chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clogged duct/mastitis in left breast; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Oct2021 09:15 (Batch/Lot Number: Ff2587) as single dose for Covid-19 immunisation. Medical history included known allergies to amoxicillin and shellfish. The patient was not pregnant at the time of vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 13Sep2021 at 12pm (Batch/Lot No: Ff2587) in left arm for Covid-19 immunisation. Concomitant medications included pre-natal (as reported); sertraline; loratadine (CLARITINE); paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. After the second dose, the patient experienced clogged duct/mastitis in left breast on 21Oct2021. It was treated with antibiotics. The event resulted in doctor/other healthcare professional office/clinic visit. Patient was not diagnosed with Covid-19 prior to vaccination. The patient was not tested for Covid-19 post vaccination. Outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
No symptoms reported. No additional AE; improperly stored administered PROQUAD; This spontaneous report has been received from a nurse concerning a 4-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 03-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA) (PROQUAD), 0.5 milliliters (ml), lot # W024551 (has been verified to be a valid lot number, expiration date reported and upon internal validation established as 31-JAN-2024) for prophylaxis (anatomical location and route of administration were not reported). The vaccine was stored at a temperature of 0.6 Celsius degrees (C) (-10C up to 8 C) for 6 hours, 15 minutes and 0 seconds. The vaccine did not suffer previous temperature excursions (Product storage error). No additional adverse event reported.; Sender's Comments:  US-009507513-2308USA001106:
Patient told me as I was setting up a Covid vaccine event on 4/15/21 when she told me she is not sure if she had an adverse reaction to the vaccine.  She normally get heart palpations under control maybe once every month or two, but after the 1st vaccination she noticed she gets the palpations every week instead. Then on 2nd vaccination 3/28/21 she started getting it palpitations every other day.   It doesn't seem as often and it has not kept her from doing her normal activities.
Patient requested the Moderna Bivalent Booster. Pharmacist inadvertently administered the Pfizer Bivalent Booster. The Pharmacist realized the error while the patient was still in the store. The Pharmacist informed the patient of the error. The patient had no adverse reactions for the approximately 15 minutes she was in the store post vaccination. Note: the answer to #21 is unknown.
pt recv vax 24JUL96 & was exposed to child who devel chickenpox on 3AUG96 or 5AUG96;7AUG96 pt exp a local rxn @ inj site consisting of a quarter-sized area of raised erythema;8AUG96 pt devel 17 lesions;9AUG96 low grade fever, itching, h/a;
administered 2 booster doses of the Moderna Covid19 Vaccine on 15Jul2002 from vial that expired on 13Jul2022; Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 booster doses of the Moderna Covid19 Vaccine on 15Jul2002 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 booster doses of the Moderna Covid19 Vaccine on 15Jul2002 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 2 booster doses of the Moderna Covid19 Vaccine on 15Jul2002 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received booster dose of Moderna COVID-19 vaccine.  Concomitant medications were not reported.  It was reported that 2 doses from 1 vial which was initially stored in the refrigerator on 15-Jul-2022. The vial did not undergo any temperature excursion.  Treatment medications were not provided.   This case was linked to MOD-2022-609104 (Patient Link).
thalamic infarct on the left lateral thalamus; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's concurrent conditions and medical history were not provided.  In or around 12-DEC-2016 the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (herpes zoster). On an unknown date (reported as " Shortly after receiving vaccine"), the pt experienced shortness of breath, chest pain and numbness and tingling on the right side of his arm extending to his fingers. The patient was also having weakness on the right lower extremity which was causing him to walk tilted and fall. The pt was hospitalized and diagnosed with thalamic infarct on the left lateral thalamus. In addition, it was reported that the pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury (disability). At the time of the report, the outcome of thalamic infarction was not recovered.  The reporter considered thalamic infarction and emotional distress to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, thalamic infarction was considered to be an important medical event , and due to the limiting, permanent and incurable injuries was also considered disabling.
Fever 99.5 - 100 started  8:30 PM 3/17/2021 - midday 3/18/2021. Low grade 99  thru (3/19/2021, 11:40 AM). Chills 10-11PM 3/17/2021. General fatigue, 8PM 3/17/2021 thru 3/19/2021 midday.
Pain at injection site (night of), total body aches/upset stomach/pain at injection site~12 hours after inj. continuing to next day.
This case was reported by a consumer (daughter of the subject) and described the occurrence of injection site cellulitis ina 64-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included chronic lymphocytic leukemia. Concurrent medications included Acyclovir, ZETIA, Simvastatin and Trazodone. On 12 September 2013 at 12:00 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 13 September 2013, 1 day after vaccination with FLUARIX, the subject experienced injection site cellulitis and small rash injection site. The reporter stated that the subject "developed a small rash located 5 fingers below the injection site." The subject sought medical attention. This case was assessed as medically serious by GSK. The subject was treated with Antibiotic for 10 days. At the time of reporting the events were improved.
Redness, lumpy, itching, tenderness, I went to the school nurse where I work and they gave me 25mg Benadryl.
Narrative: The accepted caregiver/spouse paperwork since not in the system and administered a moderna COVID first dose vaccine to a 16 year old without verifying age.
Patient with 2 Moderna vaccines, last dose 03/03/21 who admitted to hospital with COVID diagnosis and subsequently died of COVID complications.  Provider discharge summary below:  "Patient was admitted to the inpatient hospice service on 2/5/22 from her inpatient admission for refractory acute on chronic hypoxic respiratory failure due to COPD and exacerbated by acute Covid 19 pneumonia. Through discussions with the attending inpatient team and palliative care team she decided that she wished no further aggressive treatment and opted for comfort care. Her pulse oximetry was in the 80's in spite of hight flow oxygen therapy and BIPAP. After admission to hospice her oxygen was weaned and morphine PCA pump was utilized for reduction in air hunger with control of her dyspnea. She passed on 2/5/22 at 1916. "
No adverse effects. Patient was given a pediatric dose of Pfizer vaccine and was 12 years old at the time of vaccination.
ADULT OBSTRUCTIVE SLEEP APNEA NEUTROPENIC FEVER, UNSPECIFIED
Within 10 minutes she developed chest tightness, headache and chills which resolved without intervention but did require emergency department evaluation. Within 6 hours she noted drooping of her left eye similar to prior reaction which continues now (day1 after vaccination)
pt recv vax 14JUL95 & 1APR97 pt devel chickenpox that consisted of 25 lesions;pt recovered w/no sequela or tx;
Pt vaccinated with PROHIBIT developed severe hives. No other adverse rxns noted. Rash started on 7JUL90 evening.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Jan 10, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The patient had pain in extremity (axillary pain/woke up with an extreme pain under my arm like in armpit area/something else going on in arm/pain in arm), onset Jan 12, 2022, outcome unknown; sleep disorder/not been able to sleep on left-side, onset Jan 10, 2022, with outcome of unknown; and mass/lump, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
day of vax pt exp uncontrollable crying 48hr, fever 100.2-R
The positive reaction to the vaccine was that my neuropathy pain subsided. The negative reaction was that I started having a headache. It subsided by the time I left the pharmacy. By the time I got home, I experienced the worst stomach pain. I had diarrhea for 32 days. I could not keep anything in my system, not even water. I feel like there was an attack on my stomach. When I went to the doctor, she did a sonogram of my abdomen and some blood work. All testing came back normal. I was sent to do an MRI with contrast, but it was advised against because I was due to have my second vaccine. After the 32 days, the diarrhea stopped, but my neuropathy pain came back. It's not as bad as it was before the vaccine, but it did come back.
This spontaneous case was initially received on 25-Nov-2015. The case report was received from a Health Professional and concerns a 35 year old female patient. The patient received AFLURIA on 04-Nov-2015 - 4-November-2015, Batch no: U58908, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 04-Nov-2015, 1 day after starting treatment with AFLURIA the patient experienced Arm pain near injection site/Pain in context of arm. On an unknown date, after starting treatment with AFLURIA the patient experienced Intramuscular hematoma. Pharmacist suggested that the patient try oral ibuprofen. Reporter's assessment: Non serious.
I got very weak about an hour after the vaccine and my stomach hurt like I was very nauseous. I slept for about 6 hours and felt fine after that. About 2-3 days later, I got a horrible rash on my L arm right at the injection site that was hot to the touch and ITCHED! It was my entire upper left arm that was red, hot, and itchy.
Patient received Moderna vaccine in left arm around 1045am on 3/12/21 and developed whelps on left arm from elbow to wrist around 130pm.  Patient went to ER who told her to just take Benadryl since no throat or facial swelling.  Whelps have resolved but transitioned to "looks like cat scratches."  Patient is doing better.
Felt unwell day 1-2 post vaccine then sudden onset blurred vision day 2-3 found to have (L) 6th nerve paralysis.
This spontaneous report as received from a 63 years old male pharmacist refers to himself. The patient had none pertinent medical history. The patient had none drug allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) subcutaneously on 19-AUG-2012. Concomitant medications were reported as none. It was reported that the patient's arm was sore and he had a headache on 20-AUG-2012. The patient did not seek medical attention. No treatment was given. Lab diagnostics studies performed were reported as none. The patient was recovered on 22-AUG-2012. Additional information has been requested.
12 hours after injection: red mark size of dime, 2 inches below injection site 24 hours after: size of quarter, warmth, itchy (both still occurring 72 hours later) 48 hours after: size of half dollar 72 hours after: 4 in x 3 in  Ice
Patient states nausea with vomiting initiated the evening of 9-9-13, the day of vaccination. On the night of 9-11-13 pt stated nausea with vomiting and fever "low grade" with chills and shaking. Pt had treated symptoms with Pepto Bismol and ibuprofen. Much better today but still with low fever and nausea. Pt still suffering nausea and low fever. No previous reaction to first HBV vaccine.
Awoke at  1:00a.m. on the 25th of October after the shots at 10:a.m on the 24th of October; went to bathroom and bent down to adjust my slipper. Terrible vertigo (swirling in head) and fell over (Did not injure myself). Vertigo so bad, I stayed in bed the next day. Slightly better, but still had vertigo second day. 3rd and 4th day I could get up. Each day got better, but even on the 8th day I still was slightly dizzy. Also a  terrible fatigue and general malaise. On the 9th day, as I write this, I still do not feel great. I should add that I had my complete  annual exam on the 24th and the doctor pronounced me "healthy" as my blood tests revealed. I attribute all the above symptons to the vaccines, one or the other or both!
-Patient got vaccine wed 5.25.22  -Patient had fever 101 with Tylenol and Ibuprofen Thursday & Friday, chills, body aches, and cried with pain -Patient had right arm pain and swelling of lymph node in his right arm pit and his arm was tender to the tough and he held it against his body and would not movie with with out crying out in pain -Patient was taken to the doctor Friday due to the pain and inability to straighten or significantly move his arm (doctor was unsure if it was swelling from the shot or possible irritation of a nerve ) -Patient's pain and swelling improved Saturday and Sunday and he still was limited in arm movement  -Patient was taken back to the doctor Monday 5/30/22 due to still not moving his arm past 90 degrees without crying in pain (doc recommended passive movement/ arm sling/ physicals therapy)  -On Monday night after wearing the sling for a few hours after a hot shower he extended his arm, but it was painful -On Tuesday 5/31 Patient worse his sling in school and his arm "felt better" he could extend it, but it was hard to bend without increased pain. Patient's movement was limited, but can bend and straighten his arm with pain
Spouse called stating his wife had Hep B shot yesterday and woke this morning very sick. Nausea, vomiting, diarrhea, fatigue, stomach cramps. No fever. She took a Compazine. Stated she was mildly ill after 2nd dose and arm swollen. Called the pt back in the afternoon, she stated she felt much better, didn't need to go to primary MD.
After patient received the vaccine, he reported not feeling well. He was placed on a cot. Initial BP with large cuff was 88/44. On insulin and has not eaten since am. Given a snack bar. BP rechecked with large cuff and was 112/58.  Pulse 84. resp-20, Pulse ox 100. Patient started to complain of pain in his shoulders, resp increased to 32, c/o cold and chills.  EMS called and transported to hospital.
Received imms at noon on 10/18/07. Immediately after Gardasil felt dizzy, used cool cloth. Received Boostrix and fainted with some twitching and then slumped over. Back to self within 1 min. Coherent afterward. Lungs were clear. At 7 PM that night she was itching all over and had hives were on (L) arm but present all over. Pt also had fever 103.4 that night. Responded well to Benadryl. Still has temp next AM.
A report has been received from a Healthcare Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. On 16-Jan-2013, the patient was ADMINISTERED EXPIRED FLUMIST. The outcome of the event of ADMINISTERED EXPIRED FLUMIST TO PATIENT is unknown. The report was considered to be non-serious by the reporter.
Pt presented to the front desk on 10/02/2009 c/o left shoulder pain after the flu shot.  Stated he had seen a chiropracter "5 times and it still hurts".  Offered immediate physician appointment, but declined and left.  Returned on 10/21/2009 requesting lot numbers for Influenza vaccine given 10/02/2009 and TDap vaccine given 09/24/2009, stating left should pain was getting better but not fully resolved.  Again, offered immediate physician appointment for evaluation and again refused to be seen.
A 2 year old was given a Kinrix (DTaP-IPV) which is only for ages 4 years - 6 years.
Fever of 102,  treated with 2 tablets regular strength Tylenol.   Checked temp. 4 hrs. later and recorded 98.8.   Fever never returned and I have remained fever free.
first dose in 2018, never got second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1t dose received on 26th February 2018, batch number FJ57S, expiry date unknown).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient got her first dose on shingrix back in 2018 and she never got the second dose, which led to incomplete course of vaccination. The reporter asked if 4 years was too long because all literature says over 6 months they do not have to repeat the first dose. The reporter consented to follow up.
A report has been received from a Health Professional concerning a 26 year old, female subject,who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 31-OCT-2014. IT was reported that the patient received FLUMIST QUADRIVALENT while pregnant, but at the time of administration, the patient did not know that she was pregnant which started on 31-OCT-2014. The outcome of the event of patient received FLUMIST QUADRIVALENT while pregnant is unknown. Pregnancy outcome was unknown. The report was considered to be non-serious.
Pt recvd vax on 18OCT90 & exp pain,swelling & erythma @ site of inject.On 23OCT90 pt devel a rash.Pt dx w/ herpes zoster.
SHORTNESS OF BREATH, CHEST PAIN, SWELLING TO LIPS AND TONGUE, TACHY HEART RATE, TRANSPORTED VIA 911 TO HOSPITAL.
A physician reported the occurrence of numbness in a 30-year-old male who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The pt was described as "healthy". He experienced no adverse events following previous immunizations. Concurrent medications were not reported. On 03/09/2003, the pt received his first injection of Twinrix, without adverse event. On 04/09/2003, the pt received his second injection of Twinrix. Approximately one hour post-immunization, the pt telephoned the physician to report that he was experiencing numbness, tingling and lightheadedness.
Pt's mom states that he had 2 seizures in the morning following vaccination. The seizures were reportedly worse & more frequent than typical. Pt has had no problem before with vaccine. Patient on 12/18/11 called on 12/18/11 and said patient was better.
1st dose of Bexsero on 05May2022 and received a dose of Trumenba on 06June2022 as 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 5th May 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 6th June 2022, the patient received TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comment: The patient received her 1st dose of Bexsero and instead of getting a 2nd dose of Bexsero, she was given a dose of Trumenba. The healthcare professional received information from the patient's mother. The mother said her daughter received the 1st dose of Bexsero a month and a day ago and healthcare professional gave estimated date of 5th May 2022. The reporter consented to follow up via email. Additional Supportive Information: The patient received her 1st dose of Bexsero and instead of getting a 2nd dose of Bexsero she was given a dose of Trumenba, which led to interchange of vaccine products.