chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). Concomitant products included allopurinol and alprazolam. On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On 17th April 2018, the patient experienced fatigue. In April 2018, the outcome of the pain in arm, fatigue and mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain in arm, fatigue and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The patient received SHINGRIX in the left deltoid. The patient experienced extreme pain and soreness in his arm, such that he could barely move his arm. One day after vaccination, the patient experienced fatigue. The symptoms were lasted for 3 days. The reported lot number (Y553Y) for SHINGRIX did not exist and was updated to YS53Y, according to sales database.
Within 1-2 minute(s) of injection, patient experienced weakness, wheezing, (L) arm went numb, felt like a brick was on her chest & had trouble breating-chest pain, hot flash & sweats, facial flushing, dizzy, slow to respond, began crying (Experienced lasted about 1 minute)  Next day, patient was still weak & tired.
pt recvd vax 7JUL93 & on 10JUL devel a fever up to 102.7 & inc sleepiness; hospitalized for sepsis work-up-CBC, CSF, blood cultures neg; treated w/Claforan & Ampicillin; fever resolved 12JUL93; final dx viral febrile illness; sepsis r/o
Developed itching all over, slight fever, nausea within 30-40 minutes after vaccine. Denies rash or blotching. Went home and took Benadryl X 2 and felt a little better. Called out from work the next night due to nausea and vomiting. States in previous years, she had received intradermal without any problems but took the IM route this year.
Postural Orthostatic Tachycardia Syndrome (POTS) (treated with salt tabs and Florinef), syncope, Chronic Fatigue Syndrome, migraines (treated with doxepin), ferritin deficiency (treated with iron supplement), vitamin D deficiency (treated with vitamin D supplement), insomnia, abdominal pain, nausea, dizziness.
I got the vaccine when I was 20 weeks pregnant. Delivered my son at 36 weeks 6 days. He has respiratory issues and has been in the NICU for 10 days now. He is making progress but we are still days away from being released. He was born weighing 5 lbs 16 oz.
Worsening left shoulder pain and decreasing range of motion in the 14 days after vaccination with influenza and HPV without signs of cellulitis, no bursitis appreciated. Possible tendon injury or possible frozen shoulder. Will be taking nonsteroidal anti-inflammatory medication and doing home physical therapy exercises. Will follow-up to assess improvement or need for further work-up/referral.
Vial was not reconstituted before it was given. Patient received 0.3 ml of undiluted vaccine.
I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) on 30Jan2021 09:00 (age at vaccination was 50-year-old) on left arm for COVID-19 immunisation. Medical history included hypothyroidism. No Known allergies. Concomitant medications in two weeks included thyroid (ARMOUR THYROID), ethinylestradiol, levonorgestrel (SEASONALE) and cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) on 07Jan2021 14: 15 (age at vaccination was 50-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. She was transported by ambulance and admitted to the hospital with numerous blood clots in her lungs after she could not breathe on 22Feb2021 09:45 AM. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment received as Angioplasty to remove bigger clots. No covid prior vaccination. Nasal Swab test (PCR) on 22Feb2021 was negative. The outcome of the events was recovering.
Information has been received from a nurse practitioner (NP) concerning a 40 year old female who on 27, Feb 2007 was vaccinated with the first dose, 0.5 ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast). concomitant therapy included estrogens (unspecified. On 27, Feb 2007, "starting a short time after her first dose, "the NP reported that the patient experienced pain at the injection site. At the time of this report, the patient was recovering from the event. The patient sought unspecified medical attention. Additional information has been requested.
Mom called advice nurse on 11/5/10 to report child had hives on both thighs and back following her flu shot on 11/2/10. On call doctor called, advised to give child 1 tsp of BENADRYL. Mother brought child in for well check appt. with Dr. on 11/19/10 and showed him pictures on her cell phone.
R lower leg rash-potential appearance began 10/1/02. Began red, warm-then patechial. Also runny nose, cough, ? x 1.
Chest pain, headache, nausea, injection site pain all lasting 3 days, Diarrhea ongoing
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 1:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 1:56 PM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 85.04.  Concomitant products were not provided.  On 12-Feb-2021, Excursion time was 09:00 hours in the morning, temperature was 29, Excursion time was at 10:00 hours and at 11:00 hours, temperature was 35 total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. Concomitant products included LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and L-METHYLFOLATE for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 18-Dec-2020 and the estimated date of delivery was 24-Sep-2021. On 05-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) 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. Treatment information was not provided.
I wake up that morning, my right jaw at the joint had pain and tightness. I got in my clinic; he was unsure what was causing this.  He gave me pain medicine, and a muscle relaxer.  I also having pain in my left arm that started on Sept 2nd. I got an appointment for this issue soon.
Patient without shot card on second dose clinic. Dose of Pfizer given while researching shot #1.  Subsequently found on master computer syatem to have had J&J on 05/09/21 by FEMA-- second shot not indicated.
Storing Moderna vaccine in their refrigerator and administered vaccine on 18-Jan-2022  past the date 01-Nov-2021; Patient administered vaccine on 18-Jan-2022 past the date 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 18-Jan-2022 past the date 01-Nov-2021) and PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 18-Jan-2022  past the date 01-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 18-Jan-2022 past the date 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 18-Jan-2022  past the date 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 18-Jan-2022 past the date 01-Nov-2021) and PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 18-Jan-2022  past the date 01-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information reported. No treatment information reported. reported as 01-Nov-2021.
I woke up with tingling on my fingers and legs. Light pressure on my left chest. I went back to sleep and chest pressure was gone but I still have tingling on my arm and also a little numb on my cheeks.
About 1o minutes after receiving the shot, while driving home, I became very dizzy. Symptoms similar to Vertigo. I pulled the car to the side of the road and waited 15 minutes. Went to the Hospital ER. Because I have a Pacemaker, they sent me to Hospital. I stayed overnight. They could not confirm that my reaction had anything to do with the shot.
11/12/99:vax administered.On same day,pt dvlped screaming for 5 hrs., T101, & GE reflux symptoms.
VARIVAX administered on (R) leg on 5/12/15. On 5/16/15 a localized erythematous reaction began which was: 4 cm of erythema with (x5) discrete vesicles near original site on 5/21/15.
Hx of allergy to penicillin and TESSALON PERLES. Started itching, chills swelling one hr. after shot. Has itchy rash on arms and neck feels swollen.
Left arm injection of HRSV, area of injection swelled double the normal size, pain, redness area about 3x 4 ", hot to the touch, 3 days post smaller area of redness, swelling less, hardness of injection area not as painful but constant pain. Right arm pain, some soreness much less than left arm.
moderna booster on 10/30/21. chest pain for 8 hours on 10/31/21. no pain since then.
Patient arrived at the Hospital on 8/9/2022 stating, ?feeling poorly starting [on 8/8/2022] characterized by intermittent fevers as high as 101 Fahrenheit, diffuse headache, myalgias, nausea, and generalized fatigue? per hospitalist?s note. Patient?s symptoms persisted the next day and experienced a bout of syncope lasting a few seconds which was witnessed by her daughter. EMS was activated and confirmed fever with other vital signs to be within normal limits. On the physician's note, it was stated patient was given a dose of ketorolac and ondansetron 4 mg IV,but ketorolac was not seen on the medication administration report. Patient had received Pfizer Covid booster (third dose) on 8/8/2022 prior to onset of symptoms. Per history and physical, patient has a history of neurogenic bladder with self-intermittentcatheterization with prior urinary tract infections, distant history of pulmonary embolism no longer anticoagulated, history of polymyalgia rheumatica no longer on treatment, osteoporosis, hypothyroidism on supplementation, fibromyalgia, and unspecified memory impairment. Prior to admission her home medications included: ascorbic acid, cyclosporine 5% ophthalmic emulsion, thyroid 120 mg, and vitamin D.
painful hot spots on his right arm and back; hot spots; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 10-MAR-2022, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 01-SEP-2023, 540 days after receiving Shingrix, the patient experienced pain (Verbatim: painful hot spots on his right arm and back) and skin warm (Verbatim: hot spots).  The outcome of the pain and skin warm were not resolved.   The reporter considered the pain and skin warm to be possibly related to Shingrix.     The company considered the pain and skin warm to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 15-SEP-2023 The patient self-reported this case. The patient received his first Shingrix vaccine on 10th January 2022  in an unknown arm and the second dose of Shingrix vaccine. The reporter stated that there were no adverse events after the first dose of Shingrix vaccine.  About 6 to 7 months after the second dose of Shingrix vaccine, the patient reported what he described as "hot spots" on his right arm and back. The hot spots were painful and they come and go, they were now on his left trunk and back. The reporter mentioned it to his doctor but his doctor did not do anything for him.  The reporter could not give a time frame of when the hot spots go away and return but he felt it might be related to the Shingrix vaccine. The reporter did not consent to follow-up.
felt scratchy in the throat; nose started running more/ nose was like a faucet, non stop, clear; sneezing non stop; injection site was sore; can't taste; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her Doctors PA told her that they got off the phone with another gentleman that was 80 y/o who had the same symptoms and he got the vaccine 1 week ago. On an unspecified date the patient experienced felt scratchy in the throat, nose started running more/ nose was like a faucet, non stop, clear, sneezing non stop, injection site was sore and can't taste. Outcome of the events was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058185 same drug, similar events, different patients
pt recv vax 12JAN99 & pt went home around 1PM mom brought pt back to ped clinic presenting skin rash, itching, swelling, SOB & subsequently in clinic fainted & was rushed to urgent care for observation;started as IV & 02;
Within 3-4 minutes of receiving Tdap, HPV, Men4, and influenza vaccine, patient developed dizziness, frontal headache, vomiting (3x), abdominal pain, lethargy, and diaphoresis. Initial vitals demonstrated hypotension (79/50's), bradycardia (50's) with weak/thready pulse, and oxygen saturations 80's (returned to high 90's within minutes and by the time oxygen was in room). No hives, wheezing, lip/tongue edema, difficulty breathing. Symptoms improved over the next 5-10 minutes with patient being more responsive, BP 90s/60s-100s/70s, HR in the 90's, alert/interactive and no longer diaphoretic and vomiting.
he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19; he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A female patient received bnt162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19".  Clinical course: The caller mentioned that he is calling regarding the availability of the new COVID-19 vaccine, and he would also like to know where he can get it in his area. The caller also said that he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in (place name withheld) and they had a COVID 19. The caller would like to know if his wife can have the vaccine. The caller also stated that he had heart surgery and diabetes. I created two manual AE forms because his wife and took the vaccine. Also, the caller had heart surgery and diabetes, and he also took the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A booster dose was administered to a 16 year old. Was explained to patients mother the situation. She indicated that her daughter weighs 160lb  and believes there shoudnt be any issue.
Received  undiluted dose of pediatric Pfizer vaccine. Patient reported no symptoms as of 01/08/2022
1. Severe pain in my back near my spleen/ reoccur about every 7-10 days 2. lungs feel like needles sticking / Happened on April 17 & 22 3. vertebrae is week W/Pain/ Occurs about every 7-10 days 4. Rib cage hurts to breath/ Happens about every 7-10 days
I had my shingles shots 7 months apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (on an unknown date received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.    Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had his/her shingles shots 7 months apart. The follow-up could not be possible as no contact details were available. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
"1/10/21 I go the 2nd shot.  My blood pressure dropped and they had to lay me down. It went to 90/40, I broke out in a rash on my neck, I am achey all over today 1/11/21"
No additional AE reported / no reported side effects; administered a dose of PNEUMOVAX 23 that was 5 days after the expiration date; This spontaneous report has been received from a health care professional and a pharmacist referring to a patient of unknown age and gender, whose medical history, concurrent conditions, previous adverse drug reaction, or family adverse drug reactions were not provided.  On 19-JAN-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis (strength, dose, anatomical location, lot number, route of administration, and vaccine scheme were not reported; the expiration date was reported as: 14-JAN-2023). There were no adverse side effects reported (no adverse event).
given expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported No Treatment medications reported
Fever and swollen lymph node in armpit on arm where vaccine was given starting 2 days post vaccination.
Patient with severe muscle weakness with tremulousness 3 days post-vaccination, and subsequently patient developed new onset seizure like activity on 2/20/2021 around 3:30 pm requiring admission to the hospital for further evaluation and monitoring.  All events occurred within the 14-day period post vaccination.
Pt states that about 3 days after his vaccine he developed a sore arm, chills, severe tremors, ringing in ears, fever and drowsiness and low energy.