chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; felt a little bit off/didn't feel right until; upper left arm became red; Arm hurt/ upper left arm doesn't hurt as much as when he received the first injection; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in March 2020, refer case US2020AMR095093).   On 1st June 2020, the patient received the 2nd dose of Shingrix. On 1st June 2020, less than a day after receiving Shingrix, the patient experienced fever. In June 2020, the patient experienced feeling abnormal, injection site erythema and injection site pain. Rechallenge with Shingrix was positive. On 3rd June 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the feeling abnormal, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the fever, feeling abnormal, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in upper left arm and that evening he experienced a fever. The reporter claims that he felt a little bit off and just did not feel right until date of reporting and upper left arm became red now but it did not hurt as much as when he received the first injection. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR095093:same reporter.
Information has been received from a physician concerning a 35 year old female who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the pt recently developed a site reaction after vaccination. The reaction was marked by redness, swelling and pain at the injection site. The pt did not have an extended recovery period. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. The physician also reported similar reactions in two other adult pts after therapy with pneumococcal 23v polysaccharide.
Arm became red and tender to the touch. On exam the arm was described to have erythema, itching soreness, with a slight red streak in the center of the redness.
achy all over for 2-3 days in legs; generalized weakness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy all over for 2-3 days in legs) and ASTHENIA (generalized weakness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A1A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATORVASTATIN and METOPROLOL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (achy all over for 2-3 days in legs) and ASTHENIA (generalized weakness). At the time of the report, PAIN IN EXTREMITY (achy all over for 2-3 days in legs) and ASTHENIA (generalized weakness) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-406103 (Patient Link).
4Oct90 pt treated /w Engerix B & experienced shingles (1 or 2 days post vax) Event was teated /w Lortab (acetaminophen/hydrocodone) for pain. Event persists
Around 8:30 pm on April 9th I started to feel tired and my muscles were staring to hurt so i went to bed at 9:00 pm.  i woke up several times with muscle aches, head ache, chills and sweating.  I got up at 1:30 am to go to the bathroom. I then went down stairs to take my temperature. I took it 2 times.  It was 99.9 and 100.00.  I went to the kitchen to get a drink because I was going to take some Tylenol.  When I opened the refrigerator, I got lightheaded and my vision started to change.  With in 2 seconds, I put the Lemonade on the counter and  I got tunnel vision and i started to sweat.  The next thing I remember was being on the floor.  I could hear my husband calling my name but he sounded very far away.  I felt like I couldn't respond to him.  It took me about 30 seconds to become conscious but I didn't know where I was at first.   I fell straight on my face and was bleeding from lacerations to my nose and forehead.  My neck, which I already have an injury to was re-injured.  I was taking to the Emergency Room.  My lacerations were glued and was in concossion protolcal
Patient was brought in for her 3rd Covid shot. After vaccine was administered, it was discovered she was 2 weeks too early to receive her vaccine.
Hardness at the injection site; injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Patient felt pain right on the injection site when the vaccine was administered. The pain persisted and extended to the whole arm in the next few days. There was no redness or swollen tissue. Now, after 1 month since the shot, the pain is not going away. After tried some OTC pain medications, Patient still feels pain all the time, and it affects her daily movements also, i.e. reaching out or driving, and this is the reason patient came back now to report the issue.
Site: Swelling at Injection Site-Medium, Systemic: swelling and burning at injection site and neck-Medium
Injection site bumpy rash with itching and red feverish lump 6 inches long on right arm 1 week after receiving Moderna Covid vaccine Dose #1
Patient left upper arm and shoulder warm, pink, and blisters present. Vital signs stable. No temp noted. Family encouraged to use TYLENOL and ice to area. MD order KEFLEX x 5 days.
pt developed a headache a couple of days after getting the covid vax.  Pt has had this headache for almost 6 weeks.  She has been treating it with Tylenol and naproxen.  Pt went to her PCP on 2/24/21 but was told the headache may be stress related and was told to do exercises.  Pt went to ER on 3/18/21.  They did a CT w/ negative results.  She was prescribed tramadol hcl 50mg and ondansetron 4mg.  The pt did not want to take these type of medications so will see her PCP again on 3/26/21 to see if she can help with her headache symptoms.
part of the vaccine came out of the hub area of the syringe and ran down on the table with o reproted adverse event; Initial information received on 14-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who experienced part of the vaccine came out of the hub area of the syringe and ran down on the table with no reported adverse event  while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 14-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ597AAA  and expiry date was 05-Dec-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious part of the vaccine came out of the hub area of the syringe and ran down on the table with o reproted adverse event  (incorrect dose administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (part of the vaccine came out of the hub area of the syringe and ran down on the table with no reported adverse event ).  At time of reporting, the outcome was Unknown for the event part of the vaccine came out of the hub area of the syringe and ran down on the table with no reported adverse 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.
Received a dose of HPV9 that had expired on 12/1/2021.  No adverse event noted/ treatment given
Information has been received from a registered nurse concerning a female who on 6/7/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (0.5 ml lot 650454/0751P), intramuscularly. On 6/7/05 the patients vaccinated arm became red and warm to touch. She developed a raised area on the arm 38 mm x 45mm. She experienced some discomfort. It was not known if this was her first dose or a booster dose. The symptoms resolved on their own in a few days. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Recieved MMR, Varicella, Hepatitis vaccine on July 5, 2011 and on July 11 developed Fever of 101, vomiting x 1 episode, diarrhea, decrease in appetite, fuzziness.
24 hours after injection had body/muscle aches, arm painful/swollen/red at injection site, warm, flushed, weakness. Dr. prescribed Tylenol 500mg three times daily as needed/rest/fluids, Benadryl 25mg 1-2 twice daily prn and if symptoms become severe/increased will need to go to urgent care for evaluation.
Headache for 2 weeks now! Level 3 to level 7, above and behind eyebrows.  Took 1 Alieve on 4/28/21 and it helped mask pain for 12-ish hours but headache is back and now shoulder/back/neck pain on right side since 4/29/21 and today 4/30/21
19 doses administered past expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (19 doses administered past expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (19 doses administered past expiration). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (19 doses administered past expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The reporter wanted to know regarding the steps to take when a patient was given an expired Moderna Vaccine. Number of doses/vials: 19 doses: 1 dose was a 2nd primary series dose and 18 doses were booster doses. On 14-Dec-2021, vial was initially stored in the refrigerator.  Treatment information was not reported.
Patient called the immunizations clinic on 02/12/2015 c/o redness and swelling to the area around the injection site 2 days after vaccination. Patient was told that minor swelling, redness, and pain are all possible mild signs and symptoms after receiving that particular vaccination and he was advised to f/u with us today if it got any worse. Patient called back this morning stating that the amount of redness and swelling has increased and he was advised to see his primary care manager for further care. Pt was prescribed a 7 day supply of Keflex.
Information has been received from a physician concerning a "child" who was vaccinated with a dose of VAQTA on an unspecified date. Subsequently, the patient developed a high fever. It was reported that the child was seen at a local emergency room and the physician there stated that the reason for the high fever was the vaccine. It was unknown if the child was hospitalized, however, it was reported that the child recovered. No product quality complaint was involved. Additional information is not expected.
Arm swelling after few days. At injection site. Arm is still currently swollen and itchy on my arm. My harm was not immediately itching after getting the vaccine. I have also experienced a bad headache and feverish feeling after vaccination but it subsided 24-48houra after taking the shot.
This spontaneous report as received from registered nurse refers to unspecified patients of unkonwn age and gender. Medical history and concurrent conditions were not provided. On a unknown date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX23 (dose, route, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
20 m after given GARDASIL, had 20- second ser. tonic - clonic sz with mild postictal phase > 10m after.
First pregnancy, 16 weeks pregnant when I received the vaccine. I had had zero abdominal cramps prior to receiving the vaccine during pregnancy. 5 to 6 hours after receiving the first vaccine I started having mild abdominal cramps, around the same time as I started having fatigue. Over the weekend the cramps got gradually got worse and Sunday night it was keeping me from sleeping and was constant. The obgyn nurse on call at 1 AM recommended I go to the emergency room (concerned they were contractions and that I was miscarrying). And they were able to do an ultrasound and baby was moving around a lot so everything looked fine with the pregnancy, nothing to explain the cramping symptoms. They just recommended I take Tylenol and rest, and continue hydrating. I had been already hydrating a lot. By Wednesday morning 8/11, the cramps had mostly gone away. I am not planning to get the second vaccine until after baby is born to help prevent a miscarriage . Estimated delivery date is January 19, 2022.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 11-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Father called health center 5/4/05 saying son experienced a headache and dizziness 48 hours after vaccination. Patient did not want to be seen for follow up at this facility.
Temperature; Sleepless night; This is a spontaneous report from a non-contactable consumer, the patient. An unspecified aged elderly patient of unknown gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 11Jul2021 at 08:30 as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had known allergies to dust. Concomitant medications included apixaban (ELIQUIS) from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 11Jul2021 at 12:00, the patient experienced sleepless night and temperature. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event sleepless night and temperature was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected
Large 10cm area of erythema hot to touch moderate swelling and mild TTP no induration or fluctuance. Increased in size gradually. Low grade fever 99.0 tympanic. Diagnosed with cellulitis. treated with BACTRIM DS 800-160mg tabs, one tab BID, DIPHENHIST 25mg one tab every 6 hrs as needed.
Localized swelling, redness upper right arm with rash red to pink in color w/edema-Allergic urticaria 708.0 acute. Warm compresses tid-F/u for increased or change in sx's.
On 7-28-07 am noted pruritus right arm at injection site with raised area beginning size of quarter with increasing in swelling, redness, and pruritus until covered large area arm approx. 6-8 cm diameter. Also c/o fever, chills, and gen. malaise. S/S grad. decr. Did not see a physician.
Information has been received from a nurse, referring to a 24 year old female patient. Information about medical history, concurrent condition and concomitant therapy was unknown. On unknown dates (also reported as over a year ago), at the physician's office, the patient was vaccinated with the first two doses of GARDASIL 9 (dose, strength, lot# and expiration date unknown) intramuscularly for prophylaxis. On 31-AUG-2018, the patient returned to the physician's office and vaccinated with the third dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effect reported.
1) Long fever, since 01/19/2021 until now 2) Through hurts, brown/black phlegm, dry cough 3) Have hard time swallow food/water
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Leg injury (Right leg damage) in 1977 and Surgery (Many surgeries). Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for High cholesterol.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As reported patient experienced sore arm after fist dose and treatment information was not reported.   This case was linked to MOD-2021-077985 (Patient Link).
Johnson & Johnson vaccine -1 dose in left arm.  I've been having night time leg cramping in backs of both legs (calf muscles).
This is a spontaneous report received from a contactable consumer (patient).  A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Jul2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he experienced some soreness in his arm right after the injection on an unspecified date in Jul2021, he said he was not worried about it. It was expected to be. His wife and son refused him to see his grandkids because they thought he would give them the COVID virus. Caller asked if that was possible. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
My father first felt sick on August 1, 2021, with cold like symptoms and he tested positive for covid-19 on August 3, 2021. August 5th, 2021 he was taken by ambulance to the hospital. They admit him. They did a bunch of lab work. They did a C-Troponin and the results was a 59, his INR was 1.2, Many of CBC  were slightly off, Glucose 159, and Sodium was 132, his D-Dimer was 4,154, His C-reactive portion ,  Creatinine 1.89, Bum 31, Alt 15, and they did an EKG there were changes since his last EKG that was done in April of 2021. They  ran test the follow day and a day after. On August 8th, 2021 they did another EGK and they said that T-wave inversion now evident. Which could be a sign of a heart attack, On August 9th, 2021, his Alt had worsened to 73. They gave him Remdesivier on August 6th-8th, for covid-19 while in the hospital and Lovenox  injections each day in the hospital to prevent blood clotting. My father was discharged on August 10th, 2021