chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a child in twelfth grade who was vaccinated with a dose of Varivax. "Recently," in 2006, the patient experienced shingles. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
On the above date and time, the above named Guest had a reaction to the Pfizer Adult vaccine.  The Guest receivedthe vaccine, 1st dose at 1408pm, I/M, 0.3ml, Right Arm.  Within a few minutes later, the Guest complained of tingling and numbness in her right arm radiating from her forearm to her fingertips.  Guest also complained of numbness around her nose, mouth and cheeks.  Vitals were taken, Guest was COAX4, breathing adequetly, vitals were normal.  911/Ambulance was called at 1415pm, 1440pm, and again at 1457pm.  No Response.  Guest was driven to Emergency Room by her father.  Vitals were taken during the 42 minute time period repeatedly, all within a normal range.  No further action taken.
Treatment of COVID-19; Treatment of COVID-19; Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: 6H9703) at the age of 48 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 2, single (Lot number: 008B21A), in Mar2021 as dose 1, single (Lot number: 013A21A) and in Nov2021 as dose 3 (booster), single (Lot number: 039F21A) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Sep2022, outcome "not recovered", described as "Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive tests; Negative, notes: negative test. Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.
Fever & seizure 10 days after vaccine. Fever as high as 103.9 in office. Generalized, tonic-clonic seizure, lasted about 1 1/2 mins. Resolved spontaneously.
Information has been received from a nurse practitioner concerning a 38 year old female with no known drug reactions / allergies and no pertinent medical history reported who on 30-OCT-2009 was vaccinated IM with a first dose of PNEUMOVAX 23 in the left deltoid (lot number: 663150/0468Y).  Concomitant vaccine included a dose of typhoid vaccine (unspecified) on 30-OCT-2009 and concomitant therapy included VENTOLIN, ALBUTEROL, ZOLOFT and CLARITIN.  The nurse practitioner reported that on 31-OCT-2009 the patient developed injection site pain, tenderness, injection site redness and injection site swelling after her first dose of PNEUMOVAX 23.  The patient took over the counter unspecified pain relievers to treat her symptoms.  No laboratory test was performed.  At the time of the report the outcome of the patient was recovering.  The patient sought medical attention at the physician's office.  Follow up information has been received from the nurse practitioner concerning the female scientist with asthma, seasonal allergies and scoliosis who on 30-OCT-2009 was vaccinated with a first dose of PNEUMOVAX 23 (Lot No. 662842/1296X, previously reported as 663150/0468Y) in the left deltoid).  Concomitant vaccination on the same day included a first dose of TYPHIM VI (Lot No. E0213) on her right deltoid.  There was no illness at the time of vaccination.  It was also reported that the patient was also vaccinated with a first dose of BOOSTRIX (Lot No. AC52B039AA) on her right deltoid on 28-OCT-2009.  On 31-OCT-2009, the patient developed swelling and erythema at the injection site with tenderness.  Subsequently, a follow-up conversation on 24-NOV-2009 reported that the patient recovered.  Follow up information has been received from the nurse practitioner concerning the female patient with reactive airway disease and asthma and no illness at the time of vaccination who on 30-OCT-2009 was vaccinated with a first dose of PNEUMOVAX 23.  On 31-OCT-2009 the patient developed soreness and tenderness at the site of injection.  No treatment was given, just recommended OTC analgesics and warm soaks.  No further information is available.
Information has been received from a physician concerning a 75 year old male with "chronic leukopenia" who in April 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included hydrocortisone (manufacturer unknown). In May 2010, the patient developed shingles spread to his face. In October 2010, the patient was admitted to hospital with dissemination. Acyclovir IV was given for two weeks then Acyclovir oral for 2 weeks for the treatment of the adverse event. In December 2010, the patient was admitted again to the hospital and died three weeks later. On unspecified date, lab study was performed on the ZOSTAVAX (Merck) which confirmed it was the oka strain. Additional information has been requested.
-49.8' temp after vaccines - RN -bilateral redness to thighs - RN tx interventions - Tylenol q4' pain/fever/fussiness; monitor for increasing redness/swelling; call back if not better in 3-7d - RN
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received several years ago before the time of reporting). On 7th March 2018, the patient received SHINGRIX .5 ml. On 9th March 2018, 2 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site induration, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling and injection site itching were not recovered/not resolved and the outcome of the injection site induration, injection site erythema and injection site warmth were unknown. The reporter considered the injection site swelling and injection site itching to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site induration, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received a SHINGRIX in the left arm and there were no issues with the vaccination. On 9th March 2018, the patient called to report that she has a hard, red bump at the injection site the size of a silver dollar. The area was hot and itchy.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patient (age and gender not reported). Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date unspecified number of unspecified patients were all administered VARIVAX (Merck) (dose, route of administration, anatomical location, lot#, expiration date were not reported) that underwent post supported excursion. Concomitant therapies were not reported. No adverse effects were reported by any patients. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
breathing altered; throat tightened; intermittently could not breath and swallow, could not speak; intermittently could not breath and swallow, could not speak; intermittently could not breath and swallow, could not speak; tongue proceeded to swell; tongue started to tingle; lips started to swell; This spontaneous case was reported by a consumer and describes the occurrence of IRREGULAR BREATHING (breathing altered), THROAT TIGHTNESS (throat tightened), DYSPNOEA (intermittently could not breath and swallow, could not speak), SPEECH DISORDER (intermittently could not breath and swallow, could not speak), DYSPHAGIA (intermittently could not breath and swallow, could not speak) and SWOLLEN TONGUE (tongue proceeded to swell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced IRREGULAR BREATHING (breathing altered) (seriousness criterion life threatening), THROAT TIGHTNESS (throat tightened) (seriousness criterion life threatening), SWOLLEN TONGUE (tongue proceeded to swell) (seriousness criterion life threatening), PARAESTHESIA ORAL (tongue started to tingle) and LIP SWELLING (lips started to swell). On an unknown date, the patient experienced DYSPNOEA (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening), SPEECH DISORDER (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening) and DYSPHAGIA (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening). At the time of the report, IRREGULAR BREATHING (breathing altered), THROAT TIGHTNESS (throat tightened), DYSPNOEA (intermittently could not breath and swallow, could not speak), SPEECH DISORDER (intermittently could not breath and swallow, could not speak), DYSPHAGIA (intermittently could not breath and swallow, could not speak), SWOLLEN TONGUE (tongue proceeded to swell), PARAESTHESIA ORAL (tongue started to tingle) and LIP SWELLING (lips started to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded
irritability closely related to DTP vax;no etiology found-resolved quickly (48 hr duration);also had bronchiolitis&had been on albuterol-still irritable off albuterol;
Patient called the pharmacy on the morning of 01/31/2020 and complained of a possible reaction to Shingrix. She complained of vomiting, diarrhea, and sore right arm and chest. The pharmacist on duty advised the patient to contact her primary care provider that morning and be checked out. Will follow up with primary care provider on outcome and eligibility for second dose of Shingrix.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 3:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 3:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant products were not provided.  On 24-May-2021, Excursion time were 09 AM, 08 AM and 09 AM, temperature was 35, 35 and 35 respectively, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-May-2021, vial was moved to clinic on 24-May-2021. 3 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6days post expiry) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-395985 (Patient Link).
BUMP INSIDE LEFT SIDE OF MOUTH; BODY ACHES; SWELLING; FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 20 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary blood disorder, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced bump inside left side of mouth. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced swelling. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, fatigue, headaches, body aches, bump inside left side of mouth, and swelling. This report was non-serious.; Sender's Comments: v0:Medical assessment comment not required as per standard operating procedures.
Severe hairloss shedding began at first injection increased at second dose, total loss of hair baldness ear to ear 3 inches from hairline back.
Chills and Fever, sweating, dizziness, loss of appetite and desire to drink.  Chest felt like heartbeat too strong.  Horrible headaches.  Cannot get out of bed to even sit up without help  This happened with the previous four. I will not get another one.
No additional adverse event; Nurse reported a patient was administered a dose of PEDVAXHIB subcutaneously not intramuscularly; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-SEP-2022, the patient was vaccinated with a dose of dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # W006721 , expiration date 10-DEC-2021) 0.5ml, subcutaneously instead of intramuscularly (Incorrect route of product administration). At the time of reporting the outcome of the incorrect route of product administration was not reported, moreover, no additional adverse events were reported.
severe pain in right arm with inflammation and decreased range of motion in right shoulder (previous surgical site y 1 yr ago) and severe back and neck pain Seen by pcp, started on Prednisone 10 day taper with improvement by day 3
Lump to L upper arm surrounding injection site. Lump is raised, mildly red, tender to touch and warm to touch.
After receiving the J&J vaccine 6 weeks ago and started getting stomach cramps that lasted a week, after that it subsided but has never stopped, now I can hardly eat anything. I went to the ER two weeks ago but there was no concern because there were no blood clots. Now my bowel is restricted and I've had auto-immune issue about a year and a half ago. Now just cramps and bloating. I also have a tooth that's come loose and I have a strange taste in my mouth since having the vaccine. I saw the doctor and they just called and the doctor stated that I've continue to have problems I should consider having an ultrasound of my stomach. Also, in the past, I went to Hospital.
Client vaccinated approx. 2:39 PM, orthodontic appt. after vaccination. Returned to clinic 3:25 PM. Noted client face red. Mother stated client having trouble breathing and tongue feels funny. Client referred to ER immediately.
1 wk after receiving MMR and Td pt reports that her stomach hurts. Off and on she has had blood in her stools. She is from Okinawa and moved to USA 3 mo ago. Reports her diet is completely differnt. Had a fever one evening and then it subsided. Referred to PMD/assessment.
Warm to touch, red, tender, febrile (Low trade). Remains 3 days s/p completing series
Redness increased from a small circle around the injection site to a slightly bigger one over the last 24 hours; Dose 1: 27Apr2021, Dose 2: 10May2021; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 10May2021 at 09:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included that the patient had surgery on 4/5 (DI (double incision) mastectomy plus nipple graft) and allergy to avocado. Concomitant medications included paracetamol/ oxycodone hydrochloride (PERCOCET), venlafaxine (MANUFACTURER UNKNOWN) and testosterone (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 27Apr2021 at 10:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 00:00, the patient had redness which increased from a small circle around the injection site to a slightly bigger one over the last 24 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event redness increased from a small circle around the injection site to a slightly bigger one over the last 24 hours was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Roughly 1-2 weeks after COVID-19 vaccine developed burning/pain in rt side of spine upper back.  Pain progressed.  Pt tried to do acupuncture but didn't help, ended up getting trigger point injection didn't help, ended up needing steroid injections (2) in my spine.  This has made pain manageble with intermittent Ibuprofen/Diclofenac however pain has not gone away.  I now see a chiropractor since March.
This spontaneous report was received from a health professional (nurse) refers to multiple unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unspecified date, the patients were vaccinated with improperly stored ROTATEQ. Concomitant medications were not reported. No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Experienced fever, chills, dizziness and vomiting within one hour  of shot.  severe reaction came around midnight with very painful skin. Not muscle aches like with the flu but all my skin was painful to the slightest touch.  All over my body. Even my face. An excruciating pain. It was even hard to put clothes on. No rash. No skin peeling. I had not heard of this as a side effect and thought it should be brought to your attention. Severe skin pain lasted about 10 hours and then lessened and about 36 hours is now gone.
Hard, raised firm lump L arm, approx  4 cm in diameter. Painful, unable to lie on side, also headaches. Treatment is Tylenol and ice.
Itching and Swelling of injection site, with subsequent numbness of hand and arm. Shortness of breath and general feeling of agitation.
sore arm, redness, fever, flu-like symptoms, dizziness, felt a drop in blood pressure the evening of the day after receiving the shot
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2 NOS), on 21Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 25Feb2023 to 01Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.