chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose; dose 3 (booster dose) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had a breakthrough covid-19 infection, she received a Pfizer booster dose the Friday before (on an unknown date in 2021) and she tested positive for COVID in Nov2021. The patient's symptoms are mild but she does not feel well and has a fever. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccine at 11:00 on 1/4 Slight headache that went away with tylenol at 15:00.  Woke up at 02:00 on 1/5 with extreme headache. nausea, muscle pain, joint pain, and high blood glucose of 270.  Took a tylenol at 02:00 and did not help. Was in so much pain went to ER. Was seen and sent home. went to sleep at 09:00 and when I woke at 14:00 I felt fine. Had headache, site injection pain and swelling for a few more days after.
At 3:39 pm client felt nauseous and dizzy. He drank some water. At 3:43 pm, his blood pressure was 110/78, oxygen saturations were 98%, and heart rate was 56. Felt better at 3:50 and left with someone else driving.
Injection is red and hard to touch.  Upper arm/shoulder is hard to touch as well.  ?Vaccine arm? without rash.
pt to ED with c/o nausea, vomiting, diarrhea, SOB; states was recently diagnosed with COVID; has been at home and is worsening; weakness and poor appetite; CXR showed pneumonia; tested positive for COVID; placed on BiPAP; decadron; DNR; pt's condition worsened; she refused ventilator; pt expired in the hospital
Dizziness; Rash on left arm; Fatigue; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), DIZZINESS (Dizziness), RASH (Rash on left arm) and FATIGUE (Fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Drug allergy (Dilaudid allergy) and Drug allergy (Levaquin allergy).    On 08-Apr-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 10-Apr-2021 at 11:00 PM, the patient experienced DIZZINESS (Dizziness), RASH (Rash on left arm) and FATIGUE (Fatigue). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), DIZZINESS (Dizziness), RASH (Rash on left arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (Dizziness), RASH (Rash on left arm) and FATIGUE (Fatigue) to be possibly related. No further causality assessment was provided for HYPERSENSITIVITY (Hypersensitivity reaction).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received on 25-MAY-2021. Patient's relevant medical history, vaccination details, event details were updated. It contains significant information. On 19-Jul-2021: Follow up received:  Route of administration and event added
After the infant received a DTap shot in his right leg, he developed a large, warm, red, swelling at the injection site that lasted for a week.
This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with PEDVAXHIB inj (dose, route, lot# were reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Within 24 hours after the vaccine his blood pressure escalated out of control, 200's over 100's . He went to see his PCP and cardiologist Nephrologist ended up in the hospital in February and his aortic graphic had broken loose and they felt it was because of the escalation of the blood pressure which the doctor felt was a possibility caused by the vaccine.  February 7 he was in the hospital for 4 days. On march 10 he went to the hospital to repair the aneurism that had broken loose, the doctor thought it could have broken loose from the hypertension of the blood pressure. He stayed in the hospital for 48 day and was transferred to a rehab center in anther hospital he was in the hospital for a total of 78 days . He came home on the 26 of May and had home health care, he also was ended up with  pneumonia. he came home on antibiotics . He ended up passing away yesterday, May 30th, 2021
Sore arm where vaccine was given 5 months ago.   Visible spot of vaccination noted .
-pt went for covid vax #1 on 9/23/21, next day (9/24), pt was standing at kitchen, left leg went numb & slid down to the floor   -within a few minutes he was up & walking - a few hrs later, speech slurred, couldn't walk & presented to hospital 9/25 -DIAGNOSED WITH CRYPTOGENIC STROKE
Muscle weakness, redness on arm below the injection site, warm to touch and rash located upper bicep, Muscle soreness affected my left shoulder to my neck, shiver, fever, tired and weak Injection on Thursday 8th July, 2021 - Today is Sunday 11th - Still have arm weakness, rash present, warm to touch, arm soreness
iST INJECTION  WEAK NAUSEA  RIDE CIRCLE UNDER INJECTION SITE LASTED ABOUT 4 DAYS TOOK WATER & TYLENOL   2ND INJECTION    WEAK NAUSEA DRY HEAVES EXTREME PAIN IN ALL JOINTS CHILLS  CIRCLE BELOW INJECTION SITE  UNABLE TO FUNCTION ON MY OWN  FOR 5 DAYS  WEAK AND NSUSEA LASTED 4 DAYS MORE  TOOK tYLENOL AS SUGGESTED BY STAFF WHEN RECEIVING INJECTION
Patient received Pneumovax 23 inj 0.5ml on her left deltoid IM. She came back this morning 10/12/17 and reported her deltoid muscle swollen.
Minor body aches and mind cloudiness starting 24 hours after and continuing 3 days. Then on 4th day began having right shoulder/ neck tightness, severe pain in neck and shoulder, burning sensation in muscle, numbness and tingling in arm and fingers, numerous ER and Urgent Care visits with no relief from pain medication, muscle relaxer, heat, ice, topical creams. Continued muscle spasms and debilitating pain with weakness and limited use of right arm. I have been in severe pain for 3 weeks and unable to work or complete daily tasks. Continued tests and exams have shown no injury.
I caught the COVID virus after being fully vaccinated. Two weeks and still testing positive for the virus.
I had tinnitus before, but it is substantially worse now.  It is loud and constant and is affecting my sleep as well due to the excess noise.
Pt received abx. on 6/9, episode hives and difficulty breathing on 6/12 AM. Took otc Benadryl X 3 with symptom relief no in office. Treatment related.
I have the covid, and I have Pfizer covid shots, the vaccine; I have the covid, and I have Pfizer covid shots, the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have the covid, and I have Pfizer covid shots, the vaccine". Additional information: Serious was reported No.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The next day body aches and low grade fever, flu like symptoms and extremely tired, along with arm pain. Participant are on no medicines.
Patient received second dose of Pfizer vaccine.  Vaccine expiration time 0930 on 5/12/2021. Patient received vaccine on 5/12/2021 at 0936. MD made aware.  No harm to patient or adverse reactions.
breakthrough seizure lasting significantly longer than normal (20 minute episode vs 20-30 seconds for typical, twice daily episodes) requiring hospitalization
Pain the arm; Pain in hip an knees; Pain in the left side/Pain stronger in the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain the arm), ARTHRALGIA (Pain in hip an knees) and VACCINATION SITE PAIN (Pain in the left side/Pain stronger in the injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History Reported).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain the arm), ARTHRALGIA (Pain in hip an knees) and VACCINATION SITE PAIN (Pain in the left side/Pain stronger in the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain the arm) had not resolved and ARTHRALGIA (Pain in hip an knees) and VACCINATION SITE PAIN (Pain in the left side/Pain stronger in the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt reports expierencing night sweats, mylagia, rigors and chills about 12 hours after vaccination.   This continued for 3 more days.  With Left arm vaccination site hot to touch red and swollen and stiff with induration of 3 to 4 inches above and below vaccination site.  Pt went to see private Doctor where rapid flu test was negative.
pt recv vax 26OCT95 & 28OCT95 devel swelling of lymph nodes @ the inj site;
Screaming for >3hrs.  Inconsolable.  Staring & poorly responsive.  By the next morning patient back to herself.
no adverse effects; patient received two (2) doses of PNEUMOVAX 23 on 5/10/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 10-MAY-2019, the patient was vaccinated with two doses of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot# R022249, expiration date 16-APR-2020 (exact doses and site of administration were not reported) for prophylaxis. No adverse effects were reported.
red spots; skin has been itchy; This case was reported by a consumer and described the occurrence of red spotty rash in a 56-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles a couple of years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced red spotty rash and pruritus. On an unknown date, the outcome of the red spotty rash and pruritus were unknown.   It was unknown if the reporter considered the red spotty rash and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingles vaccine to prevent reoccurrence of shingles and experienced her skin had been itchy of late with red spots appearing. The patient's mother was a nurse and she thought the patient should go to urgent care. The reporter asked would GlaxoSmithKline concur. The reporter did not know which shingles shot she received. She said it was only one shot that she had (not 2) and it was about 2-3 years ago and it was after a shingles outbreak. The reporter gave GlaxoSmithKline safety permission to contact her general practitioner to confirm if she received Shingrix in the past. The reporter consented to follow-up.
Born during Covid have not spoken a word at this time/ the only word they say is "da-da"; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da") in an infant male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Ear infection (ear infection twice already but still not labelled as chronic), Maternal exposure during pregnancy and Exposure via semen.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On an unknown date, 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 experienced SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da"). At the time of the report, SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da") outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   This case was considered for the first grandson.  No concomitant and treatment medications were reported.  Caller finds it odd that both of the grandsons who were born during Covid have not spoken a word at this time, the only word they hear is "da-da".  Caller stated that they were unsure if the grandsons were given Moderna Covid-19 vaccines already. Caller stated that this could also be natural but they wanted to know if there's been research regarding the possibility of this condition being caused by the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-722092 (E2B Linked Report). This case was linked to MOD-2023-722090 (Parent-Child Link).   See case MOD-2023-722090 for details regarding the child case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722092:Case for Mother of 1st grandson
LA warm and red 24 hr after shot x 48 hr. Treated with Tylenol and ibuprofen. Watched for infection. Dr notified.
Upper arm swells, large red patch develops and itches like crazy.  Itching goes underarm near armpit also.  Skin is hot
This spontaneous report was received from a pharmacist and refers to a 69 year old male patient. The patient's medical history was not reported. Historical drugs included PREVNAR 13. Concomitant therapies and medical history was not reported. On 21-NOV-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N013521, expiration date 23-JAN-2019, dose information not reported) intramuscularly. On 01-DEC-2018 (reported as 10 days after being vaccinated), the patient developed sore arm. He sought medical attention as he went to the pharmacy, where he also reported that his arm was sore from his shoulder to his wrist. No more information was provided. The causality between the vaccine and the event was not provided.
Lost use of legs after first dose of the Covid Vaccine; Very weak after first dose of the Covid Vaccine; She couldn't do anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6208) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 1997, reaction(s): "Hives". The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lost use of legs after first dose of the Covid Vaccine"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Very weak after first dose of the Covid Vaccine"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "She couldn't do anything". The events "lost use of legs after first dose of the covid vaccine", "very weak after first dose of the covid vaccine" and "she couldn't do anything" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter states that patient has received both doses of the Covid Vaccine. reporter says patient had no symptoms before the vaccines.  patient  was gardening and mowing the lawn.Towards end of call reporter mentions that her doctor got her in for an appointment quickly since the reporter could hardly walk and had so much trouble comprehending and focusing.  States patient was focusing better. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Rash (raised, warm, itchy) below injection site noticed about a week after vaccine. Today (2/22/21) 2 raised itchy bumps in palm of right hand.
DID NOT REFRIGERATE VIVOTIF FOR TWO MONTHS AND TOOK TWO DOSES FROM IT; This spontaneous case report (PVX2019-2906) was received from a consumer on 25-Nov-2019. It described a female consumer who "did not refrigerate Vivotif for two months and took two doses from it" (PT: Product storage error). She was receiving Vivotif (lot number: 3003297 and expiry date: Sep 2020) for an unknown indication.  Case report: The consumer did not know Vivotif doses had to be refrigerated and she took first two doses on 23-Nov-2019 and 25-Nov-2019 respectively. Later, she noticed Vivotif need to be refrigerated. Thus, she wanted a replacement.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not refrigerate Vivotif for two months and took two doses from it" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not refrigerate Vivotif for two months and took two doses from it" was considered as not applicable.
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 13 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 13-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Information has been received from the patient's mother concerning her 20 year old daughter with bronchial problems developed when she was on her teens and amoxicillin allergy who in approximately August 2007 was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapy included albuterol. It was reported that on 05-AUG-2009 the patient was diagnosed of having "abnormal cells". The patient sought medical attention with the physician. On an unspecified date a biopsy was performed. It was reported that the mother called to check if the patient could still continue with GARDASIL series and if it was safe for the patient to get the second dose. It was reported that the vaccine was not reintroduced. The outcome of the patient was unknown. No further information is available.
Within 3 minutes got headache, arm pain, nausea, and dizzy.  Fatigue set in approximately 1 hour later and was severe for 2 days.  Still have fatigue  6 days later.  Nausea and dizziness stopped after 24 hours.  Headache and arm pain took 4 days to resolve getting better each day.  Fatigue is diminishing but very slowly.
After receiving an injection of GARDASIL, she had a syncopal episode, followed by myoclonic jerks.
Body aches, chills and joint and muscle pain started about 12 hours post injection. Fever between 102 and 103 for the next two days. Treated symptoms with ibuprofen.
Initial report received on 10/Aug/2006 from a physician. A four-month old male patient, with no past medical history, had received a second dose, right thigh injection of Daptacel, lot number C2432AA; a second dose, right thigh injection of IPOL, lot number not reported; a second dose, left thigh injection of Prevnar, manufacturer reported, lot number B086828; on 07/Aug/2006. The patient had also received a prior dose of Recombivax HB, manufacturer reported, lot number not reported, on 07/Jul/2006. Per the reporter, the "patient received Daptacel and IPOL in the right thigh and approximately 48 hours later it was reported to the doctor that the leg appears mottled and is swollen." Upon exam by the physician,"it appears as there was older bruising and some burst capillaries at the site." It was additionally reported by a physician, on 11/Aug/2006, that the patient had presented with marked, inconsolable fussiness, a nodule at the Daptacel injection site and numerous small purple lesions from pin to pea size on the anterior and posterior injected limb. The patient subsequently developed a similar lesion on the contralateral limb raising concern for a systemic or vasculitic process. However, the patient was afebrile and did not appear systemically ill. He was referred to an infectious disease specialist for evaluation. At the time of this report the patient had not recovered.
10/13/2021 chills, headache; 10/14/2021 severe neck pain and stiffness, chest discomfort with intermittent palpitations lasting for hours, generalized itching, fatigue; 10/15/2021 localized itching below site itching.