chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after injection, complained of joint pains, myalgia not relieved with use if Ibuprofen missed 2 days of school.
On Nov 9th starting at 0930 I started to experience an fluttering sensation at the lower portion of my heart and a weird double thumping at the top of my heart. The thumping sensation made me feel like it was in my throat and that I couldn't swallow.  Sometimes it felt as if I couldn't catch my breath. It lasted three continuous hours before I went to the Emergency room
ADMINISTRATION ERROR; VIAL LEFT OUTSIDE AT THE ROOM TEMPERATURE FOR 4 HOURS TO VACCINATE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced administration error, and vial left outside at the room temperature for 4 hours to vaccinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and vial left outside at the room temperature for 4 hours to vaccinate was not reported. This report was non-serious.
the cyst in her breast got infected, a rash occurred in arms, legs and back too. she had to get surgery to remove the cyst and take antibiotics for the infection
At 4:00 pm patient felt achy, sore, and started having chills.  At 6:00 pm, his temperature was 104.2.  I gave him 2 Extra strength Acetaminophen (500 mg each).  At 7:15 pm his fever had risen to 105.8.  At that time, I gave him 2 Advil (200mg. each).  By 8:00 pm his fever started to break and was 102 degrees.  I continued to alternate Acetaminophen and Advil every few hours.  By the morning of 3/13/21 his fever was back to normal.  He was left feeling extremely tired and had a terrific headache. By Monday, March 15 he was feeling much better.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unspecified patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017, lot # K011325, expiration date 08-APR-2017 and lot # J009788, expiration date 17-MAR-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt has kidney shaped red, raised, hot area to right thigh 60 cm x 30 cm. Edges were marked. Instructed to give BENADRYL 12.5mg/5mL - 4 mL twice daily for 1-2 days. Ibuprofen every 6-8 hrs. Apply ice to area 10-15 minutes several times per day. If not improved or is larger, more firm/hot to touch return to clinic for further evaluation.
After receiving the vaccine, I became extremely fatigued, woke up in bed 12 hours after vaccine, my left wrist was very sore, so I put my wrist brace on, wrist swelled quite a bit, wrote a message to the physician on the Sunday after, ice did not help with swelling, and I was taking Tylenol 8-hour arthritis. Saturday night there was shooting pain from my wrist to my elbow. Dr suggested to try ibuprofen and continue icing the wrist, brace would not have caused this swelling, however doctor ruled out that it was unlikely. Within 2 days after consultation, swelling was coming down and by Friday 15th wrist was back to normal.
INFLAMMATION ON NECK,SHOULDERS,THIGHS AND ARMS; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (INFLAMMATION ON NECK,SHOULDERS,THIGHS AND ARMS) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Venous insufficiency since 2011, Rheumatoid arthritis and Deep vein thrombosis.   On 10-Jun-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient experienced INFLAMMATION (INFLAMMATION ON NECK,SHOULDERS,THIGHS AND ARMS). At the time of the report, INFLAMMATION (INFLAMMATION ON NECK,SHOULDERS,THIGHS AND ARMS) had resolved. Not Provided          No relevant concomitant medications were reported.   The reporter's causality for the event of inflammation on neck, shoulders, thighs and arms with humira 40mg/0.4ml(adalimumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter did not have the lot number information, because the packaging was discarded.  No treatment information was provided.  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.
4/29/2021 right side twisted face and numb, hair shedding, eye issues. tooth loss
Pt was seen on 9/6/01. Mother reported staring episodes, jerking of arms, decreased social interaction and crying more since immunizations. Pt was seen by neurology 9/7/01 and diagnosed with tuberous sclerosis and infantile spasms.
One hour post vax the pt experienced generalized urticaria, generalized pruritus and scratchy throat. These symptoms required a doctor visit and were treated with Benadryl. Symptoms resolved over two days. The most recent information received reported the condition of the pt is resolved.
Rapid heart rate ten minutes after administration, anxiety attack and a hot face. Lasted 25 minutes in total.
Information has been received from a physician concerning a 16 year old female who on 22-JUL-2010 was vaccinated with a first dose of GARDASIL (lot# not reported). On 23-JUL-2010 the patient experienced a rash on her arm and then the rash spread all over her body. The physician reported that the patient called the office on 23-JUL-2010 about this experience and would be coming into the office to have the rash looked at. At the time of the report, the patient had not recovered. Additional information has been requested.
This has happened for each of my injections.  First 3 were Pfizer and this last one Moderna.   Severe chills while uncontrollable teeth chattering.  Severe body aches so bad that aspirin or Tylenol do not have any affect.   Coule   Did not sleep at all first night due to the pain and body-racking chills.  Pain is almost intolerable.   After the chills, which last about 12 hours, a fever with sweats that soak my sheets.  After the sweat, the aches go away.  I still had night sweats again for a second night and feel fatigued.
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (lot @ not provided). 3 months after the vaccination, the patient experienced shingles. The patient saw the physician. At the time of the report, on 11-NOV-2008, the outcome of the patient was unknown. Additional information has been requested.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medication list was not provided.  It was reported that 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up: added patient demographic details.
Information has been received from a RN concerning a 60 year old male pt who on 22Jan04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No other vaccinations were administered at the same time. Subsequently on 22Jan04. The pt developed induration at the injection site. Medical attention was sought. The pt was prescribed warm packs. A product quality complaint was not involved. The reporter also mentioned three other pt's who developed injection site reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
R thigh swelling/tenderness pain (mild to moderate) fever. all after 2 days of imm.
Left outer arm where varicella vaccine administered became red, hot and slightly raised at the injection site with a symetrical diameter of 50 mm.  No treatment at all.  The next day, it increased in size to 100 mm and was now non symmetrical.  The area was approximately 10 degrees hotter than the surrounding tissue.  No treatment given.  The area was slightly tender.  It then became itchy.  It receded and on the fouth day post vaccination was no longer present.  Child not given any medical attention.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8732), on 22Apr2021 as dose 2, single (Lot number: EW0170), on 25Oct2021 as dose 3 (booster), single (Lot number: 32030BO) and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: under control; "high cholesterol" (unspecified if ongoing), notes: under control. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had no known allergies. Patient received Paxlovid as treatment for Covid-19 from 29Dec2022 to 02Jan2023.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 05:00 (Lot number: EW0162) at the age of 52 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT taken for depression; OMEPRAZOLE; SYNTHROID. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 01May2021, outcome "not recovered" and all described as "Injection site turned very hard and warm to touch"; VACCINATION SITE NODULE (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset May2021, outcome "not recovered" and all described as "Around the injection site was a lump, it was hard, it was not fire red but red"; PAIN (non-serious) with onset May2021, outcome "recovering", described as "Did hurt"; VACCINATION SITE PAIN (non-serious) with onset 01May2021, outcome "unknown", described as "Aches at vaccination site"; FATIGUE (non-serious) with onset 01May2021, outcome "unknown", described as "I was very tired". Therapeutic measures were taken as a result of vaccination site discomfort, vaccination site nodule. Additional information: Reporter got the 1st dose of the Pfizer vaccine on Thursday, 29Apr2021 5 o'clock. Everything went well until Friday. Saturday she felt tired and the injection site turned very hard and warm to touch. She did not know if it was a local reaction but she called because she did not know what to do. She had already put a cold and hot compress and it still ached and still hard. She was hoping to get some suggestion. It was 10-15 minutes for any reaction so fine, Friday she felt fine, Saturday she was very tired but what developed around the injection site was a lump and it was hard, it was red not fire red but red it was warm to touch and it hurt, She had applied cold compresses, She had applied warm compresses and it was still that way, it did hurt but she haven't had much pain today because she had an ice. Haven't really used it much. She had called to see if there was any other recommendation of something else she could try. Anatomical site of administration was reported as "Left upper arm". Lab tests were reported as "Not in the 2021, in 2020". RA number, UPC number and Expiry date of Covid-19 vaccine was reported as unknown. No follow-up attempts are possible. No further information is expected.
Chills beginning 12 hours post injection; plus  Fever (102 max), lethargy, body aches, nausea, diarrhea beginning 24  hours post injection.; plus hallucinations beginning 30 hours post injection.   Was completely bed bound during symptoms.  Symptoms subsiding at 1:00 p.m. on 10/14/2022.   Treated with Tylenol without much results.  In contact with physician for guidance.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 20-MAY-2009, the patient received improperly stored (Oka/Merck) VARIVAX dose 1, from lot # 663710/0219Y expiry date: 13-FEB-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received form the same reporter. Additional information has been requested.
STOMACH BUG; This spontaneous report received from a patient 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 guselkumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced stomach bug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The outcome of stomach bug was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ROTATEQ 2 ml, oral. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states he received the flu shot and the same night he had very bad stomach pains, felt like "someone was punching him in the stomach". No other symptoms reported. Patient believes it was from the flu shot he received.
Low grade fever; Patient felt tired; severe shoulder pain that leave the patient to limited to No range of motion; severe shoulder pain that leave the patient to limited to No range of motion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (severe shoulder pain that leave the patient to limited to No range of motion), ARTHRALGIA (severe shoulder pain that leave the patient to limited to No range of motion), PYREXIA (Low grade fever) and FATIGUE (Patient felt tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (severe shoulder pain that leave the patient to limited to No range of motion) and ARTHRALGIA (severe shoulder pain that leave the patient to limited to No range of motion). On an unknown date, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Patient felt tired). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (severe shoulder pain that leave the patient to limited to No range of motion), ARTHRALGIA (severe shoulder pain that leave the patient to limited to No range of motion), PYREXIA (Low grade fever) and FATIGUE (Patient felt tired) outcome was unknown.            Concomitant medications were not provided. Treatment information include OTC pain killer for severe shoulder pain that leave the patient to limited to No range of motion.
Admitted for COVID pneumonia. Fully vaccinated. Treated with O2, remdesivir, steroids, zinc, singulair, eliquis. Required NC O2 but was eventually weaned to RA and discharged home with no O2 requirements.
This spontaneous report was received from a physician via company representatives and from support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with a dose of improperly stored GARDASIL or HPV GARDASIL 9 "SDV; 10 pack" and lot number K010215 with expiration date 05-APR-2017 (dose, route of administration and anatomical location were unknown) which was stored at the lowest recorded temperature of 34 (1.111111111 degrees Celsius) for 544 hours and at the lowest recorded temperature of 32 (0 Celsius degrees) for 168 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported. There was no product quality complaint involved. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
No additional AE; Nurse calling for TE evaluation in TE case 02216792 reports 1 dose of PNEUMOVAX 23 administered to 1 patient.    Names of vaccines involved (including lot/exp) PNEUMOVAX 23 PFS  U034712  7/30/2023        ?    Temperature 0.6C        ?    Time fra; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-JUL-2022, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U034712, expiration date: 30-JUL-2023 (strength, route of administration, and indication were not provided) administered for prophylaxis (Product storage error).  Administered dose of vaccine experienced the temperature excursion of 0.6 degrees Celsius for 23 hours. There was no previous temperature excursion.  There was no adverse event reported (No adverse event).
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.