chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of influenza in a 41-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included mosquito allergy, allergy to wasp and bee sting allergy. Concurrent medications included XANAX, LEXAPRO, LORCET, SIMVASTATIN, SINGULAIR, OMEPRAZOLE, SYMBICORT and Unknown injection (unknown if it was a vaccine or a vitamin B-12 shot). On 8 October 2009 at 10:00 the subject received 1st dose of Flu vaccine (unknown, right arm). On 8 October 2009, the same day after vaccination with Flu vaccine, the subject experienced a red, hot welt at the injection site. On 12 October 2009 (at mid-day), four days after vaccination with Flu vaccine, the subject experienced influenza. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the red, hot welt at the injection site was unknown and the symptoms of the influenza were unresolved. The consumer consulted a health care professional regarding the event(s). On 13 October 2009, the consumer reported that she was given an unknown manufacturer's flu shot. The injection was given on 08 October 2009. The subject reports that a red, hot welt appeared at the injection site on the day of the injection. The subject also reports that she developed the flu. Her flu symptoms began on 12 October 2009. At time of report, symptoms of the flu were unresolved. The subject said that she was given an injection in the gluteal area. She does not know if this was a vaccine or a vitamin B-12 shot.
Hives, itching, angioedema in lips. Taking medrol dose pack steroids and antihistamines. Still ongoing.
Client mother called 06/04/02 reported he had a red hot swollen left upper arm and fever of 101 deg F with nausea began at 8pm 06/03/02. Given Benadryl and Motrin and resolved 06/05/02. Did not go to MD.
Mild local reaction with vesicles, a few generalized vesicles on trunk, back and neck (approximately 10 total), induration around site of injection.
Patient's heart rate was checked at 3:20 pm and heart rate was 56. Patient's heart rate was again checked at 3:30 pm and heart rate was 44. Patient also became clammy and sweaty. He also mentioned that he felt sleepy, dizzy, weak, and had tight chest. We also noticed that his eyes began rolling backwards; however, he remained conscious. 911 was called and he was brought to the emergency room for further evaluation.
Pt reported got flu shot prior to developing small bowel obstruction and admittance to MC.
Information has been received from a female nursing technician who was vaccinated with a 0.5ml dose of PNEUMOVAX 23 "about 5 years ago". After the patient received the vaccine, she got flu symptoms that lasted about a week. Subsequently, the patient recovered "about a week after the injection". Additional information has been requested.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Other patient's demographics were not reported. Concurrent conditions, medical history and allergies were not reported. On 17-OCT-2014 the patient was vaccinated with both VARIVAX (Merck) (strength, dose, anatomical location, lot number and expiration date were not reported) and PROQUAD (Merck) (strength, dose, anatomical location, lot number and expiration date were not reported) both subcutaneously. Other suspect and concomitant therapies were not reported. Not adverse events were reported. No further information provided. Additional information has been requested.
Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age. There was no information about the patients' medical history and concurrent condition. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX23 (SDV)(strength, dose and route unknown) (Lot #: K008927, expiration date: 17-MAR-2016; lot # K016294, expiration date: 28-APR-2016) and PNEUMOVAX23 (syringes) (strength, dose and route unknown) (Lot #: L007720, expiration date: 08-JUL-2016; lot # K010466, expiration date: 23-MAR-2016). There was no information about concomitant therapy. No adverse effects were reported. This is one of the reports received from the same reporter. Additional information has been requested.
Started to swell and turn red within 1 hr. Became bruised and remained swollen slightly x 1 week. Is still bruised about the size of a "silver dollar" 12/8/17.
I have been notified from our Family Practice Center that one of the refrigerators which stores vaccines in the office was found to be at an incorrect temperature.  Unfortunately we are talking about a time frame of three years and five months.  As a result, three of my children need to be revaccinated.  My biggest concern is for my 23 month old daughter in which I'm being told that she needs to be revaccinated for ALL of her shots.  She is a tiny girl and barely weighs 20 pounds.  It is quite possible that the vaccinations she received in the past were okay.  Is it really safe for her to double up on everything?  Are there risk factors involved?  I am contacting other health officials to get some advice as well, but would greatly appreciate some input from you.  If this is something you feel is safe, do you have documented research to support that?  Thank you very much for your time.  I received some information from the CDC and they encouraged me to write my concerns to you.  Please know that I have confirmed with my doctor that ALL of my daughters vaccines MAY have been affected in which they are encouraging me to have her revaccinated on the following (DTaP #1, DTap #2, DTap#3, DTap #4, Hep A # 1, HIB #1, HIB #2, HIB #3, IPV #1, IPV #2, IPV #3, MMR #1, PCV #1, PCV #2, PCV #3, PCV #4, and Varicella).  Some of the information I filled out on the rest of this form is pretty much N/A as my question/concern is within this information.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tachycardia-Medium
Pfizer COVID-19 Bivalent Vaccine and a flu shot; Pfizer COVID-19 Bivalent Vaccine and a flu shot; feels her skin is biting her; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tuberculosis vaccines (2 weeks ago), for Immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Pfizer COVID-19 Bivalent Vaccine and a flu shot"; SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "feels her skin is biting her".  Additional information: The reporter mentioned she had a patient who received the TB shot 2 weeks ago, then the Pfizer COVID-19 Bivalent Vaccine and a flu shot today. Patient felt her skin was biting her. She wanted to know if there was any information about the administration of this vaccines together. The reporter mentioned this did not happen at her store.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events  and the suspect drug  BNT162b2
Red, swollen, warm, bruised and painful  injection site and surrounding area. Itching Tingling/numbness in arm
Chills, lethargy, HA, pain at injection sites: (R) arm pain rated 6/10, (L) arm pain rated 5/10.
Woke up with terrible chills. Felt really fatigued and sick to my stomach with a terrible headache all day following the vaccine shot (on Friday..the shot was Thursday). This was the booster. Had a very sore arm also.  After the first 2 shots, I had no symptoms.  I went to bed early last night and feel much better today.
She was dizzy the day after, but got better in 2 days. However, one week after, she got really dizzy and was diagnosed and being treated for positional vertigo.
Extremely sore arm; was unable to move it for two days after injection, swollen and very painful lymph nodes in armpit area on the injection side that lasted 6 days, extreme fatigue for 10 days, burning and itching at the injection site a week after receiving the shot that lasted 3 days.
lack of smell; sore throat; On 04-Jan-2021 at 4:23PM a phone call voicemail report was received from a physician concerning himself. He experienced Covid 19 symptoms four days after receiving Moderna's Covid 19 vaccine.  The reporter/patient did not provide any medical history prior to receiving the vaccine.  No relevant concomitant medications were reported.  On 24-Dec-2020 prior to the onset of events, the reporter/patient stated he received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid 19 infection.  On 27-Dec-2020, he stated that he started experiencing Covid symptoms like "lack of smell" and "sore throat".  The reporter/patient stated that he was diagnosed on 29-Dec-2020. He did not state what he was diagnosed with.  The patient/reporter stated that he received an immunoglobulin infusion for Covid treatment on 31-Dec-2020.  The outcome of the events, lack of smell and sore throat was considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested
Information has been received from a health professional concerning a white patient who on 07/19/2002 was vaccinated subcutaneously in the right thigh with a first dose of varicella virus vaccine live.  On 08/31/2004 the patient experienced shingles.  No additional information was provided.  Additional information has been requested.
This infant was screaming for 2 hours after her injection and redness appeared at the sight on the left thigh.
Chronic asthma, dry cough, trouble speaking with out coughing,  4 visit to MD  Albuterol, prednisone, azithromycin, fluticasone, azelastine, stiolto,
This spontaneous report as received from a pharmacist, as part of a marketing research program-ZOSTAVAX HCP competitive message testing conducted by the agency, refers to a female patient in her 70's. The concurrent condition and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route and lot details unspecified). The concomitant medication was not reported. On an unknown date, the patient experienced dizziness (non-serious). The action taken with ZOSTAVAX was not applicable. The outcome of dizziness was reported as resolving. The reporter considered dizziness to be related to ZOSTAVAX. Additional information is note expected as the reporter does not wish to be contacted.
Post vax, on 3/29/2000, child presented at ED with fever. Discharged 4/17/2000. Presented at ED with vomiting and dehydration (admission dx; Gastroenteritis) anemia. Condition deteriorated and was transferred to another medical center on 4/18/2000. Deceased on 4/21/2000.
Appendectomy Narrative: Developed abdominal pain with nausea on 12/24/2020, went to ER and noted to have appendicitis, resulting in an appendectomy
Muscle and bone ache all over, nausea, vomiting, headache, excessive sweating  and internal organs felt like they are quivering .  Did not contact doctor because had very much the same reaction in 1979 from a diphtheria vaccination I had before going traveling and lived through it..  After 3 days the only symptoms left are sweating and quivering  insides
A low grade fever and stomach aches - cramping and the next was diarrhea, was having back aches and saw doctor and got MRI in June2021 - diagnosed polycystic kidney disease and UTI.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that she received other medications in 2 weeks. Known allergies reported as yes. She started antiviral treatment for COVID-19 on 12Sep2022 and stopped on 16Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Robust take vs secondary infection, increased redness and warmth extending to elbow. Swelling of entire upper arm. Vaccine site approx 3cm in diam day 14.
Information was received in a pusblished poster abstract titled as stated above. This case concerns to a 91 year-old male patient. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (lot number, expiration date, dose, route and frequency were not provided) for prophylaxis. There was no concomitant medication reported. On an unknown date, 10 years after vaccination, the patient presented with crusted lesions on his face corresponding to the dermatome of the ophthalmic division of the left trigeminal nerve. The patient was diagnosed with herpes zoster; the clinical diagnosis was confirmed with polymerase chain reaction. The herpes zoster vaccine was not as effective with increasing age and with increasing years post-vaccination. This was concerning because the incidence of herpes zoster increases with age. If patients receive their first vaccine at 60 years old, with the advances in medicine they may live for 10 or 20 more years. However, the vaccine would not protect them from contracting herpes zoster at this age. Therefore, studies need to be conducted to evaluate the possible benefit of booster shots in the older population. The clinical characteristics of a patient presenting with a herpes zoster infection after vaccination were presented. Vaccine efficacy and guidelines were reviewed. Additional information has been requested.
20 mins after receiving vaccine I had horrible chills for like an hour.  Headache -still Anxiety-still 7 days after vaccine got a large raised red mark on arm where the injection was. Felt hot, itchy and painful. Getting bigger.
Patient was seated for adverse reactions and stood up to get out of the immunization booth and passed out.  Patient landed on the booth wall as pharmacist and mother caught the patient.  He was laid out on the floor with feel elevated and was given water.  Stayed down for about 5 more minutes just to make sure and then was helped into the chair.  We made sure that he was alright and after another 5-10 minutes him and his mother agreed he was ok and the left to get lunch.  Patient was instructed to let us know if they have any other issues.
Nurse reported the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 17-OCT-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S004548, and expiration date 12-AUG-202 for prophylaxis.  The administered dose of vaccine experienced the temperature excursion of 47.3 F degrees Fahrenheit for 20 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:  manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S004548; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
1st and 2nd dose: sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (1st and 2nd dose: sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Underlying Asthma which is usually in control) and Autoimmune disorder. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and GABAPENTIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (1st and 2nd dose: sore arm). The patient was treated with LEVALBUTEROL [LEVOSALBUTAMOL] (LEVALBUTEROL [LEVOSALBUTAMOL] NEBULISER) for Adverse event, at an unspecified dose and frequency; ITRACONAZOLE for Adverse event, at an unspecified dose and frequency; AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency and ANTIHISTAMINES for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (1st and 2nd dose: sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient used a box of Kleenex each day. The patient felt nauseated and vertigo after administration of gabapentin.   This case was linked to MOD-2021-323634, MOD-2021-323635 (Patient Link).
only side effect was severe wrist pain, and mild adema on the left hand.; only side effect was severe wrist pain, and mild adema on the left hand.; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient's only side effect was severe wrist pain, and mild edema on the left hand. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Information has been received a physician via field representative referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (lot#, expired date, dose, frequency and route were unknown). The patient had a rash for 2-3 days after receiving GARDASIL 9. The outcome of rash was unknown. Additional information has been requested.
Feverish 1 1/2 days post vax. with onset of sore throat decrease appetite with no  rash, fatigue, or muscle ache - increase in sore throat - previous history of pentonsilar abscess
Headache, Photophobia, Neck Stiffness Beginning 3 days after vaccine seizure, 10 days after vaccine 4/7/08-records received for DOS 10/27-11/03/07-DC DX: Questional aseptic menignitis vs encephalitis. New onset of left bundle branch block. Seen in ED after being found unresponsive at home. Feeling unwell, tired and weak, headache and tinnitus. Woke up screaming and found with eyes folled back, not responding. Seizures observed with jerking movements. Status epilepticus in ED, intubated. Wide complex tachycardia. Temperature increase to 102.9.
This is a spontaneous report from a contactable pharmacist. An 82-years old patient of an unspecified gender received PREVNAR 13 (batch/lot number and expiration date were not reported), via an unspecified route of administration on 19Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at the injection site on an unspecified date. The outcome of the event was unknown.
Temporary loss of vision, loud popping in right ear (shot given in right arm), cold sweat, shaking, almost passed out.
Coughing; This is a spontaneous report from a contactable consumer. Report 2 of 3. A female patient (Reporters neighbours mother) of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: was not reported) via unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization.Medical history and concomitant medications were not reported. Patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: was not reported) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.Reporter stated she was calling regarding the Pfizer Covid 19 vaccine. She had been doing some research and her neighbour and her mother had the Pfizer covid virus vaccine. She gave them a ride to pick up their car, which is about 15 minutes from her house. She had done some research and unfortunately, she was supposed to stay away from them. They were in her car. Her neighbour and her neighbours mother were both fully vaccinated with Pfizer and the caller is having massive and horrible headaches. Reporter confirmed she herself never had the covid vaccine. They (neighbour and neighbours mother) said they had received their vaccines at the end of Apr2021. They had both doses of the Pfizer vaccine. Reporter gave them a ride in her car 23Jun2021, it was the day before her birthday. She had been perfectly fine and healthy during the whole pandemic and had a mask on and everything. It was known that they were fully vaccinated at the end of Apr2021. Reporter stated that the ladies gave her numbers but does not have the number of the vaccine shot from their card. They said it was the Pfizer second dose was on 18Apr2021, she did not write down the numbers. Breathing or coughing in small, confined areas coming from those that had injections. The mother was coughing on an unspecified date in Apr2021. The outcome of the event was unknown.   Information about batch/lot number has been requested