chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious. This case, involving the same patient is linked. This case, from the same reporter is linked.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-JAN-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # K016318, expiration date: 24-DEC-2015. No adverse effect was reported. Additional information has been requested.
After my second Modern shot the septic arthritis in my hip worsened considerably; After my second Modern shot the septic arthritis in my hip worsened considerably; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS BACTERIAL (After my second Modern shot the septic arthritis in my hip worsened considerably) and CONDITION AGGRAVATED (After my second Modern shot the septic arthritis in my hip worsened considerably) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Septic arthritis (septic arthritis in my hip).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS BACTERIAL (After my second Modern shot the septic arthritis in my hip worsened considerably) (seriousness criterion medically significant) and CONDITION AGGRAVATED (After my second Modern shot the septic arthritis in my hip worsened considerably) (seriousness criterion medically significant). At the time of the report, ARTHRITIS BACTERIAL (After my second Modern shot the septic arthritis in my hip worsened considerably) and CONDITION AGGRAVATED (After my second Modern shot the septic arthritis in my hip worsened considerably) outcome was unknown.            Concomitant medications were not reported.  It was reported that after second Moderna shot the septic arthritis in patient's hip worsened considerably. Patient hope that was a coincidence, but patient thought should report it.  No treatment information was provided.  Company Comment: This is a Spontaneous case reported by a patient, concerning a patient of unknown age and gender, with relevant medical condition of septic arthritis in hip, who experienced the unexpected and serious (due to medically significant) events of Arthritis bacterial and Condition aggravated, which occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient reported that after vaccination, his/her septic arthritis in hip worsened considerably. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I had significant flu symptoms as with the 2nd shot. This was expected.   ***What is unusual is that my Rheumatoid Arthritis, which as been in remission/no symptoms for about 10 years, came back the following day after the vaccine with the flu symptoms.  My arthritis is still flaring and has  not gotten under control after 10 months of receiving the vaccine and trying different biologic drugs.  The onset was the covid vaccine and is still ongoing.
pt. recovering fr. auto accident recvd a dose of hepatitis B vac & exp. arthritic pain in knees & exp trouble walking.
Patient was vaccinated at approximately 12:00 PM. At 2:00 PM reported minor left arm pain and cramping in her hand. She was counseled this was not routine and if it worsened to notify a vaccinating pharmacist. At 4:25 PM she was in tears reporting intractable left arm pain in and an inability to use her left hand. 911 called, diphenhydramine 50mg PO given at 4:35 PM, EMS transported patient to ER at 4:40 PM. Patient was not diaphoretic, no redness or swelling observed.
was having problems with her stomach; She states she has had mostly Pfizer; she had one Moderna; She states she has had mostly Pfizer; she had one Moderna; vomiting; dizziness; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (was having problems with her stomach), VOMITING (vomiting), DIZZINESS (dizziness), COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Nov-2023, the patient experienced VOMITING (vomiting) and DIZZINESS (dizziness). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (was having problems with her stomach), COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna). On 09-Nov-2023, VOMITING (vomiting) and DIZZINESS (dizziness) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (was having problems with her stomach) had resolved and COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   The patient confirmed contact information. She had very bad symptoms, felt very dizzy and was having problems with her stomach. She threw up. She states she is better now, but it was bad when she had it in the morning. The patient states she has been getting the COVID vaccines regularly. The last one was a year ago in November. The dates and vaccines are unknown. She states she has had mostly Pfizer; she had one Moderna. The patient was not sure if she received Spikevax yesterday, but she did get a COVID19 vaccine yesterday 8 Nov 2023.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2023: Significant live follow-up received. Reporter details, event details , LRN added.
swelling to his armpit area on the side where the injection was given; Arm was pretty sore; large swelling under my armpit; my arm was pretty sore and then yesterday morning a large swelling under my armpit/ in the arm pit area in the arm where I got the shot; my arm was pretty sore and then yesterday morning a large swelling under my armpit/ in the arm pit area in the arm where I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 10May2021 (Lot number: EWO158) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2021, outcome "unknown", described as "swelling to his armpit area on the side where the injection was given"; PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Arm was pretty sore"; PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "unknown", described as "large swelling under my armpit"; INJECTION SITE PAIN (non-serious), INJECTION SITE SWELLING (non-serious) all with onset May2021, outcome "unknown" and all described as "my arm was pretty sore and then yesterday morning a large swelling under my armpit/ in the arm pit area in the arm where I got the shot".  No follow-up attempts are possible. No further information is expected.
Inappropriate schedule of vaccine; Circumstance or information capable of leading to medication error; mildly fluish; very sore arm; achy; tired; headache; "out of it"; This case was reported by a other health professional via call center representative and described the occurrence of influenza in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 13th August 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza, pain in arm, pain, tiredness, headache and spaced out. On an unknown date, the patient experienced drug dose administration interval too short and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the influenza, pain in arm, pain, tiredness, headache and spaced out were recovered/resolved and the outcome of the drug dose administration interval too short and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the influenza, pain in arm, pain, tiredness, headache and spaced out to be related to Shingrix.  Additional details were reported as follows: Health care provider was also the patient.  Asking about receiving the second dose of Shingrix before 2 months.  Also reported feeling mildly fluish, very sore arm, headache, tired, "out of it" the next day. AE reported for the possibility of early dose administered, which led to shortening of the vaccination schedule and or information capable of leading to medication error.  The patient or HCP did not state that they would be receiving the second dose early, this was a near miss.   No lot number or expiry date of vaccine available since nothing had been administered. The reporter did not give consent to follow up.
Severe stomach cramps; Diarrhea; Headache; Pain in arm; Weak feeling; Trouble focusing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 12:45 (Lot number: FC3184) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Gluten" (unspecified if ongoing), notes: known_allergies: Gluten; "known_allergies: wheat" (unspecified if ongoing), notes: known_allergies: wheat; "known_allergies: soy" (unspecified if ongoing), notes: known_allergies: soy; "known_allergies: peanuts" (unspecified if ongoing), notes: known_allergies: peanuts; "known_allergies: milk" (unspecified if ongoing), notes: known_allergies: milk. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Severe stomach cramps"; DIARRHOEA (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Diarrhea"; HEADACHE (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Pain in arm"; ASTHENIA (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Weak feeling"; VISION BLURRED (non-serious) with onset 22Sep2021 03:00, outcome "not recovered", described as "Trouble focusing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, headache, pain in extremity, asthenia, vision blurred.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 before vaccination.  Follow-Up (24Sep2021): Follow-up attempts are completed. No further information is expected.
Progress Notes  (Physician Assistant) Family Medicine Cosigned by: MD at 3/23/2021  1:26 PM Expand AllCollapse All    COVID VACCINE CLINIC 3/22/2021  Date:  3/22/2021                                                                                           MRN:     Subjective Patient a 35 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to feel very warm and her arms were tingling. She felt she was going to passout and laid on the floor in the observation area. She was wheel chaired to observation bay. Patient has a history of vasovagal response when getting vaccines or donating blood in the past.  She denied rash, hives, difficulty breathing, difficulty swallowing and facial swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to hypotension, rapid progression of symptoms, respiratory distress and skin changes.   ALLERGY REVIEW OF SYSTEMS:  Patient complains of dizziness   Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing and headaches    +diaphoretic and pale:     Previous Reactions: History of vagal response with prior vaccines and donating blood.    Objective    Vitals Vitals:   03/22/21 1434 BP: 113/81 Pulse: 82 SpO2: 99%      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Comments: diaphoreic    Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water Follow up response to treatment: good. Patient stated she felt normal prior to discharge. She was escorted out of the facility and denied any symptoms with ambulation. Discussed having her lay down in the observation bay while receiving her second vaccine.  Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash)     PA-C Electronically Signed 3/22/2021 2:54 PM       2 of 2
8 days after injection, injection site became very itchy and somewhat swollen; 8 days after injection, injection site became very itchy and somewhat swollen; extreme vertigo so that walking was not possible without support; extreme vertigo so that walking was not possible without support; extreme nausea with empty stomach retching; extreme nausea with empty stomach retching; blood pressure high (160/90), pulse 80, blood oxygen 94%; This is a spontaneous report from a contactable consumer. A 74-years-non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration in arm left on Feb2021 at 12:00 as single dose for COVID-19 immunization at 74-years age. Medical history included Low thyroid, slight cholesterol, and iodine (shellfish) allergy. Concomitant medication included pravastatin sodium (PRAVASTATIN SODIUM), levothyroxine sodium (LEVOTHYROXINE SODIUM) within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. After 8 days of vaccination (07Mar2021 at 16:00) patient experienced injection site very itchy and somewhat swollen, extreme vertigo so that walking was not possible without support, and extreme nausea with empty stomach retching. It's now been 28 hours with these symptoms. These symptoms matched a reaction at day 2, though those symptoms were modest and resolved overnight. The patient underwent lab tests and procedures which included blood pressure measurement high: 160/90, Temperature: normal, Pulse: 80 and Blood oxygen: 94%. Patient didn't received treatment for the events. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Fainting with injury-- After patient received her vaccines, she remained seated while her mother received vaccines. She did not report any dizziness. When she approached the door to leave she fainted falling forward hitting the front of her head on the door, then backwards hitting the back of her head on the floor. She quickly regained consciousness, but 911 was called to check her over.  EMT cleared and released her.  She had no signs of concussion.
Redness and soreness at left deltoid administration site. Oral area of involvement, 18cm x 16cm. No respiratory distress. No orofacial swelling.
Approx 5-10 min following receipt of the first Gardasil 4 vaccine patient had several seconds of eye blinking and generalized tonic clonic activity, at which point she was unresponsive. She then had syncopal episode and was layed on the exam table at which time she was arousable but remained groggy for approx 10 min. Her vital signs were stable. She became more alert after 10 min and left the office without assistance and with normal mental status.
Itching in different part of the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in different part of the body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic and Drug allergy. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), MONTELUKAST for Allergy, SIMVASTATIN for Cholesterol high, SERTRALINE and BUSPIRONE for Panic disorder.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itching in different part of the body). On 19-Mar-2021 at 1:00 PM, PRURITUS (Itching in different part of the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contains : Patient Details Updated, Event Stop date & Duration Updated
No energy, chills, aching all over. Lasted the afternoon and then part of next day.
Inflamed 5" x 3" around inj site, red, rash, hot to touch.
swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 08-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) was resolving.            Concomitant medication not reported.   Treatment medication not reported.  The patient experienced swollen lymph nodes. It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease, or risk factor. There were no lab data/results available.
The next morning after the vaccine I woke up with my head feeling very heavy and a little chills, but no fever which lasted less than a day and subsided on its on.  12/25 i was exposed to a few people who later tested positive to COVID.  I  developed a headache for a few days after and had a few mild symptoms but never tested.  But on 1/25 I developed a scratchy throat which progressed more towards the evening.  Later that evening I developed a headache and chills, my throat was hurting even more and the cough had gotten worse and so the next day I took a home COVID test which was questionable so I went to Urgent Care later that day and tested positive to COVID at that time.  I was put on a 5 day course of Paxlavid to help with the symptoms and to date I still have a little cough and congestion but I feel much better.  During this time my Pulse Oxy was running low to the mid 90's and still is running low to date and I will reach out to my PCP for further testing to ensure no additional affects are being experienced
Expired Rotarix given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 743NB, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th August 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 4th August 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The patient was inadvertently given an expired dose of Rotarix. The reporter consented to follow up from safety. Additional Supportive Information: The patient received Rotarix which was already expired, which led to expired vaccine used.