chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feel weak; Dizziness; Sharp joint pain when moving hand; Nausea; First dose on 18 Nov 2021 and second dose on 13 Jan 2022; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feel weak), DIZZINESS (Dizziness), ARTHRALGIA (Sharp joint pain when moving hand), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Nov 2021 and second dose on 13 Jan 2022) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced ASTHENIA (Feel weak), DIZZINESS (Dizziness), ARTHRALGIA (Sharp joint pain when moving hand), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Nov 2021 and second dose on 13 Jan 2022). On 13-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Nov 2021 and second dose on 13 Jan 2022) had resolved. At the time of the report, ASTHENIA (Feel weak), DIZZINESS (Dizziness), ARTHRALGIA (Sharp joint pain when moving hand) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications reported.  No treatment information was provided.  An hour after the second vaccination, patient started experiencing the adverse events.
Fever noticed at 11 pm, about 13.5 hours after getting the vaccine. The fever rapidly climbed from 100.3 to 103.1 and accompanied by intense, shaking and chills. The shaking was so intense that a cup of water could not be held without spilling. The fever lasted about 6 hours, preventing sleep. Soreness and swelling at injection site remained for two days, but was not a hinderence to everyday activity.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who is also a physician. Concurrent conditions, medical history and allergies were not reported. On an unknown dates in approximately 2009 (reported as about 5 or 6 years ago), the patient was vaccinated with series of hepatitis b vaccine (manufacturer unknown), (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced hepatitis b surface antibody negative. It was reported that the patient had titers measured by a blood test prior to going on an international trip on an unknown date. The outcome of hepatitis b surface antibody negative was unknown. The relatedness between hepatitis b surface antibody negative and therapy with hepatitis b vaccine (manufacturer unknown) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient received the vaccine at the pharmacy and about five minutes later stated she felt as if she was going to pass out. I exited the pharmacy to be there to stabilize the patient as she was losing strength to stand. I gently brought her to the floor and continued to talk to her as the ambulance came. We were able to move her into the counseling room so she could elevate her feet and recover privately, which is where she was also treated by the EMS. I took her blood pressure while we waited and it was 108/72 which she reported was high for her. The EMS documented her blood pressure at 114/73 when they arrived.  The patient walked out with husband and EMS to ensure she made it home. I called her at 6:10pm to check on her and the patient reports being tired but having no other symptoms.
Developed clinical chicken pox after prior varicella immunization. Non Toxic, Afebrile, less than 50 lesions (day 2).
Narrative:  91yo male Pt died on 11/30/2021. Death caused from End- Stage Renal Disease (Hemodialysis). Pt received covid vaccines on  6/15/2021 & 5/13/2021. This death is not related to covid vaccines.
I came down with COVID / I tested positive; I came down with COVID / I tested positive; 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 53 year-old male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: EL3247) at the age of 52 years as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies and no other medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "I came down with COVID / I tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Neither received other vaccine in four weeks nor other medications in two weeks.Did not had covid prior vaccination. covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
RN noted blood at the site of the Fluarix Quadrivalent vaccine, grabbed an additional cotton ball, cleaned around the site, and applied an additional piece of tape. Client reported feeling dizzy to RN. Lead responded with the anti-gravity chair. The client stood up unassisted and sat down in the anti-gravity chair. The anti-gravity chair was placed in a semi-fowler's position. RN noted blood on the client's right hand. The client reported a history of dizziness after seeing blood. RN cleaned off the client's right hand with an alcohol wipe. RN noted the client's face appeared diaphoretic. The client denied any blurry vision, shortness of breath, or nausea. Vitals obtained at 1:22PM were as follows: BP 107/68, HR 78, O2 98%. The client stated he last ate a burrito at 10:00AM. The client denied any history of loss of consciousness associated with seeing blood. The client stated his symptoms normally last 2-3 minutes. A cool pack was placed on the client's chest. The client denied any history of dizziness associated with receiving vaccines. The client denied any chronic conditions, current medications, or known allergies. The client denied any dizziness after receiving previous doses of COVID vaccine Pfizer. The client stated his symptoms have resolved. The anti-gravity chair was adjusted to a high-fowler's position. The client denied any current dizziness. The client stated he felt comfortable ambulating to the observation area. The client ambulated unassisted to the observation area and sat down in the anti-gravity chair. The client denied any dizziness. RN provided education regarding s/s of anaphylaxis and when to seek EMS. The client voiced understanding of this education. RN responded and evaluated the client's vaccine administration site on the right arm. No blood was noted on the arm or the bandage. Vitals obtained by EMT at 1:43PM were as follows: O299%, HR 84, BP 110/74. The client denied any current symptoms and stated "I feel normal." The client reported a history of low blood pressure. The client ambulated unassisted with a steady gait out of the observation area at 1:52PM.
VARICELLA  Information has been received from a physician concerning a 6 year old male who on 29-SEP-2006 was vaccinated with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). About a week after vaccination, on approximately 06-OCT-2006, the patient developed "varicella minor." Unspecified medical attention was sought.  The patient's outcome was not reported. There was no product quality complaint involved.  It was reported that the patient's sister (WAES #0612USA01595) developed chickenpox after exposure to her vaccinated brother.  Additional information has been requested.
shingles; still suffering in pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter known the people (patients) that came down with shingles 2 days after the Shingles vaccine and some people (patients) were still suffering in pain. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR195359, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195359:same reporter
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported.  No Treatment were reported.  It was reported that the vaccine was stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Pain, Immobility. Day 1-5: Complete immobility of right and shoulder. Severe pain. Inability to sleep due to stabbing pains in the arm. Day 6-19: Mobility returns to about 85%, pain receded to a bearable state. Day 20: Complete immobility and severe pain as in days 1-5. No signs of amnesia. Day 21 - 30: Mobility returns to about 85%, pain receded to a bearable state. Day 31-60: Mobility returns to about 90-95%. Pain present during movements at a certain angle and/or with extra weight on the arm. Pain varies each day, but is on a bearable level. Visit to a physician postponed due to a 2.5 month trip abroad. Waiting to get back (11/18/12) to visit a physician. Long-term/permanent damage expected.
After first shot, experienced a mild rash on stomach and back; This is a spontaneous report from a contactable consumer or other non hcp (the patient reported for self). A 65-years-old (non-pregnant) female patient received first dose of  (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm left (left arm) on 05Feb2021 09:30 (age at vaccination 65-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported and 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 concomitant medications included sertraline hydrochloride (ZOLOFT), lorazepam (ATIVAN), vitamins all for unknown indications from unknown dates and unknown if ongoing. it was reported that the patient was not a pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced after first shot, experienced a mild rash on stomach and back on 06Feb2021. The clinical outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Did not receive email confirmation after receiving shipment of Vaccine stating okay to use and Vaccine was administered; Did not receive email confirmation after receiving shipment of Vaccine stating okay to use and Vaccine was administered; This case has been considered invalid as Unspecified number of patients.  Additional Information:-  Is report related to a study or programme? Yes Details:  Selected Report Type: Initial Is the patient also the reporter?: No Reporter type: Pharmacist Reporter email: (Email address withheld)    HCP postal address:  Other Conditions: Not Provided Investigations: Not Provided  Is Pfizer Covid 19 Vaccine Gray Cap a Pfizer product? Yes Pfizer Covid 19 Vaccine Gray Cap manufacturer: unspecified NDC number of Pfizer Covid 19 Vaccine Gray Cap: Not Provided Reason for no lot number: of Pfizer Covid 19 Vaccine Gray Cap: Caller unwilling to complete the report Expiry Date of Pfizer Covid 19 Vaccine Gray Cap: Not Provided Other Products: Not Provided  Additional Context: Warm transfer   Caller's name: (Name withheld) phone number: # zip code: #  The caller is a pharmacist who had a problem with the logger of shipment for Pfizer Covid 19 Vaccine Gray Cap. The caller is reporting a temperature excursion for the same Pfizer Covid 19 Vaccine Gray Cap. The Pfizer Covid 19 Vaccine Gray Cap has been administered to a patient. Caller clarifies the problem is the caller received a shipment of the Pfizer Covid 19 Vaccine Gray Cap on 01Apr2022 at 1018. The pharmacist was asked late last night, 05Apr2022 after several doses of the Pfizer Covid 19 Vaccine Gray Cap had been administered to patients, if the pharmacist received a confirmation via email that the controllant was received. The caller and another pharmacist looked through emails and did not get a confirmation after shipment of Pfizer Covid 19 Vaccine Gray Cap was received that the Pfizer Covid 19 Vaccine Gray Cap was okay to use. The caller clarifies there was no problem with the logger, the logger was fine. Also, there was no temperature excursion, the temperatures were fine. The shipment included 300 doses of the Pfizer Covid 19 Vaccine gray Cap without any problem. The caller just did not receive the confirmation email. Caller is not currently able to provide patient identifiers to document individual report. The caller is not even sure how many doses of the Pfizer Covid 19 Vaccine Gray Cap were administered and doesn't know if there is even an issue. Next time the caller will just email someone at controllant because controllant are on top of it. No further information provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.  Follow-up (11May2022): 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.
Information has been received regarding a legal case from a physician concerning a 61 year old female with a codeine allergy who on 17-APR-2006 was vaccinated with a 0.5 mL dose of MMR II. Concomitant therapy included ZOLOFT, STRATTERA, LEVOXYL and lisinopril-HCTZ (manufacturer unknown). On 03-MAY-2006 the patient developed measles. Unspecified medical attention was sought. There were no laboratory diagnostic tests performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
back is injured after getting the covid vaccine/twisted her back; pain; This is a spontaneous report from a contactable consumer or other non hcp received from a Pfizer (Patient, reported for self). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date: not reported), via an unspecified route of administration on an unspecified date in Jan2021 as Dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got first covax 3 weeks ago and then twisted her back last night (on 07Feb2021) and patient was asking if she can take an advil for the pain. The patient was to get the second covax today. Outcome of the events were unknown  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Facial numbness and tingling, total loss of taste, appetite, and smell, muscle pain, nausea, increased temperature, irritability, dried mouth Note: I was COVID positive back in December 2020, and I by the time I got the vaccine I was fully recovered, so there was no chance for Iris infection  Vaccine date: 02-12-2021
No adverse effects.; a 12 month 13 day old patient was administered an expired dose of MMR II.; Information has been received from a nurse referring to a 12 month 13 day old unknown gender patient. Information about pertinent medical history and drug reactions/allergies was not reported. The concomitant medications included Sterile Diluent.  On 25-MAR-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot #:N009799, therapy type: Albumin status rHA (recombinant Human albumin), Expiration date: 24-MAR-2019, dose, frequency, route were not reported) for prophylaxis(expired product administered). No adverse effects.
Pt received Fluzone on 10/11/00. Presented to clinic with diarrhea, hematoemesis and was admitted on 10/12/00 to hospital with suspicion and subsequent dx of C. Difficile colitis. Pt subsequently, developed acute severe hypercarbic respiratory failure after several days of pulmonary edema. On 11/14/00, suspects respiratory failure from possible muscle weakness. Possible Guillain-barre, however, CSF on 11/14/00, revealed normal protein suggesting that Guillain-Barre is not an etiology of the respiratory failure.
Received DTaP on 5/1/06. Mom noticed redness and swelling at site on 5/2/06 before bedtime. Seen on 5/3/06 right thigh swollen with pinkish rash.
I am questioning new onset of generalized edema, no history of this prior to vaccine; I am uncertain if this could be related as no known cause yet identified. Is there any other reports of this?
Fever chills severe body aches and joint aches severe headache diarrhea nausea abdominal pain severe fatigue some mild chest pain
Full body ache, Fever that lasted 2 days(took ibuprofen), general malaise, 5day length in total. Contracted a upper respiratory bug and sought  care from medical professional and just took OTC med, no prescription Also, had a case of hives and took Claritin Currently only slight cold remains.
Less than 24 hours post dose a red rash started.  Intitally the rash only covered a small area, approximately 2inch square.  The rash has spread  to approximately a 6inch x 3inch area and continues to be hot to the touch,  it feels  like the area of the rash is burning and tingling
Case number PHHY2013US042539 is an initial literature report received on 26 Apr 2013: The author in this article investigated the use of eculizumab a therapeutic monoclonal IgG that neutralizes the complement protein C5 in neuromyelitis optica spectrum disorders. An open label pilot study was conducted to investigate the same and the patients who were AQP4-IgG-seropositive, aged at least 18 years, had a neuromyelitis optica spectrum disorder and had at least two attacks in the preceding 6 months or three in the previous 12 months were recruited into the study. The patients received meningococcal vaccine at a screening visit and 2 weeks later began eculizumab treatment. This report refers to an adult female patient. The patient received MENVEO (batch number: not reported) on an unknown date. Despite tetravalent meningococcal vaccination two weeks before the first eculizumab infusion, this patient developed meningococcal septicaemia and sterile meningitis, but responded readily to antibiotic treatment (unspecified). The authors concluded that she was unprotected to the specific serotype, because it could not be classified into a group and the vaccine protects against only serotypes A, C, W-135, and Y. The seriousness and outcome of the events were not reported.
Information has been received from a pharmacist concerning a 62 year old female patient with a drug reaction/allergy to erythromycin who in 2009 was vaccinated with a dose of ZOSTAVAX (Merck) (route, site and lot number not reported). The pharmacist reported that the patient experienced hearing loss 24 hours after receiving the ZOSTAVAX (Merck), two year ago, in approximately 2009. The patient sought medical attention by office visit. The patient was treated by her physician with "high-dose prednisone" but the dosage and duration of therapy were unknown. It was reported that the patient added that her physician felt the hearing loss was unrelated to therapy with ZOSTAVAX (Merck). Upon internal review hearing loss was considered to be an other important medical event. No further information is available.
Patient received his vaccine on Tuesday, by Wednesday early evening he presented with low energy, but otherwise good spirits.  By 7pm when his temp was taken he had a 104.7 degree temp.  Cognitives were good, mood was good.  Dose of Children's 10ml (320mg) Tylenol at 7pm and again at 12am (Thursday Morning).  Thursday 7:30am Morning temp rested at 103.5.  Another dose of Children's 10ml Tylenol (320mg) at 7:30am and fever began to wane over the course of the day.  Again Children's 10ml Tylenol  (320mg) at Thursday 4pm temp was 102.6.    At 9pm on Thursday patient's voice started to become raspy, but was still in good mood.  Again, Children's 10ml Tylenol (320mg) at 12am (Friday).  Friday Morning 7:30am  temp was resting at 99.0, however patient was having a hard time breathing and his voice was significantly worse.  Patient presented with a dry cough and difficulty catching breath.  The cough was like Croup, deep in chest, and reverberated through esophagus.    He was given another does of Children's 10ml Tylenol  (320mg) Friday at 7:30am, and a 5ml of Infant Ibuprofen (200mg) for throat swelling, and one dose of Albuterol Inhaler (90 mcg) to alleviate difficulty breathing.  We then practiced breathing exercises to calm him down, which worked fairly well.  His coughing subsided, and we administered 5ml Children's Cough DM (30mg dextramethorphan hydrobromide) to suppress coughing.  By 2:15pm (now) his voice has started to come back, but is still raspy and he feels better.
tingling in fingers approx 5 minutes after injection which resolved approximately 2 minutes later.  At 0954, complaint of feeling "clammy", 1001 states feeling "weak" overall, denies lightheadedness, dizziness while sitting up on cart with HOB elevated.  At 1011 no complaints and discharged from care.
Large local reaction left deltoid and upper arm by 4/10 - 10 x 13cm red, swollen, tender. No systemic sxes.