chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20DEC pt devel welts trunk & legs; no fever skin felt extremely hot; By next AM welts edges became purplish like bruises large patches; fever 99.4; seen by MD 21DEC91 labs nl; dx erythema multiforme; mom describes pinpoint rash, diarrhea;
Pt recv  vax on 11/4/98; 1 hr post vax pt exp chest tightness, difficulty breathing, choking feeling, nausea, vax site swelling/itching; tx=Benadryl
Patient reports pain in arm, side and neck approximately 4-5 hours after shot given. Td given in left arm, pain in left side. Patient also reports swollen jaw on left side. Jaw still swollen on 08/17/07. On scale of 1-10 with 10 being worst pain, patient reports pain of "4". No temperature reported.
No adverse event; Monovalent doses administered after the BUD to Patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to Patients) and NO ADVERSE EVENT (No adverse event ) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to Patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to Patients) and NO ADVERSE EVENT (No adverse event ) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event ) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to Patients).   ID was reported as 7552537. Concomitant medications details were not reported by the reporter.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Total 77 Monovalent doses were administered after the BUD to patients 12 and up. Breakdown of doses was, 37 doses from Lot 059H21, 26 doses from Lot 065K21A and 12 doses from Lot 058A22-2A. Treatment details were not reported by the reporter.
Severe Injection site pain/mild swelling  lasting 3-4 days with PRN Advil taken as needed Mild headache lasting 3 days with PRN Advil taken as needed Chills at night x 2 nights General fatigue and muscle aches lasting 3-4 days with PRN Advil taken as needed Esophageal spasms, causing chest pain, pain when swallowing anything. Weird sensation can be felt at rest too. Symptoms lasting 4-5 days
Pt received vaccine on Saturday (7/21) - Came into pharmacy whit large rxn site. Redness measure - 6 in x 2 in. Red area was warm to the touch & had large knot in the center. Called pt. PCP. Set up MD appt for today (7/25) at 2 pm. MD stated this was a normal rxn. Called Merck rep. who also greed this was not normal.
Second dose of Recombivax given 04/04/02 within days afterward employee experienced unequal pupils visual problems in lef teye, dizziness,muscle tremors, twitching, extreme weakness, fatigue and hair loss. ACTscan, MRI and lumbar puncture yielded no abnormal findings. After employee received 3rd dose on 10/11/02, employee realized symptoms might be due to the vaccine.
This spontaneous report as received from a nurse refers to a 10 months 14 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
2 vaccines on 9-10-15 PREVNAR and FLUZONE. Pt returns 7 days later. Arm is hot and swollen. Rph on duty explained possible cellulitis. Pt was referred to urgent care. Doc on duty reports an infection but did not use the word cellulitis according to pt. Pt prescribed clindamycin 150mg.
there is a lump underneath my left arm, in my armpit area/it just puffy is like a lump like it is full of some kind of fluid; puffy is like a lump like it is full of some kind of fluid; When probed for expiration date, consumer stated 10Nov2021; When probed for expiration date, consumer stated 10Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Lot number: FF2593, Expiration Date: 10Nov2021) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "Bronchitis" (unspecified if ongoing), notes: Verbatim: Bronchitis. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), administration date: 2021, for COVID-19 Immunisation; Bnt162b2 (Dose:2), administration date: 2021, for COVID-19 Immunisation.  The following information was reported: MASS (non-serious) with onset 12Nov2021, outcome "unknown", described as "there is a lump underneath my left arm, in my armpit area/it just puffy is like a lump like it is full of some kind of fluid"; EXPIRED PRODUCT ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset Nov2021, outcome "unknown" and all described as "When probed for expiration date, consumer stated 10Nov2021". Therapeutic measures were not taken as a result of mass, expired product administered, poor quality product administered.  Additional information: Patient stated that to have got Pfizer booster last Friday and now there is a lump underneath patient's left arm, in armpit area. It does not hurt but it just puffy is like a lump like it is full of some kind of fluid or something. Vaccination Facility: Consumer stated, Withheld, it's a pharmacy.  No follow-up attempts are possible. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 2013, the patient was inoculated with the ZOSTAVAX vaccine at a Medical Center as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about February 2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, ibuprofen and TYLENOL for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Constant tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 11Jun2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included borderline hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 12Jun2021 at 06:00, the patient experienced constant tinnitus in both ears. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant tinnitus in both ears was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 16Jul2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation.
swollen, hot, itchy welt at injection site >48 hours after injection; symptoms reduced 3 days after injection and disappeared about 4 days after injection; was 23 weeks pregnant at time, estimated date of delivery is July 24, 2021
Eye blurriness; vomiting; arm soreness; neck soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 11:45 (Lot number: EWO171) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Other medical history: Breast Cancer. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO185, Location of injection: Arm Right, Vaccine Administration Time: 12:00), administration date: 20Sep2021, when the patient was 40 years old, for Covid-19 Immunization. The following information was reported: VISION BLURRED (non-serious), outcome "recovered", described as "Eye blurriness"; VOMITING (non-serious), outcome "recovered", described as "vomiting"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm soreness"; NECK PAIN (non-serious), outcome "recovered", described as "neck soreness". Therapeutic measures were not taken as a result of vision blurred, vomiting, pain in extremity, neck pain.  Additional information: No other vaccine in four weeks and other medications in two weeks. No COVID prior vaccination and patient did not tested COVID post vaccination. Start date and time for all events were 20Sep2021 at 13:00  No follow-up attempts are possible. No further information is expected.
Soreness at her injection site/arm would be sore; Arm was also bruised and swollen. Left arm; Arm was also bruised and swollen. Left arm; Headache; tired; fever; muscle soreness to where she couldn't even walk/muscles were sore enough where she had a difficult time walking; muscle soreness to where she couldn't even walk/muscles were sore enough where she had a difficult time walking; arm would be sore; This is a spontaneous report from a contactable nurse (patient). A 69 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EW0170), intramuscular, administered in arm right on 20Apr2021 (at the age of 69-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure abnormal (reported as blood pressure), heartburn and gastrooesophageal reflux disease (GERD), all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine taken for blood pressure, pravastatin taken for an unspecified indication, esomeprazole magnesium (NEXUM) taken for dyspepsia and GERD, all start and stop dates were not reported. After the patient's first shot, her arm was killing her, it got swollen and it was bruised. It was the craziest thing she knew her arm would be sore after the shot but, not the opposite arm. She was tired, had a headache, all the ones that listed on the Pharmacy list she was given. She had a hard time with both shots, she is glad Pfizer only has 2. Soreness at her injection site after the 1st injection. Arm was also bruised and swollen. Left arm, she got it 12 in the afternoon but, the stuff showed up 5-6 hours later, nothing right away. It was the same yesterday with her shot, she was ok and about 6-7 hours after is started bothering her. She got the 1st injection on 20Apr2021. She knew her arm would be sore. She checked off everything on the her a list she got from the pharmacy, she had fever, her muscles were sore enough where she had a difficult time walking, her arm was sore. Headache, tired, fever, muscle soreness to where she couldn't even walk. This happened after her first shot that started on 20Apr2021. She confirmed that the left arm was bruised and swollen, not both. Treatment - No treatment sought. The events were assessed as serious and medically significant. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded   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.
Episode of right sided chest tightness. Denies SOB and all other associated s/s. Assisted to cot to lay down, pt reported tightness subsided 5 minutes after rest.
The day after the shot I hurt all over. I hurt three times worse than the worst flu I've ever had. In addition, I would have pain in my joints on and off through the day. In the afternoon I had a temp of 100.2   My concern is that on the news reports they say that the reaction to the second shot can be worse. I don't know if I can handle any more pain than I experienced after the first shot. The following day there was no more pain, but I was very tired. I'm ok now.
This is not a report of an adverse event, it is a report of an incorrect dose of Pfizer COVID-19 being administered to a patient.  The patient was 4 years old at the time the vaccine was given but was inadvertently given a dose of Pfizer COVID-19 vaccine for ages 5-11 years old (10 ug/0.2 ml) rather than the Pfizer COVID-19 vaccine for ages 6 months-5 years (3 ug/0.2 ml).  No side effects were reported either immediately after the vaccine administration or in the days after it was administered.
Circular erythema + tenderness to (R) upper arm (widest appx 5 cm). 2 areas of circular erythema + tenderness to (L) upper arm (top: widest appx: 1 cm; bottom: widest 4 cm). Appeared morning after vaccine.
Left arm pain at Vax site starting about 3 hours after vax.  about 20 hours after vaccine, got fatigued/tired and had a headache. At 5pm, had about +.5F fever. At 6pm, had +2F fever.  Fever lasted about 4-5 hours. Fatigue and fever were gone on Sunday, but had bad headache all day.
Patient presented to the emergency department with right-sided pleuritic chest pain-she has a pulmonary embolism on CT angiogram.  She was started on heparin and admitted to the medical center.  She received her Johnson and Johnson vaccine on 03/04/2021.
Hives and splotches on right waist, itching and burning. Left arm, site of injection, red and swollen, splotching traveling down arm into left armpit with extreme itching.
Redness, swelling, itching & pain developed within a few hours. The next day she developed worsening of generalized urticaria which had been very mild prior to receiving immunizations. HYDROXYZINE prescribed for urticaria on 5/20/10.
Symptoms began a few hours after vaccination: pain at injection site, soreness, redness, child complains of difficulty walking, trouble keeping eyes open/focusing. 5 hours after injection: trouble sleeping, fever of over 101 to 102.5. 12 hours after injection: nausea, vomiting, not eating or drinking water, not wanting to walk, trembling/body shaking, overtired/sleepy and difficulty staying awake. Fever continues.
24 hours:  Severe chill, low grade temperature (99.5 deg. F.) generalized acts and pains,  one episode nausea with vomiting, fatigue. Rx:  rest, fluids
My arm was getting really swollen, redness, itchy, warmth, tenderness and pain. I am also getting headaches and The chills. The site of the injection was getting bigger. Today 03/08/2021 I went to the emergency room and they told me it was a post-injection inflammatory reaction. So they gave me two prescriptions to take, famotidine and prednisone. Also to take Benadryl. This went on for two days.
Pt left arm was swollen and red the next morning (September 9th, 2017) after receiving the shots and there was a "knot" in her arm. She said she could not raise her left arm up more than a few inches and it really hurt. She was told by another pharmacist at another facility to apply warm compresses to the arm. The patient did so and she said that helped. She said she took some Benadryl on Tuesday September 12th, 2017. She said it was still hurting her that Friday, September 15th. When she came into the pharmacy and reported the adverse event today, Oct 1st, 2017, she said her arm was completely fine and she had completely recovered.
Severe headache; low grade fever; chills/sweats; nausea; body aches - especially back & neck; earache;
This case was reported by a pharmacist via call center representative and described the occurrence of numbness facial in a 57-year-old female patient who received FLUARIX Quadrivalent 2015-2016 season. On 1st October 2015, the patient received FLUARIX Quadrivalent 2015-2016 season .5 ml. On an unknown date, less than a year after receiving FLUARIX Quadrivalent 2015-2016 season, the patient experienced numbness facial. On an unknown date, the outcome of the numbness facial was recovered/resolved. The reporter considered the numbness facial to be unlikely related to FLUARIX Quadrivalent 2015-2016 season. Additional details were provided as follows: The patient received a dose of FLUARIX Quadrivalent 2015-2016 season in left arm and experienced facial numbness. The reporter would like to know if there were any reports associated with facial numbness.
CA125 has gone up; This case was reported by a consumer via patient support programs and described the occurrence of ca 125 increased in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Shingrix and PNEUMONIA SHOT. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix, the patient experienced ca 125 increased. On an unknown date, the outcome of the ca 125 increased was unknown.   It was unknown if the reporter considered the ca 125 increased to be related to Influenza vaccine Quadrivalent unspecified season and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that her CA125 had gone up a little (24).  This case has been linked with US2020AMR130729 reported by same reporter. Her doctors said it was from the flu shot, shingles shot and peumonia shots. The reporter did not know if that was true. This case has been linked with US2020AMR130729 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR130729:Same reporter
didnt feel well; feeling nauseous; having a headache; Chills; body aches; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills), MYALGIA (body aches) and FATIGUE (felt tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Apr-2021, VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills), MYALGIA (body aches) and FATIGUE (felt tired) had resolved.            No relevant concomitant medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Nausea; Rashes all over the body,rash on lower back,rash on legs; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), RASH (Rashes all over the body,rash on lower back,rash on legs) and PRURITUS (Itchiness) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NAUSEA (Nausea), RASH (Rashes all over the body,rash on lower back,rash on legs) and PRURITUS (Itchiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), RASH (Rashes all over the body,rash on lower back,rash on legs) and PRURITUS (Itchiness) outcome was unknown.            no concomitant medications are provided. Patient is schedule to meet with a dermatologist..   This case was linked to US-MODERNATX, INC.-MOD-2021-067707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067707:1st dose
Patient fainted from sitting on chair, felt nauseous, dizzy, and lightheaded 5 minutes after receiving vaccine.  Felt dizzy for an additional 15 minutes and laid supine.  Patient drank juice, ate a salty snack, and sat up.  Continued to feel lightheaded, laid down for additional 15 minutes.  Patient vomited, complains of headache and nausea.  Symptoms continued for an additional 45 minutes before patient felt comfortable to leave with friend.
High fever that lasted until yesterday up to 101.9 F Severe headache Chills Body ache Abdominal pelvic pain  Patient reports having first dose of shingles vaccine 11/6/2020
Client reports on 1/20/11 pain in right forearm that is present from elbow to wrist denies numbness or tingling.