chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called on 8/12/21 saying she had a reaction to her 2nd COVID19 Pfizer vaccine given on 8/9/21. She said she started to notice yesterday (8/11/21) a rash like spot under the injection site. She described it as red, hard, sore, and hot to touch.  It is still there today (8/12/21) and she called to tell us.
Arm got sore. Started swelling. Injection site to wrist - felt hot. Went to hospital emergency room 1-11-11.
Rash, hardness under skin, itchy skin below injection site on upper arm, one week after shot.   Aprox. 3" x 3".
first dose greater than 25 days\my second shot was 16Sep2021, five months later/2nd dose >36 days; tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired/fatigued) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose greater than 25 days\my second shot was 16Sep2021, five months later/2nd dose >36 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (tired/fatigued). On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose greater than 25 days\my second shot was 16Sep2021, five months later/2nd dose >36 days). On 16-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose greater than 25 days\my second shot was 16Sep2021, five months later/2nd dose >36 days) had resolved. At the time of the report, FATIGUE (tired/fatigued) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided It was reported that the patient felt fine after the second dose, except tired/fatigued.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received: New event (fatigue) was added. Vaccine administration site updated.
This spontaneous report was received from a pharmacist concerning a 28 year old female patient. The patient's medical history and concurrent conditions were not reported. On 18-APR-2018, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, intramuscularly, lot # M035388, expiration date: 19-APR-2018, rHA (recombinant Human albumin), for prophylaxis. Concomitant medications were not reported. On 18-APR-2018, the patient experienced an unspecified injection site reaction. At the time of reporting, the outcome of injection site reaction and the relatedness between the injection site reaction and M-M-R II were unknown.
I began experiencing joint pain, which I was told to expect and did not find concerning. However, the pain that began in my left elbow - the same elbow as I received my shot - has not subsided after nearly 3 months.
Received the vaccine on 4/4/2021.  On 4/8/2021 started having pain in lower left leg.  Pain off and on for two weeks.  Pain intensified on 4/23/2021.  I went to the emergency room where they performed on ultra sound examination of my left leg.  Confirmed that I have a deep vain thrombosis (DVT) behind my left knee.  Prescribed Eliquis.  Saw Dr. today.  He could not confirm that DVT was caused by vaccine, but I thought I should report it.  I am to stay on Eliquis for six months at which time I will be evaluated for a blood clot disorder.
pt recvd vax 13NOV95 & APAP was given q 4 hrs; very irritable, appetite poor; T103 when APAP wore off; had weird cry; mom said high pitched sound; seen in office T101.2 on 14NOV95
Started with a rash around injection site on my left shoulder, my muscle there felt tight and bruised, I was also more fatigued then normal. I started feeling excessive aches and pains throughout my body. The next morning I felt as though I had taken sleeping medication and was trying to wake up through it, I felt drowsy and dizzy, I didn't feel safe driving to work so I called out.
Vaccine was punctured at 1:35PM, and vial expired at 1:35AM.  Dose was given after that time but within 24 hours of puncture date.
Muscle aches all over. Slight nausea.  Extremely sore at injection site.
Injection site of upper left arm is sore, very swollen, and hard/firm to the touch
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, during as reported "2 month well visit", the patient was vaccinated with ROTARIX. On an unknown date, during the patient's "4 month well visit", the patient was vaccinated with a dose of ROTATEQ lot # N030175, expiry date 16-JUN-2019 (also reported as 15-JUN-2019), orally (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Nine days s/p vaccination: Patient awoke with severe pruritus on the palms and soles.  Progressive erythema and palpable papulo-pustular rash ensued, while traveling. Returned and admitted to Hospital. Initial pictures Jan 11-3, 6, 7, 8 are from the morning of Jan. 12th.  The other pictures are dated correctly from Jan 13th, early morning. His rash improved somewhat with Benadryl, related or not, and certainly not worsened by noon the 13th.  MD felt the rash was not a generalized vaccinia reaction, because EM on palms blanched and eruptions were on dependent portions of the leg.  Felt hydrostatic forces contributed to the eruption.  The patient felt fine otherwise, no arthralgias, no lymphadenopathy, no fever, nor chills. The rash was confined to feet, ankles, and hands to the wrist.  The arm where the vaccination was placed looked fine without any significant adverse reaction.  Discharged on 13 Jan 03, with lesions resolving with Benadryl therapy. Discharge diagnosis: Urticaria, NOS. Digital photos will be forwarded via mail once VAERS E-Report number assigned.
Severe swelling in injection site, Headache, fever, chills, chest pain, heaviness in chest.
Patient developed generalizd skin redness and itching. Received 50 mg Diphenhydramine, PO. Patient observed vital signs q5 min. Symptoms improved. Patient left with husband, stable, alert and oriented, and ambulating.
Contracted a breakthrough infection of COVID-19 on July 16, 2021, testing positive on July 18, 2021 via the at-COVID-19 Ag home test
Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral foot pain. Day three moderate bilateral foot pain, all joints have pain, hands and feet the worst. Day four: fatigue (decreased), all over joint pain mild to moderate (went home from work) fatigue. Day Five (today) continued bilateral feet and hand joints mild pain that increases with pressure (walking holding or opening anything causes increase in pain from mild to moderate.
pt vax 18Oct97 w/ live varicella; pt developed severe chickenpox 23Oct 97; pt began to hallucinate AM  27Oct97, which persists; no further info avail
vomiting; Nausea; This is a spontaneous report from a contactable consumer, the patient.   A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 15Mar2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation.  Medical history included Hashimoto's disease and psoriasis. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took gentamicin (MANUFACTURER UNKNOWN) for an unknown indication on unknown dates and experienced drug allergy.  On 15Mar2021 at 23:30, the patient experienced vomiting and nausea. The patient did not receive any treatment for the event. The clinical outcomes of the vomiting and nausea were recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
Patient reports "feeling terrible" with all-over body aches for 3 days. Especially her abdomen. She said it felt like she had "done 100 sit-ups". She took a "few doses" of ibuprofen and they helped a bit but she doesn't like taking medication so she only took it a few times. No reported fever. She improved spontaneously without medical intervention after 3 days and has had no further symptoms. She is deathly allergic to eggs and cannot have the regular flu shot because of this.
This spontaneous report as received from a registered pharmacist refers to a 76 year old female patient with allergies, high cholesterol and penicillin unspecified reaction. On 02-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # J014568, expiration date 18-FEB-2015) subcutaneously. The pharmacist reported that on 05-JUL-2014, the patient developed itchy, raised, red bumps on her forehead and both cheeks. The patient went into the pharmacy on 08-JUL-2014 and was advised to take CLARITIN and apply AVEENO lotion to the affected areas. There were no Lab diagnosis or studies performed. The outcome of itchy, raised, red bumps on her forehead and both cheeks was reported as recovering/resolving. Additional information has been requested.
Fever, extremely sore arm (could barely move it), terrible headache, body aches.
Normal heart rate of 70 BPM went to 135 BPM after  5hrs. Felt fluttering in heart. No pain or tightness. Seems to subside some in about 3 hrs but on 09/19 it cam back at 130-140 BPM with AFIB. Went to cardiologist on 09/20/21 took ekg heart rate 135bpm in flutter and afib. As of 09/28 heart rate is all over the board with added 120mg diltiazem..between 90-125 bpm
Three hours after injection arm pain and chills Twelve hours after severe full body joint and muscle pain. Fever. Could not stand up. Nausea. Headache. Could not sleep due to pain. Twenty four hours after fever abated. Fatigue. Swollen neck and throat tightness. Chest restriction. Thirty hours after fever returned. Forty Eight hours after fever gone, neck no longer swollen. Brain fog severe, fatigue and arm pain still present. Fifty Four hours brain fog and fatigue still present and had a hallucination.
Pt complains of soreness at the sight, muscle weakness.  Pain has not improved since receiving shot.
Patient reported muscle pain, and some swelling, also reported burning in the injection arm.  Counseled patient to take ALEVE or ibuprofen along with BENADRYL to help with reaction.
Pt. received DT immunization (0.5 cc) for prophylaxis treatment s/p laceration on 04/05/08.  Returned to ED c/o pain, swelling, redness right arm on 04/07/08.  Treated and released.
Pt recvd vax & 2 wks later devel nonspecific joint pain & subsequently recovered; No further details were provided;
Red, sore, swollen, warm, itchy, headache, and overall "so-so" feeling.  Patient treated with ice, Benadryl, acetaminophen, and ibuprofen but still felt the same.
There is skin discoloration in the area where the shot was given. It is in the shape of a Band-Aid and right above the Band-Aid mark.
Last time I had the flu was about 12 years ago after getting the shot / never again / suspected vaccination failure; Last time I had the flu was about 12 years ago after getting the shot / never again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.  Additional case details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The patient had flu shot 12 years before day of reporting and after getting the shot had flu. The patient did not want this again. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The follow up was not required.
This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 39 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jan2021 08:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "was diagnosed with Covid-19", start date: 26Dec2020 (unspecified if ongoing), notes: who was diagnosed with Covid-19 on 26Dec2020; "her symptom included an ear ache" (unspecified if ongoing), notes: her symptom included an ear ache. There were no concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnancy"; LYMPHADENOPATHY (non-serious) with onset 03Feb2021, outcome "unknown", described as "lymph node swelling in right lower quadrant"; NAUSEA (non-serious), outcome "unknown", described as "kind of nauseated"; DISCOMFORT (non-serious), outcome "unknown", described as "had was uncomfortable in the right lower quadrant". The events "pregnancy", "lymph node swelling in right lower quadrant", "kind of nauseated" and "had was uncomfortable in the right lower quadrant" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient stated that on 04Jan2021 her husband was diagnosed with Covid-91 as well. On 30Jan2021 8am, she received her first dose of the Pfizer Covid-19 vaccine and had complaints of RLQ lymph nodes and pregnancy, and gallstones were ruled out. The caller would like to provide background first, caller tested positive for Covid on 28Jan2021 and was scheduled for first dose on 30Jan2021. The patient called Pfizer and the recommended time was 21 days after Covid positive, but said the patient was okay to receive the first dose Pfizer Covid Vaccine. Caller states the recommendations have since changed to 90 days to receive Pfizer Covid Vaccine after testing positive for Covid. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (15Sep2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. Follow-up attempts are completed. No further information is expected. Follow-up (27Sep2021): This is a follow-up report from a contactable pharmacist communicated to a Pfizer colleague regarding BNT162B2. Follow-up attempts are completed. No further information is expected
A report was received from a health care professional on 11/18/02 concerning a vaccinee of unknown demography who developed a rash after receiving Fluvirin on an unknown date. No further information was reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200794, PJP200200793 and PJP200200792.
administers Kinrix to 4 month old infants to prevent giving an extra dose of Hep B; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. A pediatric infectious disease doctor reported knowing that one of the pediatricians in his institution administered  Kinrix to 4 month old infants to prevent giving an extra dose of Hepatitis B, which led to inappropriate age at vaccine administration. No further information was reported. Reporter did not consented to follow-up.
Both of my arms are swollen starting from my wrist after 15 days of receiving vaccine.
I have joint pain, muscle pain and a sore injection site.  the pain started with my knees and by the time i went to bed, my whole body hurt. When i got up this morning, i could barely walk.  It's now just after 1:00 P.M. and my pain level is still not back to my normal. But, it is getting there.   I should be fine soon, relatively speaking. this was my second booster.  The only issues that i have had, with the first three, is a sore injection site.
Swelling, pain, and erythema at site of injection extending down to elbow.  Information received from Medical records states cellulitis.
Cramps on the front side of upper thighs for four consecutive days. Pain level - moderate to severe.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-01-22, Adverse effect of other vaccines and biological substances, initial encounter on 2023-01-23.
Information has been received from a medical technologist concerning a 29 year old male with no allergies or pertinent medical history who on 02/27/2004 was vaccinated in the deltoid with hepatitis B virus vaccine rHBsAG (yeast) (lot # 64634/1023N).  There was no concomitant medication.  The reporter indicated that she was unsure in which arm he was vaccinated.  The patient called the doctor's office on 03/03/2004 stating that he had a hot, itchy, pimple- like rash on the neck which then spread to his chin and around the ear to the back of the neck.  Unspecified medical attention was sought and no treatment was required.  No diagnostic laboratory tests were performed at the time of the report, the patient had not recovered.  A product quality complaint was no resolved.  Additional information has been requested.
About 6 x 3 inch red rash and itching around injection site January 28 to date
This case was reported by a consumer and described the occurrence of cough in a 77-year-old patient who received Influenza vaccine (batch number unknown, expiry date unknown). Co-suspect products included ADVAIR Diskus inhalation powder (batch number 4ZP6123, expiry date February 2016) for asthma. The patient's past medical history include colon cancer, bone cancer and pneumonia. Concomitant products included Dlicicice,FLONASE nasal spray, SPIRIVA, VENTOLIN, Vitamin D, ZOCOR, phenazone, aspirin, levalbuterol, losartan, metformin and paroxetine. On 25th December 2014, the patient received influenza vaccine (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, the patient started ADVAIR Diskus (inhaled) 1 puff(s) at an unknown frequency. On an unknown date, the dose was changed to an unknown dose and frequency. In December 2014, less than a week after receiving Influenza vaccine and an unknown time after starting ADVAIR Diskus, the patient experienced cough. On 28th December 2014, the patient experienced cold. ADVAIR Diskus was continued with no change. On an unknown date, the outcome of the cough was not recovered/not resolved and the outcome of the cold was recovered/resolved. It was unknown if the reporter considered the cough and cold to be related to Influenza vaccine and ADVAIR Diskus.
Received flu vaccine on 10/4/2022, arm was sore after vaccine but now has pain running down arm to inner elbow that keeps her up at night.
Swollen lymph nodes on both sides of groin.  Pain so bad she thrashes and kicks her legs out, crying fussy all the time now.  Its been over a month since her shots been seen 2 times.
I noticed that with first vaccine with Pfizer 03/30/2021, I developed a rash, little ones after my first vaccine with Pfizer vaccine. After my third vaccine, my rash was all around waist, groin area, thighs, shins and up around my neck and chest area, the side of the arms and mid-section of my body. They looked like hives and are very itchy. My blood platelet was A negative. On all three vaccines, my lymph nodes swelled up size of a soft ball, hurt really bad. The swelling stayed for another two weeks but now it is fine. I have appointment February 3, 2022, to see my Dermatologist. I still have the rash today. When I was a small child, I had bad allergies up until I was 12-year-old.
Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; Expired vaccine was stored in refrigerator on 17-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: JANSSEN COVID-19 VACCINE (Primary dose and lot number; 1805031) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Latex allergy, Penicillin allergy (Allergy to PCN) and Drug allergy (Allergy to IBU and Zoloft).   On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The health care professional (HCP) states that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The HCP explains that since the expiration date was not written on the vial, they did not notice it had already expired.  On 17-May-2022, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  The patient did not report any side effects.  No treatment medications were reported.
Vaccine received 1/8. Pt called with injection site discoloration 7-14 days later. This was thought to be a normal rxn. Pt noticed a knot in her arm and saw MD on 3/12/13. Now has a cyst at the injection site. MD says only way to get rid of is to remove.