chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hurts so bad, arm hasn't recover; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Hurts so bad, arm hasn't recover). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-APR-2023 This case was reported by a patient via interactive digital media. The patient shingles vaccine hurts so bad, so far his/ her arm had not recovered. The follow-up could not be possible as no contact details were available.
11/2/21 COVID VAC - IMMEDIATE FLU S/S 11/3/21  FLU S/S   11/4/21  3AM  SUDDEN ONSET DIZZINESS, NAUSEA, HEADACHE. TO ER FOR EVAL.  STROKE ALERT AND TESTING. ADMIT TO OBSERVATION. DC HOME APPROX. 6PM . NO DRIVING OR WORK SYMPTOMS CONTINUE -  FOGGY, COGNITIVE FUNC. SLOWER, UNSTABLE GAIT, DBL VISION, WEAKNESS/FATIGUE, CHEST PRESSURE (SOMETIMES) 11/8/21 ER VISIT  (UNABLE TO SEE PCP - NO APPTS AVAIL)  NEW MEDS ORDERED. NO WORK OR DRIVING   NEW ONSET RINGING IN EARS CONTINUE OTHER SYMPTOMS. ARRANGING APPTS TO  FOLLOW UP WITH ENT (11/22), NEURO(AWAITING DATE), AND PCP (AWAITING DATE)
2 1/2  inch red hive around the injection site; 2 1/2 inch red hive around the injection site, its slightly puffy; 2 1/2 inch red hive around the injection site, its slightly puffy, slightly red circle; Arm was sore; tiny bruise around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE BRUISING (tiny bruise around the injection site), VACCINATION SITE URTICARIA (2 1/2  inch red hive around the injection site), VACCINATION SITE SWELLING (2 1/2 inch red hive around the injection site, its slightly puffy) and VACCINATION SITE ERYTHEMA (2 1/2 inch red hive around the injection site, its slightly puffy, slightly red circle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), LEVOTHYROXINE, LIOTHYRONINE, ATORVASTATIN, AMLODIPINE, CENTRUM SILVER +50, VITAMIN D3 and BIOTIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE BRUISING (tiny bruise around the injection site). On 04-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (2 1/2  inch red hive around the injection site), VACCINATION SITE SWELLING (2 1/2 inch red hive around the injection site, its slightly puffy) and VACCINATION SITE ERYTHEMA (2 1/2 inch red hive around the injection site, its slightly puffy, slightly red circle). On 19-Feb-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. On 23-Feb-2021, VACCINATION SITE BRUISING (tiny bruise around the injection site) had resolved. At the time of the report, VACCINATION SITE URTICARIA (2 1/2  inch red hive around the injection site), VACCINATION SITE SWELLING (2 1/2 inch red hive around the injection site, its slightly puffy) and VACCINATION SITE ERYTHEMA (2 1/2 inch red hive around the injection site, its slightly puffy, slightly red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20 Jul 2021. contains no significant information.
Body ache, chills, fever, flu like symptoms, redness to left deltoid area approx 4 inches lasting x5 days joint pain, fatigue up to 8 days.
temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccine administered post temperature excursion with no adverse event; Initial information received on 26-Sep-2022 and live follow-up received on same day (processed together) regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA409520 and 2022SA409694.  This case involves an unknown age and unknown gender  patient and reporter stated that there was a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event and vaccine administered post temperature excursion with no adverse event after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.  On 23-Sep-2022 , there was a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error) involving INFLUENZA QUADRIVAL A-B VACCINE. The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case.  In Sep-2022 the patient developed a non-serious event of vaccine administered post temperature excursion with no adverse event (poor quality product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE ( formulation: suspension for injection, strength, route, administration site was unknown, batch  number: UT7689LA and expiry date was unknown for prophylactic vaccination).  Action taken : not applicable.  Outcome: Unknown  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 guidelines. 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.; Sender's Comments:  SAD20220927002156:
Right leg swelling and redness and pain which progressed from Tuesday injection time seen on Thursday evening. Seen by provider Thursday evening. Diff dx local reaction vs. cellulitis. KEFLEX liquid with BENADRYL, TYLENOL for cough f/u appt. 12/24/2018.
Next day after vaccine - Very sleepy all day, could not get to a point where I could stay awake except for short periods of time. From 6:00 am lasting until 11:30pm When I went to bed. 02-06-20201 - Felt normal self after one day of sleepiness.
Large (approx 2 1/2 inches in diameter) red spot on the anterolateral left thigh area, not itching.  Rest of skin clear.
-FIRST HOUR, ARM GREW EXTREMELY SORE  - LATER THAT NIGHT, HEADACHE, BODY SORENESS AND BACK AND FORTH CHILLS OR SWEATSING (SOAKED SHEETS SLEEPING).  RELIEF ON  5/14  EXCEPT  FOR  RED  RASH  AROUND  INJECTION  SITE.
Sore arm in injection area; headache; dizzy feeling; extreme chills all night; body aches; fast heart beat; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 21Jan2021 07:30 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital. The patient's medical history was not reported. The patient has no concomitant medications. The patient previously took flexeril [cefixime] and experienced allergies. The patient had no other vaccine in four weeks. On 21Jan2021 17:30 (10 hours after injection), the patient experienced headache, dizzy feeling, extreme chills all night, body aches, fast heart beat. On 21Jan2021 18:00, the patient experienced sore arm in injection area. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events headache, dizzy feeling, extreme chills all night, body aches, fast heart beat, sore arm in injection area was recovering.  No follow up attempts are possible. No further information is expected.
I got the shingles vaccine (by Merck) on 1/9/2012 on recommendation of CDC, FDA, my doctor, & everywhere on the Internet, to prevent shingles. A few days later, I got shingles from the vaccine (documented by my doctor). It broke out in a rash down the right side of my face. The serious danger is that it could go into my eye - even weeks later. I did extensive research prior to shot & nowhere did it say this could happen. If I had read this, I would never have gotten the shot. Nor did I read that antiviral must be started w/in 72 hrs. This is a very dangerous vaccine...now I have to live in fear that this could get in my eye in the next several weeks. When can I rest easy? No one can tell me. I'm sorry I ever got this vaccine. You need to put these dangers on the Internet.
This spontaneous report as received from a medical assistant/healthcare worker refers to a 14 year old female patient. On 16-SEP-2013 the patient was vaccinated with first dose of GARDASIL. On 18-NOV-2013, the second dose was administered and third dose on 16-DEC-2013. No adverse effect was reported. The outcome was unknown. Additional information has been requested.
This spontaneous report was received from a female patient of unknown age reporting on herself. No relevant medical history of the patient was reported. On an unknown date the patients mail order pharmacy shipped RECOMBIVAX HB directly to her in order to bring it to her physicians office to be administered. The patient received the shipment, placed it in the refrigerator and then about an hour or two later drove it to her physician's office where the she was vaccinated with RECOMBIVAX HB (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis (date unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. No further information was provided. Additional information is not expected because the reporter details were not provided.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. On 09-SEP-2013, the patient was vaccinated with a dose of MMR II (Lot number, expiry date, route and dose were not reported). Approximately on an unknown date in September 2013, the patient experienced unspecified rash. The outcome of unspecified rash was unknown. Additional information has been requested.
Information has been received from a consumer concerning her 20 year old female daughter with drug hypersensitivity to Vantin who in August 2007 was vaccinated with her first dose of Gardasil and on 26-DEC-2007 was vaccinated with her second dose of 0.5 ml Gardasil intramuscularly. Concomitant therapy included YAZ. The mother stated that after her daughter received her second dose she developed a fever of 103 degrees Fahrenheit and had body aches and felt nauseous. This started when the patient was traveling home after getting the shot. The patient went to the emergency room but was not admitted. Right after the shot was given, while still in the doctor's office, the patient felt dizzy. The office staff gave her crackers and soda and kept her at the office until she felt better. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008.  Initial and follow up information has been received from a physician, and consumer concerning the consumer's 20 year old daughter (a female) with drug hypersensitivity (VANTIN), who in August 2007 was vaccinated with her first dose of GARDASIL vaccine, and on 26-DEC-2007 was vaccinated IM in the left deltoid with her second dose, 0.5 ml. of GARDASIL vaccine (Lot #659439/1267U). Concomitant therapy included YAZ. The mother stated that after her daughter received her second dose, she developed a fever of 103 degrees F. had body aches and felt nauseous. This started when the patient was traveling home after getting the shot. The patient went to the emergency room but was not admitted. Right after the shot was given. While still in the doctor's office, the patient felt dizzy. The office staff gave her crackers and soda and kept her at the office until she felt better. The physician added that the patient reported feeling weak, and when evaluated in the ER, was given TYLENOL. The symptoms then resolved. Additional information is not expected.
From correspondence received from manufacturer it was reported that a 4 month old female patient received an ActHIB, an IPOL, a Tripedia and a Prevnar vaccination on 7/16/01. Reportedly on 7/18/01 the patient developed high-pitched crying and hoarseness. These symptoms subsided on 7/24/01 and the patient recovered. The patient received her 6 month vaccines separately in dequential doses, no problems when administered this way.
Severe headache on only left side of head (behind left eye, affecting left ear and back of left side head) within hours of vaccine. Did respond to Tylenol.   Within first 18 hours of vaccine, intermittent dizziness where need to lay down required 2 times so far. Scared to drive at this time.    Currently nasal pressure.
Only received one dose on 2/28/21, then on 3/7/21 - 3/22/21 and again 3/27-4/1, client was hospitalized for Shortness of breath (negative for covid, tested a total of 4 times in the hospital, all negative). Currently, client's SOB symptoms have resolved, no fever and no chills.  Past medical history: CHF, pHTN, AoC renal failure, DM type 2.  Current Medications: Lasix, nifedipine, isosorbide, gabapentin, aspirin, insulin  Only side effect from vaccine reported is injection site pain that resolved after 24 hours.
Body aches, Low grade fever,  chest tightness and congestion, headache, nausea diarrhea
I BELIEVE THE SHINGLES SHOT WAS GIVEN TO ME IN MY LEFT ARM, NOT RIGHT, AND THE FLU SHOT WAS GIVEN IN MY RIGHT ARM. ON 11/02/19 I WOKE UP AROUND 5:00 AM WITH HEADACHE, CHILLS, UPSET SOTMACH, EXTREME TIREDNESS, LEFT SHOULDER WEAKNESS, AND NECK PAIN. THESE SYMPTOMS DID NOT GO AWAY. ON 11/10/19 5:00 AM, IN ADDITION TO THE PREVIOUS SYMPTOMS I WOKE UP WITH 8/10 SCALE PAIN AND MUSCLE KNOTS IN MY LEFT SHOULDER, NECK, SHOULDER BLADE, AND ARM. I MADE AN APPOINTMENT WITH MY PAIN SPECIALIST FOR 12/02/19, BUT WENT TO THE E.R. ON 11/26/19, BECAUSE THE PAIN WAS GREATER THAN 10/10 SCALE. THEY TOLD ME TO GO HOME, TAKE THE PAIN MEDS AND MUSCLE RELAXER I HAD, AND DO NECK EXERCISES. I SAW MY PAIN SPECIALIST ON 12/02/19 AND HE SCHEDULED AN EPIDURAL FOR 12/05/19 AND 12/19/19. I DID NOT RECEIVE ANY RELIEF FROM THE FIRST EPIDURAL AND ONLY SOME RELIEF FROM THE SECOND EPIDURAL.
Patient got an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAB (Twinrix) (batch number dk23d, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 21st February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administrated with an expired dose of Twinrix, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
I had a runny nose, sore throat, painful kidney, back muscle pains. I tried to hydrate and took ibuprofen. I felt pretty fatigue as well. I went to the a clinic, and they told me to keep hydrating and taking ibuprofen to aid the kidney pain caused by dehydration. My kidney pain went away, and I slowly started recovering. However, my other symptoms were still there so I took a COVID-19 test on 12/23/2022 which came back positive. A physician at a clinic told me my options as far as medication to aid my symptoms; they tested me which came back positive for COVID-19, but they thought it was best I stuck to ibuprofen and didn't prescribe PAXLOVID. Right now, I feel pretty good; I feel kind of stressed and slight brain fog still but doing better.
During sleep, pt's arm was hurting.  He got up to use the bathroom.  His spouse said he collapsed next to the bed and started convulsing.  Spouse said she called 911.  Convulsing lasted until EMT's arrived.  When pt awoke, he was in the ambulance and was vomiting.  Taken to ER at Hospital.  Given muscle relaxors and zofran for emesis.  Was also given fluids.  When fluids were complete, he was released to home.
administered an expired PENTACEL to a 15-month-old patient with no reported adverse event; Initial information received on 12-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old male patient who was administered with expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13) for prophylactic vaccination (immunization).  On 12-Jul-2022, the patient received a 0.5 ml dose (4th dose) once total of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection (lot: UJ473AAA; expiry date: 09Jul2022; strength not reported) via intramuscular route in the left thigh for prophylactic vaccination (immunization).  On 12-Jul-2022 the patient developed a non-serious event administered an expired pentacel to a 15-month-old patient with no reported adverse event (expired product administered) (latency: same day) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (Pentacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  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.
wasn't feeling that good; This is a spontaneous report received from non-contactable consumer. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "wasn't feeling that good".  Additional information: patient reported that she didn't feel like talking today because she got her second dose of COVID-19 vaccination yesterday and wasn't feeling that good due to some of the side effects and symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient already had 1st dose done elsewhere. We administered a second dose and had patient wait 15 minutes. No reaction.
Injection site muscle pain; Difficult for me to lift my arm; Adverse event; This case was reported by a consumer via interactive digital media and described the occurrence of injection site muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than 3 weeks after receiving Shingrix, the patient experienced injection site muscle pain, injected limb mobility decreased and adverse event. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved and the outcome of the injected limb mobility decreased and adverse event were unknown.   It was unknown if the reporter considered the injection site muscle pain, injected limb mobility decreased and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st Shingrix dose almost 3 weeks ago. The patient had many of the side effects for about 47 hours. The they went away. However the patient still have injection site muscle pain that makes it difficult for me to lift my arm.  The reporter asked was this a normal reaction
About 15 minutes after vaccines, while about to get her blood drawn, it was noted that she had small urticarial wheals that started on her right arm. Over several minutes they spread to her abdomen and thighs. She appeared to feel itchy but no cough, no wheezing, no emesis. Vitals taken and were normal - no fever, normal pulse ox, no tachycardia. Exam was without wheezing or swelling. She was given BENADRYL and ibuprofen and observed for 30 minutes. Mom was instructed to continue the BENADRYL every 6 hours over night and then as needed. The provider on call checked in with her via phone overnight. Wheals had gone down (but still some there) and no other new symptoms. Child has no history of egg or gelatin allergy. Mother knows she has had eggs before and thinks she has had food with gelatin in it before.
Parent signed paper work that child DOB , but the real birthday is   so child is under 12 years old calling Pfizer to check what action needed and if advised a second dose
States she developed fever but not did not use a thermometer.  She also reports chills and a headache
Febrile convulsion w/in 12 hours of receiving Hepatitis B and seasonal influenza vaccine.
Inc temp 101 ax 4DEC91 dec w/APAP rash started 5DEC91 back, chest, abdomen blotchy red, no blisters or drainage;
Erythematous patches on ant. (L) thigh 3 1/2 cm x 3 1/2 cm, 3 cm x 2 cm, 2 cm x 0.5 cm.
About 9 hours after shot, I started to develop headache. Within the next hour, my whole body ached and I had chills. This continued throughout the night. By 6:30 the next day I had less intense headache and body ache and only had a mild fever. By 36 hours after the shot, all symptoms were gone