chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & mom put pt in crib on stomach came back & pt was blue & not breathing-taken to ER:
Patient states she experienced redness, pain, and swelling in the left shoulder where the vaccines were administered as well as a fever.  She went to the local emergency room where a physician diagnosed her with cellulitis due to vaccine administration.  She was treated with a course of antibiotics.
Chills, lots of sweating at night , my pillow gets wet, headache, lost appetite, body aches specially my legs fatigue
Hepatitis A vaccination was administered two months prior to due date for series. Patient was unharmed otherwise.
Hives all over back.  Over the past months it has gotten worse and he cannot have a day without antihistamine.  It has also raised his glucose levels due to the stress of the hives.
10.27.2021  alerted to low (below 40) 38BPM; feft nothing until moved around house and felt loss of breath and dizziness; got appointment with cardiologist doctor saw PA in office; spoke iwth Dr.  about pacemaker surgery after EKG showed 42BPM as highest and inconsistent pulses.   10.29.2021 implant of pacemaker by Dr.  at  9am; discharged at 3;30 as outpatient procedure was successful.  6:30am-3;30pm from prep to discharge 11.5,2021 FOLLOWUP to surgery with Cardiology.  Incession healing; no infection; no driving or lifting of arm for another week-10days. #21 won't let me enter:   6:30am -3:30pm #22  flllu shot unknonwn
Severe body ache, trouble breathing, swelling of injection site, severe headache, soreness of skin and redness of skin on arms. Im going on third day and it hurts to touch my head anywhere.
Fever, redness at the vax site, swelling at the vax site, itching
Information has been received from a registered nurse reporting on a 37 year old male patient. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 14-NOV-2017, the patient received an expired dose of M-M-R II lot # L043702, expiration date 03-NOV-2017, subcutaneous for prophylaxis (dose and dose number were not reported) that was reconstituted with a sterile diluent (STERILE DILUENT).
CHILLS,HEADACHE,NAUSEA,TIREDNESS. I WAS FEELING A LITTLE WEIRD ON THE DAY I GOT IT AND MY ARM WAS HURTING A LOT AND THEN TODAY I STARTED FEELING BAD WITH ALL THE SYPTOMS I PROVIDED.
One week after shot, injection site was hard, swollen, and VERY itchy. After a day of rubbing and itching, the itchiness spread throughout my entire upper arm. Could not sleep at night for the itching. Now, 4 days later a red bruise is noticeable on the underside of my upper arm about 6 inches by 2 inches and the itching is intermittant.
The dose administered to the patient had come from a vial that had been punctured the day before and left in the fridge over night and had exceeded the 12 hour beyond use date recommended by the manufacturer.
Information has been received from a pharmacist concerning a 66 year old female with no drug reactions and allergies who on 18-NOV-2010 was vaccinated SQ in her left upper arm with single dose of ZOSTAVAX (Merck) (lot number 665430/1764Y, expiration date 15-MAR-2011). The patient was also administered FLUZONE on 18-NOV-2010. Concomitant therapy included levothyroxine Na, ZYRTEC and gabapentin. On 20-NOV-2010 the patient developed a bruise at the injection site of the left upper arm. The area of bruising has increased to the size of 5 centimeters in diameter. The patient came to the pharmacy and was advised to apply topical BENADRYL cream to the area of bruising. No lab diagnostics studies were performed. At time of the report, the patient's outcome was unknown. Additional information has been requested.
flu-like symptoms; little soreness in her arm; metal taste continued. Caller stated "it was like I ate hot soup".; This is a spontaneous report from a contactable consumer (patient's mother)  A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history was included had a diagnosis of MS (multiple sclerosis) and takes Ocrevus. Concomitant medication of patient included ocrelizumab (Ocrevus). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. With the first vaccine she experienced a metal taste in her mouth as soon as she received the vaccine, flu-like symptoms and soreness in her arm. On an unknown date, after second dose of vaccination she experienced a little soreness in her arm and the metal taste continued. Reporter voiced that her daughter had flu-like symptoms with both doses of vaccine. The reporter stated that her HCP was upset that she received the Pfizer Covid-19 vaccine while taking the immunosuppressant. Per reporter her daughter's MD voiced that the vaccines didn't take because her immune system was wiped out. Caller asking if Pfizer has information on individuals with MS or taking immunosuppressants?. At the time of this report event outcome was unknown.   Information on the lot/batch number has been requested
Pain initially high up on left shoulder then radiated to elbow; decreased range of motion in shoulder; currently receiving physical therapy. Injection given near top of left shoulder. Pain continues.
Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff). This case involves a two-years-old female patient for whom the doctor ordered DTaP and polio vaccine separately, but QUADRACEL was inadvertently administered, no adverse event. The patient's past vaccination(s) included three doses of PENTACEL vaccine. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included a dose of HAVRIX for Immunisation. On 03-Aug-2018, the patient received 0.5 ml dose of suspect QUADRACEL lot c5248aa, exp date: 21-August-2019 via intramuscular route in the left thigh. This is the case of medication error due to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event or symptoms were noted. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Low grade fever 99.9 for 24 hours, site pain down to elbow, body aches for 24 hours
Arm became hot and red; Arm became hot and red; This spontaneous case was received on 27-Sep-2021 from other health professional via  Communications (reference number: SEQW21-02839) and concerned a female patient, of an unknown age.   The patient's relevant medical history and concomitant medications were not reported.   On 23-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration and anatomical location: not reported) as prevention of seasonal influenza. The batch number reported was 312852 and expiry date 17-Jun-2022.    On the same day, after receiving Fluad Quadrivalent, the patient experienced an adverse site reaction as her arm became hot and red.  The outcome of the events was unknown.  The reporter assessed the events to be related to Fluad Quadrivalent.  The case is linked to cases 202103210 and 202103211 (the same reporter).  Company comment: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.; Reporter's Comments: The reporter assessed the events to be related to Fluad Quadrivalent, as it was stated the patient experienced an adverse site reaction.; Sender's Comments: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.
Feels terrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible) 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 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels terrible). At the time of the report, FEELING ABNORMAL (Feels terrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient states an anaphylaxis type of reaction with throat swelling, trouble breathing, and inability to walk. Patient has since recovered at the time of submission of this report on 9/5.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was aged 12 weeks. On 12-MAY-2017, the patient was vaccinated with PEDVAXHIB (lot# M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
Vaginal bleeding, similar to menstrual period, while taking birth control pills. Menses not due for two more weeks.
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-JUL-2015, the patient was vaccinated with a dose of an improperly stored PROQUAD (Merck), lot number L007230, expiration date 03-SEP-2016, (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. Lot number L007230 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
This spontaneous report was received from a medical assistant concerning a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Admission Date: 7/9/2022 Discharge Date: Jul 10, 2022  PRESENTING PROBLEM: Acute on chronic systolic (congestive) heart failure [I50.23] Acute on chronic congestive heart failure, unspecified heart failure type [I50.9] COVID-19 [U07.1]   HOSPITAL COURSE: 84 year old female w/PMH including systolic heart failure with recovered EF, SIAHD/chronic hyponatremia, presented with nausea, vomiting, dyspnea, found to have COVID-19 pneumonia with acute heart failure. Admitted for IV diuresis, and transitioned to oral lasix. Breathing well on room air. She does also have SIADH for which salt tabs were restarted to tid. Given the need for salt tabs for SIADh but recurrent fluid overload, nephrology were consulted. Plan was for PO lasix 10mg qdaily and 1g NaCl qdaily as a balance. Patient was agreeable to this plan. Echo EF 57% no concerning acute findings. She was discharged home in stable condition. Counseled on signs/symptoms to warrrant return to ED and she verbalized understanding.
tachycardia (up to 115 ) and high blood pressure (up to 170/90)  saw my cadiologist who said it was the vacccine and would resolve itself -- no treatment  symptoms resonved after approximately 20 hours
Patient received his immunizations given by myself at around 10:55am. DTAP LUT; ACTHIB LMT; PREVNAR 13 LTL; MMR RTU; VARIVAX RTM; Hepatitis A RTL; Mom dressed him up and went to check out at counter. Mom noticed he was itching and developed rash and she called me other there. There was diffuse erythematous rash on chest, face and abdomen with itching. He was given 5cc of BENADRYL at 11:02am, which he spit up. Then he developed urticaria rash with intense itching and difficulty breathing. His color was pale and he looked hypotensive. He was moved to exam room 3 and was given 5cc of Prednisolone at 11:05am, he immediately started vomiting continuously. He was then given EPI-PEN JR at 11:07am and 911 call was initiated. He also was given 2mg of DECADRON at 11:15am. By this time his urticaria disappeared, his color came back and was breathing much better. Then 911 team arrived and they put him on gurney and took him to ER. This was acute anaphylactic reaction to one of the vaccines.
Alleged (pt called and reported over the telephone) T 102, chills, body aches that began ~ 6hrs post vaccine was given; referred him to PCP.
This is a spontaneous report received 31-OCT-2016 via a telephone call from a physician. The physician reported that an unspecified patient received a dose of GARDASIL (lot #, expiration date unspecified) on an unspecified date for their first dose. The patient then received the second dose of the series of GARDASIL 9 (lot #, expiration date unspecified) on an unspecified date. Then, on 31-OCT-2016 the patient received the third dose of the series as GARDASIL (lot #, expiration date unspecified). No adverse effect was reported. No additional information was available. Additional information was requested.
Know others who got shots, hubby had them twice/Suspected vaccination failure; Had them 2x on his back; First time said it hurt; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's wife had the shingles all over the front of her stomach), pruritus (Family History) (patient's wife had it) and pain (Family History) (patient's wife had).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The reporter had the shingles all over the front of her stomach and up and yes it was prickiy and itchy pain wise but was not to bad so not doing the shots. The reporter's husband had the shingles twice on his back first time said it hurt twice and he did not even realize he had it . Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR013561, reported by the same reporter, for a different patients. As per narrative it seems that multiple patient included reporter's husband hence case conservatively kept valid considering patient received shingles vaccine and experienced shingles.; Sender's Comments:  US-GSK-US2023AMR013561:Same reporter. "Others" case
Got the 2 doses of Pfizer vaccine 6 weeks ago and now has covid; now has covid; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. Medical history included cancer. The patient's concomitant medications were not reported. On an unspecified date, the patient got covid after she received the 2 doses of pfizer vaccine 6 weeks ago. The outcome of event was unknown.   Information on the lot/batch number has been requested. Follow up attempts are needed.  Follow-up attempts are completed. No further information is expected.
Description: the day after receiving his first anthrax shot, SM developed hives and was seen at the local ER x2 because hives did not resolve despite treatment. Symptom: Hives Start: 09/30/2007. Symptom: Joint Pain, multiple joints Start: 10/04/2007.
Nausea within a few minutes of getting the shot. Shivering in the evening after the shot. Rapid heartbeat over 120 at rest, going up to 140 after small amount of movement (e.g., walking from one room to another.) Low grade temp (100F) in the day after the shot. The rapid heartrate lasted the longest of these, lasting almost a week.
instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:HCP states "I don't have the recipient's initials or DOB. I lost my notes." Also admits this administration occurred "4 weeks ago".     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) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose) 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 WRONG PRODUCT ADMINISTERED (instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose).    It was reported that patient admits this administration occurred 4 weeks ago. Concomitant medication was not provided. Treatment medication information was not provided by the reporter. Age at Time of Onset of Reaction reported as zero years.
The pt called the pharmacy 10-29-22 in the am regarding an adverse effect from her flu vaccine the day prior.  The pt stated is started late in the evening on 10-28-22 which is the day she received the vaccine.  She states that is started as tingling and numbness in her left arm and is worsened on the am of 10-29-22.  By the time she called, she was starting to lose muscle tone in her left arm to the extent she could not screw the cap on her baby's bottle.  She verified all other body parts were fine and that she was having no trouble breathing.  The pt explained that she was home alone with her baby and toddler and that she would not be able to go to the ER.  I told her I would research the situation and return her call.  After reviewing the effects, I paged her Dr.  The Dr. agreed that she did not have to go to the ER, but that she wanted her to start ibuprofen and take it regularly and to monitor and make sure symptoms were starting to improve and to seek ER treatment if anything got worse.  I relayed this to the pt and she did as was told.  I spoke with her that evening and she was improving and spoke with her again on 10-30 in the am and she said she was doing much better.