chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 19-feb-2018, in the left arm, not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th February 2018, intramuscular in left arm).   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 Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The reporter was patient and reported he received his first Shingrix vaccine in pharmacy and he did not receive his second Shingrix vaccine. The patient was never told he needed to come back and get the second Shingrix vaccine in 2 to 6 months by the pharmacy. The patient did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not received which led to incomplete course of vaccination. The case was linked with case US2022076281 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076281:Same Reporter
red area around the injection site; area is a little itchy; arm was a little sore; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th July 2020, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix around noon and her arm was a little sore when she moved it or pressed down on the area.   The soreness improved but there was a red area around the injection site that was about three inches in diameter.   The area was a little itchy but not so bad that she must scratch it. The reporter did not consent to follow up.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number B49F7, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 25th October 2021, the patient received Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2021, 1 days after receiving Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, pain, fatigue and joint pain. On an unknown date, the outcome of the injection site pain, pain, fatigue and joint pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fatigue and joint pain to be related to Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was the patient. The patient received a Fluarix vaccine and following day, she experienced severe aches and pains, pain at the injection site and fatigue. The reporter also said that she was extremely sore and her joints ache. He also said that the patient was extremely sore and his joints ache.  He also said that these effects were on going and had not improved and had been debilitating. The reporter was given medical advice disclaimer and was referred to healthcare professional. The reporter gave consent to contact healthcare professional (pharmacy). The reporter consented to follow up. This case was linked to the case US2021259939, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021259939:Same reporter, same product
Information has been received from a physician concerning a patient (age and gender unknown), who on an unspecified date, was vaccinated with a dose of Gardasil. On 25-JUL-2007 the patient fainted. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Had excruciating pain; felt as if I pulled something in my shoulder; Cannot lift my arm; Had trouble sleeping; Shot too high up on the arm  It may not be in the deltoid muscle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Had excruciating pain), MUSCULOSKELETAL DISCOMFORT (felt as if I pulled something in my shoulder), LIMB DISCOMFORT (Cannot lift my arm), INSOMNIA (Had trouble sleeping) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot too high up on the arm  It may not be in the deltoid muscle) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C2IA) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    On 21-Apr-2021 at 12:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (Had excruciating pain), MUSCULOSKELETAL DISCOMFORT (felt as if I pulled something in my shoulder), LIMB DISCOMFORT (Cannot lift my arm), INSOMNIA (Had trouble sleeping) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot too high up on the arm  It may not be in the deltoid muscle). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, PAIN (Had excruciating pain), MUSCULOSKELETAL DISCOMFORT (felt as if I pulled something in my shoulder), LIMB DISCOMFORT (Cannot lift my arm), INSOMNIA (Had trouble sleeping) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot too high up on the arm  It may not be in the deltoid muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The pt has had pain at the injection site since the vaccination. It has improved a little but it isn't gone.
Sore throat, runny nose, congested, sinus pressure, headache, body/muscle aches, trouble breathing at night, and heart palpitations. Woke up from half my face being numb- lasted ~20 min. Was sick up until 2nd dose then sick again for another 2 weeks. Body aches still have not gone away.
mastocytosis of the stomach; Depression; allergic reaction; tired; Itching all over; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date: not reported ), via an unspecified route of administration on 19Apr2021 11:40 (at age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. In Apr2021,The patient on the line experienced depression for no reason and an allergic reaction, itchiness all over, and was tired after getting the vaccine. She called her doctors office and talked to them but she forgot to tell them that she had masacytosis of the stomach, caller says she can't spell it the call handler would have to look it up online, basically it was a chemical off balance in the body that makes to many histamines naturally. Some things set it off like too much stress, wrong foods, whatever. She reports in Apr2021 within 12 hours or less she was very depressed for no reason, she thought she was the worst person in the world. Her daughter in law looked it up and said it does show as one of the side effects that it had and told her to go back to sleep. She got up Thursday morning and then Saturday morning when she got up, the depression was gone. She reports starting itching within about 12 hours of getting the shot in Apr2021 and continued to get worse like a crazy person itches for about 5-6 days and she took Benadryl to help control the itching. She reports this makes her nervous because her therapist said the patient could get worse and she could end up in the hospital. Her therapist said that one of the side effects started with an s, not sure what it is.Her body makes histamines. Histamines keep our body well but, so whatever is in there, her body is beefing it up, so she can get rid of it, maybe it is supposed to make her sick but having an allergic reaction is a different thing or is it the same thing. Either way she just wanted to talk to some medically to make sure she is going to be safe. She had a 9:30 appointment on the day of reporting to get the second shot but, she was not sure about getting the shot. Therapeutic measures were taken as a result of itching all over and got controlled. She was to get the second dose on day of reporting (06May2021) and inquired was it safe to take the second dose after having these symptoms. The outcome of depression was recovered. The outcome of the events itching, mastocytosis of the stomach, allergic reaction, tired was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 31-OCT-2012, the patient was vaccinated with GARDASIL (lot number was reported as 0636AE and expiry date was 09-JAN-2015, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter (MARRS# 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003713, 1212USA003714 and 1212USA004285). Additional information has been requested.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment medication was provided.   Reporter did not allow further contact
During system balance patients name appeared twice on the borrowed log one on 9/12/23 and once on 10/6/23. Pt. 1/12/11 received Tdap, Men A and HPV on 9/12/23 during office visit with Dr. Mom instructed to schedule a nurse visit for influenza vaccine since we had just ran out of the vaccine in office to give to our patients. Mom scheduled nurse visit on 10/6/23 for immunizations. Vaccines (Tdap, Men A, HPV) for this day were documented on the wrong patient on 9/12/23 by accident.  During the nurse visit on 10/6/23 the systems didn't reflect previous immunizations given on 9/12/23. Patient was given Tdap, Men A, HPV and Influenza vaccine during nurse visit  consent and Screening questions answered. Mom filled out the screening checklist for contraindications to vaccines for children and teens marking no to all questions even the question asking has the child received vaccinations in the past 4 weeks. Staff administered all vaccines that were due at this point using EMR information.
reaction she had to the vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (reaction she had to the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction she had to the vaccine). At the time of the report, VACCINATION SITE REACTION (reaction she had to the vaccine) 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.
This spontaneous report as received from office manager refers to a 74 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were unknown. On 27-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L027732 and expiration date 23-FEB-2017) intramuscular or subcutaneous. On an unknown date in July 2016 after vaccination, he developed "pain and redness at insertion site, area of 13cm x 20cm, with a sunburn resemblance, and warm to the touch". He was treated with Ibuprofen for pain, and 25 mg of BENADRYL. At the time of reporting the outcome of the events was unknown. The reporter did not provide the relatedness of the events with PNEUMOVAX 23. Additional information has been requested.
muscle aches; chronic sweating; pulse is typically in the 60s-low 70 and it was racing to 100; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, 30 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mitral valve prolapse" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "sensitive to medications" (unspecified if ongoing), notes: medication with a phedra or pedrine, cough medications that are labeled with the D/DM, and NSAIDS. The patient's concomitant medications were not reported. Past drug history included: Nsaids, reactions: "make my heart race". Vaccination history included: Comirnaty (DOSE 1), for Covid-19 immunization, reactions: "pulse is typically in the 60s-low 70 and it was racing to 100", "chronic sweating", "muscle aches". The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "chronic sweating"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "pulse is typically in the 60s-low 70 and it was racing to 100". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient felt fine after the 1st and 2nd dose, so she did not checked her pulse. When she got the booster, she got really bad muscle aches and chronic sweating for a few days. She did not even know what made her check her pulse. She never had this before. She got the vaccine, and the 2nd day after the vaccine, she called the cardiologist. She was advised to monitor for a few days, and she did this. Aches and muscle pains and joint muscle pain was that bad she could not move. After 3 days, the achiness started to go away, and her heart rate started to come down. The sweating took one month to go away. Each week it started to decline but she never had chronic sweating before or after that time frame. She never had a fever. It all seemed to be the side effect from the booster and for all 3 shots of the vaccine. She had mitral valve prolapse and heart murmur and were sensitive to medications. She can't have any medication with a phedra or pedrine at the end of it. She can't have allergy or cough medications that are labeled with the D or the DM. She can't have any NSAIDS because they made her heart race. She requested for the list of the ingredients with the functions to be sent to her. She does have a picture of them on her phone but wants to confirm that she has the right thing as she previously verbalized having a hard time finding them online. She did not think had the heart race reaction with the initial doses when she received the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201139179 same reporter/patient/drug, different dose/events; PFIZER INC-202201139221 same reporter/patient/drug/events, different dose;
Received second dose of vaccine on March 2nd, 2021.  Awoke early this am with a rash and upper lip swelling.  Caller has a history of MS.  Instructed to go to ED for evaluation.  No acute resp. distress noted.  Speaking in full clear sentences. RN.
Information has been received from a pharmacist, concerning a female patient with dyspepsia, who was vaccinated with a dose of GARDASIL (date and dose not specified). The pharmacist reported that several hours after the vaccine was administered, the patient experienced severe nausea and vomiting, and was hospitalized. Treatment included intravenous fluids and medication (unspecified) to treat the nausea and vomiting. At the time of this report, the pharmacist stated the patient was recovering. Severe nausea and vomiting was considered to be an other important medical event. Additional information has been requested.
Patient experienced nausea and headache within minutes after receiving vaccine.   She denied shortness of breath, tingling/swelling of tongue or mouth, confusion, or rash.  Patient  was observed and monitored x 60 minutes. Vital signs remained stable. No new symptoms developed. Nausea resolved after 30 minutes. Headache persisted beyond 60 minutes. Patient has history of migraine headache.
The wrong vaccine was given for this patient. Instead of the 6 month to 4 year vial, a portion of the 5 to 11 year vial was given. 1.1 mL of sterile water was added to dilute the 5 to 11 year vaccine, and 0.3 mL of this was given to the patient. I calculated this out to be 6.5 mcg of the 2023-2024 COVID vaccine, rather than the 10 mcg recommended amount.
Initial Arm pain, Fever like chills and nausea for the day after, which subsided a day later.  Starting 2 days after vaccine there was joint pain in the ankles and wrists.  This progressively got worst for about a week and then muscle cramping also started. About a day after muscle cramping started burning sensation in thighs and upper arms added to reaction.  Now 15 days later and still having pain and uneasy sensations.  When to Primary Care where steroids were administered hoping to provide relief and stop the progression of symptoms from worsening.
I have had an excruciating back and hip pain; I have had an excruciating back and hip pain; I can barely walk around; This is a spontaneous report from a contactable consumer. This consumer (Respiratory therapist) reported that the 64-year-old male patient received bnt162b2 (BNT162B2, Pfizer BioNTech Covid 19 Vaccine), via unknown route of administration on 16Dec2020 at single dose for covid-19 immunisation ("It helps so that I won't get Covid."). Medical history included Blood pressure. Consumer stated, "I need it to report that I have had an excruciating back and hip pain. This is the fifth day and I still have pain but its slightly better but I don't think I am going to work today or tomorrow. I can barely walk around." Consumer stated, "It was given to me by a nurse at hospital." Consumer stated, "I take a high blood pressure medicine." Consumer stated, "I didn't take any Lab work." Treatment was received and consumer stated, "Yes I tried Ibuprofen." The outcome of the events was unknown.   Information about lot/batch number has been requested.
pt cried inconsolably >3hrs up to 3 days duration;despite APAP;
No additional AE; a patient was administered PROQUAD after a temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, and drug reactions or allergies was provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) (lot number T018038 is an invalid lot number for sterile diluent (MERCK STERILE DILUENT). Lot number T018038 does not match any Company product as confirmed by Lot Verification team).   On 21-MAR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) at a dose of 0.5 ml for prophylaxis (lot number U039255 was verified to be a valid lot number, expiration date: 09-JUN-2023; route of administration, vaccination scheme frequency, and anatomical location were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion at minus 14 degree Celsius up to minus 10 degree Celsius (minus 10.8 degree Celsius) for 0 hours 45 minutes and 0 seconds, and at minus 10 degree Celsius up to 8 degree Celsius (minus 5 degree Celsius) for 1 hour, 0 minutes and 0 seconds. The vaccine was reconstituted with the sterile diluent, however, sterile diluent was not improperly stored. There were no previous temperature excursions. No additional adverse event (AE) was reported.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 01/28/2021 and 02/20/2021. Presented to ED on 8/18 with complaints of  fever and vomiting. On 8/22, Patient was placed on high flow oxygen and required vasopressors. Patient was intubated on 8/23. Patient continued to decline and also  developed renal failure. Patient was transitioned to comfort care on 8/26. During stay patient received cefepime, vacomycin, doxycycline, remdesivir, baricitinib, and decadron. Patient expired on 8/26/21.
NECK STIFF; HEADACHE; NAUSEA; FEVER; EARS HURTS; DIARRHEA; EARS FEEL MUFFLED; EARS RINGING; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included cervical cancer, and concurrent conditions included seasonal allergies. The patient experienced drug allergy when treated with  sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced ears hurts. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced ears feel muffled. On 09-APR-2021, the subject experienced ears ringing. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced neck stiff. On 10-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and fever, and had not recovered from headache, ears hurts, neck stiff, diarrhea, ears ringing, and ears feel muffled. This report was non-serious.