chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CILOSTAZOL for an unknown indication.    On 23-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 MYALGIA (sore arm). On 26-Feb-2021, MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking Cilostazol for a blockage in his right leg and was concerned about a bleeding risk. No treatment information was provided.
Patient given GARDASIL too soon between 2nd injection and 3rd injection. No reactions. Patient mother notified.
PURPLE SPOT ON ARM; COULD NOT SLEEP; ARM HURTS; BAD HEADACHE; This spontaneous report received from a consumer concerned an adult patient. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 12-APR-2021, the subject experienced purple spot on arm. On 12-APR-2021, the subject experienced could not sleep. On 12-APR-2021, the subject experienced arm hurts. On 12-APR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 13-APR-2021, and had not recovered from purple spot on arm, arm hurts, and bad headache. This report was non-serious.
nauseated; a horrid headache; low grade fever; chills; weird body ailments/make me feel this poorly/felt so bad all week; achiness; severe lethargy; This is a spontaneous report from a contactable other HCP. This 57-year-old female other HCP reported for herself that:  A 57-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration, administered in Arm Left on 13Mar2021 15:00 (at the age of 57 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Concomitant medication(s) included zinc Vitamin supplements and Zinc. It was reported that no other vaccine administered in four weeks. Covid prior to vaccination was no. It was reported that covid tested post vaccination was no. Patient had no known allergies.The patient experienced achiness, severe lethargy on 14Mar2021 17:45, nauseated, a horrid headache on 14Mar2021, low grade fever, chills, weird body ailments/make me feel this poorly/felt so bad all week on an unspecified date. Caller stated had all the side effects listed on the paper that they gave her and had lingering side effects 5 days later with achiness and severe lethargy.Caller stated had only the first dose so far. Felt fine the first day. But on the next evening started feeling ache & very lethargic and nauseated and a horrid headache from Sunday night thru Tuesday. Had low grade fever too and chills For 6 days had every single side effects & other weird body ailments. Felt like crap all week Just doing 1 chore like making her a meal. Took everything out of her, Had to miss a week of worth and no one could tell her why felt so bad all week. Caller was scared to take the second dose being as the first one made feel this bad. Even her Doctor acted like he didn't know how to make her feel better or what to do for her. Caller stated still not feeling hundred percent like herself. After getting the shot over a week ago, caller really regret getting it and stated was going to make her feel this poorly after getting it wouldn't had.Therapeutic measures were taken with Steroids and Nausea medicine as a result of achiness, severe lethargy.The outcome of event achiness, severe lethargy was not recovered and for event nauseated, a horrid headache, low grade fever, chills and weird body ailments/make me feel this poorly/felt so bad all week outcome was unknown.  No follow-up attempts are possible. No further information is expected.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
The day of the vaccine, my arm started to hurt, and the day after, I felt sore all over, and felt like I had a fever. Have been feeling very lethargic and have a headache as well.
Received a flu shot on Monday afternoon 10/14/19 and became very ill the next day with a fever, stomach cramps, headache and diarrhea. Fever subsided the next day but diarrhea persist and is severe. Flu shot was Fluarix Quad PFS 2019-20 #0.5.
Fever of 102 followed by seizure, diagnosed as febrile seizure at local ER.
Red, warm, raised bumps on right thigh. 1 tsp. Benadryl elixir given PO.
Severe headache onset at 9pm.  Chills, rigors overnight. Severe fatigue the following day.  R arm significant swelling, redness, and pain which worsened over 48 hrs. Arm also became very itchy. Continues to be itchy on 1/5 and rash present near injection site. Headaches daily since injection.
Redness / Redness on palms and hands; Tingling; Itching; crazy skin; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at SINGLE DOSE as work at the hospital.  The patient medical history and the concomitant medications were not reported. The patient got COVID-19 Vaccine (later confirmed) at work, got it on Friday and the patient was fine. The patient just experienced this morning on 12Jan2021, some redness, a little tingling, itching. The patient has had it for three days now. The patient hasn't had anything but this itchiness. And it just fades out when you're done itch completely. And it's a little redness on palms and hands, the patient wash hands a lot, so have kind of a crazy skin on unknown date in 21Jan2021. The outcome was unknown.  Information on the Lot/Batch number has been requested.
Fever, chills/ myalgia, redness right deltoid/ bicep, pain in right arm with movement. Pain radiates to axilla right. Treated with oral steroids
Patient felt lightheaded, and nausea. She took 50 mg diphenhydramine by mouth while still at the pharmacy. Went home after 15 minutes of sitting in pharmacy waiting area. Patient states she vomited when she got home, and immediately felt better after emesis.
Itching skin arms legs back; Burning skin arms legs back; Stinging skin arms legs back; This is a spontaneous report received from a contactable consumer, the parent. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included heart (heart disorder) and kidneys (kidney disorder). The patient had unspecified allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether the patient had received any other vaccines within 4 weeks prior to COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 20Mar2021(at the age of 79-years-old) at 13:45 as a single dose for COVID-19 immunisation. On 13Apr2021 at 12:00, the patient had itching, burning and stinging skin on arms, legs and back. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events itching, burning and stinging skin on arms, legs and back were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt was requesting Tdap vaccine.  RN checked w/ clinic provider whether it was OK for pt to have Tdap at same time as Moderna Vaccine #2, in separate arms and it was OK'd.  RN checked database in EMR and didn't see record of any recent vaccines of that type given.  Vaccine was given without problem and Moderna Vaccine #2 was given to other arm without problem.  Pt waited in clinic 15 min. after injections and no complaint was voiced or adverse reaction noted.   Left clinic in good condition.  Upon entering vaccine in pt's EMR it was discovered there was a Tdap listed as having been given 11/19/21 (and another previous one 12/13/11).  RN informed pt's PCP and other required clinic personnel.  RN called pt to inform him of the extra Tdap dose given and requested he inform clinic of any adverse reaction he might notice.  Pt stated he had not noticed anything since leaving clinic approx 1 hour prior.
At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throat, dizziness, slight confusion. Vital sings 140-78/HR76 /R16, 93@ O2Sat.  Skin warm and dry.  Forehead is slightly flushed and war,  Cap refill good, breath sounds clean bilaterally.  Had patent lay down for vital signs, sat up and given water.  Patient became dizzy upon sitting, returned to supine position.  1313 vital signs 122/80/HR76/R20. Skin warm and dry, good cap refill, breath sound clear bilaterally.  1328 had patient sit up, no initial dizziness orthostatic vital signs: Supine 118/80/HR80/R20.  Sitting 140/100..  Patient discharged in stable condition in the company of his wife.  Pt is alert and oriented times 3.  Skin pink, warm and dry.  Agrees to follow up with PCP or EMS if any signed of diff breathing, throat tightness were to occur on his arrival home.
Client had syncopal episode upon leaving vaccine admin area, hit head, regained consciousness. Positive change in mental status, inability to hold up head, answer questions. HR 50, BP 80/40. Paramedics called. No change in status in 10 minutes before they arrived.
This case was reported by a nurse via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in January 2018). In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills, injection site pain, tremor, injected limb mobility decreased, tiredness and weakness. On an unknown date, the patient experienced feels awful, influenza-like symptoms, drug dose administration interval too long and product supply issue. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, injection site pain, tremor, injected limb mobility decreased, tiredness, weakness, feels awful and influenza-like symptoms were recovered/resolved and the outcome of the drug dose administration interval too long and product supply issue were unknown. It was unknown if the reporter considered the chills, injection site pain, tremor, injected limb mobility decreased, tiredness, weakness, feels awful and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the consumer for her mother. The patient stated after 2nd dose of SHINGRIX, she felt horrible and had bad flu like symptoms. The patient stated all symptoms resolved within hours to a day following vaccination. The patient stated that her 2nd dose of SHINGRIX was delayed due to a shortage of Supply. Did not collect the lot or expiration date of the vaccine. No additional details were provided. The reporter gave consent to follow up. This case has been linked to the US2019025046, reported for the dose 1 of the same patient.
(When at home) After administration of DTaP to left thigh (intramuscular injection) pt had localized skin redness approx 6 inches by 10 inches inner thigh not underneath, but beside injection with slight dependant
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 10-JUN-2013, lot # H010915 expiration date 13-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Day1-6 shoulder pain and fatigue  Day 7 no sympathy  Day 8-9 itchy rash around vaccination site
This case was reported by a healthcare professional and described the occurrence of swollen lymph node on the right side of the neck in a male subject aged between 30 and 39 years old who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 23 July 2007 the subject received 1st dose of Engerix B at 0.5 ml in the left arm.  On 23 July 2007, 12 hours after vaccination with Engerix B, the subject experienced swollen lymph node on the right side of the neck.  On 24 July 2007, the event was resolved.
chronic headache and dizziness that has persisted through the first and second shots.  Varies in intensity but has not resolved.
States had arm pain immediately, had trouble doing lifting since her arm was sore for several days and today 9/12 her arm is still sore.  States the pain today is 2/10 and hurts when lifting or touching it.  States she developed headache, body aches on 8/30 and the body aches lasted until 9/9, states she has also had a headache every day and had a migraine last night 9/7(had not had one in a year.). States she feels her skin is really hot. Hx of migraines, also had hormone replacement increased one week ago, due to mood swings and hot flashes.
Inc temp 8 days post vax; Temp controlled w/APAP, mom states took pt to ball field on 15JUN did not give APAP; Stayed @ field in extreme heat & humidity all day; Felt warm, but thought due heat; Had sz in PM; Taken to Hosp; Dx Febrile sz;
had the vaccine and sitting here with shingles; sitting here with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (Verbatim: had the vaccine and sitting here with shingles) (serious criteria GSK medically significant) and shingles (Verbatim: sitting here with shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 Reporter's Comments:  The reporter reported the case via interactive digital media. The patient had the vaccine and he/she was sitting there with shingles on day of reporting. The reporter said no you were not good. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: had the vaccine and sitting here with shingles) (serious criteria GSK medically significant) and shingles (Verbatim: sitting here with shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 Reporter's Comments:  The reporter reported the case via interactive digital media. The patient had the vaccine and he/she was sitting there with shingles on day of reporting. The reporter said no you were not good. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
The pt developed a fever, a swollen arm with redness and warmth to the touch. The pt sought unspecified medical attention. Additionally it was noted that 5 other pt's experienced similar reactions. Additional information has been requested.
Pt recvd booster dose of MMR in DEC89; Following vax, devel urticaria & angioneurotic edema; tx Epi & DPH;
The day of the shot the right arm (shoulder) was sore the. day after the shot Right shoulder had horrible pain and under armpit swelled up (very sore to touch and a bit smaller than golf ball size swelling of lymph nodes)
This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown. It was unknown if the reporter considered the herpes simplex to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter heard from her pharmacist that the mother of a coworker had received SHINGRIX and developed a herpes lesion on her shoulder. No further details were available. This case has been linked to US2018173523, reported by the same reporter.
Patient was vaccinated on 9/14/12 (flu vaccine). She was admitted with altered mental status on 9/22/12 that soon required intubation & intensive care unit transfer. MRI brain shows white matter lesions diffuse. We think it's probably ADEM (Acute Demyelinating).
however both have tested positive to COVID-19.; however both have tested positive to COVID-19.; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 44-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 02Dec2021 (Lot number: FJ8762) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pulmonary embolism", start date: Sep2021 (unspecified if ongoing); "COVID-19", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. She had a pulmonary embolism and was taking blood thinners for the pulmonary embolism that was diagnosed in Sep2021 and now as of Dec2021 she is ok and is no longer on blood thinners. The patient has no prior vaccinations (within 4 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 22Dec2021, outcome "recovering" and all described as "however both have tested positive to COVID-19.". The event "however both have tested positive to covid-19." and "however both have tested positive to covid-19." was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: by NAAT PCR TMA test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient stated that she and her son have got their first shot of Pfizer Biontech COVID-19 vaccine. Today, they had the appointment for the second dose, however they both have tested positive to COVID-19The pharmacist told her to wait one month but she read on the Internet that she could get it after 10 days. She wanted to know if she could get the second dose of the vaccine having had a positive covid test. She was diagnosed with covid yesterday morning (22Dec2021). She went to ER yesterday and did the PCR test and the doctor told her that she tested positive for the omicron variant. She was not admitted, went there (emergency room) for a covid test. She was taking over the counter pills. The patient felt a little bit better today, yesterday was really bad. She has not received the second dose. She had covid prior in Apr2021 and wanted to take the vaccine earlier but was procrastinating. She was told that she was good after quarantine and are good to get the second dose. She went to pharmacy and they told her to go after a month. Then on the website, that she should not wait longer than 2 weeks, or it is not really good. She wanted to call Pfizer to make sure when she should get the second dose. She was advised to follow what transfer agent stated or consult with hcp. She did not get second dose yet. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101852784 same reporter/drug/AE, different patient
Patient reported to her provider that she had an anaphylactic reaction to the covid vaccine. The vaccine was not administered at one of our facilities, so there was no documentation regarding what had occurred or what medications were given to treat this.
Flu-like symptoms: headache, muscle tightness, fatigue, loss of appetite.
12-18-09 To clinic for acute bronchitis. 1-6-10 Pt with no c/o of illness at time of receiving ZOSTAVAX vaccine. 1-9-10 To clinic for asthma/cough. 1-18-10 MD - bronchitis/cough. 1-25-10 Walk-in clinic - bronchitis/cough (CXR done). 2-19-10 To clinic - asthma/cough. 2-22-10 MD Pulmonologist - asthma. 3-8-10 Hospital - Aspiration pneumonia. 3-17-10 MD cough. 4-1-10 Hospital for aspiration pneumonia, acute tracheitis with herpes virus.