chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart hurt to laugh or at high stress; First 3 days after shot seriously bad headache; slight fever; head pressure; dizzy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 58-years-old), administered in arm right on 04Jun2021 at 16:00 as dose 1, single for COVID-19 immunization. Medical history included known allergies with shrimp from an unknown date and unknown if ongoing. The patient' concomitant medications were not reported. The facility type vaccine was reported as pharmacy or drug store. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 05Jun2021, the patient experienced heart hurt to laugh or at high stress, first 3 days after shot seriously bad headache, slight fever, head pressure, dizzy. Clinical Course are as follows: First 3 days after shot seriously bad headache slight fever. Then for a month head pressure but no pain, dizzy, heart hurt to laugh or at high stress. Now symptoms only about once or twice a month with same symptoms but not as severe. The treatment was not received for all the adverse events. The clinical outcome for all the events was reported as recovered/resolved with sequel.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
I experienced unexplained tachacardia after my third vaccine for Covid Mederna. Hospitalized for four nights. Tests all normal.
pt recvd vax; devel fever to 105 R p/ immun given;fever lasted approx 24 hrs; no sz reported & mild nasal congestion;
Initial unsolicited report received from a consumer (patient parent) on 17 June 2015. A 61-year-old female patient had received first dose of ADACEL (batch number: U4870BA, expiry date: 10 March 2016, dose, route of administration were not reported) in left deltoid on 08 June 2015. Illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions reported as none. Concomitant medications were not reported. On 11 June 2015, three days after vaccination, the patient developed painful left arm with redness and heat. On 13 June 2015, the arm began weeping and the redness went more than half way down her arm. The patient went to an urgent care and was diagnosed with cellulitis. Also, the patient was worried as the product she received was orange in color. It's a product color issue. Patient required ER/doctor visit. Relevant diagnostic tests/laboratory data reported as none. Corrective treatment included application of ice, antibiotics. At the time of this report, the patient was not recovered from the events. Upon medical review, the case was considered as serious due to important medical event: cellulitis, painful left arm with redness and heat, painful left arm with redness and heat/the arm began weeping and the redness went more than 1/2 way down her arm and the product she received was orange. Documents held by sender: none.
Symptoms returned 27Apr. Rapid test positive on evening of 27Apr.; Symptoms returned 27Apr. Rapid test positive on evening of 27Apr.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine ("Primary Immunization series complete; unknown manufacturer"), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Apr2022 at 06:45, outcome "not recovered" and all described as "Symptoms returned 27Apr. Rapid test positive on evening of 27Apr.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) Negative; (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: It was reported that COVID. Symptoms resolved on 20Apr2022. Tested negative on 22Apr2022. Symptoms returned 27Apr2022. Rapid test positive on evening of 27Apr2022. Treatment Paxlovid start date was 16Apr2022 and treatment stop date was 20Apr2022.
Two days after receiving the 2nd shot, began to experience inflammation and pain in joints from head to toe. These both have been debilitating, hard to move around, hard to get out of bed, hard climb stairs, hard to use hands due to swelling, hard turn head and cannot kneel down. Life has become very hard and painful. Gabapentin was prescribed and did nothing. My doctor prescribed celecoxib for the pain and inflammation. I've only been using it for 3 days and am having moderate relief, but too soon to tell.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 at 19:53, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Spots in left eye Feb 23, normal headache cleared Feb 25.  March 2 bad headache returned, March 3 about noon I notice tightness in lower throat. Progressed into lung area around 2:00.  It became difficult to breathe.  I went to the  emergency clinic about 5:00.  They did an EKG found no serious problems and suggested I head to the hospital.  I arrived there about 6:15 the breathing was exceeding difficult.  I could not lay on my back.  My lungs on both sides felt like they were on fire when I tried to inhale
2 hours after vaccine given, patient had itchy 2" wheal on arm.  At 5:30 PM was 4" wheal.  Took Benadryl 50 mg po at 9:30PM.  Was still itchy but not much larger wheal.  Took Benadryl 50 mg po again.  By 7AM next morning was swollen from bottom of shoulder to top of elbow, very sensitive to touch but not as tight.  Over course of day, it went away.  No doctor contacted.
Fevers, chills, rigors, diarrhea, whole body pain, brain fog, severe arm pain at site of injection
sweating while sleeping overnight; pain/soreness in arm; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9261) in the hospital, via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient experienced pain/soreness in arm that has remained for 2 days and experienced sweating while sleeping overnight which is not typical for her sleep patterns. The events were reported to have occurred on 20Jan2021. The outcome of the events was recovering. The patient did not receive any treatment for the events. The events were reported as non-serious.  Since the vaccination, the patient has not been tested for COVID-19.
a 3 year old male patient  received an expired dose of Daptacel ,expiry date of 07-FEB-2020,No AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA042249 (same reporter).  This case involves a three year old male patient who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 14-Feb-2020, the patient received a 0.5 ml of booster dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5366 BA  and expiration date 07-FEB-2020) via an intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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 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.
pt recvd vax & 2 wks p/vax exp fatigue, nausea, joint pain, & muscle soreness; pt was seen by MD & recvd APAP;
red splotches on injection arm; pt said not itching but felt may be spreading; pt asked to wait 30 minutes for observation
Pt recvd 3 doses of Engerix-B & titers were checked 6 months p/last dose; titer result was 5.3, indicating a low pos response;
Some soreness in left arm where the injection was made; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 22Feb2021 12:00 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the workplace clinic. The patient medical history included diabetes, high blood pressure, reflux. The patient also had allergy to Penicillin. Concomitant medications included metformin; dulaglutide (TRULICITY); empagliflozin (JARDIANCE); esomeprazole magnesium (ESOMEPRA); and atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported. The patient experienced some soreness in left arm where the injection was made on 22Feb2021 15:00 with outcome of recovered the next day, 23Feb2021 with no treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Rash with face and neck flushed and warm. Ears red and slightly swollen. Chest exam with increased upper airway noise. No wheezing. Seen in doctor's office around 3pm
extreme itchiness; Skin reaction to allergen; raised red dots in legs and arms; discoloration on her legs; legs and arms are completely mottled/ red and white mottled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years for immunisation; for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "Hypertension" (unspecified if ongoing), notes: Hypertension; "Hyperthyroidism" (unspecified if ongoing), notes: Hyperthyroidism. Concomitant medication(s) included: JANUVIA; LEVOXYL; ATORVASTATIN; METFORMIN; GLIPIZIDE; LISINOPRIL; ELIQUIS; METOPROLOL; DESOXIMETASONE topical. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "extreme itchiness"; DERMATITIS ALLERGIC (non-serious), outcome "unknown", described as "Skin reaction to allergen"; RASH PAPULAR (non-serious), outcome "unknown", described as "raised red dots in legs and arms"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "discoloration on her legs"; LIVEDO RETICULARIS (non-serious), outcome "unknown", described as "legs and arms are completely mottled/ red and white mottled". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, dermatitis allergic, rash papular, skin discolouration, livedo reticularis. Additional information: patient had the Pfizer RSV shot on 24Oct2023 and began to develop severe skin symptoms on 31Oct2023. It began with raised red dots and extreme itchiness and it has evolved into the skin flattening out, no further dots but her legs and arms were completely, mottled meaning that they were red and white mottled and the itching has stopped that was on her legs, her arms and feet. It has not advanced but what has not improved is the discoloration and mottling on her legs. Patient has been to the dermatologist 2 times, and had a skin biopsy. Patient has a long list of documented chemical allergens and was calling to find out if a complete list of ingredients of the Pfizer RSV vaccine can be provided. Patient mentioned that she just decided that it was a vaccine that she wanted to get and went to a pharmacy to get it. Patient also mention that she has one topical medicine she was on since the adverse skin reaction, to apply 2 times daily, this is called Desoximetasone 0.25, topical apply 2 times daily. Patient also reported that she used an over the counter benadryl as a treatment not using anymore at the time of report. Finally, patient stated that it was important to know she had had two sets of patch testing and have a long list of chemical allergens, that was the reason she was calling.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
c/o shortness of breath and chest pain after vaccination. Pt was transported by EMS to  Hospital.
Severe pain in arm, tingling all over body, feel cold and can?t get warm enough, then feel too hot,  tired, headache, thirsty, insomnia from pain . Started  slowly after 8 hours from vaccine time and progressed throughout the night. Digital forehead temp 98° f and neck and chest is 101°f
I started to get winded whenever I walked a short distance around the end of January and beginning of February 2022. I called my physician and then I went to the Emergency Room. I took several tests. I was hospitalized for 2 days. A blood clot behind my right knee was discovered. I was also diagnosed with Bilateral pulmonary emboli. I have not been at work since February 2022. I was put on blood thinners.
Systemic: Dizziness / Lightheadness-Medium, Systemic: headache, and red eye also-Medium
Flushing of face, neck area a few minutes after the shot. Flushing did go away after 10 minutes. Patient also experienced muscle tightness around back (spinal cord) 15 minutes after shot. Pt felt well enough to return home with her husband. Pt later informed us she did go to emergency room b/c of stomach pain. Returned home after few hours. No treatment was given by ER.
Raised Red Warm area roughly 2 inches wide and 1/2 inches tall on left deltoid.  Continues one week post immunization.  No Pus, streaking noted at site.  Normal Range of Motion, no pain reported with movement.  No fever reported.
Information was received from a lawyer regarding a potential litigation case concerning a minor male (age unknown), who on 11OCT2013, was administered the PROQUAD (Merck), lot #J002307, expiration date 22AUG2014 (dosage and route of administration not provided). On 11OCT2013, the patient developed a serious infection following the vaccination and was hospitalized and caused to undergo an unspecified procedure as a result of the infection. The reporter was concerned that this lot number may be determined to contain contaminants, and noted a potential bodily injury claim. The outcome of the serious infection was not provided. Additional information has been requested.
Breakthrough case admission after 2 vaccines Moderna 3/5/21 Lot#023M20A;  Moderna 5/20/21 Lot# 040B21A
A legal complaint was received from an attorney alleging that a female received Orimune vaccine. As an adult, she was diagnosed with mesothelioma on or about May, 2000 and died 3/24/01. "The decedent had mesothelioma in which SV40 was a substantial factor, and therefore a cause of decedent's mesothelioma." It is alleged that the "decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent, including but not limited to breathing difficulties, asbestosis, lung and/or cancer, mesothelioma, and/or lung damage. The reporter stated that the "Decedent stopped working on 4/27/00, due to her mesothelioma."
03/30/2005 Td given 2 hours to injury, 48 hours developed severe left deltoid shoulder pain that progressed to a neuralgia and 2 hours bursitis
Late dose / 1st vaccine on September 19, 2020 and is back today (March 31, 2021) - 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on 18th September 2020, lot no: ABXB02AA, expiry date: 28th February 2022).   On 31st March 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 case details were reported as follows: On 31st March 2021, the patient was back to received the 2nd dose of Bexsero, which led to lengthening of vaccination schedule. The reporter consented to follow up.
CHILLS; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and HEADACHE (Headache) in an elderly female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (CHILLS) and HEADACHE (Headache). At the time of the report, CHILLS (CHILLS) and HEADACHE (Headache) had resolved. Unknown          No concomitant medications were reported.  No treatment medications were provided.    This case was linked to MOD-2021-016944 (Patient Link).
Resident had severe confusion. She thought she was in another state and that we were all strangers. She has a decrease in her appetite and an increase in thirst. She complained of low back pain with aches all over her body. She also stated that she had very vivid dreams. this is not at all the typical behavior that we have seen in her. Previous labs were checked and all were within normal range.
Severe muscle soreness at injection sites on left & right arm. Onset within an hour. Muscle soreness associated with typhoid vaccine resolved after 2 days. Muscle soreness associated with Anthrax vaccine resolved after 4 days.
Pt developed swelling, redness and pain, left arm, shoulder to elbow. Seen by MD. Compresses and Tylenol ordered. Not admitted. No return visit scheduled. Resolved in 48 hours.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to her zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles (onset date unknown). As a direct and proximate result of her use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not reported.
2/9/15- H/O URI sx and fever x 4-5 days the start with maculo, papular rash on face, scalp and spreading to trunk, arm and legs including hands and feet. Rash itching. Pt has fever on days of the rash with macular, papular, pustules/vesicles and one crush lesion. Dx Varicella O2.
Patient/caregiver questioning how long patient will be observed after getting the vaccine as they were anxious/concerned of reaction. Patient/caregiver advised 15 minutes and longer if any questions or issues. Patient noted a few minutes after getting the vaccine she felt it was "harder to breathe". HR normal, O2 sat normal. Provider assessed patient. Recommended patient take off mask to help breathe better. Patient noted it helped. Patient observed for a full 30 minutes. Provider re-assessed. Patient notes she felt fine.