienced fainting event seven minutes after first dose of pfizer. Feet were elevated by EMS. Pt. cleared by EMS to leave with parent.
Severe fatigue 20 hours after injection.  Lasted 8 hours.  Possible high bilirubin level (179)   in blood test 30 hours after injection/.
Bright red arm at location of injection. Hot with heat, Sore, Swollen. Lasted for over 1 week.
Lost hearing in one ear; A spontaneous report was received from a consumer concerning an age unspecified, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of hearing in one ear.  The patient's medical history was not provided. Concomitant medications were not provided.  On 14 Mar 2021, approximately a day prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On the morning of 15 Mar 2021, the reporter states that her sister had no hearing in one ear. Treatment information was not provided by reporter. Lab tests were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, lost hearing in one ear, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
1st dose Sep/2021, has not received any other dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose of Engerix B on 28th September 2021).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received a dose of Engerix B. Till the time of reporting, the patient did not receive any subsequent doses, which led to incomplete course of vaccination. The reporter was requesting a recommendation regarding whether the patient should restart the series or next steps.  Provided caller number to medical informer and warm transferred call.  No additional events were provided by the caller. The reporter did not consent to follow-up.
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed calamine (+) camphor (+) diphenhydramine hydrochloride (CALADRYL) lotion topical, acyclovir, gabapentin and tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Hot flashes running through his body; Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes running through his body) and DIZZINESS (Lightheaded) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes and Obesity. Concurrent medical conditions included Urinary tract infection.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HOT FLUSH (Hot flashes running through his body) and DIZZINESS (Lightheaded). On 03-Apr-2021, HOT FLUSH (Hot flashes running through his body) and DIZZINESS (Lightheaded) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking antibiotics for UTI
Temperature of 102. 7, bad dizziness, sore throat, very bad headache, bone pain.
Slight headache; Body aches; Weakness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 16:30 (Lot number: 33130BA) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 08Dec2021 14:00, outcome "not recovered", described as "Slight headache"; PAIN (non-serious) with onset 08Dec2021 14:00, outcome "not recovered", described as "Body aches"; ASTHENIA (non-serious) with onset 08Dec2021 14:00, outcome "not recovered", described as "Weakness"; FATIGUE (non-serious) with onset 08Dec2021 14:00, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of headache, pain, asthenia, fatigue.  Additional information: No vaccine in four weeks. Mens one-a-day multivitamin in two weeks. No covid prior vaccination and not tested post vaccination. No follow-up attempts are possible. No further information is expected.
Began Sept 19. Pt with 7 cm erythema reaction. Located on Lt upper thigh.
pressure in head; COVID-19; COVID-19; shocks in body; Vertigo; Headache; PFIZER BIONTECH COVID-19/Subcutaneous; Pneumonia; This is a solicited report for a non-Pfizer sponsored program (FACILITATED COLLECT) received from contactable reporter (Consumer). The reporter is the patient. Other Case identifier(s): 21K-163-4166618-00.  A 62-year-old female patient received BNT162B2, subcutaneous, administration date 21Jul2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for COVID-19 immunisation; adalimumab, subcutaneous (Batch/Lot number: unknown) at 40 mg cyclic (1 in 2 wk) for moderate to severe rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Nov2021, outcome "not recovered" and all described as "COVID-19"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "Pneumonia"; ELECTRIC SHOCK SENSATION described as "shocks in body", VERTIGO described as "Vertigo", HEADACHE described as "Headache" all (non-serious) with onset Aug2021, outcome "unknown"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Jul2021, described as "PFIZER BIONTECH COVID-19/Subcutaneous". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Pneumonia, Drug ineffective, Suspected Covid19, Electric shock sensation, Vertigo, Head discomfort, Headache, Incorrect route of product administration and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I was following the documentation steps when entering the information for vaccine administration. Once I reviewed the information on the vial which included the lot number and expiration date, I continued to enter the lot number and expiration date, manufacturer, injection site etc., after a warning pop-up message came up and for some reason it did not occur to me that the message mentioned that the vaccine I was entering to administer was expired and I click "ok" to override it. And at this point it still did realize with reviewing the information on the vial, box and documenting the vaccine information that the expiration year was 2020 and I probably read it as 2021, which is a big part of my error. The patient tolerated the injection well and waited in the waiting area which was in my view for 15 minutes after injection due to possible syncope as indicated by the CDC. It was not until I was reviewing the vaccine administration after the patient had left did I realize that I had administered an expired vaccine. I contacted my boss to let them know of the adverse event and we contacted the patient, and the patient was made aware of the adverse event that occurred due to my nursing error. The patient did not experience and adverse side effect or symptoms after the vaccine administration.   This adverse event occurred on 11/17/2020. Injection site: Left Deltoid Manufacturer: GlaxoSmithKline
After receiving my first vaccine, a week later I started breaking out in hives. I figured it was something I ate or came in contact with. I changed my washing powder, shower gel, lotion and diet and yet I continue to breakout in hives. My breakout occurs between 10:00pm-4:00am. They occur on random parts of my body, arms, legs, feet and face. I decided to go to the dermatogist to get a physician's opinion and he suggested I see an allergist. I am currently scheduling an appointment with an allergist to see what could be causing my hives. As of treatment, I've been taking Benadryl twice a day with the use of hydrocortisone on the affective areas.
onset rash 17DEC92 hands & face 19DEC92 w/fever undocumented, ache, chills-no lymph enlargement; no nodes;
Covid vaccine received 1/29/21 and 3/4/21, Pfizer mRNA Covid-19 vaccine.  Client died of Covid related death on 7/25/2021
25 minutes after vaccination, patient complained of tightness in throat. Patient took 2 puffs of albuterol and Claritin, which gave patient relief. Patient woke up the next morning with swelling around the eyes and a slight cough. Patient does have some soreness at the injection site but feeling much better otherwise.
3/26/2021   Ms. Rudd was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.chest pain and head ache   Assessment : Time of assessment 1707 .Actions taken: increased observation time, VS taken with BP- 125/78. P - 75, O2- 98%, JUICE OFFERED AND DRINKING, TOOK TO STRETCHER VIS WHEELCHAIR TO CONTINUE TO MONITOR. Vs RECHECKED AT520P, 141/75, P- 77. DENIES FURTHER CHEST PAIN OR DIZZINESS. GIVEN WATER, OFFERED TO CALL DAUGHTER BUT PATIENT REFUSED.         Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 40 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/26/2021  4:25 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc