chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous reported as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored PNEUMOVAX 23 lot# M022947 and expiration date: 12-NOV-2017 (strength, dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
patient said he was feeling light-headed and like he was going to pass out, he started sliding out of the chair the pharmacist was able to catch his head so it didnt hit the floor. He was unconscious for about 5 seconds, when he woke back up he wanted to lay there for a few minutes. we got him a water and called 911 immediately
Information has been received from a physician via a company representative refers to a 6 month old patient of unknown gender. The patient had no drug reactions/allergies. On 10-JUN-2016 the patient was accidentally vaccinated with GARDASIL 9 (1 shot, subcutaneous, lot number unknown). The medical assistant administering the vaccine had mistakenly done so believing it to be an injection of PEDVAXHIB. No treatment was given to the patient for the incorrect vaccine. No lab diagnostic studies performed. No adverse effect reported. The outcome of wrong drug administered was reported as not recovered. Additional information has been requested.
Sunday after 2nd dose of vaccination (May 9) I started having numbness and tingling in my arms legs, face and neck and experiencing nausea.  When I sleep at night if I lay in one position for too long my day starts to burn in that area.  I am having trouble sleeping. The nausea continues to come and go as does the numbness and tingling and burning issues at night. It seems to be getting worse every day and I am getting tired and weak.
Pt recvd 3 doses of series of Engerix-B; HBSAB tests were negative p/3rd dose; Pt given booster dose on 01MAY91 but has not been drawn yet for titer p/booster;
Patient was found to be hypercalcemic, also found to have low vitamin D, B12, folic acid and thiamine.  After he signed himself out AMA, son brought him back to ED. He got another shot of B12 and we will set up to see me as an outpatient. Wife has not reported any episodes of confusion. He will follow up with me in clinic at a future date. Hospital admission and ED visit within 6 weeks of receiving the COVID vaccine.
pt presented to clinic next morning w/reddened, edematous area to lt deltoid/upper arm;c/o significant pay;area measured 95mm x 60mm;pt instructed to use motrin for pain, rice for edema;
Local reaction at site of injection. Red, tender, itchy area approx 2 1/2 inches. Rx with ice. Resolved in 2 days.
Cyst in his back is 3 times bigger; Patient stated that all his infections grows; After getting the three shots he felt that the infection grows; Patient is very sore; Patient has very much pain in his artificial knee; This spontaneous case was reported by a consumer and describes the occurrence of CYST (Cyst in his back is 3 times bigger), INFECTION (Patient stated that all his infections grows), CONDITION AGGRAVATED (After getting the three shots he felt that the infection grows), MYALGIA (Patient is very sore) and ARTHRALGIA (Patient has very much pain in his artificial knee) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.    Co-suspect products included non-company products INFLUENZA VACCINE (FLU) for an unknown indication and PNEUMOCOCCAL VACCINE 13V for an unknown indication.    Concurrent medical conditions included Abscess oral (little abscess in mouth (before taking the booster shot)), Knee replacement (artificial knee) and Cyst (cyst in the back caused by a black pore).   On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form and dose of PNEUMOCOCCAL VACCINE 13V (unknown route) 1 dosage form. On an unknown date, the patient experienced CYST (Cyst in his back is 3 times bigger), INFECTION (Patient stated that all his infections grows), CONDITION AGGRAVATED (After getting the three shots he felt that the infection grows), MYALGIA (Patient is very sore) and ARTHRALGIA (Patient has very much pain in his artificial knee). At the time of the report, CYST (Cyst in his back is 3 times bigger), INFECTION (Patient stated that all his infections grows), CONDITION AGGRAVATED (After getting the three shots he felt that the infection grows), MYALGIA (Patient is very sore) and ARTHRALGIA (Patient has very much pain in his artificial knee) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  Patient states after getting the three shots he felt that the infection grows, he has a lot of pain in his knee and the cyst in his back was three times bigger. He is very sore.
"At 1400 patient in observation, RN vaccinator, noticed young man's head drooped over. RN went over to the patients and tapped his arm. Did not respond to verbal or physical touch. RN called for help. After a few seconds patient responded and opened his eyes. Patient transferred via wheelchair to private area. BO 76/64, diaphoretic. RR appeared normal. Patient stated he did not eat all day. patient stated his throat hurt and felt tight and he had chest pain. Patient agreed to be transported via on-sight ambulance to Medical Center for assessment with brother."
Armpit on same side shot was administered is swollen and tender.; Armpit on same side shot was administered is swollen and tender.; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration in Arm Left on 31Mar2021 09:00 (age at vaccination 33years old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and other medications within 2 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in workplace clinic. Medical history included sleep apnoea syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. On 24Apr2021 at 06:45 the patient experienced armpit on same side shot was administered is swollen and tender. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Severe headache (to the point where it was affecting my vision), dehydration, sweats and chills as though I had a fever, muscle aches, and difficulty sleeping. All of these symptoms lasted for approximately 9 hours. They started 10 hours after the vaccine itself.
Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses. The vial did not undergo any temperature excursions.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received on 08-Jun-22, non-significant information reporter details added.
After 2nd shot, the cramps have been coming and going; had my period about 6 separate times since my first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Apr2021 11:45 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "endometriosis" (unspecified if ongoing); "gallbladder disease" (unspecified if ongoing); "chronic fatigue syndrome" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Allergy: compazine". Vaccination history included: Bnt162b2 (Product: Covid 19, Brand Pfizer, Administration Time : 11:45 PM, vaccination Location : Left arm, Dose : 01), administration date: 21Mar2021, when the patient was 43 years old, for COVID-19 Immunization, reaction(s): "awful menstrual cramps that lasted about 9 days", "Then towards the end of the 9 days, menstruation returned for about 3 days.". The following information was reported: DYSMENORRHOEA (non-serious) with onset Apr2021, outcome "recovered with sequelae", described as "After 2nd shot, the cramps have been coming and going"; MENSTRUATION IRREGULAR (non-serious) with onset Apr2021, outcome "recovered with sequelae", described as "had my period about 6 separate times since my first shot". Therapeutic measures were not taken as a result of dysmenorrhoea, menstruation irregular.  Additional information: as Relevant medical History. Patient did not received other vaccines within 4 weeks and any Other Medications two weeks PRIOR to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.  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.
Pt felt fine after vaccination and proceeded to waiting area and sat down to wait 15 minutes.  A few minutes after she sat down she felt faint and fell out of her chair and bumped her forehead.  We helped her back into the chair and held on to her.  With her permission  we had her sniff an ammonia inhalant and she said she felt a little better.   She did not want us to call 911 or anybody at home.  A pharmacy technician sat with her for about a half hour and a store manager filled out a report and said we will follow up with her later.  She said she felt better and was able to leave on her own.
This spontaneous report was received from a Medical Assistant regarding multiple unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On multiple unspecified dates from 18-JAN-2016 to 28-JUN-2016, the patient was vaccinated with improperly stored VAQTA (dosing details, lot# and expiry date not known). The administered vaccines experienced a temperature excursion of 51.1 degrees Fahrenheit for 18 hours 30 minutes. There was no previous excursions. The call was because of a "data logger". No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Soreness in  left arm = later on that night date of shot (8 December 2021);  Treatment -Nothing; Outcome - soreness gone Lymph nodes in underarm pit on left arm (9 December 2021 - 14 December 2021); Treatment - Nothing; Outcome - lymph nodes shrunk Weakness and no energy = 8 December - 10 December); Treatment - Bedrest; Outcome - from shot to present - still not a lot of energy Slight headache ( 8 December  - 9 December);  Treatment -Advil; Outcome  - subsided
Dizziness bordering on fainting when walking to check the mail; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6955) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), montelukast (MANUFACTURER UNKNOWN) and allergy injection; all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8727) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 14Apr2021 at 13:00, the patient experienced dizziness bordering on fainting when walking to check the mail. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the event dizziness bordering on fainting when walking to check the mail was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected
pt recv vax 7JUL97 & 48hr post vax pt exp h/a & dizziness which persisted @ the time of this report 8JUL97;
neuropathy; other serious neurological problems; balance problems; Information was received from a lawyer regarding the case in litigation and refers to a patient of unknown age and gender. The patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On or about 28-DEC-2013, patient was administered the zoster vaccine live (ZOSTAVAX) in a clinic. Subsequently, patient was treated by providers in for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: neuropathy, balance problems, and other serious neurological problems. The outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events of neuropathy and other serious neurological problems was determined to be medically significant.
Experienced very bad chills but was not sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (Experienced very bad chills but was not sick) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Experienced very bad chills but was not sick). At the time of the report, CHILLS (Experienced very bad chills but was not sick) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Took first dose of unrefrigerated Vivotif; A spontaneous report was received from a pharmacist on 21SEP2022. It described a 52-years-old male patient who "took first dose of unrefrigerated Vivotif" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: 3003661) for immunisation. It was reported that the patient was prescribed Vivotif on 02SEP2022 and he took the first dose on 21SEP2022 which he left unrefrigerated for 10 days. Reportedly, no side effects were reported yet. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took first dose of unrefrigerated Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer took first dose of unrefrigerated Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Information has been received from a physician concerning a female (age was not reported) who was vaccinated with dose 1 and 2 (dates unknown) of Gardasil. Subsequently, after dose 2 was given, the patient developed pain at the injection site and fever. The patient did receive unspecified medical treatment and recovered from the fever and pain at injection site. Additional information has been requested. Information has been received froma physician concerning a female (age not reported) who was vaccinated with dose 1 and 2 (dates unknown) of HPV vaccine. Subsequently, after dose 2 was given, the patient developed pain at the injection site and fever. The patient did receive unspecified medical treatment and recovered fromthe fever and pain at injection site. Additional information has been received fromthe physician's office stating that they do not know which patient this adverse experience is referring to. This office did not report a adverse experience nor do they know who did reported it. No additional information is expected.
I developed pain up and down my right arm quite suddenly, basically from the shoulder all the way in to my wrist and fingers off and on, it got progressively worse it was very painful, I went to the doctor and they ordered an ultrasound to ruled out a blood clot. They had to do the ultrasound on the ER and they found a clot in my basilic vein. They gave me a pain med so I could sleep and add heat and Ibuprofen. I am being referred to another doctor because the pain is coming back and they are going to do more tests. I have donated blood about a month before I had the vaccine and the ER doctor thought this may be because of that.
Arm sore by evening of receiving first shot (as to be expected). Soreness waned after a few days. Two weeks later redness and rash appeared for approximately 48 hours. Decided to do second shot the following month in opposite arm. Second shot also caused arm pain and swelling but not as severely and with no rash.  Beginning again in August 2021 the left arm at site of original vaccination keeps re-experiencing arm pain like a localized, dull aching bruise. The sensation comes and goes over periods of days. It has been reoccurring enough now that it seems lessikely attributeable to any other particular action or circumstances.
Breakthrough case admission after 2 vaccines Moderna 2/27/21 lot# 025A21A ; Moderna 3/23/21 lot# 045A21A
Sore arm that was warm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Sore arm that was warm) and PAIN IN EXTREMITY (Sore arm) in a 62-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN WARM (Sore arm that was warm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, SKIN WARM (Sore arm that was warm) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that he was undiagnosed with health issues and he could have cardiac or intestinal related health issues. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-404708 (Patient Link).   Reporter did not allow further contact
Symptoms very similar to Guillain-Barre syndrome. Weakness in arms & legs. Muscle atrophy in same places. Occassional paralysis. Pins & Needles head to toe. Trouble breathing. Fatigue easily. Limited Mobility. Severe Mental Fog. Gastrointestinal issues. Erectile Dysfunction
Headache, Fever,  H/a sore arm chills/fever 100.4
This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject died 342 days post immunization on 10/01/2003. Subject was admitted on 9/29/03. He was transferred from ICU post AKA for decrease MS and possible CHF exacerbation. He was volume overloaded on admission and IV diuresis was started. Pt showed bilateral DVT's and was placed on Heparin and then Lovenox the same day. He remained stable until October 1, 2003 in the evening when he was found unresponsive and pulseless. Subject expired more than 30 minutes of unsuccessful resuscitation. Diagnosis: DVT with presumed PE, cardiopulmonary failure secondary to DVT, CHF exacerbation, DM, GRI, and altered MS. The death was reported by the investigator as not related to the study vaccine. Follow up on 11/26/03: "Initial SAE report received on 10/22/03.  This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine.  The subject received RSV vaccine or Placebo and Influenza vaccine on 10/22/02.  The subject died 342 days post immunization on 10/01/2003.  Subject was admitted on 09/29/03.  He was transferred from ICU post AKA for decreased MS and possible CHF exacerbation.  He was volume overloaded on admission and IV diuresis was started.  Patient showed bilateral DVT's and was placed on Heparin and then Lovenox the same day.  He remained stable until 10/01/03 in the evening when he was found unresponsive and pulseless.  Subject expired after more than 30 minutes of unsuccessful resuscitation.  Diagnosis:  1) DVT with presumed PE. 2) Cardiopulmonary failure secondary to #1. 3) CHF exacerbation. 4) DM. 5) GRI. 6) Altered MS. The death was reported by the Investigator was not related to the study vaccine.  Additional information received 11/18/03.  Death certificate: Cause of death: Pulmonary Embolism due to deep vein thrombosis due to congestive heart failure.  The pulmonary embolism secondary to deep vein thrombosis secondary to congestive heart failure was reported by the investigator as not related to the study vaccine."
flashing spot in lt eye visual field, h/a;change in acuity;inc sleeping;
Vaccination site became swollen, hot, hard, itchy and red 9 days after being administered. Lasted for 4 days, then subsided and stopped completely after a further 2 days.