chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site developed throughout the day.  Then achiness over entire body began.  During the night, chills and slight fever (99 degrees) developed with increased achiness.  The next day, fever subsided some with Tylenol, but fatigue, achiness, and light headedness continued.
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
FELT HUNGOVER; LOSS OF ENERGY/DIDN'T HAD GUMPTION TO DO ANYTHING; FELT-LIKE DRUNK/BUZZED; TROUBLE GOING BACK TO SLEEP; FEELING OF LIKE BEATEN UP/ FELT DEAD; TIREDNESS; INJECTION SITE BURNING; ARM SORENESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site burning. On 12-APR-2021, the subject experienced arm soreness. On 13-APR-2021, the subject experienced trouble going back to sleep. On 13-APR-2021, the subject experienced feeling of like beaten up/ felt dead. On 13-APR-2021, the subject experienced tiredness. On 13-APR-2021 05:30, the subject experienced felt-like drunk/buzzed. On 15-APR-2021, the subject experienced felt hungover. On 15-APR-2021, the subject experienced loss of energy/didn't had gumption to do anything. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning, and arm soreness, had not recovered from tiredness, felt-like drunk/buzzed, felt hungover, loss of energy/didn't had gumption to do anything, and feeling of like beaten up/ felt dead, and the outcome of trouble going back to sleep was not reported. This report was non-serious.
This was my 2nd shot of the Moderna COVID-19 Vaccine EUA.  The morning after day of shot I had a sore arm and felt tired through the day, I slept most of the day.  These symptoms went away quickly from the following day.
Trigeminal neuralgia flare up; Extremely Bad pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extremely Bad pain), TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 051C21A) for COVID-19 vaccination.     The patient's past medical history included Chronic kidney disease stage 3 in 2008, Microvascular decompression (05/2019 and 12/2020:  first and second failed microvascular decompression surgeries.) in May 2019 and Microvascular decompression in December 2020. Concurrent medical conditions included Trigeminal neuralgia (Became bilateral on 07/19/2021) since 2019. Concomitant products included CARBAMAZEPINE (TEGRETOL) from 09-Jan-2019 to an unknown date for Trigeminal neuralgia.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 12-Aug-2021, the patient experienced PAIN (Extremely Bad pain). On 20-Aug-2021, the patient experienced TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up). On 22-Aug-2021, TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up) had resolved. At the time of the report, PAIN (Extremely Bad pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No treatment medication reported. patient also added that extremely bad pain,on 08/12, 14, 15, 18, 19 but not quite "flare up level,"   This case was linked to MOD-2021-277719 (Patient Link).   Reporter did not allow further contact
TEMPORARY LEFT SIDE PARALYSIS; This spontaneous report received from a physician 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) 1 total, 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 temporary left side paralysis after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of temporary left side paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210916478-COVID-19 VACCINE AD26.COV2.S.- Temporary left side paralysis. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
pt stated 28OCT98 stated that child was in ER w/T106 R & abscess on arm;lt arm swollen & lesion from scheduled shots;achy; papular bulb lesions;
48hr p/vax noted erythema & swelling of rt tricep/bicep (same arm as inj);sx resolved x/for sub-cutaneous nodule @ immun site;
Previous reaction to covid vaccine- rash Immediate generalized rash/itching after vaccine vital signs stable, given Benadryl 25mg x2 improved. No acute symptoms, monitored x30min Alert/stable at discharge, Evaluated by doctor in vaccine clinic
Hives - raised flesh colored bumps.  Start in various places and spread over body.  Fever on 11/20/2009.
Information has been received from a physician concerning a healthy female who never had any problems, who "about a year ago", in approximately July 2008, was vaccinated intramuscularly with her second 0.5mL dose of GARDASIL (lot number not reported). The physician reported that the patient "passed out within 24 hours of getting the second dose of GARDASIL" (in approximately July 2008). The series was discontinued at this point so the third dose was not given. The patient was sent to the emergency room for "a complete work up" and all tests came back normal. The patient was not admitted. The physician noted that there was no adverse event after the first dose of GARDASIL. The patient recovered within an unspecified time. This is one of two reports from the same source. Additional information has been requested.
Patient reports severe dizziness and mild nausea.  She states that the "room is spinning".  Referred her to her primary care physician for follow up but she has not been seen by a healthcare professional at this time.
Felt severely ill; Unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt severely ill) and GAIT INABILITY (Unable to walk) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt severely ill) and GAIT INABILITY (Unable to walk). At the time of the report, MALAISE (Felt severely ill) and GAIT INABILITY (Unable to walk) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  Patient was unable to go to work for more than a weekend was unable to return to work later.The reporter causality for the events with respect to Rinvoq was provided as not reported.  The treatment medication was not provided.
Information has been received from a physician concerning a 2 month old pt with no drug reactions or allergies who was vaccinated with a PO first dose of Rotavirus vaccine. Subsequently one week after vaccination the pt developed intussusception and was hospitalized. X rays were performed, results not reported. At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. The patient's concurrent conditions and medical history were not provided. On 15-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L048459 (dose was not reported). The nurse was not sure if this injection with GARDASIL 9 was the first, second or third dose in series. On 16-SEP-2016, the patient called the nurse to report that she had experienced dizziness, lightheadedness and a facial rash (onset date in September 2016). The patient denied any injection site reaction on her arm or any additional symptoms. The patient's outcome was unknown. Causality assessment between events and GARDASIL 9 was not provided. Additional information is not expected there was no consent to contact physician.
that night, sore arm next morning, 101.5 fever body aches nausea
This is a spontaneous report from a contactable Pharmacy Intern calling on behalf of a Pharmacist reported similar events for 2 patients, this is report 1 of 2, for a 68-year-old male patient that: A 68-year-old male patient received PREVNAR 13 (Lot # S43277, Expiry Date Sep2018, NDC # 0005197102) intramuscular at 0.5mL, single at left arm on 11Dec2017 for immunization, given at Pharmacy/Drug Store under standing orders. Patient's medical History was unknown. Concomitant medication included chlorhexidine oral 15 ml, 2x/day from 11Dec2017 and ongoing, and Rosuvastatin 20mg once daily from Sep2016 and ongoing. Concomitant vaccination included ZOSTAVAX (Merck, Lot # N020945, Expiry date 26Oct2018) subcutaneous at right arm on 11Dec2017 for immunization. The patient's left arm has been swollen for a week primarily at the injection site on an unspecified date with outcome not recovered. Reporter seriousness for left arm swollen was reported as medically significant. Reporter stated the 2 patients received the vaccines around the same time and their reactions were pretty severe. The reporter considered the event was related to the study medication PREVNAR 13. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported event. Linked Report(s): US-PFIZER INC-2017546863 same reporter/drug/event, different patient.
1 minute p/vax pt collapsed w/twitching movement of lower extremities, non responsive to verbal or physical stimuli w/in minutes; w/in minutes was alert, vague, sitting upright; no visible s/s injury;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-MAr-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) for each time were 40, 34 and R; 136, 33 and R. The storage criteria was refrigerator R. This is one of several reports received from the same source. Additional information has been requested.
Vaccine given 10/13/15.  That evening around 6:30 pm, she noticed her upper right arm was swollen and sore. When she woke up 10/14 am, her arm was swollen, red, and tingling down to her fingers.  At 11:30 am, her upper right arm was swollen and red, and warm to the touch, but her hand and fingers were cool to the touch.  When she leaves her arm dangling down, her fingers and hand and up to the elbow tingles and gets numb.  Pain and tingling worsened, so she went to the ER at 12:30 pm on 10/14.  The doctor stated that she either had a reaction to the vaccine which caused swelling which compressed a nerve in her arm, causing the numbness and tingling, or the shot itself hit a nerve when it was given.  She was treated to steroids.
"really bad rash" at the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE RASH ("really bad rash" at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Mar-2021, the patient experienced INJECTION SITE RASH ("really bad rash" at the injection site). At the time of the report, INJECTION SITE RASH ("really bad rash" at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
the 1st dose that hurt more; This 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she received 1st dose of Shingles vaccine, that hurt more but the patient also had been taking Advil or Tylenol because of how sore was the first dose. The patient also said that, the current vaccine (Shingrix) was a 2 shot series, 2 months apart, if you were vaccinated 5 plus years ago, you would want to check with your physician as the previous one had been found to not be effective. For the tolerance of the 2nd dose, refer case US2021AMR202766, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202766:same patient same report
Patient states experiencing swelling and redness at injection site with some muscle pain. Pt was put on Prednisone 20 mg 1 po daily five days, KEFLEX 500 mg 1 po tid seven days, and Loratadine 10mg.
Patient reports received vaccine 4/14/2021.  During evening hours began having nausea that persisted all evening.  During the night she was awakened.  Upon getting up during the night, reports she "went down to the floor."  She thinks she may have fainted but is unsure.  Reports she was not injured but was unable to get up from the floor.  Her husband called EMS who arrived at their home to assist patient from the floor.  Reports no other symptoms other than feeling weak today.
10/19/17 0600 C/O Stiff neck, headache, Aching body all over, Low grade fever of 99. 10/21/17 Fever jumped to 102, spent all day on the couch, aching all over, stiff neck, headache. Treated with TYLENOL and Ibuprofen. 10/23/2017 no fever, no headache, still has a stiffness in his neck. Returned to school.
Patient returned to health on Thursday February 17th to request her Covid 19 booster injection as a result of the mandate deadline for all hospital workers to have their booster vaccine by February 21st of 2022.  Patient was given the third dose  three weeks and five days too soon as per miscalculations by  Nurse .  Patient spoke with NP to reassure that it would be reported . Patient tolerated vaccine well with no adverse reactions noted at that time nor at the 15 minute observation period after.
Swollen tongue with extremely red and raised bumps and my mouth was ?raw feeling? with burning.
Fatigue, headache  and arm soreness on same day; diarrhea that night; worsening soreness throughout the week peaking on day 7 when I brought her to the doctor bc she'd had some uncontrollable shaking in hands and arm became so sore she could barely move it in any direction--red blotchy rash developed days 6-7; headaches every single day (still going on and she normally does not have headaches)
flu like symptoms; Achy; Tired; Nauseous; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in August 2019, refer case US2020003251).   On 3rd January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain, tiredness and nausea. On 6th January 2020, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the pain, tiredness and nausea were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, pain, tiredness and nausea to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The reporter stated that after vaccination the patient on 4th January 2020, experienced flu like symptoms, achy, tired and nauseous. This case has been linked with cases US2020003251, US2020003258 and US2020AMR003738, reported for same reporter.
Lethargic and fatigue  for five to 7 days after the vaccine. Other symptoms: Purple color to the flesh - (areas that had pressure like the bra and panty had less discoloration.  Odd taste (Not the NO TASTE; odd taste in my mouth) Still having times of fatigue
I think the shot is in my joint & Tech gave shot very high up in shoulder & hit a nerve & perhaps the joint it is brutal; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (I think the shot is in my joint & Tech gave shot very high up in shoulder & hit a nerve & perhaps the joint it is brutal) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (I think the shot is in my joint & Tech gave shot very high up in shoulder & hit a nerve & perhaps the joint it is brutal). At the time of the report, PRODUCT ADMINISTRATION ERROR (I think the shot is in my joint & Tech gave shot very high up in shoulder & hit a nerve & perhaps the joint it is brutal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Patient came in for varicella vaccine and stated on his consent form that he had not had a vaccine in 4 weeks.  After the vaccine was given, he asked for his vaccination record and when looking at it, he had received a MMR vaccine 2 weeks ago.
Case number PHEH2015US019712, is an initial spontaneous report from a physician received on 02 Oct 2015. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157601) intramuscularly on 15 Sep 2015. On the same day couple hours after vaccination, the patient experienced tingling all over, shooting pains, did not feel well, pain in extremities, felt like her skin was crawling and neurologic reaction. They got better 1.5 weeks and later they got worse. The events had not gone away. Seriousness and causality were not reported.
arm pain; arm hurt immediately/; vaccine injection was pounded and  thrushed in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (arm hurt immediately/) and VACCINATION SITE PAIN (vaccine injection was pounded and  thrushed in arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 007B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (arm hurt immediately/) and VACCINATION SITE PAIN (vaccine injection was pounded and  thrushed in arm). At the time of the report, PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (arm hurt immediately/) and VACCINATION SITE PAIN (vaccine injection was pounded and  thrushed in arm) outcome was unknown.            No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-079228 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079228:1st dose vaccine
developed shingles on my right hip and a small area on my lower back.  Thought it was mosquito bite first but then after a couple of days another area appeared with blisters, red and painful.  Used self care of ibuprofen  every 6 hours and calamine lotion and benadryl spray.  Blisters have now popped but continue self care.
Information has been received from a healthcare worker concerning a 23 year old female with penicillin allergy who on 11-JAN-2012 was vaccinated with her first dose of GARDASIL (lot # 668554/0306AA expiration date: 10-MAY-2013). Concomitant therapy included LOESTRIN. Subsequently the patient became pregnant after receiving GARDASIL (last menstrual period (LMP) was 19-DEC-2011, and estimated due date (EDD) was 24-SEP-2012). Laboratory studies performed included pregnancy test with Positive result. The patient had office visit for seeking medical attention. Follow-up information as received from the healthcare worker (medical assistant). Significant Information was provided. The date of birth for baby. There was no mention in patients records of any congenital anomaly or any problems with baby or birth. This case was lost to follow up. The pregnancy outcome was made as lost to follow-up. Additional information is not expected.