chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rotarix given IM in right thigh; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate route of vaccination in a 6-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 53T9Z, expiry date 27th April 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 13th December 2021, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 13th December 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 details were provided as follows: The medical assistant (MA) stated that the patient received dose of Rotarix intramuscularly into the right thigh, which led to inappropriate route of vaccination. No further information was reported. The reporter consented to follow-up.
My bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (My bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Bronchial asthma (I have had asthma since I was about 14).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (My bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (My bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported.  Patient reported that bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine against the coronavirus. Also mentioned that luckily it did not change after the third vaccination.  Treatment medication was not reported.
This is a spontaneous report received from a contactable physician. A 9-year-old male patient received BNT162B2 (COMIRNATY, solution for injection; Batch/lot number and expiration date were not reported), intramuscularly administered in the left arm on 05Nov2021 12:00 PM (at the age of 9-years-old) as dose 1, single for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced itch, swelling (both arms and both legs), redness including on face on 05Nov2021 12:00. Treatment with Benadryl was received for the events. The outcome of the events was recovered on an unspecified date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
2 days after ZOSTAVAX injection patient developed rash/shingles on (R) trunk.
This spontaneous report was received from a Nurse refers to a patient of unknown age. The patient historical drug included unspecified PNEUMOVAX 23. On 2-APR-2014, the patient was vaccinated with expired PNEUMOVAX 23 lot # H018380 (Expiry: 12-MAR-2014), 0.5 ml, intramuscular. No adverse effect reported. No further information was provided. Additional information has been requested.
On the 9/12/2021. I had lower back pain and it was hurting really bad to the point where I couldn't move and moved towards the front of my abdominal area. Went to ER 9/14/2021. They did a CAT scan there and there was no findings and no abnormalities in that area. Normal appendix. Everything was fine. Went to see my PCP for follow up and they ordered an abdominal ultrasound for 9/28/2021, they found that my kidneys were enlarged. One was 13.6 and one was 15. From there my doctor said that that was abnormal findings. So she was going to send me for a follow up ultrasound on 12/01/2021. And those findings were: R kidney was 15.1 x 5.3 x 6.4 cm. no evidence of mast, hydronephrosis, or calcification. L kidney was 16.1 x 6.6 x 7.6 cm. mild hydronephrosis. No mast or calcification. Impressions large bilateral kidneys with normal echotextures. Could be related to urinary distension (no relation). After that, I was referred to a kidney specialist because the other kidney got larger. The kidney specialist did all tests and said I had normal functions of my urinary tract and kidneys were functioning normally. He's not sure why they are enlarged. I asked if it could be the vaccine and he said he wasn't sure. 09/14/2021 kidneys were normal then 14 days later they were enlarged. Joint pain is worse, loss of hair (hair falling out).
Numbness/tingling in left arm (from shoulder to hand) and left leg (from knee to foot)
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and MYALGIA (body ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 09-Feb-2021, PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and MYALGIA (body ache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Followup received and reporter contact details were updated.
She got her vaccine, she was dizzy and she had a headache.  She could not drive because her arm was so numb, she could see it on the steering wheel but could not feel it.  She could not hold onto anything.  On Saturday she was not able to go to work as she was vomiting, nausea, diarrhea and then started with constant urination to the  point that she was not able to make it to the bathroom.  She is still having it constantly, and having the urge to go even though she has just relieved herself.   Her arm is still numb, and also has numbness in her face on the face, she is biting the side of her mouth due to the numbness and pain coming around her shoulder girdle and onto her breast, and not able to lift her arm above her head due to the pain.  Her arm was swollen all the way to her elbow, but has gone down some.  The area where the vaccine was is extremely itchy.  She did take a couple of Tylenol and that was all.  She does not like to take pills.  She is going to call and get an APT with her doctor to be seen for the issues of urination.   She is extremely concerned about the constant urination and the numbness in her face.    She recently had appointments with her PCP and her Gynecologist and had no issues and everything was fine.
Within 15 or 20 minutes of receiving her first dose of the Pfizer Covid vaccine, the patient, felt hot and asked for a fan. She started to feel like she was going to faint and said that her mouth felt funny. She was breathing without difficult. The patient eventually had a syncopal episode and then had facial drooping.. When she regained consciousness, she could communicate and answer questions. Breathing remained normal and pulse rate was in the 50s. EMS was called when the patient said that she felt faint. They took her to to the hospital for further treatment.
PASSING IN AND OUT OF CONSCIOUSNESS; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex and ethnicity. 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 not reported, batch number: Unknown, Expiry Date: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. 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 was laying in bed with the chills passing in and out of consciousness. Patient was fine 48 hours later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from consciousness fluctuating and chills. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210541935-covid-19 vaccine ad26.cov2.s -passing in and out of consciousness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pain in chest area; Feels like contractions along the esophagus with pain radiating towards back and ribcage; Feels like contractions along the esophagus with pain radiating towards back and ribcage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 13:00 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: unknown, expiration date: unknown), for Covid-19 immunisation. The following information was reported: CHEST PAIN (non-serious) with onset 10Jun2021 12:00, outcome "not recovered", described as "Pain in chest area"; OESOPHAGEAL PAIN (non-serious), PAIN (non-serious) all with onset 10Jun2021 12:00, outcome "not recovered" and all described as "Feels like contractions along the esophagus with pain radiating towards back and ribcage". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, oesophageal pain, pain.  Additional information: Report about covid vaccine: Yes. Patient occupation: None of the above. Reporter type: Patient. Lot unknown-true, lot unknown reason-Misplaced/discarded (dose number-2, dose number-1). Other vaccine same date details: other vaccine same date product-Pfizer, other vaccine same date vaccine date-24Apr2021, other vaccine same date vaccine location-Right arm. If other vaccine in four weeks: No. Other medications in two weeks: No. Adverse event: Pain in chest area (feels like contractions along the esophagus with pain radiating towards back and ribcage. Happened twice. First time was 3 weeks after 2nd dose of vaccine and lasted for around 20 min. The other time was a month later which lasted for around 2 hours. Adverse event country. AE resulted in: None of the above. If covid prior vaccination: No. If covid tested post vaccination: Yes. Covid test post vaccination: covid test type post vaccination-Nasal Swab, covid test name post vaccination-R T-PCR, covid test date-25Jun2021, covid test result-Negative. Known allergies: No.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a currently 67-year-old female patient referring to herself. There was no information about the patient's concurrent conditions and concomitant therapies provided. The patient had no medical history and no drug reaction or allergy. On 25-OCT-2017, the patient was intramuscularly vaccinated with a second dose of PNEUMOVAX 23 (exact dose, lot# and expiry date were not reported) for prophylaxis. On an unknown date in 2017, reported that after receiving PNEUMOVAX 23, the patient could not lift her right arm to touch her left shoulder. She further stated that even though her arm was better, she still had pain when doing certain motions. She sought medical attention, talked with the pharmacist and was given a treatment for the events. The patient was not hospitalized. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. The reporter's causality assessment between the events and the PNEUMOVAX was not reported.
Pt received the Janseen vaccine and two-three minutes later the patient fainted and regained consciousness intermittently as they were waiting for the 30 min post vaccine observation. Code white as called and  was by the patient to make sure they did not fall out of the chair. EMS responded and took over as they called 911 to have the patient checked out. The ems confirmed the patient was stable and the patient did not need to be put in the ambulance. Pt was given orange juice and an ice pack. Pt was checked on before they left and they were ok.
Information was received on 10-JUL-2017 from a registered nurse regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient received an expired dose of M-M-R II (lot # L024265, expiration date 01-JUL-2017) (dose, route, site of administration not reported), reconstituted with properly store and non-expired sterile water diluent (unknown lot #, unknown expiration). No adverse effects reported. No additional information provided. Additional information has been requested.
This serious spontaneous case, initially received on 22-Jan-2018, reported by other non-health professional concerning a 32-year-old, adult, male patient. The patient's previous vaccination history included FLUVIRIN TRIVALENT on 15-Oct-2014, FLUCELVAX TRIVALENT on 16-Sep-2015 and FLUCELVAX QID on 23-Nov-2016. On 31-Oct-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, manufacturer: Seqirus, dose, route of administration and anatomical location: not reported). It was reported that, the patient experienced chills, body aches and nasal congestion. On an unspecified date, nasal swab test was performed. On 21-Jan-2018, after 2 months 22 days of vaccination, the patient was tested positive for type A flu. This case was associated with product quality complaint, hence quality assurance investigation report (QAIR) had been requested and the corresponding QAIR reference number was 1027556. It was reported that, based on the investigation performed, it can be concluded that FLUCELVAX (195250) was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. There was currently no evidence of a potential negative signal for LOE (lack of efficacy) issues of batch 195250 from the FLUCELVAX QIV campaign season and no deviations were found that for any temperature excursion of the final packaged product for batch 195250. The outcome of the event (influenza) was not reported. Non-significant follow-up report received from quality assurance team on 02-Feb-2018: The QAIR number (1027556) was updated. Follow-up received from quality assurance department (QA) on 17-Mar-2018: It was reported that, based on the investigation performed, it could be concluded that FLUCELVAX (195250) was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. There was currently no evidence of a potential negative signal for LOE (lack of efficacy) issues of batch 195250 from the FLUCELVAX QIV campaign season and no deviations were found that for any treatment excursion of the final packaged product for batch 195250. Expiry date (30-Jun-2018) of the product was updated. Narrative amended accordingly. Non-significant follow-up received from quality assurance department on 27-Mar-2018: No additional information was received. Hence, no changes were made in the narrative. Follow-up report received from the reporter on 29-Mar-2018: The patient's date of birth was added. The patient's previous vaccination history (FLUVIRIN TRIVALENT on 15-Oct-2014, FLUCELVAX TRIVALENT on 16-Sep-2015 and FLUCELVAX QID on 23-Nov-2016) was added. Laboratory investigation (nasal swab test) was added. Signs and symptoms (chills, body aches, and nasal congestion) for the event were updated. Amended narrative accordingly. Non-significant case correction received with IRD 29-Mar-2018: Acronym 'QAI' was changed to 'QAIR'. Narrative amended accordingly. Update 04-Jul-2018: Non-significant case correction was performed with IRD 22-Jan-2018: Case comment was corrected. No changes were made in narrative.
For three days I felt ill, I tested using the home COVID-19 test but it came back negative every time. On day four it came back positive, I called my PCP and asked if I should start on any of the antiviral medications. They did not suggest them since I was not that sick. I am feeling better with the exception that I do still get a headache most every day and have lingering brain fog.
Headache, Myalgia, Arthralgia gi upset, FATIGUE, CHILLS, TENDER LYMPH NODES Narrative:
Cellulitis and abscess of right leg. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Major diarrhea immediately following, joint/ muscle pain , chills, fever, headache , brain fog, burning sensation in chest
This was Moderna Covid 19 second shot.  Woke up morning after shot with fever and flu like symptoms.  Felt like I had the flu all day long, and was in bed all day long.  2nd day after shot felt better.
Mild soreness following injection (1/28), however thank her the last 4 weeks (approximately) the pain in my left upper arm/shoulder has gradually increased to constant ache and pain that is exacerbated with touch/pressure. I wake up throughout the night when I try to roll her because using that arm or laying on it is now quite painful.  I have painful range of motion at the shoulder, and have no trauma or injury to that extremity other than having had the vaccine in that arm.
PATIENT EXPERIENCED HEADACHES, SORE THROAT, NOSTRILS BURNING, LOW GRADE FEVER, EYES RED & WATERY. STARTED AFTER 5 HOURS GOT THE FLU SHOT.
8/4/06 TC from mom. Pt fainted that AM. Recovered from faint, but continued to feel weak and light headed. No other sx. Advised mom to have pt evaluated by MD. Pt was admitted to hospital for observation on 8/4/06. Per pt blood tests showed low potassium levels and EEG showed seizure activity. All other tests wnl. 8/11/06 pt reports doing fine and is taking a mineral supplement. Advised pt to get ok from MD before receiving a 2nd MMR shot.  Summary although consultation report provides diagnosis and discharge plans. HX of present illness: Patient had no convulsive movements. She had no warning leading up to the blackout which occurred on 8/4/06. She did have no response to surrounding environment for several minutes even in horizontal position, afterwards she was confused and fatigued for about 2 hours. Only last night did she begin to feel back to her normal self. Ten years ago while combating an eating disorder she did have a convulsion that was witnessed by her mother, that convulsion was blamed on the eating disorder and the patient did not seek medical attention.  PMH: Remarkable for intravenous drug abuse that the patient ceased last year. She does have occasional spells in which she develops tunnel vision with a flickering border followed by some mild head pain. Presumably this is migraine but she is not on any special medication for that. No headache or migraine's symptoms associated with the episode yesterday. Smokes 3/4 pack per day and has some smoker's cough, does abuse alcohol. PE: WNL Analysis: blackout probably epileptic mechanism, exact risk of recurrence unclear. Migraine. History of eating disorder.
I developed Postural Orthostatic Tachycardia; Dysautonomia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunization. The patient's relevant medical history included: "allergies" (unspecified if ongoing); "Allergy to gold" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Titanium dioxide, reaction(s): "known allergies titanium dioxide". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, when the patient was 47 years old, for Covid-19 immunization. The patient was neither diagnosed with covid-19 prior vaccination, nor been tested with covid post vaccination. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability) with onset May2021, outcome "recovering", described as "Dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset May2021, outcome "recovering", described as "I developed Postural Orthostatic Tachycardia". The events "i developed postural orthostatic tachycardia" and "dysautonomia" required physician office visit. The patient stated that she has been symptomatic for a year. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome, autonomic nervous system imbalance by change in diet and a specific exercise program.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6 hours after she started feeling VERY ill. Body aches, fever, cough. she went to urgent care 3 days later and tested positive for covid.  2 days after that she tested positive for pneumonia.  SHe was perfectly healthy before this shot.
Rash developing on arm near site of injection; itchy, swollen, hot, and red
Patient received vaccine 10/23/12 & said she started feeling ill that evening. The next day she was stiff all over. She went to her MD and was turned away & then went to a walk in clinic where she was diagnosed with meningitis. She will have to have vertebrae fused per patient. Patient had blood work approximately one week before vaccination and everything looked fine.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age received TRUMENBA via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at the injection site and a bruise below the injection site, on an unspecified date after vaccination, with unknown outcome.
Excessive pain in spine & hands, drenching sweat followed by chills. Reoccurred second time seven days later at around midnight. Both lasted for several hours.
Two days post vax, the pt developed a fever of 103.4. Fever on and off since that time, accompanied by decreased appetite and fatigue. On 03/26/2001 pt was seen in the office with fever still present. Ears and throat normal, chest clear, no adenopathy, rash or redness at injection site.