chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an NP concerning a female pt who on approx. 10/23/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included a dose of influenza virus vaccine. Subsequently, the pt experienced nausea and vomiting. Unspecified medical attention was sought. Additional information has been requested.
Redness, pain, swelling, radiating from elbow to shoulder, darkest closer to injection site with a knot in her arm at injection site.
she had soreness to her arm like the first, which she had gotten in her right arm; This is a spontaneous report from a contactable consumer. This consumer reported for 26-year-old female patient.  A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via unknown route of administration, administered in right arm on unspecified date in Jul2021, as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications included Products ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), colecalciferol (VITAMIN D), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), sambucus nigra (ELDERBERRY) on unspecified date and took two Tylenol two days ago for her cycle, because she was aching from her cycle. It was reported patient received her first dose was in July, it was like a two-week period between them, so she thought it was on 30Jul or 26Jul. She reported that the ache or tired like feeling just started around 3:30PM, afternoon. She reported she kept checking on her yesterday and last night to make sure she was not feverish or feeling bad, and morning she had soreness to her arm like the first, which she had gotten in her right arm, then got the second in her left arm since they told her she couldn't take both shots in same arm. She said her daughter was fine when she left here outside of the soreness of the arm and redness at the injection site and complaining of hurting. An hour ago, she had aching to the bend of her knee like a tired feeling like she has been walking too much. She said her daughter had not treated the ache or tired feeling because it just started about an hour ago. At the time of this report the outcome of the events was unknown.  The lot number for the vaccine was not provided and would be requested during follow up.
Fever and chills, muscle and joint aches, shot site sore. No headache. Began around 12:00 am Sept 9th , took 3 ibuprofen at 5:30 am, went back to bed, woke up at 8:00 am and felt good. Went to work. Did not take more ibuprofen.  Began feeling mild fever and fatigue about 1:20 pm.  Feeling subsided by 4:00pm  drove home, 20-25 mins felt fine until I got out of truck. Chills, minor aches, fever returned. Drank large glass of water, went to bed, approx 5:00 pm.  Awoke around 6:00 pm, condition same, no headache. Ate French dip sandwich, large glass of milk, 3 ibuprofen. Now at 7:05 pm, fever and chills minor aches.
This case was reported by a consumer via call center representative and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a friend of the patient. The reporter reported that the patient passed out after receiving a dose of SHINGRIX vaccine, which was a 2 part series. The patient would not receive the 2nd dose of SHINGRIX vaccine. The reporter provided limited information. The reporter disconnected call before further questions could be addressed regarding the adverse events of the patient. This case was linked with case US2018132473, reported by the same reporter.
No additional adverse event was reported; The reported stated it was unknown if his mother received one or two doses of the ZOSTAVAX; This spontaneous report was received from a consumer refers to his an 87-year-old mother. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapy were not reported.      In approximately 2018 (reported as "approximately 3 years ago"), the patient was vaccinated with one or two doses of zoster vaccine live(ZOSTAVAX) (dose, lot #, expiration date and route were not reported) for prophylaxis (extra dose administered). The reporter stated he "suspects she only received one dose", but he could not be certain since his mother could not remember the doses, the dates, where she received the vaccine. No additional adverse event and no product quality complaint were reported.
This spontaneous report was received from a patient of unknown age and gender reporting on themself as a part of market research entitled "Zostavax Competitive Profile". On an unknown date, the patient was vaccinated with the first dose of VAQTA intravenously for Hepatitis A prophylaxis (lot # and expiration date were not reported). It was reported that the patient had a bad reaction to VAQTA and they got sick. Due to the event, the patient did not go back for the second shot, action taken was interrupted. It was reported that "this would be the same if they got sick after the first shot". The outcome of the event was not reported, however, it was reported that the event diminished after stopping the suspected therapy.
Patient reported leg cramps that started in left calf and migrated to left thigh/groin area between 12am and 1am on 4/12/2021.  Patient reported symptoms at approximately 7:00pm on 4/13/21.  Symptoms lasted approximately 20 minutes and have since resolved.  Patient reports no other symptoms (patient was questioned about back pain, abdominal pain, shortness of breath, and headache).
patient received expired dose of vaccine Pentacel/ No AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who received expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C55428A/ C55428AA, expiry date- 08-Sep-2019 via unknown route in the left vastus lateralis On 25-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  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 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.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 16-OCT-2015 the patient was vaccinated with a dose of M-M-R II (lot # J008154, dose and frequency were unknown) subcutaneously, which was expired on 08-JUL-2015. No adverse effect was reported. Additional information has been requested.
Administered another seasonal flu shot on accident.  Patient had previously received seasonal flu vaccine before on 10/09/2022.  Patient originally came in to receive a Pfizer-BioNTech Bivalent COVID-19 Vaccine, which patient also received shortly after.
This initial spontaneous report was received from a physician referring to a 6 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 10-SEP-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Pt recvd vax 15OCT92 & 1 1/2 hrs following vax pt exp deep itching on upper arm; sx persisted for several days; No further details were provided;
pt recvd vax 18OCT95 & 27OCT95 pt feeling bad-general;29OCT95 broke out in a rash, red raised bumps, around the inj site &  moved to face, fever over 102 & swollen glands; 30OCT95 rash & fever persist;advised to call MD;31OCT95 dx viral syn
Patient came to the pharmacy and asked if it was something usual to lose the sense of smell after receiving the vaccine.
Refused to eat baby food at 6:00 PM. Began crying and unable to be consoled.  Cried off and on and screamed in pain and moaned. Lethargic 04/12. Sleeping a lot, temperature of 99-100. Mother giving Motrin every 6 hours.
PT FELT WARM ,HER BLOOD PRESSURE WAS LOW .GAVE PT ICE PACK AND ELEVATED FLEET. PT ALSO FELT LIGHTHEADEDED
Have had tinnitus (constant, both ears) for a number of years.  Perceived noise levels (constant) increased significantly to a level which is sometimes sufficiently distracting that I feel the need to depart discussions, work meetings, presentations, church services, etc for an environment with lower ambient noise levels.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2 NOS), on 04May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130846 same patient, different drug/events;
After administration of the pfizer covid vaccine, patient experienced dizziness, chest tightness, tingling in the hands and had sweaty  palms.  Patient reported that possible dehydration may have contributed to dizziness and was given water and monitored for 1 hour.
low grade-fever day after on 13th, low-grade fever again  on 17th, soreness at injection site, wide spread joint pain, severe low back pain, chronic join pain, chronic low back pain, chronic knee pain, chronic tiredness, chronic malaise, chronic lethargy, hot flashes, higher blood sugar readings, weight loss, hair loss, chronic fatigue, stopped having menstrual cycles, chronic pelvic pain
This spontaneous report as received from a physician refers to a 63 year old female patient. The patient's current condition included depression, asthma, and hypertension. On 09-OCT-2014, patient received both PNEUMOVAX23, intramuscular, (lot #, dose and frequency unknown) and FLUZONE (manufacturer unspecified) at the same anatomical site. Concomitant therapies included MACROBID, BACTRIM, CYMBALTA, SINGULAIR and PRINIVIL (manufacturer unspecified0.   On an unspecified date after vaccinated, the patient developed redness, pain, and scabbing all the PNEUMOVAX23 injection site. On 04-NOV-2014, "the scab fell off, and left a deep, gaping wound at the injection site". The patient was started on an unspecified antibiotic (manufacturer unspecified) on an unspecified date. The patient was recovering. Blood test were performed, result not reported. The patient went to see the physician.  The relationship of adverse events and PNEUMOVAX23 was not reported.  Additional information has been requested.
I took the first of four doses on Thurs, Feb 14 at about 5 pm, with no adverse effects.  I took the second of four doses at about 11:30 am on 2/16.  About 4 hours, around 4:00 pm that afternoon I experienced periodic stomach cramps and feeling of mild nausea.  I did not take the third and fourth dose.
Fever 100.5, sore arm, headache, nauesea, aches and pains, tired
I did not feel anything except the injection area right after the Janssen shot. It was great. Within the past week and a half, I feel a little tired and light headache. Sometimes, I had trouble sleeping at night.  But, starting end of the second week, the symptoms got worse. I am suffering from a sleep disorder. I felt exhausted, bigger and longer headaches, joint pain, muscle pain. My Blood pressure went up. I visited my family doctor today.
Information has been received from a vaccine provider referring to a 53 year old female patient. The patient's concurrent condition, medical history and concomitant therapies were reported as none.     On 15-SEP-2017, at the private doctor's office, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N011867, expiration date 08-NOV-2018) intramuscularly on left deltoid for prophylaxis. The vaccine was purchased with private funds. It was reported that the additional vaccine shelves were being placed in fridge and the temperature was out of range (incorrect product storage). There was no illness at the time of vaccination. There was no adverse reaction and no treatment was required. It was reported that there was no need to re-vaccinate or destroy the vaccine. The temperature excursion occurrence was not a result of reading from a digital data logger.
"Felt a funny sensation in my arm.  It goes all the way down to my fingers.  Its a dull numbness sensation."  She has full ROM & and feels warm.  Hasn't had this before.  More noticed on lateral position left arm.  Only fingers affected: pinky and ring.  06:14PM  SpO2 100%, HR 72, BP 120/83
Severe headache, vomiting, fever highest at 102.4, body aches, fatigue
Pt had negative rubella titer 10 - 14 days post vax. Pt experienced achiness in lower body for 24 - 48 hours followed by pain, swelling and redness of joints in fingers and wrists. Pt treated with Feldene for 10 days and improved within 48 hours. Only slight stiffness remains in right index finger.
throwing up for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up for 12 hours) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (throwing up for 12 hours). At the time of the report, VOMITING (throwing up for 12 hours) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-040393, MOD21-040423 (Patient Link).
Acne; Right lower thigh is protruding; Right lower thigh/knee pain; Feels heavier" in right lower thigh, about the knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right lower thigh/knee pain), MUSCULOSKELETAL STIFFNESS (Feels heavier" in right lower thigh, about the knee), ACNE (Acne) and INFLAMMATION (Right lower thigh is protruding) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, VITAMIN C [ASCORBIC ACID], VITAMIN B NOS, VITAMIN B3, MAGNESIUM CHLORIDE;ZINC, BIOTIN and CALCIUM for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Right lower thigh/knee pain), MUSCULOSKELETAL STIFFNESS (Feels heavier" in right lower thigh, about the knee) and INFLAMMATION (Right lower thigh is protruding). On an unknown date, the patient experienced ACNE (Acne). At the time of the report, PAIN IN EXTREMITY (Right lower thigh/knee pain), MUSCULOSKELETAL STIFFNESS (Feels heavier" in right lower thigh, about the knee), ACNE (Acne) and INFLAMMATION (Right lower thigh is protruding) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided by Reporter.   This case was linked to MOD-2021-053137 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: No new information was provided. On 01-Jun-2021: No significant information was received. On 04-Jun-2021: Non significant followup On 04-Jun-2021: Added concomitant medications and updated events outcome
Pt experienced fever, local reaction, erythema, warmth and swelling at injection site.
Chills, shakes, fever over 102, severe joint pain and muscle pain, swelling in hands and face, nausea, arm swollen to size of softball, feeling like the worse case of a bug I have ever had.
Adult female had just received her first dose COVID-19 vaccine, and proceeded to observation area.  She became weak and faint. Onsite EMS station in observation area evaluated and transported patient to Emergency Room. Patient was awake and alert at time of transport.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 04-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Child presented in office today with mom saying her arms itch and are red where she got her shots. (L) arm redness measures 5 cm x 7 cm. (R) arm redness 8 1/2 cm x 71/2 cm. Denies tenderness with palpation. (+) warmth to areas. BENADRYL 1 1/2 tsp po Q 6-8 hrs.
Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hours after shot including dizziness with bending. 35 hours after dose, had dull pain on the inside prominence of my right elbow (arm I got my shot). This pain lasted for 8 hours. Also accompanied with fatigue.
28 y/o female with pain (L) hand, arm, neck w/ more recently face (L) and head (L). Paresthesia and allodynia 5th and 4th fingers, web space index thumb w/ palmar surface. Normal motor/reflex but more recent mild motor decreased (L) compared to (R) intrinsic muscle, wrist flex/ext normal CN nerves.
Seven days post vax, the patient developed an ear infection and was treated with Amoxil. Within 48 hours, the patient developed a rash all over her body and a low grade temperature. The patient's treatment was changed from Amoxil to Benadryl. The patient developed swelling of her ears, hands, legs, arms and head with itching. The patient was also treated with Tylenol. The rash was described as clear in the center "ring worm like" and the patient also had swelling in her joints and at times did not walk. The rash lasted 7 days. The patient was not given any new foods during this time. The rash continues to come and go. The patient sought unspecified medical attention. Follow up information received 08/29/2000 from a physician indicated that on 06/28/2000 the patient broke out with hives all over her body, experienced swelling which lasted 1 week and a low grade fever. On an unspecified date, the patient recovered. No further information is expected.
SEVERELY SICK THAT COULD NOT GO UP AND DOWN THE STAIRS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced severely sick that could not go up and down the stairs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severely sick that could not go up and down the stairs was not reported. This report was non-serious.
Received 1st dose of Moderna and 2nd dose of Pfizer Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 1st dose of Moderna and 2nd dose of Pfizer Covid-19 Vaccine) 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 (No reported medical history).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received 1st dose of Moderna and 2nd dose of Pfizer Covid-19 Vaccine). On 26-Mar-2021, WRONG PRODUCT ADMINISTERED (Received 1st dose of Moderna and 2nd dose of Pfizer Covid-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  This report refers to a case of wrong product administered for mRNA-1273 with no associated AEs.; Sender's Comments: This report refers to a case of wrong product administered for mRNA-1273 with no associated AEs.