chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contacted patient to inform him/her of an issue that was discovered on the date of this patient?s covid vaccination  It was determined that this patient received a dose of the vaccine from a vial that was beyond the 12 hr post puncture time limit but within the expiration date of the product. No temperature excursion occurred. Pfizer, the manufacturer was contacted on 4/20/22 to inquire about the stability of the vaccine after more than 12 hrs post puncture.  The only relevant point to the 12 page information sent by Pfizer was with ?microbiological risk to be considered when using vaccine in vials punctured for longer than 12 hrs.?  This is a theoretical risk of this microbiological risk of decreased efficacy but this risk has not been scientifically proven or even evaluated.   This information was reviewed with 2 office physicians.  There was no consensus (as the risk has not been scientifically proven or even evaluated) that revaccination is needed.  Physicians advised that this is a case of shared decision making with the patient and that it would ultimately be patient preference once presented with this information.  If patient chose to be revaccinated the advice from one of the physicians was  to wait 5 days from previous vaccination, as that is the guidance to someone who is covid + and has not been vaccinated.  Once a person is out of quarantine, they are urged to get vaccinated right after that even though they have some antibodies from the resolved infection. Presented information to patient as above in very simple terms.   Patient asked questions about potential for waiting a few months. I indicated this would not be considered a revaccination as it is separate timeframe from this vaccination and we do not know if/when additional boosters might be needed within that timeframe.  I apologized for this experience and advised that we have instituted new practices to ensure that the discarding of the vaccines occurs promptly at the 12 hr mark to prevent any future occurrences. Patient was thankful for the notification and information. Patient does not wish revaccination at this time. No illnesses reported since incident; no reported side effects since vaccination.
On day 7 after vaccine a red rash ( dotted spots like pimples) developed at vaccine site covering Approx 4" in diameter.  The next day the whole area turned into one large red spot approx. 4" in diameter.   There is an itch and slight swelling with slight pain.  Also warm to the touch.
Swelling of tongue & tongue felt burned x 15hrs. BB sized lump on lt 4th digit-onset 4/15/21.
Pt started running temp 103 deg at 7 pm day of vaccinations. At 2 am on 2/25/04, temp same and pt developed fine red rash on back. On 2/26/04 temp 104 at 3 an. Pt mo. notified us of s+s on 2/26/04. She also reported sxs to PMD who suspects viral infection to carry child to PMD if temperature spikes again per PMD recommendation. Mo. reports she has given Tylenol since shots were given. Mo. denies hives or respiratory problems.
Client became anxious and unconscious x3 seconds in the observation area after vaccination of Pfizer.  MD assessed client on site and no injuries noted. Client left site with father driving him home via personal vehicle.
Fever, chills, body aches, headache. Fever, chills and aches lasted 24hrs. Headache 48hours
flu-like symptoms; could not move for 12-14 hours; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient felt flu like symptoms such that he could not move for 12 to 14 hours. The symptoms were resolved.  The reporter did not have any further details. This is 1 of 3 cases reported by the same reporter for different patients. The outcome of influenza-like symptoms was reported as recovered/resolved in the Argus however in source document, it was mentioned as recovered/resolved with sequel.
This spontaneous report as received from a nurse refers to a patients of unknown age. The nurse assumed that since 03-JUL-2014, the patients received ROTATEQ (lot no, route not reported). There was no concomitant medication. The nurse reported about temperature excursions, with first excursion was on 03-JUL-2014. The worst case temperature was 0 Celsius and the total timeframe was 54 hours. ROTATEQ was one of the affected products. Other products involved were RECOMBIVAX HB, PNEUMOVAX 23 (single dose) and GARDASIL and M-M-R II. Excursion was supported. No patient concerns or effects were reported to office post administration of these vaccines. The patients did not seek medical attention. Product quality complaint was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Coughing and stuff; Coming down with bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing and stuff) and BRONCHITIS (Coming down with bronchitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (Coughing and hacking with past infections and the bronchitis usually lasted for two weeks.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced COUGH (Coughing and stuff) and BRONCHITIS (Coming down with bronchitis). At the time of the report, COUGH (Coughing and stuff) and BRONCHITIS (Coming down with bronchitis) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Severe headache, chills, fever, muscle pain and nausea causing dehydration with both first and second shots
Nurse inadvertently gave Pfizer Covid 19 vaccine dose that was beyond 6 hours from dilution. Client will be notified to return for repeat dose.
I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt unwell / sick for 6 days.  My joints were extremely sore in my back, ankles and wrists.  My body felt heavy and it was hard to stand and walk. It felt as if I was losing circulation in my feet. By 5PM each day I was in bed passing out for about 2 hours each day. Most of each day on couch sick. On day 5, I broke out in hives on my face.  All symptoms began to clear on day 7. I was almost feeling normal Apr 28. Today, Apr 29 I feel OK.
Patient fainted about 5 minutes after receiving vaccination.  Patient was in shot room and watched brother take his vaccination.  Patient became light headed and woozy and fainted.  He did not hit his head on anything.  He reported a minor headache.
Information has been received from a licensed practitioner nurse referring to a female patient of unknown age. On 20-JUL-2015, the patient was vaccinated with first dose of GARDASIL (0.5 ml, once, lot #: K008931, expiry: 04-MAR-2017). On 25-DEC-2015 the patient was vaccinated with second dose of GARDASIL (0.5 ml, once, lot #: L018286, expiry date: in April 2017) (extra dose administered). On 29-JAN-2016 (reported as "today"), the patient was in the office to receive the third dose of GARDASIL but the nurse did not give her the third dose yet. No adverse effects were reported. Additional information has been requested.
29SEP98 c/o severe h/a, crying w/pain;h/a lasted 2wk;localized reaction around inj site;mom called MD;
felt sick; dizzy/lightheaded; distraction/unease up to a week after; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt sick), DIZZINESS (dizzy/lightheaded), FEELING ABNORMAL (distraction/unease up to a week after) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 VACCINATION COMPLICATION (felt sick), DIZZINESS (dizzy/lightheaded), FEELING ABNORMAL (distraction/unease up to a week after) and PYREXIA (fever). At the time of the report, VACCINATION COMPLICATION (felt sick), DIZZINESS (dizzy/lightheaded), FEELING ABNORMAL (distraction/unease up to a week after) and PYREXIA (fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication details were provided. No treatment medication details were provided.   Reporter did not allow further contact
4/27/18 Local erythema and pruritus at site of vaccine. 4/30/18 seen for burning, itchy feet. Onset 4/28/18. Feet swollen. DX: Erythema multiforme.
Positive vesicular / papular rash with surrounding erythema diffusity. Zoster post exposure to VZV.
Covid-19 vaccine given to patient @ 4pm on 5/10/21.  Patient started to feel hot within the 15 minute observation period.  She claimed she felt well and left coming back to the pharmacy immediately explaining "something was not right."  She had trouble breathing, hives, facial swelling, throat swelling, itching, flushing, shortness of breath, chest tightness, throat tightness, anxiety and sweating as well as tachycardia.  911 was called. Epi-pen was provided as recommended by 911 dispatch and per pharmacy  Immunization protocol.  Fire team arrived and gave the patient O2 and monitored stats. Emergency team arrived and took her to the Emergency room,
I am shaking uncontrollably like I am cold; I am shaking uncontrollably like I am cold; I have a temperature of 100; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), FEELING COLD (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "I am shaking uncontrollably like I am cold"; PYREXIA (non-serious) with onset 16Nov2021, outcome "unknown", described as "I have a temperature of 100". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Nov2021)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.
every day changes the color of te redness, sometimes is more pink, somedays is more red.; itching; The injection site is 2-3 inches red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (every day changes the color of te redness, sometimes is more pink, somedays is more red.), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (The injection site is 2-3 inches red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin.) and Seasonal allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (every day changes the color of te redness, sometimes is more pink, somedays is more red.), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (The injection site is 2-3 inches red). At the time of the report, VACCINATION SITE DISCOLOURATION (every day changes the color of te redness, sometimes is more pink, somedays is more red.), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (The injection site is 2-3 inches red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Patient was advised to take BENADRYL for treatment, but she didn't wanted as she never takes anything.   Reporter did not allow further contact
102 Fever 32 Hours/Continued Dizziness Tired Light Headed Nausea Chills for 12 Hours Followed by Sweating Overall weakness Confusion.
Child receive 15mcg dose instead of 10mcg dose. Mother reports no side effects following vaccine.
Redness swelling at site of injection warm to touch. Mother reports applied ice pack to site and gave TYLENOL.
pt recvd vax 28JUN94 & pt exp aches & pains in the rt leg, swelling in the rt leg, heart racing & chills & presented to ER; No further details were provided;
Pt c/o urticaria, hives intermittent starting few days after receiving vaccine. Pt states her hives are gone today.
Myalgia enlarged lymph node by left elbow Narrative: Employee noted an enlarged lymph node on injection side (left) elbow; she has a h/o lupus and discussed with rheumatologist
Pain in armpit, swelling in the arm pit area with some swelling on side of breast, weakness in arm, pain in arm. Called clinic, told to take Tylenol and Motrin staggered, ice pack for swelling.
Patient came in for COVID vaccine - did not realize he was under 18 until after patient had already receive his dose, sat for 15 minutes, and had already left. No adverse events occurred.
Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed low grade temp, flushed face, fatigue, muscle stiffness, body aches hours following vaccine. Aches and fatigue continues and it?s now day 8. The fatigue is constant but comes in waves. I?m taking unexpected naps which are abnormal for me. Caffeine and methylphenidate are ineffective. I?m still sore. I also have brain fog, maybe from the fatigue. I can?t think straight and it takes me longer to process and do tasks. I woke up 2 hours ago and I can?t wait to sleep again.
Patient got faint, cold and clammy about five minutes after his vaccination and was visibly pale.  When we went to assist him he asked to lay on the floor, before we could help him to this position he fainted, we got him on the floor and on his side, within about twenty seconds he woke up and was very aware of his situation. We applied ice packs under his neck and on his forehead.  After about twenty minutes he sat up and started to gain his color back.  At this point he told us he had fainted before after a flu shot and and donating blood.  Several minutes later he was able to stand up and sit in a chair.  Cold packs were continued and he drank a bottle of orange juice.  Twenty minutes later he said he was back to normal just felt weak like after a work out.  He wanted to use the restroom and was escorted, showed no additional signs or symptoms at this point, and wanted to go home.
Chills, body ache, extremely tender arm, tiredness, insomnia, mental fatigue, weakness.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. No pertinent medical history was reported. On 06-MAR-2015, the patient was vaccinated with ROTATEQ vial, 1 vial, oral which was expired on 26-FEB-2015. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
An immunocompromised patient who had received 2 doses of Moderna, requested 3rd (booster) dose but received Pfizer COVID 19 vaccine instead
Hair loss, Significant hair fall that comes in sections when smoothed, brushed, washed; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17May2021 at 13:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. 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 COVID vaccine. On 23May2021, the patient experienced hair loss, significant hair fall that comes in sections when smoothed, brushed and washed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event hair loss was not recovered.   No follow up attempts are needed; information about lot/batch number cannot be obtained.
1032 S/p vaccination, client reports feelings of left side chest discomfort w/ no associated symptoms or complaints; Vitals assessed: BP 152/90  HR 81 O2sat 98%; medical monitoring x 30 min w/no additional complaints; denies any sob. 11:18 BP 136/90; "Feels better" post monitoring, released from facility w/ self.
got sick; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Pfizer-BioNTech COVID- 19 Vaccine EUA: On leaving the facility, vaccine recipient stated she was "fatigued, dizzy, and fell into the bike rack" on her way to the car. National Guard placed her in a wheelchair and offered water Patient stated she felt fine upstairs but felt overwhelmed by the time she was downstairs. Her skin was cool, clammy, and pale. She was talking slowly. EMS was called when she stated her top of mouth and tongue were swelling and tingly. She was having difficulty speaking at a regular rate and was extremely lethargic. EMS called via 911 and patient was transported to  Emergency Department. Patient was subsequently discharged to home from the emergency department.
Sore and raspy throat at 10:00 pm. Gargled with salt water.  By morning symptoms included a fever of 101.5, body aches, muscle weakness, inability to complete a sentence or think clearly, fatigue.
Expired vaccine used with no adverse event; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from the other health professional (Agency inbound US-SANOFI-00338223).  This case involves Adult male patient who had received expired HIB (PRP/T) VACCINE [ACT-HIB] Powder and solvent for solution for injection at a dose of 0.5 ml (lot number UI974AAA) via intramuscular route in the right thigh.  Medical history, medical treatments, concomitant medications and family history were not provided. It was a potential medication error due to Expired product administered.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA), MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) and INFLUENZA VACCINE (FLU) for Immunisation.  at the time of this report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mother brought her daughter in for flu vaccine put in schedule as a nurse visit. Dr. order vaccine and Nurse gave vaccine. The next day mom states she forgot that her daughter already had the flu vaccine and had a fever. RN spoke with mother. Mother gave Tylenol for fever.
Fever to 101.5, joint pain, body aches, swollen lymph nodes, migraine headache
PAIN IN LEFT ARM; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced pain in left arm. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in left arm, and nausea on 04-APR-2021. This report was non-serious.
Muscle at injection site is sore since vaccination (49 days ago at time of writing). Pain is triggered by a wide range of motions. Stretches help temporarily relieve the pain, but it always returns and the painless range of motion does not seem to be increasing.
The patient has been briefed that no conclusive studies have highlighted the adverse effect of mixing vaccines from different manufacturers for CoVid19.  The patient insisted that she does not have the privilege to be choosing vaccines. The client insisted that she would rather complete the inoculation for the virus than miss out on the opportunity.
None Stated. No adverse reaction.  VAERS form completed due to expired H1N1 vaccine given.
Information has been received from a registered nurse concerning a 7 year old female with recurrent ear infection who on 5/20/97 was vaccinated with a first dose of varicella virus vaccine live (lot # 622971/0420E), in the right anterior thigh. There was no illness at the time of vaccination. On 4/17/04 at 9:00 AM, the patient developed chicken pox. It was reported that the patient's mother had chicken pox, then child came down with them. The patient's mother reported to the doctor's office that the child had 15 pox and ran temperature of 100-101 for 2 days. The patient recovered. It was also reported that the patient's brother had a similar reaction (WAES0405USA02057). Additional information has been requested.
R arm. Site of injection became hard, swollen and very hot to touch. Rash all over body with high fever.