chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She was in her usual state of health until January 26 when she received her first dose of the Pfizer COVID-19 vaccine and the second dose on February 18, 2021.  Within 4 days of receiving this vaccine she noticed she fell on Monday, February 22 she was able to raise herself up she fell again on Tuesday, February 23 and on Thursday, February 24.  By Friday she could not get up and she presented to hospital where she was noted to have lower extremity weakness.  An MRI has revealed extensive edema of the whole of the spinal cord extending from the cervical region to the sacral area.  She has lost motor function and sensation to the lower extremities as well.  She has not had a bowel movement since Thursday, February 24 and she has had to have a Foley catheter placed because of difficulties passing urine.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe
Unusually painful vaccination at the time of administration.  Continued to be sore, red, and swollen for several days.  Then began itching with more swelling and induration. On 15 Dec 14, I was treated at an acute care clinic and ordered Cephalexin 500 mg TID for 10 days to treat cellulitis RUA post 1 wk. of Prevnar 13 vaccination.  Had received first pneumonia vaccination in 2009.
The pt experienced tightness in chest, shortness of breath, extreme fatigue and weakness, headaches, numbness on left side of body, reduced vision in left eye, dizziness, nausea, joint pain, and stomach discomfort.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, she got a mild case of shingles, diagnosed via her physician, two weeks after receiving the 1st dose of Shingrix. Shingles started on her left side of arm, and across her back to the right side of her breast. The patient thought that, the event was related to the Shingrix. The nurse did not think the event was related to the Shingrix. The nurse agreed to be followed up.
Narrative:  Patient contacted telephone triage nurse today requesting advice. States he received his second Moderna vaccine yesterday, "Around midnight I just started shaking uncontrollably, it was awful-couldn't get warm and I was having convulsions. " Patient states he is now experiencing body aches, " very bad headache", nausea and still experiencing chills. Temperature 98.6 at this time Also c/o low back pain " just feel horrible.
This spontaneous report was received from the patient's mother concerning her son of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced mercury poisoning (metal poisoning). The outcome of metal poisoning was unknown at the time of the report. The casual relationship between the aforementioned event and M-M-R II was not established or mentioned by the reporter. Upon internal review, the event of metal poisoning was considered as medically significant. Additional information has been requested.
low grade fever; arm swelling; arm hot to touch; patient required treatment with cephalexin
burning sinsation in chest the first night. followed by high blood pressure, headach, shortness of breath, and clammy skin
numb/tingling tongue  - 5hours  hormonal disturbance- hot flashes, no period. still having symptoms
None - Given Hep A 2nd dose, 3 months apart from 1st dose.
This spontaneous report as received from a Pharmacy Technician refers to unspecified patients of unknown age and gender. The Pharmacy Technician reporting that improperly stored doses of RECOMBIVAX HB (lot # N002202, Expiration Date 04-NOV-2019, dose, frequency and route were not provided) were administered to unspecified patients from  21-JUN-2017 to 21-JUL-2017. No adverse effects. The RECOMBIVAX HB was stored between 47 Fahrenheit to 77 Fahrenheit for 1 hour and 45 minutes. No previous temperature excursion occurred. The data logger was involved.
My daughter?s fingers and toes became numb, her lips and face swelled. She also broke out in hives. After she started exhibiting signs of an allergic reaction, I immediately gave her 50mg of Benadryl. After about a 45 minutes 90% of her symptoms were resolved. She still had some swelling of the lips and face. By the morning 99% of the swelling was resolved. For precautionary measures she was given 25mg of Benadryl and 10mg of Claritin.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported/ On 24-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at 1.11 Celsius Degrees for 40 hours, 0.55 Celsius Degrees for 200 hours, 0 Celsius Degrees for 152 hours and -0.55 Celsius Degrees for 32 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
The patient had an episode of syncope 25 minutes post immunization. She was found on the floor of the elevator- awake and pale.
Day of vaccine: sore arm tired Day after: sore arm, felt great 2 days after: fatigue, headache, muscle aches, chills, decreased appetite: temp low 96.7 3 days after: low grade fever: 99. 5
Blood vessel in eye burst; Missed period; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:30 (35-year old at the time of vaccination)  (Batch/Lot Number: EN6204) as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none. Concomitant medications was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications received within 2 weeks of vaccination. On 17Mar2021 15:30 the patient experienced blood vessel in eye burst and missed period. Patient did not receive any treatment for the adverse events. The reported seriousness of the event was medically significant. The clinical outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Patient reports 6 hrs. post vaccine developed fever (temp max 102) resolving 36 hrs later with excessive fatigue and joint pain and stiffness. Patient presented in office 4/21/21 with persistent excessive fatigue and joint pain and stiffness.
Back pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (Back pain) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-511426 (Patient Link).
pt recv vax & exp fever which may have been as high as 104 to 105 & which lasted for more than 24hr;pt also exp infrequent rash & what appeared to ben an allerg rash w/large welts
pt recvd vax & approx 3 months p/vax exp elevated liver function tests;
Patient claims within 30 min of receiving vaccination, she became extremely confused and couldn't speak her thoughts. Called pharmacist who told her to take 50 mg BENADRYL and go to ER (Rph). 20 min after taking BENADRYL, all symptoms subsided. Next morning patient awoke with vomiting, severe headache, light hurt eyes, sugar dropped. 10-24-14 patient is still having these symptoms.
Began to get chills and was shaking uncontrollably.  By the time I got home I was shivering and fingers felt like frost bite.  My temp reached 101.7. Fever broke by morning.
This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored MMR II, lot # L012479, expiration date 15-APR-2017, and lot # L002873, expiration date 27-JAN-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Given client expired Rotavirus, had client to wait 15 min after meds given; no problem noted inform Dr. & supervisor. Will call or send letter to revaccinate.
Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023; No adverse event; Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023), PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023), PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023).    Concomitant medication not reported.  Treatment medication not reported.
On 17JUL92 around 2PM temp went to 105 & had sz; pt was taken to ER then admitted to hosp & released the next afternoon; MD said sz was caused from viral infect;
3/16 Experienced extreme lethargy.  3/18 noticed injection site swelling and redness.  There was also itching.
Had temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Dose was administered post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Had temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Had temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Had temperature excursion with our Moderna Covid-19 vaccine).    No concomitant medications were reported.  The temperature excursion occurred for both monovalent and bivalent. 9 doses of monovalent doses given. Multiple doses of 1st and 2nd doses administered. 27 total doses were administered post excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Administered past the 30 day refrigeration time; Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
ended up with fluid in the brain; he was not acting right; This spontaneous case was reported by a consumer and describes the occurrence of HYDROCEPHALUS (ended up with fluid in the brain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYDROCEPHALUS (ended up with fluid in the brain) (seriousness criterion medically significant) and ABNORMAL BEHAVIOUR (he was not acting right). At the time of the report, HYDROCEPHALUS (ended up with fluid in the brain) and ABNORMAL BEHAVIOUR (he was not acting right) outcome was unknown.            The fluid was drained on Wednesday 19-May-2021. At the time of the report, the patient was waiting to see if a shunt would need to be placed in his head.  No relevant concomitant medications were reported. No additional treatment information was provided.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Information has been received on 09/14/2001 from a medical assistant concerning a patient with no known allergies who "a few weeks ago" was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the arm. Subsequently, the patient developed a hot, swollen arm, same arm as the injection site. The patient did not seek medical attention. Additional information has been requested.
Pt states her arm hurts (not just at injection site) and possibly some numbness down to her fingers. Pt stated she was going to try ADVIL for the pain.
Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  hives, mouth dry, lightheaded, throat itching, chest tightness.   Assessment : Time of assessment 1035.   Actions taken: Patient was placed in a wheelchair, taken to the triage area. She had hives to her arms, behind her neck and ears. She was flushed in the face. BP 138/91, P 135 initially, last BP 132/91, P 116.    Medications administered: 1039 Benadryl 50 mg IM to RD given; 1047-Solumedrol 125 mg IV given via 20 G Saline Lock Left AC all by EMS.    Disposition: Hospital via Ambulance   Patient's symptoms of rash improved, she still had itching of her throat and chest tightness with no audible wheezing after medications given and when ambulance arrived.
bigger and bigger; little red (good size) and itch; Itch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (little red (good size) and itch), PRURITUS (Itch) and PERIPHERAL SWELLING (bigger and bigger) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371620A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ERYTHEMA (little red (good size) and itch) and PRURITUS (Itch). On an unknown date, the patient experienced PERIPHERAL SWELLING (bigger and bigger). At the time of the report, ERYTHEMA (little red (good size) and itch), PRURITUS (Itch) and PERIPHERAL SWELLING (bigger and bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Patient was given a nonviable vaccine. The vaccine was exposed to cold holding temperatures. Patient had no adverse symptoms from the nonviable vaccine.
Patient reported tingling of extremities and feeling of facial swelling starting about 1 1/2 hours after receiving the vaccine, reported to the emergency department for evaluation.
The patients DOB was incorrect and system prompted to give Td vaccine, patient was supposed to received Tdap instead.
-Fatigue and aches all day-8:30 pm itchy palms and feet, stuffy nose, swollen throat, rash on both arms and torso (chest and back). Took 2 Tylenol for aches and fever prevention, 2 Benadryl for allergy side effects. Drank lots of water all day. 7:00 am (following day) swollen throat and lymph nodes (no interventions). 10:00am swollen face. Took 1 bendryl, applied cold compress. Continued to push water. Swelling went away by 1:00pm. No further side effects.
Patient has a rash located on side of the injection site on right thigh. Rash appeared 24 hrs after vaccination. No other symptoms reported.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unknown dates the patients were vaccinated with VARIVAX lot # L040422, Expiration dates 15-OCT-2017; lot# L049534, expiration date 08-DEC-2017; dose and route were not reported. The vaccines were exposed to 9.8 F for 30 minutes due to a data logger. There was no previous temperature excursion. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
no appetite; diarrhea; vomiting; muscle pain; joint pain; nausea; tiredness; chills; feeling unwell; This is a spontaneous report from a contactable consumer. A 77-year-old female patient reported that she received second dose of BNT162B2 (Pfizer Covid 19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 01Apr2021, as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient received first dose of BNT162B2 (Pfizer Covid 19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on unknown date, as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced reoccurring muscle pain, joint pain, nausea, diarrhea, tiredness, chills, vomiting, tiredness, no appetite and feeling unwell. At the time of this report the outcome of the events were unknown.  The lot number for BNT162B2, was not provided and would be requested during follow up.
pain at the injections site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060904   Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced pain at the injections site. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060904:Same patient/reporter
heart beats 97 for two and a half days  still , dizzy  ,when walking, lost balance till the  10th day after shot   and fever for two and a half days.