chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who was vaccinated with a dose of Recombivax HB. It was reported that the patient was positive for hepatitis B after the patient was already given a vaccine for hepatitis B. The patient was possibly given Recombivax HB before she was found to be positive for hep B. It was also reported that patient might be pregnant. It was unknown whether medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Follow-up information has been received from the reporting physician indicating that the 31 year old female state tested nurse aid with no known drug allergies had hepatitis B confirmed by labs (pending). No adverse event was reported. Additional information has been requested.
Patient received expiration vaccine. There was a recall on this specific lot number FL2757 which had the wrong date printed for manufactured date. We were notified on 10/12/2022 of this recall. Patient received the vaccine on 10/01/2022, product expired on 9/30/2022 according to the new updated information.
6 inch whelp on right arm post immunization, went to PCP, gave steroid shot and antihistamines and is healing. Thinks a delayed allergy to vaccine.
pt recv vax 15JUL96 & reports redness, warmth, soreness, & streaking to inj site;also reports twitching to leg, feet, & toes;22JUL96 phone call to MD  to inquire about rxn;stated soreness & redness almost gone now;tingling & twitching gone;
Injection site pain with erythema (4-5cm) Approx 100F fever for 12 hours managed with ibuprofen Joint and muscle pain (generalized) focused pain in hips and lower extremities Pronounced lymph node with pain in left axilla after 36hours.
On the evening of the 8th day after receiving the vaccine, my injection site became red, extremely itchy, warm to touch and covered in hives.  The area affected was about 3x5 inches.  The morning after onset the hives were gone but the site was still red, slightly raised, itchy, and warm to the touch for the next  2 days.  I also experienced a small lymph node lump and slight pain in my armpit on the same side as the rash during the time of the reaction.  Site is still slightly itchy, on and off,  but redness and warmness to the touch is gone.
Hives on top lip, tongue itching.  Observed in office.  Administration of BENADRYL.
1300 Patient reports tingling throat and tongue 1315 Patient administered 50mg Benadryl PO 1400 Patient released; reports symptoms remain mild
mass on shoulder blade; Salivary gland not working on right side with swelling under ear; Salivary gland not working on right side with swelling under ear; bone growth after tooth pulled on left side; bone growth after tooth pulled on left side; Arm pain on right side; shoulder pain on right side; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (mass on shoulder blade), SALIVARY GLAND DISORDER (Salivary gland not working on right side with swelling under ear), EAR SWELLING (Salivary gland not working on right side with swelling under ear), EXOSTOSIS (bone growth after tooth pulled on left side) and TOOTH EXTRACTION (bone growth after tooth pulled on left side) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Oct-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 Milligram, Solution for injection in pre-filled pen. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PRURITUS (Itchiness). On an unknown date, the patient experienced LIMB MASS (mass on shoulder blade), SALIVARY GLAND DISORDER (Salivary gland not working on right side with swelling under ear), EAR SWELLING (Salivary gland not working on right side with swelling under ear), EXOSTOSIS (bone growth after tooth pulled on left side), TOOTH EXTRACTION (bone growth after tooth pulled on left side), PAIN IN EXTREMITY (Arm pain on right side) and ARTHRALGIA (shoulder pain on right side). At the time of the report, LIMB MASS (mass on shoulder blade), SALIVARY GLAND DISORDER (Salivary gland not working on right side with swelling under ear), EAR SWELLING (Salivary gland not working on right side with swelling under ear), EXOSTOSIS (bone growth after tooth pulled on left side), TOOTH EXTRACTION (bone growth after tooth pulled on left side), PAIN IN EXTREMITY (Arm pain on right side) and ARTHRALGIA (shoulder pain on right side) had not resolved and PRURITUS (Itchiness) outcome was unknown.            No concomitant medications was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  The reporter's causality for the event(s) of mass on shoulder blade, salivary gland not working on right side with swelling under ear, bone growth after tooth pulled on left side, first dose of Moderna caused itchiness, arm pain on right side and shoulder pain on right side with Humira(adalimumab) was no reasonable possibility.   This case was linked to MOD-2022-600621 (Patient Link).
Approximately three days after receiving the vaccine injection, pt. began to experience numbness in (L) arm to tip of index finger plus a tingling sensation. Saw her private M.D. - prescribed ice to injection site and a pulsating shower to (L) arm.
terrible chills that lasted fo 4 hours  and then immediately got a ever of 102. Took two tylenol and went to ER
COVID 19 Treatment/Rebound COVID-19 symptoms; COVID 19 Treatment/Rebound COVID-19 symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment/Rebound COVID-19 symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (May2022) negative, notes: home rapid test; (26May2022) positive, notes: home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks Lipitor, Alendronate start date=Sep2020, stop date=17May2022. Rebound COVID-19 symptoms after completing Paxlovid course. Patient completed Paxlovid treatment, symptoms resolved and patient had a negative at home rapid test. Patient developed similar URI type symptoms. Repeat at home rapid test was positive. Anti viral details COVID 19 Treatment Start date=18May2022, stop date=22May2022, Indication: Treatment of COVID-19, administrator route=Oral. The patient known allergies was sulfa, erythromycin. The patient other medical history osteoporosis, hyperlipidemia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Patient broke in hives. Patient complained of redness, itchiness.  Patient lips were swollen too. Patient states her lips were 4 times her  normal size.  Patient immediately went to healthcare provider where she was prescribed Prednisone. When speaking with the patient today, 4/26/2021, she stated that she was feeling much better and symptoms were resolved.
On the 8 day my arm started to itch I thought what am I starching for the size of the rash was raised.  Measured 4 inches wide 6 inches long oval shaped. Hot to the  touch and very painful.  Virtual visit: Hydrocortisone cream
Tiredness, out for 3 days, some days she was sick after 30 min she had to lay down, chills , sore arm for 3 weeks.
Initial unsolicited report received from a pharmaciston 15 November 2016. This case involves a 72-year-old female patient who was vaccinated with INFLUENZA VACCINE (Flu vaccine) intramuscularly       (batch number, expiry date of the product, dose, dose in series and site of administration were not reported) on an unspecified date (reported as 'last year'). Illness at the time of vaccination was reported as none. The reporter was unaware that she had any other symptoms at the time of administration. The patient did not receive any other vaccinations within four weeks of vaccinations noted above. No further information regarding concomitant medications was reported. On an unspecified date and duration following the vaccination, the patient suffered from pain. Relevant laboratory data was reported as none. Corrective treatment was unknown. The outcome of the event was not recovered. List of documents held by sender: none.
4 patients were administered vaccines from a vial that has been punctured for greater than 12hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 045A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   Doses were administered from the same vial which was initially punctured on 26-OCT-2021 and administered up until 3-NOV-2021.
Information has been received from a registered nurse and a medical assistant concerning an 8 weeks old male patient who on 04-MAR-2010 was vaccinated with the first dose of ROTATEQ (Lot#664650/1098Y). Concomitant vaccine included PENTACEL (Lot#C3542A). The medical assistant reported that on 04-MAR-2010, the patient's parents reported that the patient was crying and had stomach pain throughout the night. On 11-MAR-2010, the patient was seen in the physician's office, it was reported that the patient had blood in his stool. A stool culture was performed and the result was negative for rotavirus. On an unspecified date, the crying and stomach pain subsided. On 16-MAR-2010, the patient's parent reported that the patient continued with blood in his stool. At the time of the report, the patient had not recovered. Upon internal review, blood in stool was determined to be an other important medical event. Additional information has been requested.
AE: hot and sweaty( at 10am) Treatment: no medication was given. Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
c/o of throat feeling tight; seen by MD about 2 wks ago who did throat culture strep; pt was told culture neg; dx was pharyngitis &/or bronchitis; c/o throat tightness, hacky cough, nasal congestion & drainage;
Patient is fully vaccinated. COVID + 1/27/2022. Hospitalized 1/27/2022. Patient was admitted with worsening of shortness of breath and leg swelling. Work-up showed that she had acute DVT and pulmonary embolism. Heparin given. Discharged home with home care.
Cough; All over body aches; Burning sensation in her chest; Chills; Fever of 100.6; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills) and PYREXIA (Fever of 100.6) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills), PYREXIA (Fever of 100.6) and HEADACHE (Headaches). At the time of the report, COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills), PYREXIA (Fever of 100.6) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
MODERNA COVID - 19 VACCINE EUA Day 7 or 8  post-  vaccination  noted  right arm was red / swollen / firm to the touch  over a 3 x 3.5 inch area. Strong headache  ,  shoulder / neck pain ,  and strong fatigue .    All symptoms noted here continued for approximately 6 to 7 days. The 3 rd day of symptoms   I went to my Family Doctor who advised me to NOT take Dose # 2 of the Moderna Covid-19 vaccine due to possibility of having a worse reaction , possible anaphylaxis  reaction .  I notified Health Dept. that same day  and cancelled my scheduled 2 nd dose vaccine  appointment.
Presented to clinic with c/o upper arm, shoulder neck pain with red, swollen posterior arm with 2cm wide x 3cm orange peal texture eruption IV ROCEPHIN x 3d; oral KEFLEX, PO acyclovir.
On an unspecified date, the patient received her second dose of Lymerix. On the injection date, she experienced soreness in the injection arm which lasted 24 hours and resolved. On 04/17/2001, the patient received her third vaccine. On 04/22/2001, the patient noticed a dime-size lump on her left arm approx 1/4 inch above the injection site. The patient was advised to "wait one week" and to treat the lump with warm compresses. As of 04/24/2001, the outcome of the event was ongoing.
Td given IM in right deltoid. Student returned to class, then fainted. School nurse took BP and pulse and stated they were WNL. Nurse also reports that several minutes after fainting students exhibited seizure like activity (stiff neck, hand movements) 911 and parents were called. Parents refused ambulance. Will FU with MD.
red rash at injection site; itchy rash, believes it is bed bugs; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd February 2023, 2 days after receiving Shingrix, the patient experienced injection site rash. In February 2023, the patient experienced itchy rash. On an unknown date, the outcome of the injection site rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and itchy rash to be related to Shingrix.     Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: The reporter was the patient. The reporter reported that she received her second Shingrix vaccine in the left deltoid.  The patient reported that 2 days later she developed a red rash at the injection site. The patient still had the rash, and it was getting itchy during the past 2 weeks.  The patient believes it was bed bugs that caused the rash. The patient did not provide date of birth. The reporter did not consent to follow up.
1-2min p/vax fell to carpet - no loss of consciousness sl. lethargic for several min, also vomited x 3;
Swelling on face; itchiness on face; chills; body aches; fever; redness on face; A spontaneous report was received from a consumer concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, body aches/Myalgia, fever/Pyrexia, redness on face/Erythema, itchiness on face/Pruritus, swelling on face/Swelling face.  The patient's medical history was not provided. Concomitant medications reported were Diphenhydramine, Methylprednisolone for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M29A) intramuscularly in the left arm shoulder deltoid muscle for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) chills, body aches, fever, redness on face, itchiness on face, Swelling on face.The patient went to see her Physician on friday 19 Feb 2021 for facial swelling  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, body aches, fever, redness on face, itchiness on face, swelling on face was unknown.
Golf ball sized lump appeared on left side of neck, painful to touch, returned to work 11-30-21. December 8th followed up with breast physician due to ongoing bracheomutation risk of breast cancer. In the office there was clear water looking discharge form left nipple with a little pain. Physician unsure if related to vaccination. Several more episodes in the days after of drainage and discomfort. On December 13th another call was made to breast physician.
Starting on or about Feb. 24, 2021, 18 days after my 2nd dose I developed significant hair loss which led to partial baldness over the next 3-4 weeks.
Autoimmune skin disease; COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AUTOIMMUNE DERMATITIS (Autoimmune skin disease) and COVID-19 (COVID-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DERMATITIS (Autoimmune skin disease) and COVID-19 (COVID-19). At the time of the report, AUTOIMMUNE DERMATITIS (Autoimmune skin disease) and COVID-19 (COVID-19) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported after the Pfizer booster, on unreported dates, the patient got COVID-19. She also got a weird eczema and burning skin. She went to the dermatologist. The dermatologist stated she had an autoimmune skin disease and was seeing more of this in her medical practice. She also stated she thinks the mRNA vaccines are the cause.  Treatment information was not provided.
Information has been received from a physician and a family nurse practitioner concerning a 6 year old female who on 6/16/97 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (lot # 620614/1106D). There was no concomitant medication. The reporter indicated that in March 2003 the patient developed a very heavy and severe outbreak of varicella with vomiting and dehydration five years post immunization. The patient was hospitalized for three days and treated with acyclovir sodium (ZOVIRAX), antibodies and IV hydration. The patient subsequently recovered. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. It was also reported that the patient's brother was immunocompromised. Additional information has been requested.
Starting the day of the shot, I had chills and heat flashes, often back to back along with muscle pain. Starting June 12th, I had random shaking of my right arm, so much so that I believed the baby in my lap was having a seizure, only to realize it was my arm. It happened every few minutes daily, however, I was out of town and didn?t know of any places to report it. I have video footage of the shaking. Since then, if I get excited or nervous about anything, I feel a sensation that I can only describe as my blood vibrating. I quickly calm myself and it goes away. Other than that, I have persistent stomach pain whenever I eat. It?s a pain I?ve never felt before and don?t know how to describe it. It takes place right above my navel and lasts for what I assume is the duration of me eating.
4 days after ear infection with med. grade fever. Fever and ear treated with over counter childrens motrin. Symptoms seemed to subside. Fever returened on 10/15/08 along with severe chicken pox type rash covering entire body including head, neck, and face. No treatment yet. Going to doctor first thing in the morning 10/16/08
Pt developed syncope and LOC for ~ 3 min. VS WNL when monitored.No other adverse reaction noted.
About a week after receiving the second COVID-19 vaccination I noticed that my sense of taste was significantly degraded and I have a slightly metallic taste in my mouth. The condition has continued without any resolution or improvement since its onset
Information has been received from a nurse practitioner via a field representative referring to a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history were unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot # and expiration date  were not reported) for prophylaxis. After receiving ZOSTAVAX, the patient started to get swelling and rash around the injection site. The outcome of the events was unknown. The causality between ZOSTAVAX and the events was unknown. Additional information has been requested.
My vision in my left eye very blurry after 1st vaccine dose and tetanus shot the same day. Again I asked nurse if it was OK to have both the same day , she said yes.  The vaccine was given at Facility. And I noticed that my vision got worse I made the next earliest available appointment the same day Monday the 7/12/2021 same day at 1:30pm at Facility.