chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 6 hours after the vaccine was administered, the injection site (upper right arm) became very sore and I experienced flu-like symptoms (e.g., severe chills, body ache, and extreme fatigue) which. lasted approximately 48 hours, although acetaminophen did alleviate some discomfort . I am currently nursing/breastfeeding a newborn, and in addition to those initial symptoms I also experienced painful breast engorgement followed by a dip in my breastmilk supply in my right breast only.  The engorgement was caused by fluid retention of the lymphatic system, which was alleviated by sunflower lecithin and. massage after four days. However, the adverse effect to my breastmilk production has not recovered despite other symptoms of the vaccine dissipating.
Patient complained severe flu symptoms after getting the shots. It started about 3 hours after she got vaccinated: aching, chills, fever, pain. Symptoms last till next morning and patient feeling  some relief after taking some TYLENOL.
Sxs. extreme fatigue, HA, skin rash over upper (L) arm extending from distal to injection site -> elbow, which is pruritic, hyperemic. Reports episodes of SOB, and back discomfort up to 1 week post vaccination. Arthralgias.
joint pain; muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), MYALGIA (muscle ache) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ARTHRALGIA (joint pain), MYALGIA (muscle ache) and HEADACHE (headache). At the time of the report, ARTHRALGIA (joint pain), MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-AUG-2015, the patient was vaccinated with an improperly stored dose of Gardasil 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 224, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (incorrect product storage) (dose and route not reported, lot # L027287 and Exp. date 21-JUL-2017). The vaccinates were exposed to 13.8F for 43 hours. There was no previous temperature excursion reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
103.7 Fahrenheit fever next day, chills, waking up in cold sweats, severe headache, was regaining taste and smell from Covid-19, then the taste and smell went away again, metal taste.  About 3 days long.  Took tylenol, which helped with fever. Metal taste has not gone away. Needed to increase his intake on oxygen tank.
Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and felt very bad. Was taking Tylenol every 4-6 hours but headache continued to get worse throughout the evening and into the night 3/4-3/5/21. Left arm began hurting too on 3/4/21 but no swelling or redness, just sore.  Finally began feeling a little better by late evening on 3/5/21 and headache was beginning to ease but did not fully go away until 3/6/21.  Was able to manage the side effects at home without going to my Dr.
Pt. receive BOOSTRIX influenza at Flu Clinic. Experience itchiness raised bumps at site of injection. Subsided within 1-2 days.
Swollen lymph nodes a day after Moderna COVID booster that lasted about 5 days . 9 days after booster extreme itching began in middle of night that caused rash hives after scratching that don't go away. Feeling like something is stuck in throat. Symptoms still present at time of writing this.
Bump on right side of arm; Arm itch like crazy; Upper arm red through elbow and up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itch like crazy), ERYTHEMA (Upper arm red through elbow and up) and VACCINATION SITE SWELLING (Bump on right side of arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRURITUS (Arm itch like crazy) and ERYTHEMA (Upper arm red through elbow and up). On 04-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Bump on right side of arm). At the time of the report, PRURITUS (Arm itch like crazy), ERYTHEMA (Upper arm red through elbow and up) and VACCINATION SITE SWELLING (Bump on right side of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure meds, pacemaker, heart medicine for drug use for unknown indication. No treatment information was provided.
Nausea; Chills; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Apr2021 at 09:15, (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 at 09:15, (at the age of 79-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 12:00, the patient experienced nausea, chill and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event nausea which included treatment with shot for nausea. The clinical outcome of the events of nausea, chill and exhaustion was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I was at an Urgent Care 3 days after my second dose, where I was diagnosed with Vertigo; After receiving both doses, I have been feeling fatigued/ tired; And extremely dizzy; Sometimes I get nauseous from the dizziness; This is a spontaneous report from a contactable other Health Care Professional (patient). A 33-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right arm on 07Sep2021 06:45 (at the age of 33-year-old) (Lot Number: EN6202) as dose 2, single for COVID-19 immunization. The vaccine was administered in a hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 16Aug2021 06:00 (at the age of 32-year-old) (Lot Number: not reported) as dose 1, single for COVID-19 immunization and experienced fatigue, dizziness and nausea. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient has been feeling fatigued and extremely dizzy. Patient was at an urgent care 3 days after her second dose, where she was diagnosed with vertigo. The patient reported that she never had any health issues. After over 2 weeks since vaccine dose 2, the patient was still experiencing symptoms and had thought that it would have just lasted the first few days of vaccination. The patient reported that she sometimes get nauseous from the dizziness. The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the event vertigo and other reported events  and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Received vaccine on Thursday 12/23/2021 she vomited at 0300 12/24/2021 .  I provided here Zofran 2 mg she continued to have severe nausea and vomiting (x 4) over the course of 4 days.  My parents attempted to take her somewhere and she could not get 10 miles down the road before having to turn around due to severe nausea.  She was taken to medical facility on 12/27/2021 for follow up as she was not eating much and having so much nausea.  She had no other symptoms, however, out of abundance of caution flu and COVID swabs were done and were negative.  She was sent home with refill of Zofran.  Today (12/31/2021) is the first day she has not complained of nausea requiring treatment with Zofran.  She is only 35 pounds part of me is wondering if she needs to be vaccinated with the 4 year old dosing as she is so small.
pt recvd vax; pt devel jaundice; nausea;weakness;abdominal discomfort;scleral jaundice;tx mylanta & fat free carbohydrate diet; pt dx w/ acute hepatitis b;
Member experienced swelling, tenderness, pain, redness, warmth and itching at the site. Symptoms persisted for 5 days without relief. Symptoms began to worsen, and the member visited Urgent Care for treatment. Member was prescribed Prednisone 20mg, Triamcinolone acetonide 0.5% topical ointment, and  Hydroxyzine HCI 25mg.
Patient given Pedvax HIB, PPV23 and MPSV4 on 28 Jan 2013 in facility per Dr prescription from PCM for splenectomy. Copy of vaccines given to patient before leaving clinic. On 06 Feb 2013 Patient was admitted to hospital and given as vaccines again due to pharmacist/doctors saying he had not recieved the vaccines. On 02/21/2013 patient passed away at the hospital from kidney failure.
Joint pain to right elbow and wrist area.  "Bone" pain to  right upper arm and right shoulder/shoulder blade and neck. Dull ache pain.
Cried for the entire first 3 nights, would not nurse, extreme discomfort. Complete Loss of balance. Went from walking to not being able to take 2 steps without falling. He was not able to stand in one place alone, he constantly fell down. I bought him a helmet because he fell so many times, he would hit his head. He was so frustrated, it was awful for him and my family. We changed his shoes and everything. It has taken 4 months and he is up to 8 steps, still falls and balance is NOT 100%. Rash and welts day of shots and came back week 2 and week 3. Constant head banging for the first 5 weeks. He would bang his own head with his toys. He would bang his head on kitchen cabinets, and walls. Loss of speech. He used to say MAMA over 10 times a day. He has only said mama twice in the last 4 months. He used to say BALL 3 to 10 times a day. (Depending if he sees the ball he would pick it up and say BALL) He has never said the word ball since 1/26/18. Daycare said his behavior was aggressive for the first 3-4 weeks. Hitting and pushing kids, which he didn't do before. Constantly still cries and wants to be held all the time, loss of independence.
Cellulitis; Arm is hot; Arm is itching; Arm is swelling; A spontaneous report was received from a consumer concerning a 68-year-old ,female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, arm swelling/vaccination site swelling, arm itching/vaccination site pruritus and arm hot/vaccination site warmth.  The patient's medical history was not provided. Concomitant medications were not provided.  On 2 Jan 2021, approximately 11 days prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021 the patient reported her arm was swelling, itching and hot. On 14 Jan 2021, she reported she went to the ER and was diagnosed with cellulitis.  Treatment information includes antibiotic (Keflex) and steroid (prednisone). Lab tests were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, cellulitis, arm swelling, arm itching and arm hot were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
CLIENT WAS VACCINED WITH AN ADULT DOSE OF HEPATITIS A AND THEN VACCINATED WITH A PEDIATRIC DOSE OF HEPATITIS A ON THE SAME DAY AND IN THE SAME VACCINE SITE.  NO ADVERSE REACTION NOTED.
I previously experienced this adverse event after dose 2 in the series, but it went away after several months. Adverse event began again after having the Booster shot.  Menorrhagia during period. Extremely heavy bleeding. Filling-up an ultra tampon and overnight pad every hour, for several days. In the past I would have heavy periods, but nothing like this and heavy days never lasted this long. Heavy days now last almost a week. Accompanied by passage of large clots - some as large as a golf ball. General feeling of unwell. Period timing also somewhat irregular now.
Extreme joint pain for 24 hours which got better after 48 hours, but  1-1/2 month later I am still suffering from joint pain. Never had it before. Most uncomfortable are my both pinkies. They are now very swollen and painful still to this day. I feel they are getting worse. I never had that before. Knee, hip, hands, clavicle, lower back, toes,  ankles, and hands are still sore.
24AUG95 approx 430PM lt leg got hard knot, cried constantly, fever 103.8; vomited x 1, ulcers in mouth;
large hives/welts over left leg, right leg(thigh surface), abdomen, left side neck.
inadvertently given a dose of Fluzone Quadrivalent instead of Fluzone High-Dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Medical Information (Reference number- 00774841) and transmitted to Sanofi on 17-Sep-2021.  This case involves a 65 years old female patient who was inadvertently given a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a 0.5 mL (once, total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE via unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  It was reported "He inquired whether the patient could receive a dose of Fluzone HD. Second: He requested the stability letter for Fluzone Quadrivalent, Fluzone High-Dose and Flublok."  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information on the batch number for this case.
Steadily increasing Prostate-specific antigen (PSA) level...02/15/2011 doctor noticed an exponential increase in PSA level and requested a prostate biopsy which confirmed aggressive prostate cancer...radical retropubic prostatectomy, bilateralpelvic lymphadenectomy treatment conduct 06/19/2012 at medical center.
Client received Pfizer Booster COVID vaccine (lot # FL3198, exp. 01/23/22) on 01/13/22 at SRPHC site. LVN noticed the needle was bent as she punctured the client?s skin with the needle of the Pfizer COVID vaccine. Without notifying the lead PHN or vaccine monitor, LVN used a new syringe with a Pfizer COVID vaccine dose and administered the Pfizer COVID vaccine dose to the client. LVN reported that the client's skin was punctured after slightly poking the skin and that she quickly withdrew the needle after observing that the needle was bent. There was a small amount of blood after the skin was punctured. LVN showed vaccine monitor PHN, the syringe with the bent needle afterwards and was instructed to apply safety mechanism and waste the Pfizer COVID vaccine in the syringe. PHN notified Lead PHN. Lead PHN was unable to assess client or educate client on the Pfizer COVID vaccine adverse reactions since client left the site before LVN notified lead PHN. PHN texted the Clinical Project Coordinator on how to proceed with this incident. Clinical Project Coordinator instructed to educate the vaccinator about elevating any needle or syringe issue to PHN lead in the future and to complete a VAERS and VERP for this incident report. PHN educated LVN to notify lead PHN anytime she has a needle or syringe issue so that lead PHN can make sure client and vaccinator are safe. LVN verbalized understanding.
Redness of skin and right eye, inflammation in the right eye, itching all over body, red hives all over body, very tired and difficulty breathing.
Suspected vaccination failure; We caught the virus; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that the patient received got both shots and still caught the virus. Those shots were probably the thing that kept us old folks (80's )from dying from it.  The patient recommended to get the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided. The case has been linked with the case US2021AMR195650 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195650:Same reporter.
Breakthrough case admission after 4 vaccines Moderna 1/27/21 lot# 007M20A;  Moderna 2/24/21 lot# 010A21A;  Moderna 10/27/21 lot# 939905;  MOderna 4/25/22 lot# 056M21A
Patient concerned that development of Bells Palsy on 12/6/09 may have been due to flu shot (H1N1) give on 11/6/09.
- left arm swelling/warmth  2 days ago , complaining of pain .  Minimal redness , more this am .
Patient received 1 dose (0.3ml) of undiluted pediatric bivalent -pt has had no adverse reaction-called Pfizer and this dose equals one adult dose
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. Ages, genders and other patients' identifiers were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23, subcutaneously in the abdomen. Doses, lot#, expiration dates were not provided. No adverse effects were reported. Additional information is not expected.
Migraine headache, sleepy for about 36 hours, no appetite for breakfast or lunch, very sore at the injection. I received the shot around 11:00am on 4/5/21 and woke up with a headache around 6am on 4/6/21. I was feeling close to normal around 11am on 4/7/21
patient had normal glucose nearly 6 months ago. Patient vaccinated and a week later, pt went into full DKA
Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on right arm on 04Feb2021 at 12:30 (at the age of 49years) at single dose for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure and high cholesterol. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on right arm on 14Jan2021 at 08:00 (at the age of 49years) at single dose for Covid-19 immunization. The patient experienced loss of taste and smell on 05Feb2021 at 18:00. Treatment was received for the adverse events. The events were considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, non- disabling/incapacitating and no congenital anomaly/birth defect. The facility where the most recent COVID-19 vaccine was administered was in a military base. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
shortness of breath, chills Narrative: Patient received COVID vaccine and started experiencing symptoms a/b 10-12 hours later which lasted for about 2 days. Patient reported fever, cough, wheezing, SOB, chills, muscle aches, and decreased O2 saturation to 81%. Patient took use dose of Tylenol and one dose of Advil for symptoms.
Red, swollen, itchy injection site beginning 7 days after injection. Redness continued through day 9 after injection.
Had a fever of 101 for two days with bad muscle aches chills and skin sensitivity. Sore at injection site.